Pregabalin: A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
pregabalin : A gamma-amino acid that is gamma-aminobutyric acid (GABA) carrying an isobutyl substitutent at the beta-position (the S-enantiomer). Binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]
| ID Source | ID |
|---|---|
| PubMed CID | 5486971 |
| CHEMBL ID | 1059 |
| CHEBI ID | 64356 |
| SCHEMBL ID | 8227 |
| MeSH ID | M0214473 |
| Synonym |
|---|
| AC-1158 |
| pregabalin sandoz |
| pregabalin zentiva |
| ynp-1807 |
| vronogabic |
| pregabalin sandoz gmbh |
| CHEMBL1059 , |
| pregabalin mylan |
| chebi:64356 , |
| nsc-759256 |
| lyrica |
| pd-144723 |
| ci-1008 |
| pregabalin |
| 148553-50-8 |
| pregabalin (jan/usan/inn) |
| lyrica (tn) |
| D02716 |
| (r-)-3-isobutyl gaba |
| ci 1008 |
| (s)-3-(aminomethyl)-5-methylhexanoic acid |
| pregabalin [usan] |
| pd 144723 |
| hexanoic acid, 3-(aminomethyl)-5-methyl-, (3s)- |
| (s+)-3-isobutyl gaba |
| (s)-3-isobutyl gaba |
| DB00230 |
| 3-isobutyl gaba |
| pregablin |
| 121GE001 |
| bdbm50164279 |
| (s)-3-aminomethyl-5-methyl-hexanoic acid |
| AKOS005145504 |
| (3s)-3-(aminomethyl)-5-methylhexanoic acid |
| A808784 |
| cas-148553-50-8 |
| tox21_111475 |
| dtxcid9025950 |
| dtxsid1045950 , |
| HY-17414 |
| CS-1247 |
| pregabalin [usan:inn:ban:jan] |
| nsc 759256 |
| 55jg375s6m , |
| hsdb 7530 |
| unii-55jg375s6m |
| dea no. 2782 |
| NCGC00346738-01 |
| AM20080369 |
| pregabalin [ema epar] |
| pregabalin [ep monograph] |
| pregabalin [usp monograph] |
| pregabalin [jan] |
| pregabalin [inn] |
| pregabalin [vandf] |
| pregabalin [orange book] |
| pregabalin [mart.] |
| pregabalin [hsdb] |
| lyrica cr |
| pregabalin [usp-rs] |
| pregabalin mylan pharma |
| pregabalin [who-dd] |
| pregabalin [mi] |
| gtpl5484 |
| (s)-pregabalin |
| nervalin |
| CCG-221247 |
| AKOS001476611 |
| (s)-3-aminomethyl-5-methylhexanoic acid |
| (s)-3-(aminomethyl)-5-methylhexanoicacid |
| (s)-(+)-4-amino-3-(2-methylpropyl)butanoic acid |
| (s)-(+)-3-aminomethyl-5-methylhexanoic acid |
| SCHEMBL8227 |
| pd144723 , |
| AB01563007_01 |
| hexanoic acid, 3-(aminomethyl)-5-ethyl-, (3s)- |
| gaba, 3-isobutyl |
| 3 isobutyl gaba |
| KS-5378 |
| sr-01000942257 |
| SR-01000942257-2 |
| pregabalin, >=97% (nmr) |
| pregabalin, europepharmacopoeia (ep) reference standard |
| pregabalin 1.0 mg/ml in methanol |
| HMS3715J16 |
| lyrica;ci-1008;pd-144723 |
| (3s)-3-(aminomethyl)-5-methyl hexanoic acid |
| Q412174 |
| 1414928-41-8 |
| pregabalin- bio-x |
| BP163672 |
| pregabaline |
| pregabalina |
| P2840 |
| pregabalin (mart.) |
| pregabalin extended release |
| pregabalin (usp monograph) |
| pregabalin (ep monograph) |
| n03ax16 |
| pregabalinum |
| pregabalin capsules, cv |
| (3s)-3-(aminomethyl)-5-methylhexanoic acid |
| pregabalin (usp-rs) |
| pregabalin, 1mg/ml in methanol |
Pregabalin, in doses of 150-600 mg/day, was a safe and effective treatment of generalised anxiety disorder in patients 65 years and older. The rate of adverse events (sleepiness, dizziness, and headache) was insignificantly higher.
Pregabalin is a second-generation antiepileptic drug (AED) developed after gabapentin. The pharmacokinetic disposition of pregabalin was changed in the association with amitriptyline.
| Excerpt | Reference | Relevance |
|---|---|---|
| " Pregabalin pharmacokinetic parameters were evaluated by established noncompartmental methods." | ( Pharmacokinetics of pregabalin in subjects with various degrees of renal function. Alvey, CW; Bockbrader, HN; Cook, JA; Posvar, EL; Randinitis, EJ; Sedman, AJ, 2003) | 0.32 |
| " Likewise, PGB steady-state pharmacokinetic parameter values were similar among patients receiving CBZ, PHT, LTG, or VPA and, in general, were similar to those observed historically in healthy subjects receiving PGB alone." | ( Pregabalin drug interaction studies: lack of effect on the pharmacokinetics of carbamazepine, phenytoin, lamotrigine, and valproate in patients with partial epilepsy. Alvey, CW; Bockbrader, HN; Brodie, MJ; Bron, NJ; Gibson, GL; Hounslow, NJ; Posvar, EL; Randinitis, EJ; Wesche, DL; Wilson, EA, 2005) | 0.33 |
| " For drugs that are eliminated renally completely unchanged (gabapentin, pregabalin and vigabatrin) or mainly unchanged (levetiracetam and topiramate), the pharmacokinetic variability is less pronounced and more predictable." | ( Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed? Johannessen, SI; Tomson, T, 2006) | 0.33 |
| " The focus of this study was to determine the influence of sildenafil on the pharmacokinetics (PK) of pregabalin with the objective of informing the design of a quantitative pharmacodynamic (PD) study." | ( Population pharmacokinetic model of the pregabalin-sildenafil interaction in rats: application of simulation to preclinical PK-PD study design. Bender, G; Bies, R; Danhof, M; DeJongh, J; Field, M; Florian, J; Gosset, J; Marshall, S; Tan, K, 2009) | 0.35 |
| " Noncompartmental analysis was used to estimate pharmacokinetic variables." | ( Pharmacokinetics of single-dose oral pregabalin administration in normal dogs. Badgley, BL; Dewey, CW; Gleed, RD; Horne, W; Ludders, JW; Salazar, V; Schwark, W, 2009) | 0.35 |
| " The median (range) pharmacokinetic parameters were: Area under the curve from time 0 to 36 hours = 81." | ( Pharmacokinetics of single-dose oral pregabalin administration in normal dogs. Badgley, BL; Dewey, CW; Gleed, RD; Horne, W; Ludders, JW; Salazar, V; Schwark, W, 2009) | 0.35 |
| " Pregabalin elimination half-life is approximately 6 hours and steady state is achieved within 1 to 2 days of repeated administration." | ( Clinical pharmacokinetics of pregabalin in healthy volunteers. Alvey, CW; Bockbrader, HN; Boyd, RA; Busch, JA; Corrigan, BW; Haig, GM; Posvar, EL; Radulovic, LL; Randinitis, EJ; Strand, JC; Wesche, DL, 2010) | 0.36 |
| "Pregabalin and gabapentin share a similar mechanism of action, inhibiting calcium influx and subsequent release of excitatory neurotransmitters; however, the compounds differ in their pharmacokinetic and pharmacodynamic characteristics." | ( A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Bockbrader, HN; Burger, P; Chapel, S; Janiczek, N; Miller, R; Wesche, D, 2010) | 0.36 |
| " The aim of this study was to develop a population pharmacokinetic model and quantify the influence of covariates on the parameters." | ( Population pharmacokinetics of pregabalin in healthy subjects and patients with post-herpetic neuralgia or diabetic peripheral neuropathy. Bockbrader, HN; Matsui, S; Shoji, S; Suzuki, M; Tomono, Y, 2011) | 0.37 |
| "This pregabalin population pharmacokinetic analysis was conducted on data from 14 clinical trials involving healthy subjects, subjects with impaired renal function and patients with post-herpetic neuralgia or diabetic peripheral neuropathy (n= 616)." | ( Population pharmacokinetics of pregabalin in healthy subjects and patients with post-herpetic neuralgia or diabetic peripheral neuropathy. Bockbrader, HN; Matsui, S; Shoji, S; Suzuki, M; Tomono, Y, 2011) | 0.37 |
| " To evaluate if pregabalin coadministration affects pharmacokinetics of other antiepileptic drugs, population pharmacokinetic analyses using NONMEM software were performed on data from three epilepsy trials involving seven antiepileptic drugs with pregabalin as add-on therapy." | ( Pregabalin effect on steady-state pharmacokinetics of carbamazepine, lamotrigine, phenobarbital, phenytoin, topiramate, valproate, and tiagabine. Bockbrader, HN; Burger, P; Knapp, L, 2011) | 0.37 |
| " Two different gabapentin to pregabalin transition designs were simulated based on their respective population pharmacokinetic profiles." | ( Gabapentin to pregabalin therapy transition: a pharmacokinetic simulation. Bockbrader, HN; Budhwani, MN; Wesche, DL, 2013) | 0.39 |
| "Pregabalin , the S-enantiomer of 3-aminomethyl-5-methylhaxanoic acid, is a second-generation antiepileptic drug (AED) developed after gabapentin with improved pharmacokinetic and pharmacodynamics properties." | ( Pharmacokinetic and pharmacodynamic profile of pregabalin and its role in the treatment of epilepsy. Schulze-Bonhage, A, 2013) | 0.39 |
| " The article also looks at its clinical application as a combination therapy with particular respect to its pharmacokinetic profile." | ( Pharmacokinetic and pharmacodynamic profile of pregabalin and its role in the treatment of epilepsy. Schulze-Bonhage, A, 2013) | 0.39 |
| "This review aims to analyze pharmacokinetic profile, plasma level variations so as the metabolism, interactions and possible relation to clinical effect of several drugs which are used primarily as anxiolytics." | ( Understanding the pharmacokinetics of anxiolytic drugs. Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013) | 0.39 |
| "There is a need for a more balanced assessment of the benefits and risks associated with benzodiazepine use, particularly considering pharmacokinetic profile of the drugs to ensure that patients, who would truly benefit from these agents, are not denied appropriate treatment." | ( Understanding the pharmacokinetics of anxiolytic drugs. Altamura, AC; Bareggi, S; Maffini, M; Mauri, MC; Moliterno, D; Paletta, S, 2013) | 0.39 |
| " Pharmacokinetic variables were estimated by means of noncompartmental analysis." | ( Pharmacokinetics of single-dose intragastric and intravenous pregabalin administration in clinically normal horses. Divers, TJ; Mullen, KR; Schwark, W, 2013) | 0.39 |
| "The pharmacokinetic properties of the immediate-release (IR) and the recently developed controlled-release (CR) formulation of pregabalin are dose proportional." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| " The objectives of this analysis were: (1) to evaluate the effect of administration time and fat or caloric content of an accompanying meal on the pharmacokinetic properties of a single dose of pregabalin CR (330 mg) relative to a single dose of pregabalin IR (300 mg); (2) to evaluate the pharmacokinetic properties of a single dose of pregabalin CR administered fasted relative to a single dose of pregabalin CR administered immediately after food; and (3) to determine the safety and tolerability of single-dose administration of pregabalin CR and IR with and without food." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| "The effect of food on the pharmacokinetic properties of pregabalin CR was determined in five phase I, open-label, single-dose, crossover studies (24-28 participants/study)." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| "Time of day of administration and the fat and caloric content of the accompanying meal had minimal overall effect on the pharmacokinetic properties and bioavailability of the pregabalin CR formulation." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| "The pharmacokinetic properties of pregabalin CR were determined in four phase I, open-label, multiple-dose crossover studies (18-24 participants/study)." | ( Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| " Pregabalin CR pharmacokinetic parameters were dose proportional following administration of 82." | ( Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| " Pharmacokinetic parameters were estimated from concentration-time data using standard noncompartmental methods." | ( Effect of the gastrointestinal prokinetic agent erythromycin on the pharmacokinetics of pregabalin controlled-release in healthy individuals: a phase I, randomized crossover trial. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2015) | 0.42 |
| " To validate the pharmacodynamic biomarkers for GABA-ergic anxiolytics, this study determined the pharmacodynamics of two anxiolytics and a nonanxiolytic control, and linked them to their anxiolytic and sedative effects, during an anxiety-challenge study day." | ( Pharmacodynamic response profiles of anxiolytic and sedative drugs. Baas, J; Broeyer, F; Chen, X; Cohen, A; de Kam, M; van Gerven, J, 2017) | 0.46 |
| " Thus, the potential influence of anxiety on CNS pharmacodynamic markers could be examined." | ( Pharmacodynamic response profiles of anxiolytic and sedative drugs. Baas, J; Broeyer, F; Chen, X; Cohen, A; de Kam, M; van Gerven, J, 2017) | 0.46 |
| " Areas covered: We describe the pharmacokinetic properties of pregabalin and their implications for the treatment of GAD." | ( Pharmacokinetic evaluation of pregabalin for the treatment of generalized anxiety disorder. Buoli, M; Caldiroli, A; Serati, M, 2017) | 0.46 |
| " The method is suitable for routine pharmacokinetic analysis and therapeutic monitoring of PGB." | ( An Improved LC-ESI-MS/MS Method to Quantify Pregabalin in Human Plasma and Dry Plasma Spot for Therapeutic Monitoring and Pharmacokinetic Applications. Chilkoti, DC; Dwivedi, J; Namdev, KK; Sharma, S; Verma, S, 2018) | 0.48 |
| "Combination therapy of pregabalin and tramadol is used to treat chronic neuropathic pain; however, the pharmacokinetic (PK) interactions of these drugs has not been studied." | ( A pharmacokinetic drug-drug interaction study between pregabalin and tramadol in healthy volunteers. Cho, JY; Chung, JY; Im, G; Kim, Y; Lee, JJS; Lee, S; Yoon, S, 2018) | 0.48 |
| " In this study, the pharmacokinetic interaction between pregabalin and thioctic acid was investigated at steady state." | ( Lack of a Clinically Significant Pharmacokinetic Interaction Between Pregabalin and Thioctic Acid in Healthy Volunteers. Ahn, LY; Lee, H; Lim, KS; Rhee, SJ; Yu, KS, 2018) | 0.48 |
| " Pharmacokinetic parameters were calculated by using noncompartmental analysis methods." | ( Lack of a Clinically Significant Pharmacokinetic Interaction Between Pregabalin and Thioctic Acid in Healthy Volunteers. Ahn, LY; Lee, H; Lim, KS; Rhee, SJ; Yu, KS, 2018) | 0.48 |
| "The aim of this study was to evaluate the dose-proportional pharmacokinetic characteristics of pregabalin following the administration of GLA5PR GLARS-NF1 tablets (150, 300, 450, and 600 mg) in the fed state." | ( Dose-proportional pharmacokinetic properties of GLA5PR GLARS-NF1 controlled-release pregabalin in healthy Korean volunteers: a randomized, open, single-dose, parallel study. Jang, K; Jeon, JY; Kim, MG; Kim, TE; Shin, KH, 2018) | 0.48 |
| "A population pharmacokinetic (PK) model was developed to characterize the properties of pregabalin extended-release (ER) in healthy volunteers and was subsequently applied to patient data from efficacy/safety studies investigating pregabalin ER for postherpetic neuralgia, fibromyalgia, and partial-onset seizures." | ( Population Pharmacokinetics of Pregabalin Extended-Release in Healthy Volunteers and Patients With Postherpetic Neuralgia, Fibromyalgia, and Partial-Onset Seizures. Bockbrader, H; Chapel, S; Chew, M; Ma, G; Marshall, S; Xie, R, 2019) | 0.51 |
| " Serum and brain levels of antiepileptic drugs and cannabidiol were determined by using HPLC in order to ascertain any pharmacokinetic contribution to the observed behavioral effects." | ( Acute effect of cannabidiol on the activity of various novel antiepileptic drugs in the maximal electroshock- and 6 Hz-induced seizures in mice: Pharmacodynamic and pharmacokinetic studies. Nieoczym, D; Socała, K; Szafarz, M; Wlaź, P; Wyska, E, 2019) | 0.51 |
| "The physical properties of the TL tablets, including dissolution and swelling rates, were compared with those of the MM tablets and the pharmacokinetic parameters of the TL tablet were compared with those of an IR capsule in beagles and humans." | ( Development of a Novel Controlled-Release Tablet of Pregabalin: Formulation Variation and Pharmacokinetics in Dogs and Humans. Choi, HG; Kim, KH; Kwon, MC; Lee, JH; Lim, SH; Park, J; Park, JS; Shim, CR; Song, WH, 2020) | 0.56 |
| " For the pharmacokinetic study of the TL tablet, the beagles demonstrated absorption results similar to those of an IR capsule, whereas the humans demonstrated low total absorption compared with an IR capsule." | ( Development of a Novel Controlled-Release Tablet of Pregabalin: Formulation Variation and Pharmacokinetics in Dogs and Humans. Choi, HG; Kim, KH; Kwon, MC; Lee, JH; Lim, SH; Park, J; Park, JS; Shim, CR; Song, WH, 2020) | 0.56 |
| " This study used population pharmacokinetic (PK) and exposure-response (E-R) analyses from pooled pregabalin concentration and efficacy data to compare pregabalin exposure and E-R relationships in pediatric and adult patients with FOS, to support pediatric dosage recommendations." | ( Pregabalin Population Pharmacokinetic and Exposure-Response Analyses for Focal Onset Seizures in Children (4-16 years) and Adults, to Support Dose Recommendations in Children. Chan, PLS; Liu, J; Marshall, SF; McFadyen, L, 2021) | 0.62 |
| " Pharmacokinetic analysis of pregabalin or combination (pregabalin + amitriptyline or pregabalin + duloxetine) in the plasma were performed by ultraperformance liquid chromatography tandem mass spectrometry." | ( Investigation of the Combination of Pregabalin with Duloxetine or Amitriptyline on the Pharmacokinetics and Antiallodynic Effect During Neuropathic Pain in Rats. Barros, CM; Boralli, VB; Costa, LH; Galdino, G; Kawano, T; Placido, RV; Podesta, MHMC; Rodrigues, RF; Santos, RS, 2021) | 0.62 |
| "The pharmacokinetic disposition of pregabalin was changed in the association with amitriptyline, presenting a clearance reduction and consequently an increase in bioavailability." | ( Investigation of the Combination of Pregabalin with Duloxetine or Amitriptyline on the Pharmacokinetics and Antiallodynic Effect During Neuropathic Pain in Rats. Barros, CM; Boralli, VB; Costa, LH; Galdino, G; Kawano, T; Placido, RV; Podesta, MHMC; Rodrigues, RF; Santos, RS, 2021) | 0.62 |
| " This study aimed to compare the pharmacokinetics of pregabalin SR and immediate-release (IR) formulations after multiple oral doses and to assess the effect of food on the pharmacokinetic profile of the pregabalin SR formulation after a single dose in healthy individuals." | ( Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. An, T; Jang, SB; Jeon, JY; Kim, MG; Kim, S; Lee, SY; Lim, Y; Moon, SJ; Na, WS, 2021) | 0.62 |
| "Two clinical trials were conducted: a randomized, open-label, multiple-dose, 2-treatment, 2-period crossover study to evaluate the steady-state pharmacokinetic properties of SR treatment (pregabalin SR 300 mg once daily for 3 days) and IR treatment (pregabalin IR 150 mg twice daily for 3 days) under fed conditions and a randomized, open-label, single-dose, 2-treatment, 2-period, crossover study to evaluate the effect of food intake on the pharmacokinetic properties of the pregabalin SR formulation." | ( Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. An, T; Jang, SB; Jeon, JY; Kim, MG; Kim, S; Lee, SY; Lim, Y; Moon, SJ; Na, WS, 2021) | 0.62 |
| "Thirty-one individuals in the bioequivalence study and 23 in the food effect study completed the pharmacokinetic sampling." | ( Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. An, T; Jang, SB; Jeon, JY; Kim, MG; Kim, S; Lee, SY; Lim, Y; Moon, SJ; Na, WS, 2021) | 0.62 |
| " To design optimized PGB regimens for pediatric patients with varying degrees of RI and predict exposure to PGB, physiologically based pharmacokinetic (PBPK) models of PGB were developed and verified, and its disposition was simulated in the healthy population and adults with RI." | ( Development of Physiologically Based Pharmacokinetic Model for Pregabalin to Predict the Pharmacokinetics in Pediatric Patients with Renal Impairment and Adjust Dosage Regimens: PBPK Model of Pregabalin in Pediatric Patients with Renal Impairment. Chen, J; Guo, G; Huang, P; Ke, C; Lin, C; Wu, W; Ye, L; You, X, 2022) | 0.72 |
The preemptive analgesia regimen of pregabalin combined with celecoxib had positive effects on improving acute pain. The frequency and financial impact of potential drug-drug interactions (DDIs) and drug-condition interactions (DCIs) in patients with painful diabetic peripheral neuropath.
Pregabalin oral bioavailability is approximately 90% and is independent of dose and frequency of administration. The absolute bioavailability of gabapentin drops from 60% to 33% as the dosage increases from 900 to 3600 mg/day.
| Excerpt | Reference | Relevance |
|---|---|---|
| " In healthy volunteers, it is rapidly absorbed with peak blood concentrations within 1 h and it has a bioavailability of approximately 90%." | ( Pregabalin: a new anxiolytic. Lauria-Horner, BA; Pohl, RB, 2003) | 0.32 |
| " Peak plasma levels occur approximately 1 hour after oral doses and oral bioavailability is about 90%." | ( Pregabalin: a new agent for the treatment of neuropathic pain. Zareba, G, 2005) | 0.33 |
| " Unlike gabapentin, pregabalin was well absorbed (> 90%), and its absorption was dose independent." | ( Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin? Guay, DR, 2005) | 0.33 |
| " Pregabalin oral bioavailability is approximately 90% and is independent of dose and frequency of administration." | ( Clinical pharmacokinetics of pregabalin in healthy volunteers. Alvey, CW; Bockbrader, HN; Boyd, RA; Busch, JA; Corrigan, BW; Haig, GM; Posvar, EL; Radulovic, LL; Randinitis, EJ; Strand, JC; Wesche, DL, 2010) | 0.36 |
| " The absolute bioavailability of gabapentin drops from 60% to 33% as the dosage increases from 900 to 3600 mg/day, while the absolute bioavailability of pregabalin remains at > or = 90% irrespective of the dosage." | ( A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Bockbrader, HN; Burger, P; Chapel, S; Janiczek, N; Miller, R; Wesche, D, 2010) | 0.36 |
| " Our study investigated whether a single 300-mg dose of pregabalin in patients has sufficient central nervous system bioavailability to be useful under acute conditions where brain or spinal cord excitability may lead to long-term disease, such as chronic pain." | ( Can a single dose of 300 mg of pregabalin reach acute antihyperalgesic levels in the central nervous system? Buvanendran, A; Kari, M; Kroin, JS; Tuman, KJ, ) | 0.13 |
| "This pharmacostatistical model showed that: (1) pregabalin oral clearance (CL/F) was directly proportional to creatinine clearance (CLcr), but was independent of gender, race, age, female hormonal status, daily dose, and dosing regimen; (2) apparent volume of distribution was dependent on body weight and gender; (3) absorption rate was decreased when given with food; and (4) coadministration with marketed antiepileptic drugs (AEDs) had no significant effect on pregabalin CL/F." | ( Population pharmacokinetics of pregabalin in healthy subjects and patients with chronic pain or partial seizures. Bockbrader, HN; Burger, P; Corrigan, BW; Knapp, L, 2011) | 0.37 |
| " Pregabalin is well absorbed in patients with chronic pancreatitis, and the pharmacokinetic profile of pregabalin is not extensively affected by chronic pancreatitis." | ( The absorption profile of pregabalin in chronic pancreatitis. Andresen, T; Dahan, A; Drewes, AM; Olesen, AE; Olesen, SS; Olofsen, E; Staahl, C, 2012) | 0.38 |
| " Pregabalin has a linear uptake without transporter saturation at therapeutic dosages, high bioavailability with rapid absorption independent of food intake." | ( Pharmacokinetic and pharmacodynamic profile of pregabalin and its role in the treatment of epilepsy. Schulze-Bonhage, A, 2013) | 0.39 |
| "To determine the oral bioavailability of a pregabalin capsule relative to a pregabalin solution." | ( Bioequivalence assessment of a pregabalin capsule and oral solution in fasted healthy volunteers: a randomized, crossover study. Alvey, CW; Bockbrader, HN; Corrigan, BW; Radulovic, LL, 2013) | 0.39 |
| " Bioavailability was 97." | ( Pharmacokinetics of single-dose intragastric and intravenous pregabalin administration in clinically normal horses. Divers, TJ; Mullen, KR; Schwark, W, 2013) | 0.39 |
| " Overall, pregabalin is characterized by higher potency, quicker absorption rates and greater bioavailability levels than gabapentin." | ( Misuse and abuse of pregabalin and gabapentin: cause for concern? Schifano, F, 2014) | 0.4 |
| " Bioequivalence criteria for comparison of pregabalin CR after a low- or medium-calorie breakfast relative to pregabalin IR were not met; however, bioavailability of the pregabalin CR vs." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| "Time of day of administration and the fat and caloric content of the accompanying meal had minimal overall effect on the pharmacokinetic properties and bioavailability of the pregabalin CR formulation." | ( Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| " Relative bioavailability of pregabalin CR was 93-97 % of pregabalin IR, and bioequivalence criteria with respect to the 24-h steady-state exposure (area under the plasma concentration-time curve from 0 to 24 h [AUC24]) were met." | ( Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Alebic-Kolbah, T; Alvey, CW; Bockbrader, HN; Chew, ML; Pitman, VW; Plotka, A; Scavone, JM, 2014) | 0.4 |
| " Compared with conventional capsules, the relative bioavailability of gastro-floating tablet in fasted conditions or in fed conditions was only 62." | ( Design and optimization of gastro-floating sustained-release tablet of pregabalin: In vitro and in vivo evaluation. Dong, Y; Han, X; He, W; Qin, C; Shi, W; Wang, X; Wu, M; Xu, S; Yang, L; Yin, L, 2018) | 0.48 |
| "The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs." | ( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019) | 0.51 |
| "The data demonstrated that combined therapy of pregabalin plus amitriptyline improved the bioavailability of pregabalin and potentiated the efficacy of the antiallodynic effect of pregabalin alone, proving to be advantageous for the treatment of sciatic neuropathic pain." | ( Investigation of the Combination of Pregabalin with Duloxetine or Amitriptyline on the Pharmacokinetics and Antiallodynic Effect During Neuropathic Pain in Rats. Barros, CM; Boralli, VB; Costa, LH; Galdino, G; Kawano, T; Placido, RV; Podesta, MHMC; Rodrigues, RF; Santos, RS, 2021) | 0.62 |
| "The bioavailability of the pregabalin SR 300 mg formulation is increased if taken with a high-fat meal." | ( Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. An, T; Jang, SB; Jeon, JY; Kim, MG; Kim, S; Lee, SY; Lim, Y; Moon, SJ; Na, WS, 2021) | 0.62 |
| " Given its faster onset, increased bioavailability and potency, and nonsaturable absorption, pregabalin's pharmacokinetics theoretically enhance its misuse liability versus gabapentin." | ( Gabapentinoid Pharmacology in the Context of Emerging Misuse Liability. Covvey, JR; Evoy, KE; Peckham, AM; Tidgewell, KJ, 2021) | 0.62 |
Pregabalin was associated with an inhibitory effect on heart rate fluctuations and reduced hemodynamic complications after intubation. Cosmetic side effects leading to dosage change or discontinuation occurred most frequently with pregabalin and valproic acid compared with all other AEDs.
| Role | Description |
|---|---|
| anticonvulsant | A drug used to prevent seizures or reduce their severity. |
| calcium channel blocker | One of a class of drugs that acts by selective inhibition of calcium influx through cell membranes or on the release and binding of calcium in intracellular pools. |
| [role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] | |
| Class | Description |
|---|---|
| gamma-amino acid | A non-proteinogenic amino-acid in which the amino group is located on the carbon atom at the position gamma to the carboxy group. |
| [compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] | |
| Protein | Taxonomy | Measurement | Average (µ) | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| EWS/FLI fusion protein | Homo sapiens (human) | Potency | 16.6261 | 0.0013 | 10.1577 | 42.8575 | AID1259253 |
| estrogen nuclear receptor alpha | Homo sapiens (human) | Potency | 13.3332 | 0.0002 | 29.3054 | 16,493.5996 | AID743079 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Protein | Taxonomy | Measurement | Average | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| ATP-binding cassette sub-family C member 3 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.6315 | 4.4531 | 9.3000 | AID1473740 |
| Multidrug resistance-associated protein 4 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.2000 | 5.6774 | 10.0000 | AID1473741 |
| Bile salt export pump | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 0.1100 | 7.1903 | 10.0000 | AID1473738 |
| Sodium-dependent noradrenaline transporter | Homo sapiens (human) | IC50 (µMol) | 10.0000 | 0.0008 | 1.5416 | 20.0000 | AID1709035 |
| Sodium-dependent noradrenaline transporter | Homo sapiens (human) | Ki | 10.0000 | 0.0003 | 1.4656 | 10.0000 | AID1709034 |
| Voltage-dependent calcium channel subunit alpha-2/delta-1 | Homo sapiens (human) | Ki | 0.0190 | 0.0190 | 0.0190 | 0.0190 | AID1709032; AID1766516 |
| Canalicular multispecific organic anion transporter 1 | Homo sapiens (human) | IC50 (µMol) | 133.0000 | 2.4100 | 6.3433 | 10.0000 | AID1473739 |
| Voltage-dependent calcium channel subunit alpha-2/delta-2 | Homo sapiens (human) | Ki | 0.0990 | 0.0990 | 0.0990 | 0.0990 | AID1709033 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Protein | Taxonomy | Measurement | Average | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| Voltage-dependent calcium channel subunit alpha-2/delta-1 | Homo sapiens (human) | INH | 0.0390 | 0.0390 | 0.0390 | 0.0390 | AID1496105 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Assay ID | Title | Year | Journal | Article |
|---|---|---|---|---|
| AID598759 | Inhibition of Voltage-dependent calcium channel subunit alpha-2/delta | 2011 | Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12 | Part 3: Design and synthesis of proline-derived α2δ ligands. |
| AID719113 | Toxicity against mouse assessed as protection against maximal-electroshock-induced tonic seizure at 15 mg/kg | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID1496106 | Analgesic activity in db/db mouse mechanical hyperalgesia model assessed as reversal of mechanical hyperalgesia at 100 mg/kg, po pretreated for 2 hrs by Von Frey test relative to control | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID412174 | Displacement of [3H]gabapentin from alpha2-delta subunit of voltage gated calcium channel in pig brain membrane | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID1682452 | Analgesic activity in rat model of sciatic nerve ligation-induced neuropathic pain assessed as reversal of hyperalgesia at 10 mg/kg, po by paw pressure test | 2020 | Bioorganic & medicinal chemistry letters, 12-15, Volume: 30, Issue:24 | Pyrrolinone derivatives as a new class of P2X3 receptor antagonists. Part 3: Structure-activity relationships of pyrropyrazolone derivatives. |
| AID591494 | Antihyperalgesic activity against thermal hyperalgesia in saline treated rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 45 mins by hot plate test (Rvb = 17.8 +/- 1.5 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID625292 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID591502 | Antihyperalgesic activity against thermal hyperalgesia in saline treated rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 60 mins by hot plate test (Rvb = 18.4 +/- 1.6 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID625290 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID252209 | Brain levels 2 hours after peroral dosing of 30 mg/kg in rats was determined | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID412185 | AUC in rat | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID267891 | Protection of DBA/2 mouse against audiogenic-induced tonic seizure at 30 mg/kg, po after 1 hr | 2006 | Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13 | Carboxylate bioisosteres of pregabalin. |
| AID267892 | Protection of DBA/2 mouse against audiogenic-induced tonic seizure at 30 mg/kg, po after 2 hrs | 2006 | Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13 | Carboxylate bioisosteres of pregabalin. |
| AID625283 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID625287 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID412177 | Anxiolytic activity in DBA/2 mouse assessed as restoration of punished drinking behavior at 30 mg/kg, po relative to pregabalin | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID454488 | Displacement of [3H]gabapentin from calcium channel alpha2delta in pig cerebral cortex membrane after 30 mins | 2010 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1 | Synthesis and in vivo evaluation of 3-substituted gababutins. |
| AID719121 | Antiallodynic activity in CD rat SNL pain model assessed as increase in paw withdrawal threshold at 20 mg/kg, po measured from 30 to 180 mins | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID779483 | Inhibition of oxaliplatin-induced peripheral neuropathic pain in acetone spray-induced cold allodynia C57/BL6 mouse model assessed as inhibition of nocifensive paw licking behavior at 10 mg/kg, po | 2013 | Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21 | Synthesis and pharmacological evaluation of novel N-aryl-3,4-dihydro-1'H-spiro[chromene-2,4'-piperidine]-1'-carboxamides as TRPM8 antagonists. |
| AID625285 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1473740 | Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
| AID189469 | Antiallodynic effect investigated in chronic sciatic nerve constriction injury rats before 1 hr of 60 mg/kg i.p. administration and value reported as paw withdrawal threshold | 2004 | Bioorganic & medicinal chemistry letters, May-17, Volume: 14, Issue:10 | Effect of gabapentin derivates on mechanical allodynia-like behaviour in a rat model of chronic sciatic constriction injury. |
| AID267890 | Binding affinity to alpha-2delta calcium channel | 2006 | Bioorganic & medicinal chemistry letters, Jul-01, Volume: 16, Issue:13 | Carboxylate bioisosteres of pregabalin. |
| AID1178517 | Antinociceptive activity in spinal nerve ligation CD rat model of neuropathic pain assessed as inhibition of mechanical allodynia measured as paw withdrawal threshold at 39 mg/kg, po up to 15 mins | 2014 | Bioorganic & medicinal chemistry letters, Jul-15, Volume: 24, Issue:14 | DDD-028: a potent potential non-opioid, non-cannabinoid analgesic for neuropathic and inflammatory pain. |
| AID977599 | Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM | 2013 | Molecular pharmacology, Jun, Volume: 83, Issue:6 | Structure-based identification of OATP1B1/3 inhibitors. |
| AID1158690 | Analgesic activity in po dosed Sprague-Dawley rat Chung spinal nerve ligation model assessed as reversal of mechanical hypersensitivity relative to control | 2014 | Journal of medicinal chemistry, Jul-10, Volume: 57, Issue:13 | Maximizing diversity from a kinase screen: identification of novel and selective pan-Trk inhibitors for chronic pain. |
| AID591503 | Antihyperalgesic activity against streptozotocin-induced thermal hyperalgesia in rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 60 mins by hot plate test (Rvb = 10.4 +/- 1.2 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID701147 | Antihyperalgesic activity in CD1 mouse partial sciatic nerve ligation model assessed as inhibition of thermal hyperalgesia at 16 to 64 mg/kg, ip administered 45 mins by plantar test | 2012 | Journal of medicinal chemistry, Oct-11, Volume: 55, Issue:19 | Synthesis and biological evaluation of the 1-arylpyrazole class of σ(1) receptor antagonists: identification of 4-{2-[5-methyl-1-(naphthalen-2-yl)-1H-pyrazol-3-yloxy]ethyl}morpholine (S1RA, E-52862). |
| AID719119 | Antiallodynic activity in CD rat SNL pain model assessed as increase in paw withdrawal threshold at 20 mg/kg, po measured at 90 mins | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID1180195 | Analgesic activity in rat Bennett model for neuropathic pain at 100 mg/kg, po | 2014 | Bioorganic & medicinal chemistry letters, Aug-15, Volume: 24, Issue:16 | 2-Alkyl/alkenyl substituted pyridine C-region analogues of 2-(3-fluoro-4-methylsulfonylaminophenyl)propanamides as highly potent TRPV1 antagonists. |
| AID249978 | The ability of 30 mg/kg oral dose of compound to restore punished drinking behavior in rats expressed as percent reference activity (PRA) | 2005 | Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7 | Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. |
| AID454492 | Analgesic activity in po dosed rat assessed as increase in number shocks received for 10 mins | 2010 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1 | Synthesis and in vivo evaluation of 3-substituted gababutins. |
| AID1542807 | Anti-nociceptive activity in Sprague-Dawley rat assessed as reduction in total time spent licking injected paw during delayed phase (15 to 45 mins) at 40 mg/kg, po dosed 1 hr before formalin injection | 2019 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 29, Issue:12 | Synthesis and evaluation of histamine H |
| AID1766518 | Inhibition of recombinant CYP3A4 (unknown origin) using BFC as substrate at 1 uM measured after 30 mins in presence of NADPH generating system by fluorescence assay relative to control | 2021 | ACS medicinal chemistry letters, Nov-11, Volume: 12, Issue:11 | Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels. |
| AID1496105 | Displacement of [3H]gabapentin from human voltage-gated Ca2+ channel alpha2delta1 subunit expressed in HEK293A cell membranes after 30 mins by liquid scintillation counting method | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID412175 | Displacement of [3H]leucine from Large neutral amino acids transporter system L in CHO cells | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID1363935 | Decrease in KCl-induced exocytotic release of [3H]GABA in Wistar rat synaptosomes at 100 uM preincubated for 20 mins followed by Kcl addition in Ca2+ containing media measured after 5 mins | |||
| AID1744121 | Inhibition of human ACMSD assessed as QUIN level at 1 mM by HPLC analysis (Rvb = 16.4 +/- 2.9%) | 2021 | Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1 | Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway. |
| AID239675 | Equilibrium dissociation constant for Voltage-gated calcium channel alpha2-delta subunit as inhibition of [3H]gabapentin binding to pig brain membranes | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID1421718 | Antiallodynic activity in Wistar rat assessed as reduction in oxaliplatin-induced neuropathic pain in late phase by measuring paw withdrawal force at 5 to 10 mg/kg, ip measured after 60 mins by Von Frey test | 2018 | European journal of medicinal chemistry, Oct-05, Volume: 158 | Novel amide derivatives of 1,3-dimethyl-2,6-dioxopurin-7-yl-alkylcarboxylic acids as multifunctional TRPA1 antagonists and PDE4/7 inhibitors: A new approach for the treatment of pain. |
| AID412182 | Bioavailability in rat | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID625291 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID263823 | Inhibition of [3H]leucine uptake at System L in CHO cells | 2006 | Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9 | Heteroaromatic side-chain analogs of pregabalin. |
| AID735854 | Antiallodynic activity against capsaicin-induced secondary mechanical pain in CD-1 mouse assessed as paw withdrawal-latency at 64 mg/kg, sc measured after 30 mins post compound administration | 2013 | Journal of natural products, Apr-26, Volume: 76, Issue:4 | Antiallodynic and analgesic effects of maslinic acid, a pentacyclic triterpenoid from Olea europaea. |
| AID1777969 | Antiallodynic activity in hyperglycemic Swiss Webster mouse model of neuropathic pain assessed as reversal of carrageenan-induced tactile allodynia at 30 ug/paw, it and measured after 6 hrs | |||
| AID1411515 | Antipain activity in tibial nerve transection surgery model of rat assessed as reduction of noxious pinch evoked activity at 9 to 18 mg/kg administered as iv bolus dose measured every 15 mins for 30 mins | 2017 | MedChemComm, Jun-01, Volume: 8, Issue:6 | The discovery of a potent Na |
| AID591495 | Antihyperalgesic activity against streptozotocin-induced thermal hyperalgesia in rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 45 mins by hot plate test (Rvb = 9.3 +/- 1.2 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID1363938 | Effect on ambient level of L-[3H]glutamate in Wistar rat synaptosomes assessed as L-[3H]glutamate level at 100 uM preincubated for 20 mins (Rvb = 24.68 +/- 1.49%) | |||
| AID1235126 | Increase in [3H]GABA uptake initial velocity in Wistar rat synaptosomes measured per mg of protein at 100 uM by scintillation counting (Rvb = 205.4 +/- 5 pmol/min*mg of protein) | 2015 | Bioorganic & medicinal chemistry, Aug-01, Volume: 23, Issue:15 | Synthesis of new fluorinated analogs of GABA, Pregabalin bioisosteres, and their effects on [(3)H]GABA uptake by rat brain nerve terminals. |
| AID1744122 | Inhibition of human ACMSD assessed as picolinic acid level at 1 mM by HPLC analysis (Rvb = 83.6 +/- 3.1%) | 2021 | Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1 | Diflunisal Derivatives as Modulators of ACMS Decarboxylase Targeting the Tryptophan-Kynurenine Pathway. |
| AID477062 | Inhibition of [3H]gabapentin binding to voltage gated calcium channel alpha2delta from rat cerebral cortex at 10 uM by scintillation counting | 2010 | European journal of medicinal chemistry, Apr, Volume: 45, Issue:4 | Synthesis, characterization and in vitro pharmacology of novel pregabalin derivatives. |
| AID1473738 | Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
| AID1178518 | Antinociceptive activity in spinal nerve ligation CD rat model of neuropathic pain assessed as inhibition of mechanical allodynia measured as time required for maximal effect at 39 mg/kg, po | 2014 | Bioorganic & medicinal chemistry letters, Jul-15, Volume: 24, Issue:14 | DDD-028: a potent potential non-opioid, non-cannabinoid analgesic for neuropathic and inflammatory pain. |
| AID1363933 | Effect on ambient level of [3H]GABA in Wistar rat synaptosomes assessed as [3H]GABA level at 100 uM preincubated for 20 mins (Rvb = 14.20 +/- 1.03%) | |||
| AID1561392 | Analgesic activity in mouse model of spared nerve injury assessed as reduction in cold hyperalgesia at 30 mg/kg, ip measured at 7 days interval for up to 21 days post spared nerve injury by cold plantar test | 2020 | Journal of medicinal chemistry, 04-09, Volume: 63, Issue:7 | TREK Channel Family Activator with a Well-Defined Structure-Activation Relationship for Pain and Neurogenic Inflammation. |
| AID1474167 | Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status | 2016 | Drug discovery today, Apr, Volume: 21, Issue:4 | DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans. |
| AID1496115 | Effect on motor coordination in mouse at 30 mg/kg, po measured over 120 secs at 2 hrs post drug administration by rota rod test | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID598762 | Displacement of [3H]gabapentin from voltage gated calcium channel alpha2delta from pig cerebral cortex by scintillation counting | 2011 | Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12 | Part 2: Design, synthesis and evaluation of hydroxyproline-derived α2δ ligands. |
| AID735849 | Neurotoxicity in CD-1 mouse assessed as impairment in motor coordination at 64 mg/kg, sc measured up to 3 hrs by rotarod test | 2013 | Journal of natural products, Apr-26, Volume: 76, Issue:4 | Antiallodynic and analgesic effects of maslinic acid, a pentacyclic triterpenoid from Olea europaea. |
| AID1766543 | Analgesic activity in CD1 mouse model of capsaicin-induced mechanical hypersensitivity assessed as reduction in mechanical hypersensitivity at 20 mg/kg, ip administered 30 mins prior to capsaicin stimulation and measured after 15 mins | 2021 | ACS medicinal chemistry letters, Nov-11, Volume: 12, Issue:11 | Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels. |
| AID710667 | Antinociceptive activity in rat assessed as reversal of complete Freund's adjuvant-induced pain at 10 mg/kg, po after 3 hrs | 2012 | Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22 | Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain. |
| AID1411522 | Antipain activity in tibial nerve transection surgery model of rat assessed as reduction of heat evoked activity at 9 to 18 mg/kg administered as iv bolus dose measured every 15 mins for 30 mins | 2017 | MedChemComm, Jun-01, Volume: 8, Issue:6 | The discovery of a potent Na |
| AID625282 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1363936 | Induction of plasma membrane depolarization in Wistar rat synaptosomes at 100 uM by rhodamine 6G based spectrofluorimeteric method | |||
| AID189468 | Antiallodynic effect investigated in chronic sciatic nerve constriction injury rats after 1 hr of 60 mg/kg i.p. administration and value reported as paw withdrawal threshold | 2004 | Bioorganic & medicinal chemistry letters, May-17, Volume: 14, Issue:10 | Effect of gabapentin derivates on mechanical allodynia-like behaviour in a rat model of chronic sciatic constriction injury. |
| AID1235128 | Increase in [3H]GABA uptake initial velocity in Wistar rat synaptosomes measured per mg of protein pretreated at 100 uM for 20 mins by scintillation counting (Rvb = 153 +/- 7.7 pmol/min*mg of protein) | 2015 | Bioorganic & medicinal chemistry, Aug-01, Volume: 23, Issue:15 | Synthesis of new fluorinated analogs of GABA, Pregabalin bioisosteres, and their effects on [(3)H]GABA uptake by rat brain nerve terminals. |
| AID1473739 | Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
| AID1411521 | Antipain activity in tibial nerve transection surgery model of rat assessed as reduction of mechanical punctate stimuli evoked activity at 9 to 18 mg/kg administered as iv bolus dose measured every 15 mins for 30 mins | 2017 | MedChemComm, Jun-01, Volume: 8, Issue:6 | The discovery of a potent Na |
| AID412180 | Ratio of drug level in brain to plasma of Sprague-Dawley rat | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID1496111 | Oral bioavailability in mouse at 10 mg/kg | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1496108 | Half life in mouse at 10 mg/kg, po or 5 mg/kg, iv | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1474166 | Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index | 2016 | Drug discovery today, Apr, Volume: 21, Issue:4 | DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans. |
| AID412179 | Plasma concentration in Sprague-Dawley rat at 30 mg/kg, po after 2 hrs | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID242017 | Inhibition of [3H]gabapentin binding to pig brain membranes | 2005 | Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7 | Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. |
| AID779489 | Inhibition of icilin-induced wet dog shakes in C57/BL6 mouse at 30 mg/kg, po administered 60 mins prior to icilin-challenge measured for 30 mins | 2013 | Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21 | Synthesis and pharmacological evaluation of novel N-aryl-3,4-dihydro-1'H-spiro[chromene-2,4'-piperidine]-1'-carboxamides as TRPM8 antagonists. |
| AID591456 | Antihyperalgesic activity against thermal hyperalgesia in saline treated rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 15 mins by hot plate test (Rvb = 18.1 +/- 1.1 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID248174 | Inhibition of [3H]leucine uptake by L-amino acid transporter system in rats | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID598559 | Displacement of [3H]Gabapentin from alpha2delta calcium channel in pig brain tissue homogenates after 45 mins by scintillation counting | 2011 | Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12 | Part 1: N-alkylated glycines as potent α2δ ligands. |
| AID1626228 | Toxicity in Kun Ming mouse assessed as decrease in rotarod latency at 40 mg/kg, ip measured after 60 to 120 mins by rotarod test relative to vehicle-treated control | 2016 | Journal of medicinal chemistry, 07-14, Volume: 59, Issue:13 | Development of Novel Alkoxyisoxazoles as Sigma-1 Receptor Antagonists with Antinociceptive Efficacy. |
| AID591465 | Antihyperalgesic activity against streptozotocin-induced thermal hyperalgesia in rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 30 mins by hot plate test (Rvb = 10.1 +/- 0.8 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID1709032 | Displacement of [3H]-gabapentin from human Cav alpha2delta1 expressed in CHO-K1 cell membranes incubated for 60 mins by scintillation counting method | 2021 | Journal of medicinal chemistry, 02-25, Volume: 64, Issue:4 | Bicyclic Diazepinones as Dual Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels and the Norepinephrine Transporter. |
| AID263825 | Anticonvulsant activity against DBA/2 mouse at 30 mg/kg, po 2 hrs post dose | 2006 | Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9 | Heteroaromatic side-chain analogs of pregabalin. |
| AID242165 | Inhibition of [3H]leucine uptake into CHO cells by L-amino acid transporters | 2005 | Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7 | Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. |
| AID1496109 | AUC in mouse at 10 mg/kg, po or 5 mg/kg, iv | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1496112 | Analgesic activity in STZ-induced diabetic rat model assessed as pain threshold AUC (0 to 8 hrs) at 10 mg/kg, po by Von Frey test | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID252319 | Plasma levels 2 hours after peroral dosing of 30 mg/kg in rats was determined | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID412184 | Half life in rat plasma | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID1496107 | Cmax in mouse at 10 mg/kg, po or 5 mg/kg, iv | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1766546 | Induction of motor coordination impairment in CD1 mouse assessed as latency to fall at 20 mg/kg, ip measured upto 180 mins by rotarod test | 2021 | ACS medicinal chemistry letters, Nov-11, Volume: 12, Issue:11 | Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels. |
| AID1363937 | Induction of plasma membrane hyperpolarization in Wistar rat synaptosomes at 100 uM by rhodamine 6G based spectrofluorimeteric method | |||
| AID1363934 | Effect on ambient level of [3H]GABA in Wistar rat synaptosomes assessed as [3H]GABA level at 100 uM preincubated for 20 mins in presence of GAT1 specific blocker NO-711 (Rvb = 25.07 +/- 2.1%) | |||
| AID412186 | Volume of distribution at steady state in rat | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID477702 | Displacement of [3H]gabapentin from Voltage-dependent calcium channel subunit alpha-2/delta in pig cerebral cortex by scintillation counting | 2010 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1 | Synthesis and in vivo evaluation of 3,4-disubstituted gababutins. |
| AID244699 | Ratio of brain level and plasma level 2 hours after peroral dosing of 30 mg/kg in rats was determined | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID248057 | Inhibition of [3H]leucine uptake into CHO cells | 2005 | Journal of medicinal chemistry, Apr-21, Volume: 48, Issue:8 | Novel cyclopropyl beta-amino acid analogues of pregabalin and gabapentin that target the alpha2-delta protein. |
| AID1199454 | Antagonist activity at P2X7 receptor in neuropathic rat dorsal horn assessed as inhibition of long term potentiation-induced neropathic pain at 20 uM relative to control | 2015 | Journal of medicinal chemistry, Mar-12, Volume: 58, Issue:5 | Discovery of novel 2,5-dioxoimidazolidine-based P2X(7) receptor antagonists as constrained analogues of KN62. |
| AID263822 | Displacement of [3H]gabapentin from alpha-2delta calcium channel in pig brain membrane | 2006 | Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9 | Heteroaromatic side-chain analogs of pregabalin. |
| AID263824 | Anxiolytic effect in rat at 30 mg/kg, po by Vogel water lick conflict assay assessed by ability to reverse shock-induced suppression of drinking | 2006 | Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9 | Heteroaromatic side-chain analogs of pregabalin. |
| AID1233965 | Antallodynic effect in Sprague-Dawley rat tibial nerve transection-induced mechanical allodynia model assessed as 50% shift in paw withdrawal threshold in ipsilateral paw at 10 mg/kg, single dose after 1.5 hrs (Rvb = 1.7 +/- 0.2 g) | 2015 | ACS medicinal chemistry letters, Jun-11, Volume: 6, Issue:6 | Discovery and Optimization of Selective Nav1.8 Modulator Series That Demonstrate Efficacy in Preclinical Models of Pain. |
| AID1421715 | Antiallodynic activity in Wistar rat assessed as reduction in oxaliplatin-induced neuropathic pain in early phase by measuring paw withdrawal force at 5 to 10 mg/kg, ip measured after 60 mins by Von Frey test | 2018 | European journal of medicinal chemistry, Oct-05, Volume: 158 | Novel amide derivatives of 1,3-dimethyl-2,6-dioxopurin-7-yl-alkylcarboxylic acids as multifunctional TRPA1 antagonists and PDE4/7 inhibitors: A new approach for the treatment of pain. |
| AID701146 | Neurotoxicity in CD1 mouse assessed as motor impairment at 32 to 64 mg/kg, ip measured after 30 to 180 mins by rotarod test | 2012 | Journal of medicinal chemistry, Oct-11, Volume: 55, Issue:19 | Synthesis and biological evaluation of the 1-arylpyrazole class of σ(1) receptor antagonists: identification of 4-{2-[5-methyl-1-(naphthalen-2-yl)-1H-pyrazol-3-yloxy]ethyl}morpholine (S1RA, E-52862). |
| AID625288 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID719112 | Toxicity against mouse assessed as protection against maximal-electroshock-induced tonic seizure at 45 mg/kg | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID701148 | Antiallodynic activity in CD1 mouse partial sciatic nerve ligation model assessed as inhibition of mechanical allodynia at 16 to 64 mg/kg, ip administered 30 mins by von Frey test | 2012 | Journal of medicinal chemistry, Oct-11, Volume: 55, Issue:19 | Synthesis and biological evaluation of the 1-arylpyrazole class of σ(1) receptor antagonists: identification of 4-{2-[5-methyl-1-(naphthalen-2-yl)-1H-pyrazol-3-yloxy]ethyl}morpholine (S1RA, E-52862). |
| AID625284 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID625280 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID625279 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1496116 | Effect on motor coordination in mouse at 100 mg/kg, po measured over 120 secs at 2 hrs post drug administration by rota rod test | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1235130 | Increase in [3H]GABA uptake initial velocity in Wistar rat synaptosomes measured per mg of protein pretreated at 100 uM for 20 mins with combined application of 30 uM NO-711 GAT1 blocker by scintillation counting | 2015 | Bioorganic & medicinal chemistry, Aug-01, Volume: 23, Issue:15 | Synthesis of new fluorinated analogs of GABA, Pregabalin bioisosteres, and their effects on [(3)H]GABA uptake by rat brain nerve terminals. |
| AID625289 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1599711 | Antiallodynic activity in C57BL/6J mouse assessed as reduction in cuff-induced pain at 3 mg/kg, ip bid for 3 weeks administrated 2 weeks post cuff-insertion and measured after 15 days by Von Frey test | 2019 | European journal of medicinal chemistry, Sep-01, Volume: 177 | Design and synthesis of 3-aminophthalazine derivatives and structural analogues as PDE5 inhibitors: anti-allodynic effect against neuropathic pain in a mouse model. |
| AID625281 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1868465 | Analgesic activity in C57BL/6 mouse model of formalin-induced allodynia assessed as reduction on foot licking pain response at 20 mg/kg,po measured after 10 mins | 2022 | European journal of medicinal chemistry, Jul-05, Volume: 237 | Optimization of 4-arylthiophene-3-carboxylic acid derivatives as inhibitors of ANO1: Lead optimization studies toward their analgesic efficacy for inflammatory pain. |
| AID412178 | Drug level in Sprague-Dawley rat brain at 30 mg/kg, po after 2 hrs | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID625286 | Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis | 2011 | PLoS computational biology, Dec, Volume: 7, Issue:12 | Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps). |
| AID1777967 | Antiallodynic activity in hyperglycemic Swiss Webster mouse model of neuropathic pain assessed as reversal of carrageenan-induced tactile allodynia at 30 ug/paw local peripheral administration and measured after 6 hrs | |||
| AID412183 | Clearance in rat | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID719107 | Toxicity against rat assessed as somnolence at 30 mg/kg | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID246002 | Inhibition of carrageenan-induced thermal hyperalgesia in rats 1 hr after administration of a 30 mg/kg dose of test compound | 2005 | Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7 | Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. |
| AID1473741 | Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay | 2013 | Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1 | A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development. |
| AID1709033 | Displacement of [3H]-gabapentin from human Cav alpha2delta2 expressed in HEK293 cell membranes incubated for 60 mins by scintillation counting method | 2021 | Journal of medicinal chemistry, 02-25, Volume: 64, Issue:4 | Bicyclic Diazepinones as Dual Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels and the Norepinephrine Transporter. |
| AID779487 | Inhibition of oxaliplatin-induced peripheral neuropathic pain in acetone spray-induced cold allodynia C57/BL6 mouse model assessed as inhibition of nocifensive paw licking behavior at 30 mg/kg, po | 2013 | Bioorganic & medicinal chemistry, Nov-01, Volume: 21, Issue:21 | Synthesis and pharmacological evaluation of novel N-aryl-3,4-dihydro-1'H-spiro[chromene-2,4'-piperidine]-1'-carboxamides as TRPM8 antagonists. |
| AID604877 | Analgesic activity in rat assessed as reversal of complete Freund's adjuvant-induced hypersensitivity at 10 mg/kg | 2010 | Bioorganic & medicinal chemistry letters, Aug-01, Volume: 20, Issue:15 | Pyrazolopyridazine alpha-2-delta-1 ligands for the treatment of neuropathic pain. |
| AID591464 | Antihyperalgesic activity against thermal hyperalgesia in saline treated rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 30 mins by hot plate test (Rvb = 18 +/- 1.5 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID1766516 | Displacement of [3H]-gabapentin from human Cav alpha2delta1 expressed in CHO-K1 cell membranes incubated for 60 mins by scintillation counting method | 2021 | ACS medicinal chemistry letters, Nov-11, Volume: 12, Issue:11 | Piperazinyl Bicyclic Derivatives as Selective Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels. |
| AID977602 | Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM | 2013 | Molecular pharmacology, Jun, Volume: 83, Issue:6 | Structure-based identification of OATP1B1/3 inhibitors. |
| AID252186 | Percent protection of DBA/2 mice from audiogenically induced tonic seizures at a dose of 30 mg/kg of test compound | 2005 | Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7 | Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein. |
| AID1426394 | Antiallodynic activity in mouse model of spared nerve injury-induced tactile allodynia assessed as tactile threshold at 30 mg/kg, po measured 90 mins post dose by Von Frey filament assay | 2017 | Journal of medicinal chemistry, 02-09, Volume: 60, Issue:3 | The Discovery and Hit-to-Lead Optimization of Tricyclic Sulfonamides as Potent and Efficacious Potentiators of Glycine Receptors. |
| AID1411520 | Antipain activity in tibial nerve transection surgery model of rat assessed as reduction of innocuous brush evoked activity at 9 to 18 mg/kg administered as iv bolus dose measured every 15 mins for 30 mins | 2017 | MedChemComm, Jun-01, Volume: 8, Issue:6 | The discovery of a potent Na |
| AID719111 | Toxicity against mouse assessed as protection against pentetrazole-induced death at 45 mg/kg | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID1496110 | Clearance in mouse at 10 mg/kg, po or 5 mg/kg, iv | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID1496114 | Analgesic activity in STZ-induced diabetic rat model assessed as pain threshold AUC (0 to 8 hrs) at 30 mg/kg, po by Von Frey test | 2018 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 28, Issue:11 | Alkylsulfanyl analogs as potent α |
| AID591457 | Antihyperalgesic activity against streptozotocin-induced thermal hyperalgesia in rat diabetic neuropathy model assessed as licking latency time at 30 mg/kg, po after 15 mins by hot plate test (Rvb = 9.4 +/- 1.3 sec) | 2011 | Journal of medicinal chemistry, Apr-14, Volume: 54, Issue:7 | Synthesis and biological evaluation of 3,7-diazabicyclo[4.3.0]nonan-8-ones as potential nootropic and analgesic drugs. |
| AID719115 | Toxicity against CD rat SNL pain model assessed as hypalgesic activity on the contralateral side of paw at 20 mg/kg, po at 90 mins relative to control | 2012 | Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24 | (R)- and (S)-4-Amino-3-(trimethylsilyl)methylbutanoic acids ameliorate neuropathic pain without central nervous system-related side effects. |
| AID1059215 | Antinociceptive activity in rat spinal dorsal horn assessed as inhibition of electrically-stimulated long term potentiation at 20 uM by Di-4-ANEPPS dye-based assay relative to control | 2013 | European journal of medicinal chemistry, , Volume: 70 | Design and synthesis of potent and selective P2X₃ receptor antagonists derived from PPADS as potential pain modulators. |
| AID1709034 | Displacement of [3H]-nisoxetine from human NET expressed in HEK293 cell membranes incubated for 60 mins by scintillation counting method | 2021 | Journal of medicinal chemistry, 02-25, Volume: 64, Issue:4 | Bicyclic Diazepinones as Dual Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels and the Norepinephrine Transporter. |
| AID1542806 | Anti-nociceptive activity in Sprague-Dawley rat assessed as reduction in total time spent licking injected paw during early phase (0 to 5 mins) at 40 mg/kg, po dosed 1 hr before formalin injection | 2019 | Bioorganic & medicinal chemistry letters, 06-15, Volume: 29, Issue:12 | Synthesis and evaluation of histamine H |
| AID1709035 | Inhibition of human NET expressed in HEK293 cells assessed as reduction in ASP+ uptake incubated for 20 mins before ASP+ addition and measured after 90 mins by scintillation counting method | 2021 | Journal of medicinal chemistry, 02-25, Volume: 64, Issue:4 | Bicyclic Diazepinones as Dual Ligands of the α2δ-1 Subunit of Voltage-Gated Calcium Channels and the Norepinephrine Transporter. |
| AID412176 | Anticonvulsant activity in DBA/2 mouse assessed as protection from audiogenically-induced tonic seizures at 30 mg/kg, po after 1 hr | 2009 | Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1 | Oxadiazolone bioisosteres of pregabalin and gabapentin. |
| AID1159550 | Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening | 2015 | Nature cell biology, Nov, Volume: 17, Issue:11 | 6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling. |
| AID1347411 | qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary | 2020 | ACS chemical biology, 07-17, Volume: 15, Issue:7 | High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle. |
| AID1296008 | Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening | 2020 | SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1 | Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening. |
| AID1346986 | P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
| AID1346987 | P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
| AID1347091 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347082 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
| AID1347107 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347095 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347101 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347083 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
| AID1347093 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347108 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347103 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1745845 | Primary qHTS for Inhibitors of ATXN expression | |||
| AID1347099 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347105 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347096 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347154 | Primary screen GU AMC qHTS for Zika virus inhibitors | 2020 | Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49 | Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors. |
| AID1347094 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347100 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1508630 | Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay | 2021 | Cell reports, 04-27, Volume: 35, Issue:4 | A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome. |
| AID1347098 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347092 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347097 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347104 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347086 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
| AID1347090 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347102 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347106 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| AID1347089 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
| [information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||||
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 10 (0.42) | 18.2507 |
| 2000's | 413 (17.46) | 29.6817 |
| 2010's | 1450 (61.31) | 24.3611 |
| 2020's | 492 (20.80) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 555 (22.03%) | 5.53% |
| Reviews | 455 (18.06%) | 6.00% |
| Case Studies | 297 (11.79%) | 4.05% |
| Observational | 32 (1.27%) | 0.25% |
| Other | 1,180 (46.84%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin In The Treatment Of Postherpetic Neuralgia [NCT00394901] | Phase 3 | 372 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| PROSPECTIVE RANDOMIZED 12-WEEK CONTROLLED STUDY OF VISUAL FIELD CHANGE IN SUBJECTS WITH PARTIAL SEIZURES RECEIVING PREGABALIN OR PLACEBO [NCT00351611] | Phase 4 | 187 participants (Actual) | Interventional | 2006-07-26 | Completed | ||
| A Double-Blind, Placebo-Controlled Cross-Over Study In Fibromyalgia Subjects To Examine Effects Of Pregabalin On Brain Response To Mechanical Pain As Assessed By Functional Magnetic Resonance Imaging, Proton Magnetic Resonance Spectroscopy And Subjective [NCT00760474] | Phase 1 | 27 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| The Effect of Pregabalin Premedication on Anaesthetic Requirements and Recovery Time After Knee Arthroscopy [NCT03926000] | 112 participants (Anticipated) | Interventional | 2019-06-30 | Not yet recruiting | |||
| Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients [NCT04705480] | Phase 4 | 210 participants (Anticipated) | Interventional | 2021-04-12 | Recruiting | ||
| Oral Pregabalin Versus Intravenous Hydrocortisone in Treatment of Postdural Puncture Headache After Spinal Anesthesia for Elective Cesarean Section [NCT03910088] | Phase 4 | 30 participants (Actual) | Interventional | 2019-04-20 | Completed | ||
| The Efficacy of Pregabalin as a Monotherapy Versus Combined Pregabalin and Milnacipran in the Management of Fibromyalgia. [NCT03905486] | 58 participants (Actual) | Interventional | 2019-04-01 | Completed | |||
| A Phase 1, Open-Label, Randomized, Cross-Over Study to Evaluate the Effects of Multiple Doses of Erythromycin on the Pharmacokinetics of a Single Dose of Pregabalin Controlled Release in Healthy Subjects [NCT01342198] | Phase 1 | 18 participants (Actual) | Interventional | 2011-06-30 | Completed | ||
| An Open-Label, Extension Safety And Efficacy Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With Human Immunodeficiency Virus (HIV) Neuropathy [NCT00264875] | Phase 3 | 220 participants (Actual) | Interventional | 2006-02-28 | Completed | ||
| Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile? [NCT01359514] | 32 participants (Actual) | Interventional | 2008-04-30 | Completed | |||
| Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus [NCT01073501] | Phase 4 | 36 participants (Anticipated) | Interventional | 2010-04-30 | Not yet recruiting | ||
| Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial [NCT05795478] | 264 participants (Anticipated) | Interventional | 2023-04-15 | Not yet recruiting | |||
| An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative T [NCT01257516] | Phase 1 | 18 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of Caloric Content And Time Of Dosing On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Release [NCT01291524] | Phase 1 | 24 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population [NCT01298466] | Phase 4 | 0 participants (Actual) | Interventional | 2012-02-29 | Withdrawn | ||
| Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption [NCT04495374] | Phase 4 | 58 participants (Actual) | Interventional | 2019-09-02 | Terminated(stopped due to Due to an atypical health scenario caused by the COVID-19 pandemic) | ||
| The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain [NCT03748290] | Phase 4 | 50 participants (Anticipated) | Interventional | 2018-08-23 | Recruiting | ||
| Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial. [NCT03735368] | Phase 2 | 60 participants (Actual) | Interventional | 2018-12-10 | Completed | ||
| Randomized, Double-blind, Parallel Group, Single-center, Placebo-controlled Study to Evaluate Efficacy and Safety of Analgesic Combo in Prevention and Treatment of Post-surgical Dental Pain in Healthy Subjects [NCT03652818] | Phase 2 | 115 participants (Actual) | Interventional | 2018-06-15 | Completed | ||
| A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Peripheral Neuropathic Pain [NCT00219544] | Phase 3 | 158 participants (Actual) | Interventional | 2005-11-30 | Completed | ||
| Sleep Structure in Neuropathic Pain Patients, Psychological Factors, Brain Connectivity, and the Effect of Pregabalin on Sleep and Pain [NCT06155916] | 40 participants (Anticipated) | Interventional | 2022-11-22 | Recruiting | |||
| A Phase II, Placebo-controlled, Double-blind, Randomized Crossover Trial of Pregabalin for the Prophylaxis of Pegfilgrastim-induced Bone Pain [NCT03407430] | Phase 2 | 11 participants (Actual) | Interventional | 2016-01-27 | Terminated(stopped due to Low patient accrual) | ||
| Efficacy, Safety, Tolerability and Pharmacokinetics of Concomitant Administration of Tramadol With Duloxetine or Pregabalin: a Randomized Controlled Flexible-dose Study in Patients With Neuropathic Pain [NCT01116531] | Phase 4 | 0 participants (Actual) | Interventional | 2010-04-30 | Withdrawn | ||
| Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia [NCT01226667] | Phase 4 | 174 participants (Actual) | Interventional | 2010-07-31 | Completed | ||
| Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Unilateral Total Knee Arthroplasty- A Randomised, Double Blind, Active Control, Clinical Trial [NCT03604354] | Phase 4 | 95 participants (Actual) | Interventional | 2018-08-01 | Completed | ||
| Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? [NCT01268631] | 150 participants (Anticipated) | Interventional | 2011-01-31 | Not yet recruiting | |||
| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered At Lunch Following Various Caloric Intakes As Compared To The Immediate Re [NCT01270815] | Phase 1 | 28 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| Comparison of Analgesic Efficacy Among Pregabalin, Celecoxib, Pregabalin With Celecoxib and Placebo After Total Knee Arthroplasty Under Intrathecal Morphine [NCT01344213] | Phase 4 | 100 participants (Actual) | Interventional | 2008-07-31 | Completed | ||
| Magnesium Oral Supplementation to Reduce Pain in Patients With Severe Peripheral Arterial Occlusive Disease: The MAG-PAPER Randomized Clinical Trial [NCT02455726] | 150 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting | |||
| A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination of Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy [NCT04495283] | Phase 2 | 87 participants (Actual) | Interventional | 2020-07-28 | Completed | ||
| Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study) [NCT05598905] | Phase 4 | 24 participants (Anticipated) | Interventional | 2022-10-10 | Recruiting | ||
| A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY [NCT01057693] | Phase 3 | 633 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Randomized, Single-dose, Parallel-group Study to Evaluate the Pharmacokinetic Profiles of Two Formulation of Pregabalin in Healthy Volunteers Under Fasting Conditions [NCT03712475] | Phase 4 | 28 participants (Actual) | Interventional | 2018-01-19 | Completed | ||
| Comparison of Conventional Flexible Dose Regimen of Pregabalin and New Flexible Dose Regimen of Pregabalin Using Low Dose: A Randomized Controlled Trial [NCT03691038] | 10 participants (Actual) | Interventional | 2018-10-10 | Terminated(stopped due to Participants couldn't be enrolled due to complain of frequent visit.) | |||
| Effect of Preemptive Pregabalin for Post-operative Pain Relief in Myringoplasty [NCT03603626] | 0 participants (Actual) | Interventional | 2015-09-30 | Withdrawn(stopped due to the article is not a clinical trial but is a hospital based randomized comparative study. This was inadvertently uploaded.) | |||
| The Pharmacokinetics Of Pregabalin Controlled Release Formulation In Fed State Compared To The Controlled Release And Immediate Release Formulations In The Fasted State [NCT01321671] | Phase 1 | 24 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| An Interventional Randomized, Double-blind, Placebo and Active Comparator-controlled, Four-way Crossover Trial Investigating the Analgesic Properties of a Single Oral Dose of Lu AG06474 in Healthy Participants [NCT06077786] | Phase 1 | 24 participants (Anticipated) | Interventional | 2023-10-13 | Recruiting | ||
| A Prospective, Double-blind, Randomized Pilot Study Evaluating the Effects of Toradol and Lyrica Verses Placebo for Pain Control After Donor Nephrectomy (TORPEDO) [NCT03669081] | Phase 2 | 64 participants (Actual) | Interventional | 2016-09-20 | Completed | ||
| Pain Relief Following Arthroscopic Rotator Cuff Repair: Perioperative Pregabalin Administration Versus Interscalene Brachial Plexus Block. a Prospective, Randomized, Double Blinded, Multicenter Trial [NCT01359085] | 56 participants (Anticipated) | Interventional | 2011-06-30 | Not yet recruiting | |||
| Pre- vs. Post-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Orthopedic Oncologic Patients: A Comparative, Randomized, Double Blind Study Protocol [NCT01359059] | 80 participants (Anticipated) | Interventional | 2011-06-30 | Not yet recruiting | |||
| A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects [NCT02103686] | Phase 1 | 30 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| Perioperative Administration of Pregabalin for Pain After Septoplasty [NCT01370915] | 100 participants (Anticipated) | Interventional | 2010-09-30 | Recruiting | |||
| Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery: A Randomized Double-Blind Trial [NCT05640479] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-12-15 | Recruiting | ||
| [NCT00852683] | Phase 3 | 70 participants (Anticipated) | Interventional | 2008-05-31 | Completed | ||
| An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 165 Mg And 330 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Me [NCT01202422] | Phase 1 | 24 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy. [NCT00368745] | Phase 3 | 108 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release For [NCT01080612] | Phase 1 | 24 participants (Actual) | Interventional | 2010-04-30 | Completed | ||
| A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain [NCT00381095] | Phase 4 | 152 participants (Actual) | Interventional | 2006-12-31 | Terminated(stopped due to See termination reason in detailed description.) | ||
| A Multicenter, Randomized, Double-blind Study on the Efficacy and Safety of Tongluo-Kaibi Tablet in the Treatment of Fibromyalgia Syndrome [NCT05933486] | Phase 4 | 150 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting | ||
| Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms. [NCT05096468] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2021-12-01 | Completed | ||
| The Effect of Oral Pregabalin on Epidural-induced Shivering and Epidural Characteristics in Gynecological Surgeries, a Prospective Randomized Double-blind Study [NCT03721432] | 77 participants (Actual) | Interventional | 2018-05-20 | Completed | |||
| A Double-Blind, Placebo-Controlled, Enriched-Enrollment, Randomized Withdrawal Study to Evaluate an Optimal Methodology for Conducting Proof of Concept Trials in Patients With Chronic Neuropathic Pain Syndromes Using Pregabalin as a Test Drug [NCT00570310] | Phase 1 | 104 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
| Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence [NCT02205879] | Phase 4 | 100 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| Effect of Orally Pregabalin Given Before Knee Joint Replacement on Reperfusion Injury Which Caused by Bandage [NCT03482544] | Phase 4 | 54 participants (Actual) | Interventional | 2018-10-10 | Completed | ||
| Multimodal Nonopioid Pain Protocol Following Shoulder Arthroplasty Surgery [NCT05488847] | Phase 4 | 80 participants (Anticipated) | Interventional | 2022-06-25 | Recruiting | ||
| Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery [NCT05478382] | Phase 4 | 132 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting | ||
| Evaluation of Pregabalin's Abuse Liability and Its Effects on Benzodiazepine Withdrawal Symptoms in Inpatients Undergoing Medically Assisted Benzodiazepine Withdrawal [NCT02423018] | Phase 4 | 1 participants (Actual) | Interventional | 2015-04-30 | Terminated(stopped due to Low enrollment.) | ||
| The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: A Comparative Study [NCT05150795] | Early Phase 1 | 80 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting | ||
| Comparison of Effectiveness of Opioid Only and Pregabalin add-on for the Treatment of Neuropathic Pain in Cervical Myelopathy Patients [NCT03618589] | Phase 1 | 60 participants (Anticipated) | Interventional | 2016-11-26 | Recruiting | ||
| Comparison of Oral Lamotrigine Versus Pregabalin for Control of Acute and Chronic Pain Following Modified Radical Mastectomy: Controlled Double-blind Study [NCT03419949] | 0 participants | Expanded Access | Available | ||||
| The Clinical Effect of Pregabalin on Neuropathic Pain in Central Sensitized Patients Who Are Treated With Duloxetine After Total Knee Arthroplasty: Randomized Controlled Trial. [NCT05254652] | 90 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting | |||
| A Randomized, Open-label, Single Dose, Parallel Study to Evaluate the Pharmacokinetics Dose Proportionality of GLA5PR GLARS-NF1 Tablet in Healthy Male Volunteers [NCT02327000] | Phase 1 | 40 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
| Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial [NCT01333956] | Phase 1/Phase 2 | 120 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Peri-Operative Pregabalin for Reducing opIoid Consumption AfTer Cardiac surgEry: A Randomized Trial [NCT04517110] | Phase 3 | 17 participants (Actual) | Interventional | 2021-04-09 | Terminated(stopped due to The COVID-19 pandemic has reduced recruitment such that the study is no longer feasible) | ||
| Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combined Celecoxib With Pregabaline and Repetition Dose Combined Celecoxib With Pregabaline (Double Blind Controlled Clinical Trial) [NCT03523832] | Phase 2 | 30 participants (Actual) | Interventional | 2015-07-01 | Completed | ||
| Radiofrequency Thoracic Sympathectomy for Chronic Postmastectomy Pain; Randomized Placebo Controlled Study [NCT03494426] | 70 participants (Actual) | Interventional | 2018-04-01 | Completed | |||
| An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164 [NCT00372528] | Phase 3 | 21 participants (Actual) | Interventional | 2007-03-31 | Terminated(stopped due to This study was terminated on April 8, 2011 as Pfizer Canada could no longer supply study drug. No efficacy or safety concerns factored into this decision.) | ||
| A Double Blind, Double Dummy, Randomized, Placebo-controlled, 4 Period Cross-over Study To Examine The Effect Of Pf-06372865 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin As A Positive Control [NCT02238717] | Phase 1 | 20 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial [NCT02180880] | Phase 4 | 63 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| Unravelling the Local and Systemic Effects of Primary Surgery and Perioperative Use of Ketorolac and Pregabalin in Primary Breast Cancer Patients According to Adiposity [NCT06150898] | Phase 2 | 112 participants (Anticipated) | Interventional | 2024-02-20 | Not yet recruiting | ||
| A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) [NCT01314222] | Phase 2 | 178 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| "A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of CG-651 in Healthy Volunteers" [NCT05370716] | Phase 1 | 47 participants (Actual) | Interventional | 2019-11-11 | Completed | ||
| Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial [NCT05640453] | Phase 4 | 70 participants (Anticipated) | Interventional | 2022-12-15 | Recruiting | ||
| Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial. [NCT02120703] | Phase 3 | 78 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL) [NCT03530280] | 51 participants (Actual) | Interventional | 2018-06-01 | Completed | |||
| A Double Blind, Double Dummy, Randomized, Placebocontrolled, 5 Period Cross-over Study To Examine The Effect of Pf-06273340 On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive Controls [NCT02260947] | Phase 1 | 20 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
| Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study [NCT03387644] | 70 participants (Actual) | Interventional | 2015-04-15 | Completed | |||
| The Effect of the Combination of Pregabalin and Dexmedetomidine on the Management of Postoperative Pain in Patients Undergoing Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) Under Spinal Anesthesia [NCT03512574] | Phase 4 | 150 participants (Actual) | Interventional | 2018-01-02 | Completed | ||
| Pregabalin Versus Pulsed Radiofrequency Ablation of Dorsal Root Ganglion for Treatment of Chronic Post Thoracotomy Pain Syndrome [NCT03942796] | 30 participants (Actual) | Interventional | 2018-01-01 | Completed | |||
| [NCT01122004] | Phase 1 | 0 participants | Interventional | Recruiting | |||
| A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Peripheral Neuropathic Pain [NCT00141219] | Phase 3 | 241 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| An Open Label, Randomized Study Prospectively Examining the Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin [NCT01128712] | Phase 4 | 4 participants (Actual) | Interventional | 2010-04-30 | Terminated(stopped due to lack of enrollment. terminated in 2014. no data analysis.) | ||
| A Randomized, Double-Blind, Placebo- and Active-Controlled Study of Carisbamate in the Treatment of Neuropathic Pain in Diabetic Peripheral Neuropathy Followed by a Blinded Extension Phase [NCT00870454] | Phase 2 | 386 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic P [NCT05624853] | Phase 4 | 130 participants (Actual) | Interventional | 2020-05-12 | Completed | ||
| Pregabalin for the Treatment of Abdominal Pain From Adhesions: Placebo Controlled Trial [NCT00310765] | Phase 4 | 18 participants (Actual) | Interventional | 2006-03-31 | Terminated(stopped due to Study was terminated by the sponsor due to low accrual.) | ||
| A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of VX-548 in Subjects With Painful Diabetic Peripheral Neuropathy [NCT05660538] | Phase 2 | 192 participants (Actual) | Interventional | 2022-12-20 | Completed | ||
| A Double-blind, Randomized, Cross-over, Feasibility Trial of Pregabalin for the Treatment of Recessive Dystrophic Epidermolysis Bullosa-associated Neuropathic Pain and Itch [NCT03928093] | Phase 3 | 15 participants (Anticipated) | Interventional | 2019-08-07 | Active, not recruiting | ||
| An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Evaluate The Effects Of A Low, Medium And High Fat Evening Meal On The Pharmacokinetics Of Pregabalin Controlled Release Formulation As Compared To The Immediate Rel [NCT01257529] | Phase 1 | 28 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| A Phase 2 Study of the Effects of LY545694, an iGluR5 Antagonist, in the Treatment of Subjects With Painful Diabetic Neuropathy. [NCT00785577] | Phase 2 | 273 participants (Actual) | Interventional | 2008-11-30 | Completed | ||
| Effect of Preoperative Pregabalin on Propofol Induction Dose [NCT01158859] | Phase 4 | 50 participants (Anticipated) | Interventional | 2010-04-30 | Completed | ||
| The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery [NCT01168531] | 108 participants (Actual) | Interventional | 2009-12-31 | Completed | |||
| Use of Single Dose Pre-Operative Pregabalin for Post-Operative Analgesia in Bilateral Head and Neck Cancer Surgery: A Randomized, Double-Blinded, Placebo-Controlled Trial [NCT03714867] | Phase 4 | 0 participants (Actual) | Interventional | 2019-03-22 | Withdrawn(stopped due to Inability to recruit patients) | ||
| An Open-Label, Multiple-Dose, Randomized, 3-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg And 165 Mg Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening M [NCT01220219] | Phase 1 | 24 participants (Actual) | Interventional | 2010-11-30 | Completed | ||
| Pharmacokinetic Non-interaction Study Between Pregabalin 150 mg and Tramadol 50 mg, Administered Individually or in Combination, Single Dose in Healthy Subjects of Both Genders Under Fasting Conditions [NCT05389150] | Phase 1 | 30 participants (Actual) | Interventional | 2019-01-17 | Completed | ||
| Preoperative Use of Pregabalin and Analgesia Levels After Laparoscopic Cholecystectomy [NCT01321801] | 50 participants (Actual) | Interventional | 2009-11-30 | Completed | |||
| A Randomised, Double Blind, Placebo Controlled Study to Investigate the Pharmacodynamic Effects of IP2015 in Healthy Male Subjects Using the Intradermal Capsaicin Model [NCT05181852] | Phase 1 | 24 participants (Anticipated) | Interventional | 2022-01-05 | Not yet recruiting | ||
| An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of The 82.5 Mg Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 25 Mg Of T [NCT01202435] | Phase 1 | 18 participants (Actual) | Interventional | 2010-10-31 | Completed | ||
| The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting [NCT00623285] | Phase 3 | 40 participants (Anticipated) | Interventional | 2008-04-30 | Recruiting | ||
| A 6-month, Open-label, Safety Trial Of Pregabalin In Adolescent Patients With Fibromyalgia [NCT01020526] | Phase 4 | 63 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| A Placebo-Controlled Trial of Pregabalin (Lyrica) for Irritable Bowel Syndrome [NCT00977197] | Phase 2 | 85 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pregabalin-Referenced, Parallel-Group, Adaptive Design Study of DVS SR in Adult Female Outpatients With Fibromyalgia Syndrome [NCT00696787] | Phase 2 | 125 participants (Actual) | Interventional | 2008-06-30 | Terminated | ||
| A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous Pregabalin and Acetaminophen (Ofirmev®) in Healthy Volunteers [NCT04265456] | Phase 1 | 63 participants (Actual) | Interventional | 2020-01-14 | Completed | ||
| Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial. [NCT00772291] | Phase 3 | 140 participants (Anticipated) | Interventional | 2007-05-31 | Completed | ||
| A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Comp [NCT00978341] | 15 participants (Actual) | Interventional | 2007-02-28 | Terminated(stopped due to See Detailed Description) | |||
| Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia [NCT00629681] | Phase 4 | 217 participants (Actual) | Interventional | 2004-11-30 | Completed | ||
| Lumbar Stenosis Outcomes Research (LUSTOR)- A Randomized, Double-blind, Cross-over Trial of Pregabalin vs. Diphenhydramine in Patients With Lumbar Spinal Stenosis and Neuropathic Low Back Pain [NCT00638443] | Phase 4 | 29 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| Pregabalin (Lyrica) Action In Neuropathic Pain Syndrome (PAINS): A Post Marketing Surveillance Study On Efficacy, Safety And Tolerability Of Pregabalin [NCT00892008] | 2,278 participants (Actual) | Observational | 2006-09-30 | Completed | |||
| Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal [NCT05995535] | Phase 2 | 150 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting | ||
| Prophylactic Pregabalin to Decrease Pain During Medical Abortion: a Randomized Controlled Trial [NCT02782169] | Phase 4 | 110 participants (Actual) | Interventional | 2015-06-30 | Completed | ||
| Bioequivalence Study of 150 mg Pregabalin Capsules Produced by PT Dexa Medica in Comparison With the Comparator Product (Lyrica® Capsule 150 mg, Pfizer Manufacturing Deutschland GmbH, Germany) [NCT02233777] | 20 participants (Actual) | Interventional | 2014-06-30 | Completed | |||
| A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain [NCT01345045] | Phase 2 | 193 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| Development of a Personalised Care Plan Designed to Reduce Chronic Post-Operative Pain Following Breast Surgery [NCT02170415] | 154 participants (Anticipated) | Interventional | 2014-06-30 | Active, not recruiting | |||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With HIV Neuropathy. [NCT00232141] | Phase 3 | 302 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Safety, Efficacy and Patient Acceptability of Topical Treatment Versus Systemic Treatment: a Randomized, Multicentre, Comparative Pragmatic Trial in Adult Patients Suffering From Diverse Localized Neuropathic Pain (LNP) Syndromes [NCT03348735] | Phase 4 | 33 participants (Actual) | Interventional | 2018-12-03 | Terminated(stopped due to Low inclusion rate) | ||
| A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia [NCT01603394] | Phase 4 | 9 participants (Actual) | Interventional | 2012-10-31 | Terminated(stopped due to See termination reason in detailed description.) | ||
| Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome [NCT00584246] | Phase 4 | 0 participants (Actual) | Interventional | 2007-11-30 | Withdrawn(stopped due to Study stopped due to budget (personnel) limitations.) | ||
| Exploratory Study on the Use of Pregabalin for the Treatment of Taxol Related Arthralgia-Myalgia [NCT02024568] | Phase 2 | 38 participants (Anticipated) | Interventional | 2013-12-31 | Not yet recruiting | ||
| the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia [NCT05071118] | Phase 4 | 70 participants (Actual) | Interventional | 2021-03-21 | Completed | ||
| Investigation of Pregabalin Therapy and Complex Rehabilitation in Treating Chronic Fatigue Associated With Post-COVID Syndrome [NCT05967052] | Phase 2 | 132 participants (Anticipated) | Interventional | 2023-10-24 | Recruiting | ||
| Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial [NCT03241875] | Phase 4 | 90 participants (Actual) | Interventional | 2016-12-01 | Completed | ||
| A Multi-center, Randomized, Double-blind, Parallel, Active-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of 'GLA5PR GLARS-NF1 Tab.' and 'Pregabalin' in Peripheral Neuropathic Pain [NCT03221907] | Phase 3 | 352 participants (Actual) | Interventional | 2016-04-11 | Completed | ||
| A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg and Immediate Release Formulation After Multiple Dosing Under Fasted Condition in Healthy Male Subjects [NCT02103647] | Phase 1 | 24 participants (Actual) | Interventional | 2013-05-31 | Completed | ||
| An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy [NCT00159731] | Phase 4 | 160 participants | Interventional | 2005-01-31 | Completed | ||
| Pregabalin in Partial Seizures (PREPS) Extension Study: An 18-month Follow-on Open-label, International, Multicenter Add-on Therapy Trial [NCT00143130] | Phase 3 | 227 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
| PROUD Study - Preventing Opioid Use Disorders [NCT04766996] | Phase 4 | 57 participants (Actual) | Interventional | 2021-05-17 | Terminated(stopped due to Loss of surgery team member deemed the study procedures impossible to achieve, and no replacement could be found in a timely manner to complete trial as initially planned.) | ||
| Preemptive Analgesia Combination of Celecoxib and Pregabalin in Total Hip Arthroplasty: Comparison of the Effects of Single Dose and Repeated Doses (Double-Blind Randomized Clinical Trial) [NCT05509946] | Phase 2/Phase 3 | 30 participants (Anticipated) | Interventional | 2022-10-01 | Not yet recruiting | ||
| The Impact of Pain on Behavioural Disturbances in Patients With Moderate and Severe Dementia. A Cluster Randomized Trial [NCT01021696] | Phase 2/Phase 3 | 352 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| A Multicenter, Double-Blind Randomized, Placebo-Controlled Study Of The Efficacy And Safety Of Pregabalin In The Treatment Of Subjects With Post-Operative Pain Following Total Knee Arthroplasty (TKA) [NCT00442546] | Phase 3 | 307 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
| An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy [NCT00553280] | Phase 3 | 123 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| A Phase 2, 26 Week, Multicentre, Randomized Double Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Tolterodine, Pregabalin and a Tolterodine-Pregabalin Combination for Idiopathic Overactive Bladder [NCT00746681] | Phase 2 | 188 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A LONG-TERM STUDY TO EVALUATE SAFETY AND EFFICACY STUDY OF PREGABALIN IN THE TREATMENT OF POSTHERPETIC NEURALGIA. [NCT00424372] | Phase 3 | 126 participants (Actual) | Interventional | 2007-01-12 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic Pancreatitis [NCT00755573] | Phase 2/Phase 3 | 64 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Randomized, Double-Blind, 6-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome [NCT00676403] | Phase 2 | 137 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A Multicenter Prospective Randomized Double-blind Placebo Controlled Trial Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome [NCT00998816] | Phase 3 | 0 participants (Actual) | Interventional | 2012-05-31 | Withdrawn(stopped due to No funding) | ||
| Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency [NCT00922987] | 286 participants (Actual) | Observational | 2009-09-30 | Completed | |||
| A 17 Week, Investigator-initiated, Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Trial of Pregabalin in Essential Tremor [NCT00646451] | Early Phase 1 | 20 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Pregabalin vs. Placebo as an Add on for Complex Regional Pain Syndrome of the Upper Limb Managed by Stellate Ganglion Block [NCT00891397] | 14 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to Unable to recruit patients) | |||
| Neurologic Signatures of Chronic Pain Disorders [NCT02747940] | Phase 4 | 200 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| Effects of Duloxetine on Pain Relief After Total Knee Arthroplasty in Central Sensitization Patient : A Randomized, Controlled, Double-Blind Trial [NCT02600247] | 100 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting | |||
| An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain [NCT00631943] | Phase 3 | 112 participants (Actual) | Interventional | 2004-11-30 | Completed | ||
| Efficacy of Pregabalin in Patients With Radicular Pain [NCT00908375] | Phase 4 | 39 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Phase 1, Randomized, Open-label, Single-dose, 6-period Study To Investigate The Effect Of In Vitro Dissolution Rate On The In Vivo Bioavailability Of Extended Release Formulations Of Pregabalin In Healthy Volunteers [NCT02725112] | Phase 1 | 25 participants (Actual) | Interventional | 2016-02-12 | Completed | ||
| Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting [NCT04181346] | Phase 2 | 82 participants (Anticipated) | Interventional | 2019-09-01 | Recruiting | ||
| Shifting Pain Modulation From Pro-to Anti-nociceptive: Individualized Prevention of Post Operative Pain [NCT02672202] | 9 participants (Actual) | Interventional | 2016-02-29 | Terminated(stopped due to Recruitment rate was slow so we could not complete the study.) | |||
| Preemptive Analgesia With Pregabalin in Heart Surgery: a Randomized Clinical Trial [NCT04173390] | Phase 2 | 230 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Pregabalin and Naproxen Sodium on Postoperative Pain After Bunionectomy [NCT00601458] | Phase 1 | 100 participants (Actual) | Interventional | 2007-07-31 | Completed | ||
| Pregabalin BID Add-on Trial: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Single-Center Sleep EEG Study in Patients With Partial Seizures and Sleep Disturbance Part B: a Randomized, Double-Blind, Placebo-Controlled Parallel-Group Study of [NCT00643136] | Phase 3 | 17 participants (Actual) | Interventional | 2002-11-30 | Completed | ||
| A Randomized Double-Blind Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP) [NCT02673866] | Phase 2 | 0 participants (Actual) | Interventional | 2016-02-29 | Withdrawn(stopped due to reassessment of phase 2 study indication) | ||
| The Effect of Pregabalin on Pain of Propofol Injection [NCT02668094] | 120 participants (Actual) | Interventional | 2016-02-29 | Completed | |||
| Efficacy of Perioperative Pregabalin in Reducing the Incidence of Chronic Neuropathic Pain and Postthoracotomy Syndrome. [NCT00967135] | 110 participants (Actual) | Interventional | 2010-06-30 | Completed | |||
| A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia [NCT00645398] | Phase 3 | 751 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
| Efficacy of Preoperative Melatonin Versus Pregabalin on Intraoperative Anxiolysis and Sedation During Hip Arthroplasty Under Regional Anesthesia [NCT05221151] | Phase 4 | 78 participants (Actual) | Interventional | 2022-01-30 | Completed | ||
| A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers [NCT02783183] | Phase 1 | 32 participants (Actual) | Interventional | 2016-06-30 | Completed | ||
| Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study [NCT00883740] | Phase 3 | 119 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| An Open-Label Multicenter Extension Study To Determine Long Term Safety And Efficacy Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures [NCT00596466] | Phase 3 | 75 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Qualification of Single Dose Administration of Analgesic Therapy in the Treatment of Chronic Neuropathic Pain in Patients With Painful Diabetic Neuropathy [NCT00837941] | Phase 2 | 0 participants (Actual) | Interventional | 2009-04-30 | Withdrawn | ||
| The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome [NCT05704374] | 36 participants (Anticipated) | Interventional | 2023-11-02 | Not yet recruiting | |||
| Assessment of Effect of an Experimental Pregabalin Gel in Reducing Post-operative Tooth Sensitivity Surgery Caused by Bleaching With 35% Hydrogen Peroxide [NCT06180707] | Phase 3 | 75 participants (Anticipated) | Interventional | 2024-01-05 | Not yet recruiting | ||
| A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms [NCT06049797] | 1,000 participants (Anticipated) | Observational | 2023-11-15 | Recruiting | |||
| Analgetic and Anxiolytic Effect of Preoperative Pregabalin in Patients Undergoing Surgery of the Vertebral Columna [NCT00353704] | Phase 4 | 50 participants (Actual) | Interventional | 2005-11-30 | Completed | ||
| A Double-Blind, Randomized, Multicenter Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures [NCT00524030] | Phase 3 | 161 participants (Actual) | Interventional | 2007-09-30 | Terminated(stopped due to See termination reason in detailed description.) | ||
| An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain [NCT00385671] | Phase 4 | 407 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury [NCT00407745] | Phase 3 | 220 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy [NCT00553475] | Phase 3 | 314 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
| A Randomized, Double Blind Multi Center Dose Ranging Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Adjunctive Treatment Of Post Surgical Pain After Primary Inguinal Hernia Repair [NCT00551135] | Phase 3 | 425 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropath [NCT00407511] | Phase 4 | 121 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo [NCT00631696] | Phase 4 | 222 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| A Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety and Efficacy of the Perioperative Administration of Pregabalin in Reducing the Incidence of Postoperative Delirium and Improving Acute Postoperative Pain Management [NCT00819988] | Phase 3 | 240 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Pregabalin (Lyrica) for the Treatment of Vulvodynia: A Randomized, Double-blinded, Placebo-controlled Cross-over Study [NCT00853229] | Phase 2 | 16 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to Not feasible due to low accrual) | ||
| Assessment of Pregabalin Efficacy for the Treatment and Prevention of At-level Non-evoked and Evoked Spinal Cord Injury Neuropathic Pain [NCT01479556] | Phase 4 | 82 participants (Anticipated) | Interventional | 2011-12-31 | Not yet recruiting | ||
| Analgesic Potentials of Preoperative Oral Pregabalin,Intravenous Magnesium Sulphate and Their Combination in Acute Post-thoracotomy Pain.(Randomized,Double-Blind Study) [NCT02678117] | Phase 3 | 120 participants (Actual) | Interventional | 2015-07-31 | Completed | ||
| Effects of Oral Pregabalin on Spinal Neurotransmitters in Patients Undergoing Total Knee Replacement (TKA) [NCT00729690] | Phase 3 | 48 participants (Actual) | Interventional | 2008-08-31 | Completed | ||
| A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery [NCT04015908] | Phase 4 | 100 participants (Actual) | Interventional | 2019-08-01 | Completed | ||
| A Placebo-Controlled, Escalating Dose, Multiple Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Pregabalin In Pediatric Patients With Partial Onset Seizures [NCT00437281] | Phase 1/Phase 2 | 65 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
| A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224) [NCT01270828] | Phase 3 | 806 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| Evaluation of Pregabalin in Idiopathic Small Fiber Neuropathy [NCT00787462] | 3 participants (Actual) | Interventional | 2008-02-29 | Terminated(stopped due to Restrictive inclusion criteria/limited pool of suitable subjects with SFN.) | |||
| Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS) [NCT00843284] | 691 participants (Actual) | Observational | 2006-09-30 | Completed | |||
| An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain [NCT00301223] | Phase 3 | 309 participants (Actual) | Interventional | 2006-02-28 | Completed | ||
| A Randomised Controlled Trial in the Palliative Setting Regarding Off-Label Medication: Investigating the Efficiency of Amitriptyline Versus Pregabalin From a Societal Perspective [NCT00740571] | Phase 3 | 130 participants (Anticipated) | Interventional | 2008-09-30 | Recruiting | ||
| A Randomized, Double-blind, Placebo-Controlled, Cross-over Study on the Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy [NCT02927951] | Phase 3 | 44 participants (Actual) | Interventional | 2011-01-31 | Completed | ||
| Effects of Pregabalin on Mechanical Hyperalgesia - EPOM [NCT00310583] | Phase 4 | 120 participants | Interventional | 2006-07-31 | Recruiting | ||
| The Short and Long Term Effects of Perioperative Pregabalin Use on Functional Rehabilitation, Pain Outcomes and Anxiety Following Total Hip Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. [NCT00762099] | Phase 4 | 184 participants (Anticipated) | Interventional | 2009-05-31 | Recruiting | ||
| Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial [NCT02868801] | Phase 3 | 280 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting | ||
| A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy [NCT00781131] | Phase 4 | 101 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Open Label Trial Concerning the Effectiveness of Trazodone in the Treatment of Fibromyalgia (Phase I) and Its Augmentation With Pregabalin in Trazodone Partial Responders (Phase II) [NCT00791739] | Phase 4 | 66 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Pregabalin Given to Tobacco Users to Study Addiction [NCT00644137] | Early Phase 1 | 24 participants (Actual) | Interventional | 2007-08-31 | Completed | ||
| Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study. [NCT00629889] | Phase 2 | 52 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| Post Marketing Surveillance Study For Observing Safety And Efficacy Of Lyrica [NCT01220180] | 4,175 participants (Actual) | Observational | 2006-07-31 | Completed | |||
| Pregabalin Acute Effects on Cortical Excitability, Psychophysical Parameters, and Serum Markers of Neuroplastic Processes in Fibromyalgia: a Placebo Controlled, Double Blinded, Randomized, Crossover Clinical Trial [NCT02639533] | Phase 2/Phase 3 | 27 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
| Efficacy of Pregabalin in the Treatment of Orofacial Neuropathic Pain [NCT00852436] | Phase 2 | 1 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to difficulty to recruit patients) | ||
| Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial. A Phase IV Open-Label Trial Using 150,300, 600 mg/Day Of Pregabalin [NCT00407797] | Phase 4 | 136 participants (Actual) | Interventional | 2007-03-31 | Terminated | ||
| Does Pregabalin Improve Post-operative Pain After C-section Delivery [NCT04259073] | 138 participants (Actual) | Interventional | 2018-03-01 | Completed | |||
| Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial [NCT04653792] | Phase 4 | 84 participants (Actual) | Interventional | 2018-06-04 | Completed | ||
| The Effects Of Pre-emptive Single Oral Dose Pregabalin on Attenuating Maternal Anxiety And Stress Response To Intubation During Caesarean Section [NCT04622202] | Phase 1/Phase 2 | 74 participants (Anticipated) | Interventional | 2020-11-15 | Recruiting | ||
| Can Pregabalin Prevent the Development of Neuropathic Pain Following Spinal Cord Injury? A Double-Blind, Randomized, Placebo Controlled Trial. [NCT00879021] | Phase 3 | 5 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to lack of funding and patients) | ||
| Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin [NCT01397006] | Phase 4 | 0 participants (Actual) | Interventional | 2011-09-30 | Withdrawn | ||
| Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia for Postoperative Pain Control, Placebo-controlled RCT, 2021 [NCT05389813] | Phase 2/Phase 3 | 150 participants (Anticipated) | Interventional | 2021-08-15 | Enrolling by invitation | ||
| A Methodology Study To Assess The Feasibility Of Using Functional Magnetic Resonance Imaging (fRMI) To Quantify The Effects Of Analgesic Drugs In Post-Traumatic Neuropathic Pain Subjects [NCT00610155] | 18 participants (Actual) | Interventional | 2008-09-30 | Completed | |||
| Perioperative Administration of Pregabalin in Laparoscopic Living Donor Nephrectomy (L-LDN) - an Adjuvance to Peroral Analgetic Treatment - a Randomized Controlled Study [NCT01059331] | Phase 4 | 80 participants (Actual) | Interventional | 2010-02-28 | Completed | ||
| A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery [NCT00785382] | Phase 4 | 62 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For The Treatment Of Fibromyalgia [NCT00830128] | Phase 3 | 106 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
| The Effect of Preemptive Oral Pregabalin as an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized, Prospective, Double Blind Study. [NCT05804591] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-04-24 | Recruiting | ||
| A Randomized, Double-blind, Parallel-group Multi-center Comparative Flexible-dose Trial Of Pregabalin Versus Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures. [NCT00537940] | Phase 4 | 482 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| A Randomized, Double-Blind, Parallel-Group Multi-Center Comparative Flexible-Dose Study Of Pregabalin Versus Levetiracetam As Adjunctive Therapy To Reduce Seizure Frequency In Subjects With Partial Seizures [NCT00537238] | Phase 3 | 509 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
| A Study of Pregabalin (Lyrica) Augmentation in Serotonin Reuptake Inhibitor-Refractory Obsessive Compulsive Disorder [NCT00994786] | Phase 4 | 15 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| Long Term Safety And Efficacy Study Of Pregabalin (Lyrica) In Subjects With Generalized Anxiety Disorder [NCT00624780] | Phase 4 | 615 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Effect of Preoperative Pregabalin Administration on the Postoperative Opioid Consumption in Patients Undergoing Nephrectomy [NCT00957177] | Phase 3 | 20 participants (Anticipated) | Interventional | 2009-04-30 | Completed | ||
| An Asian, Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Pregabalin-controlled, Dose-finding Study of DS-5565 in Patients With Pain Associated With Diabetic Peripheral Neuropathy [NCT01504412] | Phase 2 | 450 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| An Observational Study Efficacy and Safety of Memantine XR (Extended Release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) [NCT03709888] | 20 participants (Actual) | Observational | 2016-07-09 | Completed | |||
| A Prospective, Randomized, Double Blinded, Placebo Controlled Pilot Study Assessing the Effect of Perioperative Pregabalin on the Incidence of Chronic Post Thoracotomy Pain Syndrome [NCT00663962] | Phase 4 | 15 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia [NCT03797560] | 104 participants (Actual) | Interventional | 2019-03-22 | Completed | |||
| A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders [NCT00150449] | Phase 3 | 511 participants | Interventional | 2001-01-31 | Completed | ||
| Study PXN110448: A Dose-response Study of XP13512, Compared With Concurrent Placebo Control and LYRICA(Pregabalin), in Subjects With Neuropathic Pain Associated Withdiabetic Peripheral Neuropathy (DPN) [NCT00643760] | Phase 2 | 421 participants (Actual) | Interventional | 2008-03-31 | Completed | ||
| Open Labelled Study of Pregabalin in the Treatment of Neuropathic Pain in Cervical Myeloradiculopathy (Pregabalin and Radicular Pain Study (PARPS)) [NCT01061697] | Phase 4 | 50 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD) [NCT00413010] | Phase 3 | 356 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| A 12-month Open-label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Pregabalin In Pediatric Patients With Partial Onset Seizures [NCT00448916] | Phase 3 | 54 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
| Lyrica (Pregabalin) Administered As An Add-On Therapy For Partial Seizures (LEADER) An Open-Label, Multicenter Add-On Therapy Trial [NCT00288639] | Phase 4 | 98 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Randomized, Comparative, Double-Blind, Parallel-Group, Multicenter, Monotherapy, Study Of Pregabalin (Lyrica) And Lamotrigine (Lamictal) In Patients With Newly Diagnosed Partial Seizures [NCT00280059] | Phase 3 | 660 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer [NCT00380874] | Phase 4 | 64 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to See detailed description for termination reason) | ||
| Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy [NCT01047488] | Phase 4 | 75 participants (Anticipated) | Interventional | 2010-02-28 | Not yet recruiting | ||
| An Open-Label, Multiple-Dose, Randomized, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate R [NCT01009541] | Phase 1 | 20 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia [NCT00346034] | Phase 3 | 357 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia. [NCT00333866] | Phase 3 | 747 participants (Actual) | Interventional | 2006-07-31 | Completed | ||
| Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome [NCT01061372] | Phase 3 | 0 participants (Actual) | Interventional | 2010-05-31 | Withdrawn | ||
| A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain [NCT00292188] | Phase 4 | 255 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
| A Multiple Dose, Randomized, Double-Blind Multicenter Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo In The Treatment Of Patients With Post-Surgical Pain From Hysterectomy [NCT00468845] | Phase 3 | 501 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
| A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-St [NCT00313820] | Phase 4 | 220 participants (Actual) | Interventional | 2006-08-31 | Completed | ||
| A 15 Week, Randomized, Double Blind, Parallel-group, Placebo-controlled, Flexible-dose, Safety And Efficacy Study Of Pregabalin In Adolescents (12-17 Years Old) With Fibromyalgia [NCT01020474] | Phase 4 | 107 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| A Randomized, Double-Blind, Comparative, Multi-Center, Phase Ⅳ Clinical Trial to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis [NCT01888536] | Phase 4 | 182 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| Study of the Brain With Optic Functional Neuroimaging in Patients With Chronic Pain Using Transcranial Direct Current Stimulation [NCT01904097] | Phase 2 | 34 participants (Anticipated) | Interventional | 2013-03-31 | Recruiting | ||
| The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain [NCT06066918] | 50 participants (Anticipated) | Interventional | 2021-07-13 | Recruiting | |||
| Effectiveness of Preemptive Use of Pregabalin on Pain Intensity and Postoperative Morphine Consumption After Laparoscopic Colorectal Surgery [NCT01940224] | 50 participants (Actual) | Interventional | 2013-07-31 | Completed | |||
| "Use of Duloxetine or Pregabalin in Monotherapy Versus Combination Therapy of Both Drugs in Patients With Painful Diabetic Neuropathy The COMBO - DN (COmbination vs Monotherapy of pregaBalin and dulOxetine in Diabetic Neuropathy) Study" [NCT01089556] | Phase 3 | 811 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy. [NCT00209495] | Phase 4 | 130 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
| Does Perioperative Pregabalin Reduce Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery Under Spinal Anesthesia? [NCT03211728] | 96 participants (Actual) | Interventional | 2017-07-19 | Completed | |||
| An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Chronic Neuropathic Pain. [NCT00141362] | Phase 3 | 325 participants | Interventional | 2001-10-31 | Completed | ||
| Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial [NCT04122196] | Phase 2/Phase 3 | 118 participants (Actual) | Interventional | 2020-06-01 | Active, not recruiting | ||
| Multicentric, Open, Randomized Study Comparing Topical Treatment by Patch of Capsaicin to 8% (Qutenza) to Pregabalin Oral in the Early Treatment of Neuropathic Pain After Primary Surgery for Breast Cancer [NCT03794388] | Phase 3 | 140 participants (Actual) | Interventional | 2019-03-19 | Completed | ||
| [NCT02020122] | 5 participants (Actual) | Interventional | 2014-01-31 | Completed | |||
| Evaluation of the Efficacy of Perioperative Administration of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery. A Double-Blinded Randomized Controlled Trial. [NCT05935059] | 90 participants (Anticipated) | Interventional | 2023-06-21 | Recruiting | |||
| Effectiveness of Pregabalin Treatment for Trigger Points in Patients With Comorbid Myofascial Pain Syndrome and Fibromyalgia Syndrome: a Randomized Controlled Trial [NCT04600037] | 40 participants (Actual) | Interventional | 2014-04-26 | Completed | |||
| Does Optimal Pain Control With Pregabalin and Celecoxib Predict Improved Function After Total Hip Arthroplasty? [NCT00581685] | Phase 3 | 31 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| The Role of Pregabalin in the Treatment of Post-Operative Pain in Fracture Patients [NCT00583869] | Early Phase 1 | 86 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
| A Multi-site, Double-blind, Randomized, Placebo-controlled, Crossover Study of Pregabalin (Lyrica, PGB) in the Treatment of Essential Tremor [NCT00584376] | Phase 4 | 29 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
| Research of Pregabalin Stabilize Cardiovascular Response to Laryngoscopy and Tracheal Intubation of Patients Under General Anesthesia [NCT03456947] | Phase 4 | 90 participants (Actual) | Interventional | 2017-01-01 | Completed | ||
| An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain) [NCT01202227] | Phase 3 | 104 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain [NCT04532684] | Phase 4 | 66 participants (Actual) | Interventional | 2016-10-31 | Completed | ||
| Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty [NCT04471233] | Phase 4 | 250 participants (Actual) | Interventional | 2020-12-09 | Completed | ||
| An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Periph [NCT01332149] | Phase 3 | 626 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
| Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial [NCT02724293] | Phase 2/Phase 3 | 60 participants (Actual) | Interventional | 2014-09-30 | Completed | ||
| Methodology Study To Assess The Ability Of A Randomized, Double-Blind, Placebo-Controlled, Two Period Crossover Study To Detect The Effect Of Pregabalin In Post-Traumatic Neuropathic Pain Patients [NCT00654940] | Phase 1 | 25 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice [NCT00855738] | Phase 4 | 111 participants (Actual) | Interventional | 2007-05-31 | Completed | ||
| The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia [NCT02868814] | Phase 3 | 240 participants (Anticipated) | Interventional | 2016-05-31 | Recruiting | ||
| A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome [NCT00991276] | Phase 3 | 85 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| The Effect of Pregabalin on the Spinal Anesthesia: Randomized Controlled Placebo Study [NCT02690506] | 44 participants (Actual) | Interventional | 2016-02-29 | Completed | |||
| An Open-Label, Extension Safety Trial Of Pregabalin In Subjects With Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081251) [NCT01145417] | Phase 3 | 217 participants (Actual) | Interventional | 2010-07-31 | Terminated(stopped due to See termination reason in detailed description.) | ||
| Effect of Pregabalin on Colonic Sensorimotor Function in Healthy Adults. [NCT01094808] | Phase 4 | 62 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| A Open-label, Randomized, Crossover Clinical Trial to Assess the PK of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR and the Food Effect of High Fat Diet After Single Dosing in Healthy Male Volunteers [NCT02783638] | Phase 1 | 64 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
| Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin（CI-1008）In The Treatment Of Fibromyalgia [NCT00830167] | Phase 3 | 498 participants (Actual) | Interventional | 2009-03-31 | Completed | ||
| Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin [NCT02612233] | Phase 4 | 81 participants (Actual) | Interventional | 2013-09-30 | Completed | ||
| A TWO WEEK DOUBLE-BLIND PLACEBO-CONTROLLED CROSSOVER STUDY TO COMPARE THE EFFICACY AND SAFETY OF A PREGABALIN/PF-00489791 COMBINATION VERSUS PREGABALIN ALONE IN PATIENTS WITH POST-HERPETIC NEURALGIA [NCT00599638] | Phase 2 | 72 participants (Actual) | Interventional | 2008-04-09 | Completed | ||
| A Comparison of Pregabalin (Lyrica®) to Placebo in Postoperative Pain Relief of Patients Status-post Photorefractive Keratectomy: A Double-masked Randomized Prospective Study [NCT01097577] | 130 participants (Actual) | Interventional | 2010-03-31 | Completed | |||
| Postoperative Oxycodone Consumption After Spinal Surgery in Pregabalin-treated Patients Compared to a 48-h Perioperative Administration: a Prospective, Observational Study [NCT02866396] | 70 participants (Actual) | Observational | 2016-09-30 | Completed | |||
| Randomized Double-Blind, Multi-Center Study Of Efficacy And Tolerability Of Pregabalin Versus Placebo As An Adjunct To Standard Of Care For Perioperative Management Of Patients Undergoing Total Hip Arthroplasty [NCT00905437] | Phase 3 | 72 participants (Actual) | Interventional | 2009-11-30 | Terminated(stopped due to The Study was terminated on May 24th 2012 due to a slow recruitment rate. The study was not terminated for reasons of safety or efficacy.) | ||
| A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo [NCT01117766] | 31 participants (Actual) | Interventional | 2006-12-31 | Completed | |||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial Of Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy (Pregabalin A0081244) [NCT01049217] | Phase 3 | 377 participants (Actual) | Interventional | 2010-04-30 | Terminated(stopped due to See termination reason in detailed description.) | ||
| NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS [NCT04660773] | Phase 2 | 40 participants (Anticipated) | Interventional | 2021-08-01 | Recruiting | ||
| Randomized Phase II Trial Evaluating Activity and Tolerability of Fixed Dose of Oxycodone and Increasing Dose of Pregabalin Versus Increasing Dose of Oxycodone and Fixed Dose of Pregabalin for the Treatment of Oncological Neuropathic Pain [NCT00637975] | Phase 2 | 80 participants (Anticipated) | Interventional | 2007-09-30 | Completed | ||
| Effect of Preoperative Administration of Oral Pregabalin on the Postoperative Analgesia in Patients Scheduled for Radiofrequency Ablationof Focal Lesions in the Liver [NCT03151213] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-05-01 | Recruiting | ||
| Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study [NCT04771741] | 72 participants (Actual) | Observational | 2020-12-01 | Completed | |||
| [S,S]-Reboxetine Add-On Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial Of [S,S]-Reboxetine In Patients With Postherpetic Neuralgia (PHN) Concomitantly Treated With Pregabalin. [NCT00334685] | Phase 2 | 136 participants (Actual) | Interventional | 2006-08-22 | Terminated(stopped due to The Data Monitoring Committee terminated the study on the basis of futility (insufficient clinical response).) | ||
| Pregabalin Has Additive Analgesic and Ventilatory Depressive Effects in Combination With Remifentanil [NCT01419405] | Phase 4 | 12 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects [NCT01420913] | Phase 1 | 28 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy [NCT01466101] | 0 participants (Actual) | Interventional | 2011-01-31 | Withdrawn(stopped due to PI left the institution. No subjects screened or enrolled.) | |||
| Effect of Application of Low Dose of Pregabalin in TJA Before the Day of Surgery on Reducing Postoperative Side Effect of This Medicine [NCT04599894] | Phase 4 | 58 participants (Actual) | Interventional | 2020-11-01 | Completed | ||
| Randomized, Double Blind, 12-Month Study Of Pregabalin In Subjects With Restless Legs Syndrome [NCT00806026] | Phase 3 | 731 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
| POST-MARKETING SURVEILLANCE (PMS) TO OBSERVE THE SAFETY AND EFFECTIVENESS OF LYRICA(REGISTERED) CR EXTENDED RELEASE TABLETS [NCT04171453] | 600 participants (Anticipated) | Observational | 2020-02-03 | Recruiting | |||
| A Phase 2a Randomized, Double-Blind, Multicenter, Placebo and Active Controlled Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy [NCT02372578] | Phase 2 | 115 participants (Actual) | Interventional | 2015-05-27 | Terminated(stopped due to The study was terminated due to futility analysis.) | ||
| The Clinical Effect of Pregabalin on Neuropathic Pain in Non Central Sensitized Patients After Total Knee Arthroplasty: Randomized Controlled Trial [NCT05322681] | 90 participants (Anticipated) | Interventional | 2022-05-31 | Not yet recruiting | |||
| An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy. [NCT00150423] | Phase 3 | 384 participants | Interventional | 2001-01-31 | Completed | ||
| Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery [NCT03216187] | Phase 3 | 300 participants (Anticipated) | Interventional | 2018-01-09 | Recruiting | ||
| A Multicenter, Double-blind, Randomized, Placebo and Active-controlled Study of Pregabalin for the Treatment of Uremic Pruritus [NCT01852318] | Phase 4 | 210 participants (Anticipated) | Interventional | 2014-04-30 | Not yet recruiting | ||
| Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain [NCT01863810] | Phase 3 | 394 participants (Anticipated) | Interventional | 2013-08-31 | Not yet recruiting | ||
| Effect of Pregabalin in Patients With Radiotherapy-Related Neuropathic Pain: a Randomized, Double-blind, Placebo-controlled Trial [NCT01869569] | Phase 2 | 137 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| A 12-MONTH OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC SUBJECTS 1 MONTH TO 16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES AND PEDIATRIC AND ADULT SUBJECTS 5 TO 65 YEARS OF AGE WITH PRIMARY GENERAL [NCT01463306] | Phase 3 | 605 participants (Actual) | Interventional | 2012-02-21 | Completed | ||
| RCT of Duloxetine & Pregabalin for the Treatment of Gulf War Illness in Veterans [NCT01846182] | Phase 2 | 112 participants (Actual) | Interventional | 2015-06-24 | Terminated(stopped due to Terminated by Funder) | ||
| A Phase 2A, Randomized, Blinded, Placebo- and Active-controlled, 2-Period Crossover Study to Assess the Analgesic Efficacy, Safety, and Tolerability of ADL5747 in Subjects With Postherpetic Neuralgia [NCT01058642] | Phase 2 | 41 participants (Actual) | Interventional | 2010-01-31 | Terminated | ||
| Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction [NCT06025474] | Phase 3 | 203 participants (Anticipated) | Interventional | 2023-01-01 | Recruiting | ||
| A Double-blind, Placebo-Controlled Trial of Pregabalin for the Treatment of Alcohol Use Disorder [NCT04322305] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-01-11 | Suspended(stopped due to U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.) | ||
| Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer. [NCT02924675] | Phase 2 | 42 participants (Actual) | Interventional | 2015-06-05 | Terminated(stopped due to not sufficiency recruitment) | ||
| A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures [NCT01262677] | Phase 3 | 325 participants (Actual) | Interventional | 2011-02-17 | Completed | ||
| A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Pregabalin Capsule-Controlled, 13-Week, Adaptive-design Phase 2/3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Diabetic Peripheral Neuropathic P [NCT04647773] | Phase 2/Phase 3 | 687 participants (Anticipated) | Interventional | 2020-12-02 | Not yet recruiting | ||
| 'Fix the Dysfunction' Concept for Mechanism-based Pharmacological Treatment of Neuropathic Pain by Drug [NCT03276689] | 300 participants (Actual) | Interventional | 2017-10-19 | Completed | |||
| A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking [NCT01474772] | Phase 3 | 217 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| A 14-week, Randomized, Double-blind Placebo-controlled Study For Pregabalin In Subjects With Fibromyalgia [NCT01387607] | Phase 3 | 343 participants (Actual) | Interventional | 2012-02-06 | Completed | ||
| An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn ) [NCT01455428] | Phase 4 | 223 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial [NCT02240199] | Phase 3 | 100 participants (Actual) | Interventional | 2014-11-30 | Completed | ||
| A Double-blind, Randomised, Parallel Groups Investigation Into the Effects of Pregabalin, Duloxetine and Amitriptyline on Aspects of Pain, Sleep, and Next Day Performance in Patients Suffering From Diabetic Peripheral Neuropathy [NCT00370656] | Phase 2/Phase 3 | 90 participants (Anticipated) | Interventional | 2007-02-28 | Completed | ||
| SPECIAL INVESTIGATION OF LONG TERM USE OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN) [NCT01279850] | 891 participants (Actual) | Observational | 2011-08-31 | Completed | |||
| Prospective, Double-blinded, Randomised, Placebo Controlled Trial of Pre-emptive Analgesia to Prevent Pain Following Sternotomy for Cardiac Surgery. [NCT01480765] | Phase 4 | 150 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting | ||
| A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia [NCT00230776] | Phase 3 | 740 participants | Interventional | 2005-10-31 | Completed | ||
| Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for a Primary Total Hip Replacement [NCT00235261] | Phase 4 | 120 participants (Anticipated) | Interventional | 2005-10-31 | Completed | ||
| A 12-Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia [NCT00282997] | Phase 3 | 500 participants | Interventional | 2006-02-28 | Completed | ||
| A Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or Paroxetine [NCT00291148] | Phase 3 | 75 participants (Anticipated) | Interventional | 2006-03-31 | Completed | ||
| A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF PREGABALIN AS ADJUNCTIVE THERAPY IN CHILDREN 4 -16 YEARS OF AGE WITH PARTIAL ONSET SEIZURES [NCT01389596] | Phase 3 | 295 participants (Actual) | Interventional | 2011-09-27 | Completed | ||
| Placebo-Controlled Study of Pregabalin for the Pain of Acute Herpes Zoster [NCT00352651] | Phase 2 | 34 participants (Anticipated) | Interventional | 2006-06-30 | Terminated(stopped due to "This study should be terminated as the study has been closed for years and the investigator has since retired. No records are available.~Thank you, Marlene") | ||
| Pregabalin Add-On Titration Trial: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Pregabalin (150 mg - 600 mg/Day) Using a Flexible, Optimized Dose Schedule in Subjects With Partial Seizures [NCT00141258] | Phase 3 | 178 participants (Actual) | Interventional | 2005-10-31 | Completed | ||
| Pregabalin BID Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures. [NCT00141336] | Phase 3 | 750 participants | Interventional | 1999-11-30 | Completed | ||
| An Open-Label Extension to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury. [NCT00141375] | Phase 3 | 132 participants | Interventional | 2002-08-31 | Completed | ||
| Pregabablin Open-Label, Follow-On Safety Trial In Patients With Refractory Partial Epilepsy. [NCT00141414] | Phase 2 | 82 participants | Interventional | 1997-11-30 | Completed | ||
| A Double-Blind Randomized Placebo-Controlled Trial of the Time to Onset of Pain Relief in Subjects With Post Therapeutic Neuralgia (PHN) Treated With Pregabalin (150 - 600 Mg/Day Flexible Optimized Dose or 300 Mg/Day Fixed Dose) or Placebo [NCT00159666] | Phase 4 | 255 participants | Interventional | 2004-10-31 | Completed | ||
| A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy [NCT00159705] | Phase 3 | 276 participants (Actual) | Interventional | 2005-04-30 | Completed | ||
| Pregabalin Open-Label, Multicenter Add-On Trial Following a 4-Day Double-Blind Transition Period to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures. [NCT00141245] | Phase 3 | 325 participants | Interventional | 1998-10-31 | Completed | ||
| An Open-Label, Extension Safety and Efficacy Study of Pregabalin in Patients With Painful Diabetic Peripheral Neuropathy. [NCT00141401] | Phase 3 | 240 participants | Interventional | 1999-09-30 | Completed | ||
| The Effects of GABA Medications on Cocaine Responses in Humans [NCT00142883] | 72 participants (Actual) | Interventional | 2004-09-30 | Terminated(stopped due to Study has been completed) | |||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial of Pregabalin Versus Placebo in the Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy [NCT00143156] | Phase 3 | 450 participants | Interventional | 2005-03-31 | Completed | ||
| A 14-Week, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Pregabalin (150mg-600mg/Day) Using A Flexible Optimal Dose Schedule In Patients With Painful Diabetic Peripheral Neuropathy (DPN). [NCT00156078] | Phase 4 | 450 participants | Interventional | 2005-01-31 | Completed | ||
| Randomized Clinical Trial of Pregabalin for Opioid Withdrawal Syndrome [NCT03017430] | Phase 4 | 100 participants (Actual) | Interventional | 2014-01-31 | Completed | ||
| PharmacofMRI of Anxiolytic Medications (Pregabalin) [NCT00706836] | Phase 4 | 16 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy [NCT00905580] | Phase 4 | 99 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study) [NCT01789216] | Phase 3 | 450 participants (Actual) | Interventional | 2013-07-31 | Completed | ||
| A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled, 2-way Crossover Study Of Pregabalin In The Treatment Of Fibromyalgia With Concurrent Antidepressant Therapy For Comorbid Depression (Protocol A0081275) [NCT01432236] | Phase 3 | 197 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| Behavioral Effects of Drugs (Outpatient)(43) [NCT01511640] | Early Phase 1 | 30 participants (Actual) | Interventional | 2017-02-01 | Completed | ||
| Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures. [NCT00150293] | Phase 3 | 337 participants | Interventional | 2002-03-31 | Completed | ||
| The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy. [NCT05160493] | Phase 2/Phase 3 | 246 participants (Anticipated) | Interventional | 2021-12-20 | Recruiting | ||
| A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Fibromyalgia (Protocol A0081245) [NCT01271933] | Phase 3 | 441 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| [NCT00447369] | Phase 3 | 70 participants (Anticipated) | Interventional | 2007-05-31 | Withdrawn(stopped due to Because we did not find funds to do it) | ||
| Perioperative Administration of Pregabalin in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: Does it Help to Relieve Postoperative Pain? [NCT01242332] | Phase 4 | 60 participants (Actual) | Interventional | 2009-08-31 | Completed | ||
| Outcomes Of Perioperative Pregabalin On Total Knee Arthroplasty: A Randomized Controlled Trial [NCT02954484] | Phase 3 | 116 participants (Actual) | Interventional | 2015-04-30 | Completed | ||
| Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCT [NCT01528540] | 87 participants (Actual) | Interventional | 2012-04-30 | Completed | |||
| Effect of Preoperative Pregabalin on Pain Intensity and Interleukin-6 Levels in Living Donor Kidney [NCT01529190] | Phase 2 | 40 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy [NCT00378547] | Phase 4 | 147 participants (Actual) | Interventional | 2006-01-31 | Terminated(stopped due to ENT surgery stopped at the recruiting hospital) | ||
| Pregabalin Open-Label Add-On Trial: An Open-Label, Multicenter Follow-On Study to Determine Long-Term Safety and Efficacy in Patients With Partial Seizures. [NCT00141388] | Phase 3 | 455 participants (Actual) | Interventional | 1998-07-31 | Completed | ||
| Pregabalin In Partial Seizures (Preps) : An Open-Label, International, Multicenter Add-On Therapy Trial [NCT00141427] | Phase 4 | 540 participants | Interventional | 2004-11-30 | Completed | ||
| Pregabalin BID Open-Label Add-On Trial: A Follow-Up Study To Determine Long-Term Safety and Efficacy in Patients With Partial Seizures [NCT00143143] | Phase 3 | 300 participants | Interventional | 2001-09-30 | Completed | ||
| Pregabalin for Pain Reduction in Critical Limb Ischemia - A Double Blind, Randomized Controlled Study [NCT00403780] | Phase 4 | 18 participants (Actual) | Interventional | 2006-06-30 | Terminated(stopped due to low inclusion rate) | ||
| An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia [NCT00150436] | Phase 3 | 276 participants | Interventional | 2002-02-28 | Completed | ||
| An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients [NCT00151450] | Phase 3 | 390 participants | Interventional | 2005-03-31 | Completed | ||
| A Six-Month, Double-Blind, Placebo Controlled, Durability of Effect Study of Pregabalin for Pain Associated With Fibromyalgia [NCT00151489] | Phase 3 | 1,020 participants | Interventional | 2005-04-30 | Completed | ||
| A Long-Term, Open-Label, Safety Trial of Pregabalin in Patients With Fibromyalgia [NCT00151528] | Phase 3 | 428 participants | Interventional | 2005-01-31 | Completed | ||
| A 13 Week, Double-Blind, Placebo-Controlled Phase 4 Trial of Pregabalin (CI-1008, 600 mg/Day) for Relief of Pain in Subjects With Painful Diabetic Peripheral Neuropathy [NCT00159679] | Phase 4 | 167 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
| A Prospective, Randomized Controlled Trial on Perioperative Pregabalin to Reduce Late-onset Complex Regional Pain Syndrome After Total Knee Arthroplasty [NCT00558753] | Phase 2 | 240 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| Investigation of Somatosensory Predictors of Response to Pregabalin in Painful Chemotherapy-induced Peripheral Neuropathy (CIPN) [NCT02394951] | 26 participants (Actual) | Interventional | 2015-04-30 | Completed | |||
| Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline [NCT01309074] | Phase 4 | 0 participants (Actual) | Interventional | 2009-11-30 | Withdrawn(stopped due to No subjects could be enrolled and therefore we decided to withdraw/stop the study.) | ||
| Comparative Study for Decrease of Pain Intensity and Pain Sensitivity Between Pregabalin + COX-2 Inhibitor and COX-2 Inhibitor in Patients With Lumbar Spinal Stenosis: Randomized Controlled Trial [NCT03584074] | Phase 4 | 60 participants (Anticipated) | Interventional | 2018-07-01 | Not yet recruiting | ||
| Psychosocial and Psychophysical Factors Influencing the Effect of Preemptive Systemic Analgesia in Combination With Regional Anesthesia on Postoperative Pain Following Upper Limb Surgery [NCT05248152] | 90 participants (Anticipated) | Interventional | 2022-01-13 | Recruiting | |||
| Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial [NCT05447364] | Phase 4 | 82 participants (Anticipated) | Interventional | 2021-07-01 | Recruiting | ||
| A Phase 2, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Study Evaluating the Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Postherpetic Neuralgia (PHN) [NCT01688947] | Phase 2 | 105 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Of The Anxiolytic Efficacy Of Pregabalin And Alprazolam IR In Subjects With Anxiety Prior To Dental Procedure [NCT00245609] | Phase 2 | 90 participants | Interventional | 2006-01-31 | Completed | ||
| DRUG USE INVESTIGATION OF LYRICA(REGULATORY POST MARKETING COMMITMENT PLAN) [NCT01256593] | 3,827 participants (Actual) | Observational | 2011-02-05 | Completed | |||
| Analgesic Efficacy of Pre-operative Oral Pregabalin in Dacryocystorhinostomy Surgery [NCT05455944] | 100 participants (Actual) | Interventional | 2020-01-01 | Completed | |||
| Pregablin for Anxiety-comorbidity in Patients With Schizophrenia - a Double-blinded Randomized Placebo Controlled Study [NCT01496690] | Phase 4 | 54 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg With Immediate Release Formulation and to Assess The Effect of High Fat Diet in Healthy Male Subjects [NCT01635751] | Phase 1 | 30 participants (Actual) | Interventional | 2012-10-31 | Completed | ||
| A Randomized, Open-label, Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin GLARS Tablet 150mg and Immediate Release Formulation After Multiple Dosing Under Fed Condition in Healthy Male Subjects [NCT01638273] | Phase 1 | 24 participants (Actual) | Interventional | 2014-02-28 | Completed | ||
| A Comparison Between Pregabalin and Gabapentin as Adjuvants to Opioids in Elective Lumber Micro Discectomy to Control Postoperative Pain. (A Prospective Randomized Controlled Study) [NCT05539924] | Phase 3 | 72 participants (Anticipated) | Interventional | 2022-09-15 | Enrolling by invitation | ||
| Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome [NCT05324761] | Phase 4 | 60 participants (Actual) | Interventional | 2022-04-25 | Completed | ||
| The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery [NCT01701921] | Phase 2/Phase 3 | 94 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
| Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study [NCT01713426] | Phase 4 | 568 participants (Actual) | Interventional | 2012-07-11 | Completed | ||
| Efficacy of Preoperative Pregabalin on the Post-caesarean Pain; a Dose-response Study [NCT01719705] | Phase 1 | 135 participants (Actual) | Interventional | 2012-11-30 | Completed | ||
| Efficacy Of Pregabalin In The Treatment Of Pancreatic Cancer Pain. A Randomized Controlled Double-Blind, Parallel Group Study [NCT01768988] | Phase 4 | 20 participants (Actual) | Interventional | 2012-08-31 | Terminated(stopped due to Change of PI. Former PI changed from Research Center and Promoter obliged unexpectedly to change the PI.) | ||
| Evaluation of the Impact of Subject and Staff Training on the Pregabalin vs. Placebo Difference in Subjects With Painful Diabetic Neuropathy (PDN) [NCT01770964] | Phase 4 | 90 participants (Anticipated) | Interventional | 2012-12-31 | Recruiting | ||
| A Randomized,Open-label,Six-sequence,Three-period,Three-treatment,Multiple Dosing Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Pregabalin and Thioctic Acid After Oral Administration in Healthy Male Volunteers [NCT01808300] | Phase 1 | 42 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery [NCT01811251] | Phase 3 | 162 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
| Opioid-Induced Hyperalgesia in Prescription Opioid Abusers: Effects of Pregabalin [NCT01821430] | Phase 2 | 4 participants (Actual) | Interventional | 2013-03-31 | Terminated(stopped due to poor recruitment) | ||
| Efficacy of Pregabalin and Duloxetine in Patients With Painful Diabetic Peripheral Neuropathy (PDPN): the Effect of Pain on Cognitive Function, Sleep and Quality of Life (BLOSSOM) [NCT04246619] | Phase 4 | 254 participants (Actual) | Interventional | 2019-11-12 | Terminated(stopped due to The statistical analysis will still provide relevant results with the same statistical power as initially planned.COVID-19 pandemic prolonged the recruiting period and consequently affected the costs of the clinical trial.) | ||
| Pregabalin for the Treatment of Pain After Posterior Spinal Fusions. [NCT01366196] | 86 participants (Actual) | Interventional | 2008-10-31 | Completed | |||
| Effects of Oral Pregabalin Versus Placebo on Postoperative Pain and Morphine Consumption After Mastectomy [NCT01391858] | Phase 3 | 80 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| A Pilot Study at a Single-Institution of Pregabalin in the Management of Mucositis Pain in Patients Undergoing Chemoradiation Therapy to the Head and Neck. [NCT02277548] | 20 participants (Actual) | Interventional | 2014-05-31 | Completed | |||
| A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain [NCT02985216] | Phase 3 | 371 participants (Actual) | Interventional | 2017-02-07 | Completed | ||
| A Multiple Dose Pharmacokinetic Open-label Study Of Pregabalin (Lyrica Registered) In Healthy Lactating Women [NCT01727791] | Phase 4 | 10 participants (Actual) | Interventional | 2012-12-31 | Completed | ||
| A Phase 1, Randomized, Open Label, Single Dose, 5-treatment, 5- Period Crossover Study in Healthy Volunteers to Assess The Safety, Tolerability, and Pharmacokinetics of Four Controlled Release Pregabalin Tablet Formulations Administered Following an Eveni [NCT01443169] | Phase 1 | 16 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
| PHASE III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin in Prevention and Reduction of Oxaliplatin-induced Painful Neuropathy [NCT01450163] | Phase 3 | 200 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| A Phase 4, Double-Blind, Placebo-Controlled, Crossover Study Comparing Simulated Driving Performance, Daytime Sedation, and Cognition in Healthy Volunteers Taking Therapeutic Doses of Gralise®, Neurontin®, or Lyrica® [NCT03179345] | Phase 4 | 32 participants (Actual) | Interventional | 2015-09-24 | Completed | ||
| Efficacy of Pre-emptive Different Doses of Oral Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Patients Subjected for Elective Lumbar Spine Fixation Surgery: a Randomized Controlled Trial [NCT04342065] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2019-01-01 | Completed | ||
| A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain [NCT00838799] | Phase 2 | 458 participants (Actual) | Interventional | 2009-02-28 | Completed | ||
| A Randomized Double Blind Placebo And Active Controlled Parallel Group Phase 2 Study To Evaluate PF-05089771 As A Monotherapy And As An Add-on To Pregabalin For The Treatment Of Painful Diabetic Peripheral Neuropathy [NCT02215252] | Phase 2 | 141 participants (Actual) | Interventional | 2014-11-10 | Completed | ||
| SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA [NCT01773993] | 534 participants (Actual) | Observational | 2013-02-28 | Completed | |||
| Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain [NCT01450345] | Phase 3 | 72 participants (Anticipated) | Interventional | 2009-09-30 | Recruiting | ||
| Comparative Study Between Analgesic Effect of Oral Prednisolone and Oral Pregabalin in Management of Post-dural Puncture Headache in Patients Undergoing Lower Limb Surgeries [NCT04662125] | 63 participants (Actual) | Interventional | 2020-12-10 | Completed | |||
| Confirmatory Study of Efficacy and Safety of the Pregabalin/Tramadol Combination Versus Pregabalin in the Management of Acute Pain of Neuropathic Origin. [NCT05324059] | Phase 3 | 110 participants (Actual) | Interventional | 2022-07-11 | Completed | ||
| Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Urological Surgical Operations [NCT03229668] | Phase 2/Phase 3 | 78 participants (Actual) | Interventional | 2017-07-28 | Completed | ||
| Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery [NCT04862845] | Phase 1 | 72 participants (Anticipated) | Interventional | 2021-05-15 | Not yet recruiting | ||
| Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy [NCT05547659] | Phase 1/Phase 2 | 95 participants (Actual) | Interventional | 2019-01-01 | Completed | ||
| A Randomized Controlled, Single-blind, Esketamine Adjuvant Therapy for the Efficacy and Safety of Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder [NCT04847245] | 80 participants (Anticipated) | Interventional | 2021-05-01 | Not yet recruiting | |||
| A Japan Post-Marketing, Randomized, Double-Blind, Parallel-Group, Flexible Dose Comparative Study to Assess the Non-Inferiority of Duloxetine Compared With Pregabalin in Patients With Diabetic Peripheral Neuropathic Pain [NCT02417935] | Phase 4 | 304 participants (Actual) | Interventional | 2015-04-30 | Completed | ||
| [NCT01726205] | Phase 4 | 45 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Does Pregabalin Reduce the Sevoflurane Requirement During Laparoscopic Cholecystectomy? Mansoura University Hospitals Experience. [NCT01571804] | Phase 2 | 42 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy [NCT01587339] | 6,498 participants (Actual) | Observational | 2010-09-30 | Completed | |||
| Effects of Perioperative Low-dose Pregabalin on Post-craniotomy Pain: A Two-centre Randomized Controlled Trial [NCT01591980] | Phase 4 | 0 participants (Actual) | Interventional | 2013-08-31 | Withdrawn(stopped due to Pfizer Canada and the SMH ORA could not come into an agreement on responsibility to be the Importer of Record for the trial.) | ||
| Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization [NCT05460871] | Phase 4 | 24 participants (Anticipated) | Interventional | 2023-02-21 | Recruiting | ||
| Peri-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Elective Neurosurgical Patients: A Randomized, Comparative, Placebo-controlled, Double Blind Study [NCT01612832] | 100 participants (Anticipated) | Interventional | 2012-06-30 | Not yet recruiting | |||
| [NCT01614236] | 100 participants (Anticipated) | Interventional | 2012-07-31 | Not yet recruiting | |||
| A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 150 mg Will Improve Pain Control in Patients With Hepatocellular Carcinoma Undergoing Partial Hepatectomy [NCT01923948] | 40 participants (Actual) | Interventional | 2013-05-31 | Completed | |||
| Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD [NCT02884908] | Phase 3 | 252 participants (Anticipated) | Interventional | 2016-09-30 | Active, not recruiting | ||
| Effect of Two Different Doses of Oral Pregabalin Premedication for Postoperative Pain Relief After Gynecological Surgeries [NCT04708353] | 90 participants (Anticipated) | Interventional | 2020-08-20 | Recruiting | |||
| Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot [NCT03927781] | Phase 3 | 10 participants (Actual) | Interventional | 2019-04-01 | Completed | ||
| Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study. [NCT00954187] | 8 participants (Actual) | Interventional | 2009-11-30 | Terminated(stopped due to PI left institution) | |||
| A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain [NCT04641273] | Phase 2 | 154 participants (Actual) | Interventional | 2021-01-22 | Terminated(stopped due to Lack of efficacy) | ||
| Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB (Ultraviolet)-Irradiated Skin in Healthy Male Volunteers (a Single-blinded [NCT02037165] | Phase 1 | 25 participants (Actual) | Interventional | 2014-01-21 | Completed | ||
| RC11C3, Pilot Placebo-controlled Evaluation of Pregabalin as a Means to Prevent the Paclitaxel-Associated Acute Pain Syndrome [NCT01637077] | Phase 2 | 46 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Combining Pregabalin (LYRICA®) With Lofexidine (LUCEMYRATM): Can it Increase the Success of Transition to Naltrexone? [NCT04218240] | Phase 2 | 90 participants (Actual) | Interventional | 2020-12-20 | Completed | ||
| Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine [NCT02285010] | Phase 4 | 125 participants (Actual) | Interventional | 2014-11-30 | Completed | ||
| A Randomized Controlled Trial Comparing Pregabalin and Placebo in Patients With Persistent Globus Sensation [NCT05432843] | Phase 4 | 90 participants (Anticipated) | Interventional | 2010-03-12 | Recruiting | ||
| A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) [NCT00371033] | Phase 3 | 318 participants (Anticipated) | Interventional | 2006-03-31 | Active, not recruiting | ||
| A Phase 4 Randomized Double-Blind Double-Dummy Placebo & Active-Controlled Single-Dose Six-Way Crossover Study Evaluating the Abuse Potential of Lyrica® Taken Orally With Oxycodone HCL in Healthy Non-Drug Dependent Recreational Opioid Users [NCT05053126] | Phase 4 | 60 participants (Actual) | Interventional | 2021-07-27 | Completed | ||
| Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia [NCT05020600] | 40 participants (Anticipated) | Observational | 2021-08-19 | Recruiting | |||
| An Open-Label Pilot Study of Pregabalin as Treatment for Alcohol Use Disorder [NCT03256253] | Phase 2 | 18 participants (Actual) | Interventional | 2018-02-15 | Completed | ||
| MAST Trial: Multi-modal Analgesic Strategies in Trauma [NCT03472469] | Phase 4 | 1,561 participants (Actual) | Interventional | 2018-04-02 | Completed | ||
| A Clinical Approach to Validate the Biological Significance of LPC16:0 as a Discriminating and Pathogenic Biomarker of Fibromyalgia [NCT04832100] | 400 participants (Anticipated) | Observational | 2017-08-01 | Recruiting | |||
| Efficacy and Safety of Pregabalin in Treatment of Neuropathic Pain in Patients With Idiopathic Small Fiber Neuropathy [NCT02607254] | Phase 2 | 11 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
| Comparison Between Single Dose Pregabalin and Magnesium Sulfate in Controlled Hypotension During Functional Endoscopic Sinus Surgery [NCT05442931] | Phase 1/Phase 2 | 60 participants (Anticipated) | Interventional | 2022-05-01 | Recruiting | ||
| Comparison Between the Effect of Dexmedetomidine, Melatonin and Pregabalin on Hypotensive Anesthesia in Patients Undergoing Functional Endoscopic Sinus Surgery [NCT05829148] | Early Phase 1 | 120 participants (Anticipated) | Interventional | 2023-05-01 | Not yet recruiting | ||
| A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 300 mg Will Improve Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass (Bariatric Surgery) [NCT01801189] | Phase 4 | 61 participants (Actual) | Interventional | 2013-02-28 | Completed | ||
| Double Blinded, Randomized, Placebo Controlled Study in Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae [NCT03031340] | Phase 3 | 3 participants (Actual) | Interventional | 2012-05-31 | Terminated(stopped due to Incidence of AE) | ||
| A Prospective Randomized Blinded Placebo Controlled Comparison of Multimodal Pre-emptive Analgesia on Long Term Outcome Following Uterine Artery Embolization [NCT01555073] | Phase 4 | 23 participants (Actual) | Interventional | 2011-10-31 | Terminated(stopped due to Subjects did not meet inclusion criteria) | ||
| A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions [NCT01455415] | Phase 3 | 306 participants (Actual) | Interventional | 2011-12-31 | Completed | ||
| A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy [NCT01496365] | Phase 2 | 452 participants (Actual) | Interventional | 2011-11-28 | Completed | ||
| Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery [NCT03202459] | 60 participants (Anticipated) | Interventional | 2017-03-02 | Recruiting | |||
| Pregabalin Effects on Hypotensive Anesthesia During Spine Surgery. [NCT03301025] | 106 participants (Actual) | Interventional | 2018-01-08 | Completed | |||
| Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial [NCT03186443] | Phase 3 | 342 participants (Anticipated) | Interventional | 2017-10-01 | Not yet recruiting | ||
| A Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Of The Efficacy And Safety Of Pregabalin As Adjunctive Therapy In Children 1 Month Through <4 Years Of Age With Partial Onset Seizures [NCT02072824] | Phase 3 | 175 participants (Actual) | Interventional | 2014-09-16 | Completed | ||
| [NCT02340455] | 0 participants (Actual) | Interventional | 2014-12-31 | Withdrawn(stopped due to To rebalance the study plan because it is not desirable to set up comparators using placebo.) | |||
| The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study [NCT05083793] | Phase 2 | 90 participants (Anticipated) | Interventional | 2020-04-01 | Enrolling by invitation | ||
| National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Praga Formulation in the Treatment of Neuropathic Pain [NCT04666714] | Phase 3 | 136 participants (Anticipated) | Interventional | 2023-07-31 | Not yet recruiting | ||
| Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567] | Phase 3 | 407 participants (Actual) | Interventional | 2015-01-31 | Terminated | ||
| Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy. [NCT01939366] | Phase 2 | 699 participants (Actual) | Interventional | 2013-09-27 | Completed | ||
| A Double Blind, Double Dummy, Randomized, Placebo-controlled, 5 Period Cross-over Study To Examine The Effect Of Pf-05089771 Alone And In Combination With Pregabalin On Evoked Pain Endpoints In Healthy Volunteers Using Pregabalin And Ibuprofen As Positive [NCT02349607] | Phase 1 | 25 participants (Actual) | Interventional | 2015-01-31 | Completed | ||
| A Randomized, Open, Single-dose, 3-treatment, 3-period, 6-sequence Crossover Study in Healthy Male Subjects to Evaluate the Pharmacokinetics of GLA5PR GLARS-NF1 Tablet 150mg and LYRICA® Capsule 75mg [NCT02326987] | Phase 1 | 30 participants (Actual) | Interventional | 2013-10-31 | Completed | ||
| Efficacy of Variable Doses of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain: A Comparative Study [NCT05292066] | Early Phase 1 | 126 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting | ||
| A Randomized, Double-Blind, Placebo-Controlled, Single Center Study Designed to Assess the Effects of Pregabalin on Change in Patients With Diabetic Neuropathy [NCT00573261] | Phase 4 | 40 participants (Actual) | Interventional | 2006-03-31 | Completed | ||
| Population Pharmacokinetics of Antiepileptic in Pediatrics [NCT03196466] | 1,000 participants (Anticipated) | Observational | 2017-06-19 | Recruiting | |||
| Effectiveness of Adding Duloxetine to Pregabalin in Treatment of Acute Postoperative and Prevention of Chronic Pain Following Thoracotomy Surgeries; Randomized Controlled Study [NCT04782310] | Phase 4 | 75 participants (Anticipated) | Interventional | 2021-03-10 | Recruiting | ||
| The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs [NCT03473093] | Early Phase 1 | 80 participants (Anticipated) | Interventional | 2018-03-31 | Not yet recruiting | ||
| Prospective Controlled Crossover Study of the Role of Pentoxifylline in the Management of Lumbar Radiculopathy [NCT03060434] | Phase 4 | 67 participants (Actual) | Interventional | 2018-06-01 | Active, not recruiting | ||
| Multimodal Opioid-free Anesthesia Versus Opioid-based Anesthesia for Patients Undergoing Cardiac Valve Surgeries: A Randomized Controlled Trial [NCT04648540] | Early Phase 1 | 60 participants (Actual) | Interventional | 2020-12-01 | Completed | ||
| A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER TRIAL OF PREGABALIN AS ADJUNCTIVE THERAPY IN PEDIATRIC AND ADULT SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES - PROTOCOL A0081105 [NCT01747915] | Phase 3 | 219 participants (Actual) | Interventional | 2013-04-03 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With Painful Diabetic Neuropathy and Good Pain Reporting Ability [NCT01928381] | Phase 2 | 150 participants (Actual) | Interventional | 2013-11-30 | Completed | ||
| A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain [NCT01701362] | Phase 3 | 542 participants (Actual) | Interventional | 2012-10-31 | Completed | ||
| Duloxetine Versus Pregabalin for Alcohol Dependence [NCT00929344] | Phase 2 | 150 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
| Perioperative Administration of Pregabalin for Pain After Mastectomy [NCT00938548] | Phase 4 | 70 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| [NCT01675986] | Phase 2 | 306 participants (Actual) | Interventional | Completed | |||
| Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial) [NCT04846673] | Phase 4 | 150 participants (Anticipated) | Interventional | 2021-05-14 | Recruiting | ||
| Multicenter, Randomized, Open-label, Parallel Group, Phase IV Study to Compare the Efficacy and Safety of Gabapentin/B-complex Versus Pregabalin in the Management of Diabetic Peripheral Neuropathic Pain [NCT01364298] | Phase 4 | 353 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| A Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of 6-week Treatment of Pregabalin Against Frequent Muscle Cramp in Patients With Liver Cirrhosis [NCT01271660] | Phase 3 | 60 participants (Actual) | Interventional | 2011-07-31 | Completed | ||
| Efficacy of Pregabalin for the Treatment of Acute Herpetic Neuralgia and for the Prevention of Post Herpetic Neuralgia- a Randomized Controlled Trial [NCT03809702] | Phase 4 | 82 participants (Actual) | Interventional | 2018-07-15 | Completed | ||
| Effect of Pregabalin on Colonic Motor and Sensory Function in Adults With Irritable Bowel Syndrome With Predominant Constipation [NCT01331213] | Phase 4 | 18 participants (Actual) | Interventional | 2011-04-30 | Completed | ||
| Efficacy of Pregabalin on Chronic Cough: A Double Blind, Randomized Control Trial Comparing Pregabalin With Placebo in Patients With Non-asthmatic Chronic Cough [NCT02482818] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2015-09-30 | Recruiting | ||
| Role of Preoperative Oral Pregabalin in Reducing Inhalational Anesthetic Requirements in Elective Abdominal Hysterectomy Under General Anesthesia: A Randomized Controlled Trial [NCT03302208] | Phase 3 | 50 participants (Actual) | Interventional | 2017-06-29 | Completed | ||
| A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess Efficacy and Safety of Pregabalin in Willis-Ekbom Disease/Restless Legs Syndrome [NCT04161027] | Phase 3 | 116 participants (Actual) | Interventional | 2020-02-24 | Completed | ||
| Effects of Pre-operative Pregabalin and Ketamine to Prevent Development of Phantom Pain in Patients Undergoing Lower Extremity Amputation [NCT02311777] | Phase 3 | 0 participants (Actual) | Interventional | 2015-05-15 | Withdrawn(stopped due to Preoperative period is very short time) | ||
| Evaluation of the Effectiveness, Safety, and Tolerability of Tapentadol PR Versus a Combination of Tapentadol PR and Pregabalin in Subjects With Severe Chronic Low Back Pain With a Neuropathic Pain Component [NCT01352741] | Phase 4 | 622 participants (Actual) | Interventional | 2011-03-31 | Completed | ||
| Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology [NCT03890133] | 60 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting | |||
| Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery. [NCT06117917] | Phase 2/Phase 3 | 150 participants (Anticipated) | Interventional | 2023-11-10 | Not yet recruiting | ||
| A Multicenter, Randomized, Double-Blind, Double-Dummy , Pregaballin-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Herpetic Neuralgia [NCT05763550] | Phase 2 | 331 participants (Actual) | Interventional | 2023-02-27 | Completed | ||
| Comparison of Pain and Comfort in Patients Following Cardiac Surgery: Opioid- Morphine Managed Versus Multimodal Pain-management [NCT04987372] | Phase 4 | 100 participants (Actual) | Interventional | 2019-01-21 | Completed | ||
| Evaluation of the Efficacy, Tolerability, and Safety of 7 Days of Treatment With GRT6010 or Pregabalin in Comparison to Placebo in Subjects With Peripheral Neuropathic Pain. [NCT01485094] | Phase 2 | 114 participants (Actual) | Interventional | 2012-02-29 | Terminated(stopped due to The trial was early terminated after it was concluded that there was no added benefit from exposing further participants after an unblinded interim analysis.) | ||
| A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia [NCT02146430] | Phase 3 | 1,293 participants (Actual) | Interventional | 2014-10-27 | Completed | ||
| A Phase 1, Single-Center, Randomized, Placebo-Controlled, Ascending Single-Dose Study of the Pharmacokinetics, Safety, and Tolerability of Oral XG005 in Healthy Volunteers [NCT04499209] | Phase 1 | 50 participants (Actual) | Interventional | 2017-10-16 | Completed | ||
| A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia [NCT02187159] | Phase 3 | 1,270 participants (Actual) | Interventional | 2014-11-30 | Completed | ||
| A Phase III, Randomized, Double-Blind, Placebo-Controlled Evaluation of Pregabalin for Alleviating Hot Flashes [NCT00702949] | Phase 3 | 207 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| Effect of Pregabalin on Immediate Post-operative and Longterm Pain and Spinal Cord Monitoring in Children Undergoing Instrumented Spinal Surgery. [NCT02464813] | Phase 4 | 64 participants (Actual) | Interventional | 2015-08-01 | Completed | ||
| A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing [NCT03261427] | Phase 1 | 17 participants (Actual) | Interventional | 2017-09-14 | Completed | ||
| Effect of Pregabalin Administration on Catheter- Related Bladder Discomfort in Orthopedic Surgical Operations [NCT03232021] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2017-08-16 | Withdrawn(stopped due to All patients during the study period were subjected to peripheral blocks or were excluded from the study due to exclusion criteria) | ||
| Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis? [NCT02701764] | Phase 2/Phase 3 | 43 participants (Actual) | Interventional | 2016-07-26 | Completed | ||
| A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia [NCT02187471] | Phase 3 | 1,301 participants (Actual) | Interventional | 2015-01-16 | Completed | ||
| A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Concomitant Administration Of Celecoxib And Pregabalin Compared With Celecoxib Monotherapy, In Patients With Chronic Low Back Pain Having A Neuropathic Compone [NCT01838044] | Phase 4 | 180 participants (Actual) | Interventional | 2013-10-31 | Terminated(stopped due to Recruitment terminated on 3Apr2015 due to slow recruitment rate and lack of operational feasibility. Study was not terminated for reasons of safety/efficacy.) | ||
| Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS) [NCT02260388] | Phase 4 | 402 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
| NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions In Denmark [NCT01524796] | 128 participants (Actual) | Observational | 2012-01-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Awaken Short of Breath or with a Headache sub-scale scores range from 0 to 100, lower scores indicate less difficulty. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.90 |
| Placebo | 9.98 |
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 30% responder at endpoint is a subject who has a 30% or more reduction in mean pain score at endpoint compared to baseline (NCT00141219)
Timeframe: Endpoint- Week 8 or Early Discontinuation
| Intervention | participants (Number) | |
|---|---|---|
| Yes | No | |
| Placebo | 27 | 50 |
| Pregabalin | 68 | 93 |
HADS-A consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.01 |
| Placebo | 6.86 |
PGIC is a subject-rated instrument that measured change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse. (NCT00141219)
Timeframe: Week 8
| Intervention | participants (Number) | ||
|---|---|---|---|
| Improved | No change | Worse | |
| Placebo | 54 | 12 | 9 |
| Pregabalin | 118 | 29 | 11 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Optimal Sleep sub-scale score is a binary outcome derived from Sleep Quantity (SQ): the response is YES (or 1) if SQ = 7 or 8 hours per night. (NCT00141219)
Timeframe: Week 8
| Intervention | participants (Number) | |
|---|---|---|
| No | Yes | |
| Placebo | 44 | 31 |
| Pregabalin | 85 | 73 |
DSIS consists of an 11-point rating scale ranging from 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Overall Comparison= 8-week average. (NCT00141219)
Timeframe: Weeks 1 to 8
| Intervention | score on scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall Comparison (Weeks 1 to 8) | Week 1 (n= 161, 77) | Week 2 (n=156, 75) | Week 3 (n=154, 72) | Week 4 (n=151, 68) | Week 5 (n=146, 66) | Week 6 (n=145, 65) | Week 7 (n=142, 62) | Week 8 (n=138, 62) | |
| Placebo | 3.97 | 4.56 | 4.24 | 4.13 | 3.95 | 3.73 | 3.74 | 3.71 | 3.72 |
| Pregabalin | 3.46 | 4.18 | 3.74 | 3.55 | 3.41 | 3.29 | 3.22 | 3.19 | 3.10 |
DPRS is 11-point rating scale (0=no pain to 10=worst possible pain). Subjects instructed to describe pain (upon awakening) during preceding 24 hrs by choosing appropriate number between 0-10. Mean endpoint pain score obtained from last 7 available DPRS scores of daily pain diary while subject on study medication. Overall Comparison=8-week average. (NCT00141219)
Timeframe: Weeks 1 to 8
| Intervention | score on scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall Comparison (weeks 1 to 8) | Week 1 (n=161, 77) | Week 2 (n=156, 75) | Week 3 (n=154, 72) | Week 4 (n=151, 68) | Week 5 (n=146, 66) | Week 6 (n=145, 65) | Week 7 (n=142, 62) | Week 8 (n=138, 62) | |
| Placebo | 5.29 | 6.18 | 5.61 | 5.42 | 5.27 | 5.11 | 4.93 | 4.87 | 4.92 |
| Pregabalin | 4.91 | 5.80 | 5.30 | 5.02 | 4.84 | 4.69 | 4.64 | 4.52 | 4.47 |
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed. (NCT00141219)
Timeframe: Weeks 1 to 8
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -1.24 |
| Placebo | -0.87 |
EQ-5D is a subject-completed questionnaire to assess health-related QOL (Health State Profile (HSP) & Visual Analog Scale (VAS)). The VAS is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 61.53 |
| Placebo | 58.03 |
EQ-5D, a subject-completed questionnaire, assesses health-related QOL. QOL Health State Profile (HSP) is designed to record subject's level of current health across 5 domains (mobility, self-care, usual activities, pain/discomfort & anxiety/depression); scores are used to calculate EQ-5D Utility Score; range: -0.594 to 1.000 (from worst to best). (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.651 |
| Placebo | 0.626 |
"HADS-D consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression" (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 7.54 |
| Placebo | 7.73 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Overall Sleep Problems Index is a 9-item sub-scale; scores range from 0 to 100, lower scores indicate fewer sleep problems. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 32.27 |
| Placebo | 34.40 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Adequacy sub-scale scores range from 0 to 100, higher scores indicate greater sleep adequacy. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 48.81 |
| Placebo | 46.65 |
DAAC is a score used to assess treatment effects averaged over the entire length of the study. DAAC from baseline to weekly mean pain score was derived by calculating the mean of all post-baseline scores minus baseline mean pain score, and then weighing this according to the proportion of the planned study duration the subject actually completed. (NCT00141219)
Timeframe: Weeks 1 to 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.27 |
| Placebo | -0.89 |
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication. (NCT00141219)
Timeframe: Endpoint- Week 8 or Early Discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.47 |
| Placebo | 4.94 |
DPRS is 11-point rating scale from 0 (no pain) to 10 (worst possible pain). Subjects instructed to describe their pain (daily upon awakening) during preceding 24 hrs by choosing the appropriate number between 0-10. Mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while subject on study medication. (NCT00141219)
Timeframe: Endpoint- Week 8 or Early Discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.63 |
| Placebo | 5.13 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Disturbance sub-scale scores range from 0 to 100, lower scores indicate less disturbance. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 28.96 |
| Placebo | 34.58 |
DPRS consists of an 11-point rating scale ranging from 0 (no pain) to 10 (worst possible pain). A 50% responder at endpoint is a subject who has a 50% or more reduction in mean pain score at endpoint compared to baseline. (NCT00141219)
Timeframe: Endpoint- Week 8 or Early Discontination
| Intervention | participants (Number) | |
|---|---|---|
| Yes | No | |
| Placebo | 11 | 66 |
| Pregabalin | 42 | 119 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Sleep Quantity sub-scale scores range from 0 to 24 (number of hours slept). (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.46 |
| Placebo | 6.02 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Snoring sub-scale scores range from 0 to 100, lower scores indicate less snoring. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 34.21 |
| Placebo | 29.16 |
DSIS consists of an 11-point rating scale (0 = pain did not interfere with sleep to 10 = completely interfered with sleep). Higher score indicating greater level of sleep disturbance. (NCT00141219)
Timeframe: Endpoint- Week 8 or Early Discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.26 |
| Placebo | 3.91 |
MOS Sleep Scale is a subject-rated questionnaire consisting of 12 items that assess the key constructs of sleep; assesses sleep for the 4 weeks prior to evaluation. The MOS Somnolence sub-scale scores range from 0 to 100, lower scores indicate less somnolence. (NCT00141219)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 34.02 |
| Placebo | 29.31 |
CGIC is a clinician-rated instrument that assesses the subject's overall global improvement on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improved = minimally improved, much improved, and very much improved; Worse = minimally worse, much worse, and very much worse. (NCT00141219)
Timeframe: Week 8
| Intervention | participants (Number) | ||
|---|---|---|---|
| Improved | No change | Worse | |
| Placebo | 51 | 16 | 10 |
| Pregabalin | 117 | 37 | 6 |
two components to the EQ-5D: a Health State Profile (scores from five domains are used to calculate the utility score :0 refers to dead and a score of 1 refers to perfect health) and a Visual Analogue Scale (VAS) (0 represents the worst imaginable health state and 100 represents the best imaginable health state) (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| Health State Profile | Visual Analog Scale | |
| Placebo | -0.07 | -2.09 |
| Pregabalin | -0.01 | -0.03 |
Mean Change from Randomization in Score from Hospital Anxiety and Depression Scale (HADS): 2 subscales, measuring anxiety (HADS-A)and depression (HADS-D). 7 items in each subscale assessed on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). which yields the score ranging 0-21. (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| HADS-A | HADS-D | |
| Placebo | 1.2 | 0.8 |
| Pregabalin | -0.1 | -0.4 |
Mean Change from Randomization: score at mBPI observation minus score at randomization. mBPI is extent to which pain interferes with daily activities on a 0 (no interference) to 10 (completely interfered) scale. (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| Pain interference | Pain severity | |
| Placebo | 0.92 | 1.06 |
| Pregabalin | 0.16 | 0.29 |
"Change in Mean Pain score = Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)." (NCT00219544)
Timeframe: 9 weeks
| Intervention | score on scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Change from randomization to Week 5 (n=70, 64) | Change from randomization to Week 6 (n=66, 63) | Change from randomization to Week 7 (n=60, 56) | Change from randomization to Week 8 (n=63,53) | Change from randomization to Week 9 (n=67,58) | |
| Placebo | 0.71 | 1.05 | 0.87 | 0.83 | 0.84 |
| Pregabalin | -0.01 | 0.08 | -0.06 | -0.10 | 0.14 |
"Mean Change: score from observation minus score from randomization: PTSS Impact module of 8-items & Satisfaction module of 6-items; item scores 1-5.~Mean score for each module transformed onto scale 0- 100, where score 0 =worst possible response and score 100~=best possible response: Score =[(5 - mean non-missing items)*100]/4." (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| impact of current pain medication | satisfaction with current pain medication | |
| Placebo | -7.95 | -8.35 |
| Pregabalin | -1.96 | -1.86 |
"Change in Mean SI score: Mean SI score at observation minus mean SI score at week 4. Mean SI Score = mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) is 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep." (NCT00219544)
Timeframe: 9 weeks
| Intervention | score on scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Change from randomization to Week 5 (n=70, 64) | Change from randomization to Week 6 (n=66, 63) | Change from randomization to Week 7 (n=60, 56) | Change from randomization to Week 8 (n=63,53) | Change from randomization to Week 9 (n=67,58) | |
| Placebo | 0.59 | 0.97 | 0.78 | 0.72 | 0.73 |
| Pregabalin | 0.07 | 0.10 | -0.03 | -0.13 | -0.01 |
"Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)." (NCT00219544)
Timeframe: Week 4 (end of single-blind treatment phase)
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-Responders | |
| Pregabalin | 165 | 90 |
"Number of subjects that responded to PGIC Categories. PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from~1 (very much improved) to 7 (very much worse)." (NCT00219544)
Timeframe: Week 9
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 12 | 32 | 17 | 7 | 6 | 0 | 1 |
| Pregabalin | 21 | 35 | 15 | 6 | 0 | 1 | 0 |
"Mean Pain scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11-point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)." (NCT00219544)
Timeframe: Week 4 - 9
| Intervention | score on scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 4 (n=73, 70) | Week 5 (n=70,64) | Week 6 (n=66,63) | Week 7 (n=60,56) | Week 8 (n=63,53) | Week 9 (n=67,58) | |
| Placebo | 2.49 | 3.14 | 3.40 | 3.20 | 3.16 | 3.29 |
| Pregabalin | 2.68 | 2.62 | 2.75 | 2.53 | 2.51 | 2.80 |
"Pain score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available pain scores from daily pain diary while on single-blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)." (NCT00219544)
Timeframe: 0 and 4 weeks
| Intervention | score on scale (Mean) | |
|---|---|---|
| Week 0 - Baseline | Week 4 - end of single-blind treatment | |
| Pregabalin | 6.29 | 3.79 |
"Mean Sleep Interference scores for weeks 4, 5, 6, 7, 8 and 9. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep." (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 4 (n=73, 70) | Week 5 (n=70,64) | Week 6 (n=66,63) | Week 7 (n=60,56) | Week 8 (n=63,53) | Week 9 (n=67,58) | |
| Placebo | 1.62 | 2.24 | 2.53 | 2.38 | 2.36 | 2.40 |
| Pregabalin | 1.68 | 1.76 | 1.85 | 1.66 | 1.59 | 1.66 |
"Sleep Interference (SI) score at Week 0 and Week 4, end of single-bind treatment. Mean of last 7 available SI scores from daily SI diary while on single-blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep." (NCT00219544)
Timeframe: 0 and 4 weeks
| Intervention | score on scale (Mean) | |
|---|---|---|
| Week 0 - Baseline | Week 4 - end of single-blind treatment | |
| Pregabalin | 4.80 | 2.72 |
"Change from baseline of mean of last 7 available pain scores from daily pain diary while on single-blind treatment. Daily Pain Rating Score:11-point numerical scale 0 (no pain) to 10 (worst possible pain). Non-Responders = <30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline." (NCT00219544)
Timeframe: Week 4
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -0.49 |
"Daily Pain Rating Score:11-point numerical scale 0 (no pain) to 10 (worst possible pain). Responders = ≥30% reduction in mean pain score at end of single-blind treatment phase compared to weekly mean pain score at baseline." (NCT00219544)
Timeframe: Week 4
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -3.60 |
"Mean Sleep Interference (SI) score at end of Double-Blind treatment = mean of last 7 available SI scores from daily SI diary while on Double-Blind treatment. Daily SI rating scale (DSIS) consists of an 11-point numerical scale : Zero means pain does not interfere with sleep and 10 means pain completely interferes with sleep." (NCT00219544)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.81 |
| Placebo | 2.52 |
"Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 (no pain) to 10 (worst possible pain)." (NCT00219544)
Timeframe: 9 weeks
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.84 |
| Placebo | 3.62 |
Number of participants who experienced a meaningful increase in pain also includes participants who took rescue medication for pain due to peripheral neuropathic pain or discontinued from the study . (NCT00219544)
Timeframe: Week 9
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 28 |
| Placebo | 28 |
Mean number of days in each pain category. DPRS Daily Pain Rating Score Categories: No pain (score 0), Mild pain (scores 1-3), Moderate pain (scores 4-6), Severe pain (scores 7-10) (NCT00219544)
Timeframe: Week 9
| Intervention | days (Mean) | |||
|---|---|---|---|---|
| No pain | Mild pain | Moderate pain | Severe pain | |
| Placebo | 0.9 | 17.4 | 8.6 | 1.7 |
| Pregabalin | 3.3 | 19.5 | 7.4 | 1.2 |
Change in Scale from randomization to Week 9. Scale to measure Neuropathic Pain -Visual Analog Scale (NeP - VAS): the subject places a mark on the VAS scale (0 to 100) where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. (NCT00219544)
Timeframe: Week 4, Week 9
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.9 |
| Placebo | 15.9 |
Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. 10 pain descriptors questions answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). 2 items related to temporal pain assessed on 5-point scales. The NPSI derives 5 pain subscores & a total intensity score calculated from the 5 pain subscores (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Burning (n=127,126) | Pressing (n=125,126) | Paroxysmal (n=127,127) | Evoked (n=126,128) | Paresthesia/dysesthesia (n=126,128) | Total score (n=124,126) | |
| Placebo | -0.22 | -0.15 | -0.17 | -0.15 | -0.23 | -0.01 |
| Pregabalin | -0.19 | -0.17 | -0.16 | -0.16 | -0.19 | -0.01 |
The modified Gracely Pain Scale is a 13-point verbal rating scale based on sensory pain descriptors ranked by severity from nothing (rank = 0) to extremely intense (rank = 15). Subjects selected the verbal descriptors that best matched their average neuropathic pain during the last 24 hours prior to assessment. (NCT00232141)
Timeframe: Week 14
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -2.70 |
| Placebo | -2.76 |
"Change from baseline in MOS-Sleep subscales & Sleep Problem Indices. Twelve item subject-rated questionnaire assessing sleep constructs. Scores range from 0 - 100 and higher scores reflect more impairment. Subscales sleep adequacy, quantity of sleep and optimal sleep low scores reflect impairment." (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Disturbances (n=127,125) | Quantity (n=123,122) | Adequacy (n=126,128) | Awaken Short of Breath or w/Headache (n=125,128) | Somnolence (n=125,128) | Snoring (n=122,126) | Sleep problems Index I (n=122,127) | Sleep problems Index II (n=122,125) | |
| Placebo | -14.71 | 0.65 | 10.09 | -7.93 | -7.01 | -5.00 | -11.18 | -11.59 |
| Pregabalin | -13.17 | 0.39 | 10.04 | -6.52 | -5.61 | 4.34 | -10.11 | -10.16 |
Change from Baseline in scale at endpoint: normal (score 0) to severe (score 21). (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| Anxiety | Depression | |
| Placebo | -1.59 | -1.52 |
| Pregabalin | -1.33 | -1.10 |
"Change from baseline to endpoint in the mBPI-sf to assess pain severity and pain interference with functional activities: 11-point scale ranging from no pain (0) to pain as bad as you can imagine (10)" (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) | |
|---|---|---|
| Pain Severity Index (n=148,147) | Pain Interference Index (n=146,146) | |
| Placebo | -2.56 | -2.39 |
| Pregabalin | -2.42 | -2.32 |
Change in a quantitative assessment of the participants' neuropathic pain were on an 11-point scale ranging from 0 (no pain) to 10 (most intense pain imaginable). (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Static mechanical allodynia (n=120,119) | Dynamic mechanical allodynia (n=120,119) | Punctate hyperalgesia testing area (n=118,119) | Temporal summation to tactile stimuli (n=120,118) | Cold allodynia testing area (n=120,117) | Cold hyperalgesia testing area (n=117,112) | |
| Placebo | -1.22 | -0.77 | -0.68 | -1.04 | -0.90 | -0.93 |
| Pregabalin | -1.11 | -0.99 | -0.78 | -1.21 | -1.19 | -0.82 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,142) | Week 6 (n=131,134) | Week 10 (n=126,128) | Week 14 (n=116,120) | Endpoint (n=148,147) | |
| Placebo | -1.12 | -1.86 | -2.68 | -2.71 | -2.90 | -2.74 |
| Pregabalin | -1.80 | -2.22 | -3.06 | -3.10 | -2.65 | -2.51 |
The PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). PGIC was evaluated using 3 categories of Improvement (Scores 1-3), No Change (Score 4), and Worsening (Scores 5-7). (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | participants (Number) | ||
|---|---|---|---|
| Improved (scores 1-3) | No Change (score 4) | Worsened (scores 5-7) | |
| Placebo | 84 | 32 | 10 |
| Pregabalin | 106 | 17 | 5 |
11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.53 |
| Placebo | -2.34 |
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.88 |
| Placebo | -2.63 |
Change from baseline in the number of pain attacks at endpoint. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | participants (Number) | ||
|---|---|---|---|
| Improved from baseline to endpoint | No change from baseline to endpoint | Worsened from baseline to endpoint | |
| Placebo | 66 | 32 | 21 |
| Pregabalin | 65 | 35 | 19 |
Change in mean Pain-related sleep interference was assessed on an 11-point scale from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Weekly mean score was the sum of the daily diary scores divided by the number of diary entries during that week. (NCT00232141)
Timeframe: Baseline, Weeks 1-14
| Intervention | score on scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=135, 133) | Week 2 (n=123,132) | Week 3 (n=117,121) | Week 4 (n=117,124) | Week 5 (n=115,121) | Week 6 (n=110,119) | Week 7 (n=110,111) | Week 8 (n=109,111) | Week 9 (n=105,111) | Week 10 (n=104,114) | Week 11 (n=100,106) | Week 12 (n=94,105) | Week 13 (n=94,105) | Week 14 (n=90,94) | |
| Placebo | -0.68 | -1.36 | -1.68 | -2.01 | -2.22 | -2.18 | -2.28 | -2.29 | -2.25 | -2.32 | -2.32 | -2.29 | -2.28 | -2.30 |
| Pregabalin | -1.04 | -1.99 | -2.26 | -2.34 | -2.57 | -2.73 | -2.89 | -2.98 | -2.73 | -2.79 | -2.76 | -2.83 | -2.95 | -2.93 |
Change from baseline in mean NRS-Pain scores at endpoint-BOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). Change from baseline in mean weekly pain scores was analyzed using longitudinal models assuming data were missing at random (MAR) (NCT00232141)
Timeframe: Baseline, Weeks 1 - 14 and Endpoint-BOCF
| Intervention | score on scale (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=136,133) | Week 2 (n=126,132) | Week 3 (n=118,121) | Week 4 (n=118,124) | Week 5 (n=116,121) | Week 6 (n=111,119) | Week 7 (n=112,111) | Week 8 (n=111,111) | Week 9 (n=107,111) | Week 10 (n=106,114) | Week 11 (n=102,106) | Week 12 (n=96,105) | Week 13 (n=96, 105) | Week 14 (n=92,94) | Endpoint BOCF (n=142,140) | |
| Placebo | -0.69 | -1.43 | -1.83 | -2.24 | -2.50 | -2.45 | -2.53 | -2.58 | -2.56 | -2.66 | -2.61 | -2.59 | -2.59 | -2.70 | -2.64 |
| Pregabalin | -1.14 | -1.92 | -2.36 | -2.66 | -2.79 | -2.98 | -3.22 | -3.33 | -3.09 | -2.98 | -3.05 | -3.14 | -3.21 | -3.19 | -2.72 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14, Endpoint - LOCF
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=126,128) | Week 14 (n=116,120) | Endpoint -LOCF (n=148,147) | |
| Placebo | -1.09 | -2.20 | -2.95 | -3.03 | -3.01 | -2.88 |
| Pregabalin | -1.52 | -2.18 | -3.08 | -3.02 | -2.97 | -2.82 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14, Endpoint-LOCF
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=126,128) | Week 14 (n=116,120) | Endpoint (n=148,147) | |
| Placebo | -0.80 | -1.44 | -2.05 | -2.13 | -2.41 | -2.20 |
| Pregabalin | -0.84 | -1.49 | -2.37 | -2.32 | -2.27 | -2.07 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=144,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=126,128) | Week 14 (n=116, 120) | Endpoint (n=148,147) | |
| Placebo | -1.01 | -1.98 | -2.66 | -2.57 | -2.72 | -2.57 |
| Pregabalin | -1.56 | -2.02 | -2.66 | -2.72 | -2.43 | -2.26 |
Change from baseline to endpoint in the duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | participants (Number) | ||
|---|---|---|---|
| Improved from baseline to endpoint | No change from baseline to endpoint | Worsened from baseline to endpoint | |
| Placebo | 60 | 40 | 26 |
| Pregabalin | 63 | 46 | 19 |
PGIC is a participant-rated instrument that measures change in the participants overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse). (NCT00232141)
Timeframe: Baseline, Week 14, Endpoint-LOCF
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved (score 1) | Much improved (score 2) | Minimally improved (score 3) | No change (score 4) | Minimally worse (score 5) | Much worse (score 6) | Very much worse (score 7) | |
| Placebo | 27 | 38 | 19 | 32 | 5 | 5 | 0 |
| Pregabalin | 27 | 41 | 38 | 17 | 2 | 3 | 0 |
Shift from baseline in maximum sensory thresholds (in grams representing the force equivalent of various sizes of von Frey filaments) as measured on QANeP. Improved - decrease in the maximum of the 3 trials at endpoint. Worsened - an increase. Note:Sensory Thresholds are the highest values of the 3 trials at baseline (Week=0) and endpoint (Week 14) (NCT00232141)
Timeframe: Baseline-Week 14 (Endpoint)
| Intervention | participants (Number) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weight 2.83 Improved | Weight 2.83 No Change | Weight 2.83 Worsened | Weight 3.61 Improved | Weight 3.61 No Change | Weight 3.61 Worsened | Weight 4.31 Improved | Weight 4.31 No Change | Weight 4.31 Worsened | Weight 4.56 Improved | Weight 4.56 No Change | Weight 4.56 Worsened | Weight 5.07 Improved | Weight 5.07 No Change | Weight 5.07 Worsened | Weight 6.65 Improved | Weight 6.65 No Change | Weight 6.65 Worsened | Not Perceived Improved | Not Perceived No Change | Not Perceived Worsened | |
| Placebo | 0 | 1 | 3 | 2 | 2 | 4 | 12 | 13 | 18 | 6 | 7 | 8 | 15 | 3 | 5 | 5 | 6 | 0 | 4 | 5 | 0 |
| Pregabalin | 0 | 0 | 0 | 1 | 3 | 9 | 4 | 17 | 8 | 5 | 4 | 9 | 10 | 8 | 10 | 12 | 7 | 2 | 3 | 8 | 0 |
Shift from baseline in median sensory thresholds (designated as Weight) from 3 trials as measured on the QANeP. Improved - a decrease in the median of the three trials at endpoint. Worsened - an increase. Note: Sensory Thresholds are the highest values of the three Trials at both baseline (Week=0) and endpoint (Week 14). (NCT00232141)
Timeframe: Baseline-Week 14 (Endpoint)
| Intervention | participants (Number) | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weight 2.83 Improved | Weight 2.83 No Change | Weight 2.83 Worsened | Weight 3.61 Improved | Weight 3.61 No Change | Weight 3.61 Worsened | Weight 4.31 Improved | Weight 4.31 No Change | Weight 4.31 Worsened | Weight 4.56 Improved | Weight 4.56 No Change | Weight 4.56 Worsened | Weight 5.07 Improved | Weight 5.07 No Change | Weight 5.07 Worsened | Weight 6.65 Improved | Weight 6.65 No Change | Weight 6.65 Worsened | Not Perceived Improved | Not Perceived No Change | Not Perceived Worsened | |
| Placebo | 0 | 3 | 3 | 2 | 9 | 13 | 11 | 11 | 12 | 7 | 8 | 7 | 11 | 3 | 1 | 8 | 3 | 0 | 3 | 4 | 0 |
| Pregabalin | 0 | 1 | 5 | 0 | 10 | 10 | 12 | 7 | 9 | 8 | 6 | 5 | 16 | 5 | 6 | 10 | 2 | 0 | 2 | 6 | 0 |
Number of subjects that experienced at least 30% decrease in mean weekly pain. (NCT00232141)
Timeframe: Weeks 1-14 endpoint BOCF
| Intervention | participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=140,141) | Week 2 (n=136,139) | Week 3 (n=131,133) | Week 4 (n=126,132) | Week 5 (n=124,131) | Week 6 (n=124,130) | Week 7 (n=125,124) | Week 8 (n=120,119) | Week 9 (n=116,121) | Week 10 (n=116,121) | Week 11 (n=113,117) | Week 12 (n=107,115) | Week 13 (n=103,111) | Week 14 (n=101,108) | Endpoint-BOCF (n=146,147) | |
| Placebo | 21 | 46 | 51 | 60 | 68 | 70 | 64 | 62 | 65 | 69 | 63 | 57 | 62 | 54 | 81 |
| Pregabalin | 33 | 51 | 63 | 64 | 65 | 63 | 69 | 75 | 68 | 64 | 67 | 65 | 62 | 58 | 77 |
Number of subjects that experienced at least a 50% decrease in mean weekly pain. (NCT00232141)
Timeframe: Weeks 1-14 Endpoint BOCF (modified baseline observation carried forward)
| Intervention | participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=140,141) | Week 2 (n=136,139) | Week 3 (n=131,133) | Week 4 (n=126,132) | Week 5 (n=124,131) | Week 6 (n=124,130) | Week 7 (n=125,124) | Week 8 (n=120,119) | Week 9 (n=116,121) | Week 10 (n=116,121) | Week 11 (n=113,117) | Week 12 (n=107,115) | Week 13 (n=103,111) | Week 14 (n=101,108) | Endpoint-BOCF (n=146,147) | |
| Placebo | 6 | 23 | 33 | 41 | 47 | 47 | 38 | 43 | 45 | 49 | 46 | 46 | 47 | 44 | 62 |
| Pregabalin | 13 | 28 | 35 | 45 | 48 | 49 | 53 | 54 | 50 | 45 | 43 | 45 | 45 | 42 | 54 |
Anxiety subscale analyzes generalized anxiety (anxious mood,restlessness, anxious thoughts, panic attacks). The depression subscale focuses on the state of lost interest and diminished pleasure response. A score of Normal = 0-7, Mild = 8-10, Moderate = 11-14, Severe = 15-21. (NCT00232141)
Timeframe: Baseline, Week 14
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anxiety-normal (baseline&endpoint) | Anxiety-normal (baseline)& mild (endpoint) | Anxiety-normal (baseline)& moderate(endpoint) | Anxiety-normal(baseline)&severe(endpoint) | Anxiety-mild(baseline)& normal(endpoint) | Anxiety-mild(baseline)& mild(endpoint) | Anxiety-mild(baseline)& moderate(endpoint) | Anxiety-mild(baseline)& severe(endpoint) | Anxiety-moderate(baseline)& normal(endpoint) | Anxiety-moderate(baseline)& mild(endpoint) | Anxiety-moderate(baseline)& moderate(endpoint) | Anxiety-moderate(baseline)& severe(endpoint) | Anxiety-severe(baseline)& normal(endpoint) | Anxiety-severe(baseline)& mild(endpoint) | Anxiety-severe(baseline)& moderate(endpoint) | Anxiety-severe(baseline)&severe(endpoint) | Depression-normal (baseline&endpoint) | Depression-normal (baseline)&mild (endpoint) | Depression-normal (baseline)&moderate (endpoint) | Depression-normal (baseline)&severe (endpoint) | Depression-mild (baseline)&normal(endpoint) | Depression-mild (baseline)&mild(endpoint) | Depression-mild (baseline)&moderate(endpoint) | Depression-mild (baseline)&severe(endpoint) | Depression-moderate (baseline)&normal(endpoint) | Depression-moderate (baseline)&mild(endpoint) | Depression-moderate (baseline)&moderate(endpoint) | Depression-moderate (baseline)&severe(endpoint) | Depression-severe (baseline)&normal(endpoint) | Depression-severe (baseline)&mild(endpoint) | Depression-severe (baseline)&moderate(endpoint) | Depression-severe (baseline)&severe(endpoint) | |
| Placebo | 55 | 6 | 2 | 0 | 19 | 6 | 6 | 0 | 8 | 9 | 5 | 1 | 1 | 2 | 6 | 2 | 69 | 7 | 2 | 0 | 21 | 5 | 2 | 0 | 11 | 7 | 2 | 1 | 0 | 0 | 0 | 1 |
| Pregabalin | 47 | 7 | 2 | 0 | 23 | 7 | 2 | 2 | 11 | 6 | 8 | 3 | 0 | 1 | 7 | 2 | 75 | 8 | 2 | 1 | 19 | 5 | 3 | 0 | 5 | 6 | 2 | 1 | 0 | 0 | 0 | 1 |
Number of subjects reporting pain attacks. The NPSI includes the temporal item for assessing the numbers of pain attacks. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. (NCT00232141)
Timeframe: Baseline-Week 14 (Endpoint)
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >20 attacks (baseline & endpoint) | >20 attacks (baseline), 11-20 attacks (endpoint) | >20 attacks (baseline), 6-10 attacks (endpoint) | >20 attacks (baseline), 1-5 attacks (endpoint) | >20 attacks (baseline), no pain attacks (endpoint) | 11-20 attacks (baseline), >20 attacks (endpoint) | 11-20 attacks (baseline), 11-20 attacks (endpoint) | 11-20 attacks (baseline), 6-10 attacks (endpoint) | 11-20 attacks (baseline), 1-5 attacks (endpoint) | 11-20 attacks (baseline), no attacks (endpoint) | 6-10 attacks (baseline), >20 attacks (endpoint) | 6-10 attacks (baseline), 11-20 attacks (endpoint) | 6-10 attacks (baseline), 6-10 attacks (endpoint) | 6-10 attacks (baseline), 1-5 attacks (endpoint) | 6-10 attacks (baseline), no attacks (endpoint) | 1-5 attacks (baseline), >20 attacks (endpoint) | 1-5 attacks (baseline), 11-20 attacks (endpoint) | 1-5 attacks (baseline), 6-10 attacks (endpoint) | 1-5 attacks (baseline), 1-5 attacks (endpoint) | 1-5 attacks (baseline), no attacks (endpoint) | no attacks (baseline), >20 attacks (endpoint) | no attacks (baseline), 11-20 attacks (endpoint) | no attacks (baseline), 6-10 attacks (endpoint) | no attacks (baseline), 1-5 attacks (endpoint) | no attacks (baseline), no attacks (endpoint) | |
| Placebo | 6 | 4 | 4 | 3 | 2 | 0 | 2 | 8 | 8 | 5 | 7 | 2 | 8 | 17 | 4 | 1 | 2 | 3 | 15 | 11 | 2 | 0 | 1 | 3 | 1 |
| Pregabalin | 4 | 2 | 1 | 3 | 3 | 2 | 2 | 7 | 10 | 9 | 1 | 2 | 5 | 14 | 6 | 3 | 3 | 7 | 21 | 10 | 0 | 0 | 0 | 1 | 3 |
Number of subjects reporting duration of spontaneous pain. The NPSI includes the temporal item for assessment of duration of spontaneous, ongoing and paroxysmal pain. Assessed using a 5-point specific categorical scale and refers to the past 24 hours at endpoint. (NCT00232141)
Timeframe: Baseline-Week 14 (Endpoint)
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Permanently (baseline&endpoint) | Permanently (baseline), 8-12 hours (endpoint) | Permanently (baseline), 4-7 hours (endpoint) | Permanently (baseline), 1-3 hours (endpoint) | Permanently (baseline), < 1 hr (endpoint) | 8-12 hours (baseline), permanently (endpoint) | 8-12 hrs (baseline), 8-12 hrs (endpoint) | 8-12 hrs (baseline), 4-7 hrs (endpoint) | 8-12 hrs (baseline), 1-3 hours (endpoint) | 8-12 hrs (baseline), <1 hr (endpoint) | 4-7 hrs (baseline), permanently (endpoint) | 4-7 hrs (baseline), 8-12 hrs (endpoint) | 4-7 hrs (baseline), 4-7 hrs (endpoint) | 4-7 hrs (baseline), 1-3 hrs (endpoint) | 4-7 hrs (baseline), < 1 hr (endpoint) | 1-3 hrs (baseline), permanently (endpoint) | 1-3 hrs (baseline), 8-12 hrs (endpoint) | 1-3 hrs (baseline), 4-7 hrs (endpoint) | 1-3 hrs (baseline), 1-3 hrs (endpoint) | 1-3 hrs (baseline), <1 hr (endpoint) | Less than 1 hr (baseline), permanently (endpoint) | Less than 1 hr (baseline), 8-12 hrs (endpoint) | Less than 1 hr (baseline), 4-7 hrs (endpoint) | Less than 1 hr (baseline), 1-3 hrs (endpoint) | <1 hr (baseline), <1 hr (endpoint) | |
| Placebo | 21 | 5 | 6 | 5 | 5 | 7 | 7 | 9 | 4 | 5 | 3 | 6 | 9 | 8 | 8 | 0 | 2 | 5 | 3 | 5 | 1 | 0 | 0 | 2 | 0 |
| Pregabalin | 15 | 11 | 8 | 4 | 4 | 2 | 10 | 5 | 4 | 8 | 3 | 7 | 9 | 3 | 7 | 1 | 2 | 1 | 6 | 9 | 0 | 2 | 0 | 1 | 6 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=144,147) | Week 2 (n=139,142) | Week 6 (n=132,134) | Week 10 (n=125,128) | Week 14 (n=115,120) | Endpoint (n=148,147) | |
| Placebo | -1.23 | -1.84 | -2.33 | -2.33 | -2.54 | -2.42 |
| Pregabalin | -1.40 | -1.84 | -2.44 | -2.13 | -2.09 | -2.11 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=144,147) | Week 2 (n=138,143) | Week 6 (n=131,134) | Week 10 (n=125,128) | Week 14 (n=115,120) | Endpoint (n=147,147) | |
| Placebo | -1.20 | -2.06 | -2.41 | -2.37 | -2.76 | -2.46 |
| Pregabalin | -1.58 | -2.23 | -2.60 | -2.52 | -2.53 | -2.31 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=126,128) | Week 14 (n=115,120) | Endpoint (n=148,147) | |
| Placebo | -0.87 | -1.39 | -1.67 | -1.91 | -2.10 | -1.99 |
| Pregabalin | -1.06 | -1.54 | -1.91 | -1.84 | -2.08 | -2.00 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=144,147) | Week 2 (n=138,143) | Week 6 (n=130,134) | Week 10 (n=125,128) | Week 14 (n=114,120) | Endpoint (n=147,147) | |
| Placebo | -1.42 | -1.99 | -2.45 | -2.36 | -2.70 | -2.61 |
| Pregabalin | -1.47 | -2.10 | -2.54 | -2.49 | -2.21 | -2.30 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=125,128) | Week 14 (n=116,120) | Endpoint (n=148,147) | |
| Placebo | -1.04 | -1.87 | -2.25 | -2.26 | -2.46 | -2.23 |
| Pregabalin | -1.35 | -1.95 | -2.37 | -2.32 | -2.16 | -2.15 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,146) | Week 2 (n=139,141) | Week 6 (n=132,131) | Week 10 (n=126,127) | Week 14 (n=116,119) | Endpoint (n=148,146) | |
| Placebo | -1.20 | -2.13 | -2.64 | -2.45 | -2.79 | -2.60 |
| Pregabalin | -1.52 | -2.20 | -2.69 | -2.59 | -2.78 | -2.64 |
Change in mean BPI-sf, is a self-administered questionnaire to assess pain severity 0 (no pain to 10 (pain as bad as you can imagine) and pain interference 0 (does not interfere) to 10 (completely interferes) during a 24 hour period. The BPI-sf was used to derive the change from baseline in 4 pain severity questions & 7 pain interference questions. (NCT00232141)
Timeframe: Baseline, Weeks 1,2,6,10,14 and Endpoint
| Intervention | score on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=145,147) | Week 2 (n=139,143) | Week 6 (n=132,134) | Week 10 (n=126,128) | Week 14 (n=116,120) | Endpoint (n=148,147) | |
| Placebo | -0.90 | -1.77 | -2.55 | -2.61 | -2.71 | -2.60 |
| Pregabalin | -1.15 | -1.79 | -2.64 | -2.86 | -2.58 | -2.37 |
Duration Adjusted Average Change(DAAC) in NRS-Pain score = (mean at observation - mean at baseline)x(proportion of planned study duration that the subject completed). (NCT00232141)
Timeframe: Weekly: Week 1 - Week 14
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.45 |
| Placebo | -2.07 |
"Pain scores were assessed on a 100 mm Visual Analogue Scale (VAS); scores range from 0= no pain to 100= worse pain. Subjects assessed their pain during the last week.~Endpoint = last non-missing observation carried forward after Baseline visit." (NCT00264875)
Timeframe: Baseline, Week 4, Week 8, Week 12, and Endpoint
| Intervention | score on scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n=203) | Week 4 (n=204) | Week 8 (n=200) | Week 12 (n=207) | Endpoint (n=217) | |
| Pregabalin | 38.61 | 30.75 | 30.16 | 28.95 | 29.39 |
Number of participants who exited the study due to any reason after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit after Day 28 of the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit or did not reach this phase were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 78 |
| Lamotrigine | 58 |
Number of participants who exited the study due to lack of efficacy after the 4-week dose escalation phase. Time in days, from first day of study treatment to day of exit due to lack of efficacy after Day 28 of the escalation phase (ie, last day on study medication) was inestimable. Participants who did not exit or exited for a different reason were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 78 |
| Lamotrigine | 58 |
Number of participants who exited the study for any reason during the double blind treatment phase. Time in days, from first day of study treatment to day of exit from the study due to any reason (ie, last day on study medication) was inestimable. Participants who did not exit the study were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 0 to Week 56
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 94 |
| Lamotrigine | 80 |
Responder = participant who achieved at least 6-months of seizure freedom (all seizures) after Week 4, and up to Week 56. Dose Level defined as last total-daily-dose received after Week 4, and up to Week 56. (NCT00280059)
Timeframe: Week 5 up to Week 56
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 150 mg/Day | 70.5 |
| Pregabalin 300 mg/Day | 59.7 |
| Pregabalin 450 mg/Day | 20.4 |
| Pregabalin 600 mg/Day | 13.0 |
| Lamotrigine 100 mg/Day | 80.5 |
| Lamotrigine 200 mg/Day | 67.9 |
| Lamotrigine 400 mg/Day | 38.2 |
| Lamotrigine 500 mg/Day | 16.7 |
Responders = participants who achieved any 6 consecutive months (>182 days) of seizure-freedom (absence of partial seizures, generalized seizures and unclassified epileptic seizures) during the 52 week efficacy assessment phase. (NCT00280059)
Timeframe: Week 5 up to Week 56
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 51.6 |
| Lamotrigine | 67.9 |
Time in days, from first day of study treatment to the day of first seizure after Day 28 of the escalation phase (ie, last day on study medication). Participants who did not reach this phase or who did not have a seizure after Day 28 were right censored from the analysis as of the last day on study medication. (NCT00280059)
Timeframe: Week 4 up to Week 56
| Intervention | days (Median) |
|---|---|
| Pregabalin | 85 |
| Lamotrigine | 211 |
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)
| Intervention | 28-day seizure rate (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Month 1 (n=162, 208) | Month 2 (n=155, 194) | Month 3 (n=147, 184) | Month 4 (n=139, 173) | Month 5 (n=127, 158) | Month 6 (n=122, 152) | Month 7 (n=105, 136) | Month 8 (n=1, 5) | Month 9 (n=0, 1) | |
| Lamotrigine | 0.04 | 0.03 | 0.07 | 0.05 | 0.10 | 0.03 | 0.28 | 0.00 | 6.00 |
| Pregabalin | 0.19 | 0.28 | 0.05 | 0.09 | 0.15 | 0.02 | 0.00 | 0.00 | NA |
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)
| Intervention | 28-day seizure rate (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Month 1 (n=162, 208) | Month 2 (n=155, 194) | Month 3 (n=147, 184) | Month 4 (n=139, 173) | Month 5 (n=127, 158) | Month 6 (n=122, 152) | Month 7 (n=105, 136) | Month 8 (n=1, 5) | Month 9 (n=0, 1) | |
| Lamotrigine | 0.05 | 0.03 | 0.07 | 0.05 | 0.10 | 0.03 | 0.29 | 0.00 | 6.00 |
| Pregabalin | 0.19 | 0.28 | 0.07 | 0.09 | 0.18 | 0.02 | 0.00 | 0.00 | NA |
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60
| Intervention | seizures/28 days (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose escalation phase (n=329, 330) | Month 1 (n=314, 308) | Month 2 (n=300, 295) | Month 3 (n=287, 288) | Month 4 (n=279, 278) | Month 5 (n=274, 276) | Month 6 (n=266, 272) | Month 7 (n=260, 270) | Month 8 (n=256, 266) | Month 9 (n=253, 262) | Month 10 (n=250, 257) | Month 11 (n=242, 254) | Month 12 (n=238, 252) | Month 13 (n=210, 227) | Taper (n=71, 45) | |
| Lamotrigine | 5.08 | 4.21 | 3.21 | 3.54 | 1.67 | 1.58 | 1.41 | 1.50 | 1.36 | 1.38 | 1.33 | 1.41 | 1.67 | 2.11 | 19.97 |
| Pregabalin | 2.56 | 2.23 | 1.18 | 0.94 | 0.89 | 0.78 | 0.82 | 0.78 | 0.77 | 0.71 | 1.05 | 0.79 | 0.94 | 0.65 | 2.13 |
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60
| Intervention | seizures/28 days (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose-escalation phase (n=329, 330) | Month 1 (n=314, 308) | Month 2 (n=300, 295) | Month 3 (n=287, 288) | Month 4 (n=279, 278) | Month 5 (n=274, 276) | Month 6 (n=266, 272) | Month 7 (n=260, 270) | Month 8 (n=256, 266) | Month 9 (n=253, 262) | Month 10 (n=250, 257) | Month 11 (n=242, 254) | Month 12 (n=238, 252) | Month 13 (n=210, 227) | Taper (n=71, 45) | |
| Lamotrigine | 5.10 | 4.24 | 3.22 | 3.57 | 1.68 | 1.59 | 1.41 | 1.50 | 1.37 | 1.38 | 1.33 | 1.41 | 1.67 | 2.12 | 19.97 |
| Pregabalin | 2.74 | 2.31 | 1.53 | 1.02 | 1.06 | 0.87 | 0.89 | 0.83 | 0.82 | 0.78 | 1.06 | 0.81 | 0.96 | 0.65 | 2.13 |
Time in days, from first day of study medication to the first 6 months of seizure freedom after Day 28. Participants who did not achieve 6 months seizure freedom after Day 28 were censored from analysis. (NCT00280059)
Timeframe: Week 4 up to Week 56
| Intervention | days (Median) |
|---|---|
| Pregabalin | 254 |
| Lamotrigine | 183 |
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)
| Intervention | seizures/28 days (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Month 1 (n=162, 208) | Month 2 (n=155, 194) | Month 3 (n=147, 184) | Month 4 (n=139, 173) | Month 5 (n=127, 158) | Month 6 (n=122, 152) | Month 7 (n=105, 136) | Month 8 (n=1, 5) | Month 9 (n=0, 1) | |
| Lamotrigine | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 6.0 |
| Pregabalin | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA |
Number of participants who exited the study due to adverse events during the double-blind treatment period. Time in days, from first day of study treatment to day of exit from the study due to an adverse event (ie, last day on study medication) during the double blind treatment period (including dose escalation phase) was inestimable. Observations with other reasons for exiting or participants who did not exit the study were right censored as of the last day on study medication. (NCT00280059)
Timeframe: Week 0 to Week 56
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 33 |
| Lamotrigine | 31 |
Participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items; range: 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of symptoms. Scores relative to start of randomized treatment. (NCT00280059)
Timeframe: Baseline to Week 56
| Intervention | scores on scale (Least Squares Mean) | |
|---|---|---|
| Anxiety | Depression | |
| Lamotrigine | -1.1 | -0.7 |
| Pregabalin | -0.3 | -0.1 |
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60
| Intervention | seizures/28 days (Median) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose-escalation phase (Weeks 1 - 4)(n=329, 330) | Month 1 (n=314, 308) | Month 2 (n=300, 295) | Month 3 (n=287, 288) | Month 4 (n=279, 278) | Month 5 (n=274, 276) | Month 6 (n=266, 272) | Month 7 (n=260, 270) | Month 8 (n=256, 266) | Month 9 (n=253, 262) | Month 10 (n=250, 257) | Month 11 (n=242, 254) | Month 12 (n=238, 252) | Month 13 (n=210, 227) | Taper (Week 57 to Week 60) (n=71, 45) | |
| Lamotrigine | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Pregabalin | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
All partial seizures include complex partial seizures, simple partial seizures, and partial seizures evolving to secondarily generalized seizures. Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Month of time = number of months after Week 4 (Dose Escalation). (NCT00280059)
Timeframe: Baseline up to Week 60
| Intervention | seizures/28 days (Median) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose-escalation phase (Weeks 1 - 4) (n=329, 330) | Month 1 (n=314, 308) | Month 2 (n=300, 295) | Month 3 (n=287, 288) | Month 4 (n=279, 278) | Month 5 (n=274, 276) | Month 6 (n=266, 272) | Month 7 (n=260, 270) | Month 8 (n=256, 266) | Month 9 (n=253, 262) | Month 10 (n=250, 257) | Month 11 (n=242, 254) | Month 12 (n=238, 252) | Month 13 (n=210, 227) | Taper (Week 57 to Week 60) (n=71, 45) | |
| Lamotrigine | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
| Pregabalin | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
Seizure frequency based on 28-day seizure rate: number (#) of seizures in period (month) divided by # days in period minus # of missing diary days in period * 28. Responder = participant who achieved at least 6 months of seizure freedom after Week 4 and up to Week 56. Monthly seizure frequency measured from day of achievement of 6 months of seizure freedom. (NCT00280059)
Timeframe: Month 1 through Month 9 (after 6 months seizure freedom achieved)
| Intervention | seizures/28 days (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Month 1 (n=162, 208) | Month 2 (n=155, 194) | Month 3 (n=147, 184) | Month 4 (n=139, 173) | Month 5 (n=127, 158) | Month 6 (n=122, 152) | Month 7 (n=105, 136) | Month 8 (n=1, 5) | Month 9 (n=0, 1) | |
| Lamotrigine | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 6.0 |
| Pregabalin | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | NA |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response Optimal if sleep quantity was 7 or 8 hours of sleep per night, and Non-optimal if average sleep was less than or greater than 7 to 8 hours per night. Analysis assesses the MOS-Sleep scale relative to the start of randomized treatment. (NCT00280059)
Timeframe: Week 8, Week 32, and Week 56
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 8: Optimal sleep | Week 8: Non-optimal sleep | Week 32: Optimal sleep | Week 32: Non-optimal sleep | Week 56: Optimal sleep | Week 56: Non-optimal sleep | |
| Lamotrigine | 173 | 126 | 155 | 103 | 145 | 90 |
| Pregabalin | 195 | 103 | 167 | 97 | 152 | 82 |
Count of subjects with a weight gain of at least 7 percent relative to baseline. (NCT00288639)
Timeframe: Baseline, End of 21-week treatment
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Weight gain ≥7% to <10% | Weight gain ≥10% to <15% | Weight gain ≥15% to <20% | Weight gain ≥20% | |
| Pregabalin | 8 | 2 | 2 | 1 |
Percentage change from baseline = [(4 week seizure frequency minus 8 week baseline) / (8 week baseline seizure frequency)] x 100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. (NCT00288639)
Timeframe: 8 week baseline period and 21 week treatment period
| Intervention | percentage change of events (Median) | |||||
|---|---|---|---|---|---|---|
| 1-28 Days | 29-56 Days | 57-84 Days | 85-112 Days | 113-140 Days | >140 Days | |
| Pregabalin | -28.12 | -22.50 | -25.00 | -40.00 | -58.72 | -85.42 |
Number of subjects with at least a 50% or 75% reduction in partial seizure frequency between baseline and treatment period. (NCT00288639)
Timeframe: 8 week baseline observation period & last 4 weeks of observation period
| Intervention | participants (Number) | |
|---|---|---|
| >= 50% reduction | >= 75% reduction | |
| Pregabalin | 42 | 33 |
Number of subjects achieving seizure freedom (no seizures) during last 4 weeks or duration of 12 week observation period. (NCT00288639)
Timeframe: Day 147 from the first dose of study drug
| Intervention | participants (Number) | |
|---|---|---|
| seizure-free during last 4 weeks | seizure-free during 12 weeks | |
| Pregabalin | 30 | 18 |
Number of subjects that responded optimal or non-optimal sleep in Optimal Sleep subscale of Medical Outcomes Study (MOS) Sleep scale. (NCT00288639)
Timeframe: Baseline, End of 21-week treatment
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Optimal Sleep Baseline, Optimal Sleep Wk21 | Optimal Sleep Baseline, Non-Optimal Sleep Wk21 | Non-Optimal Sleep Baseline, Optimal Sleep Wk21 | Non-Optimal Sleep Baseline, Non-Optimal Sleep Wk21 | |
| Pregabalin | 21 | 8 | 12 | 25 |
The CGIC is a clinician's judgment of the overall change in the patient's condition over a defined period on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00288639)
Timeframe: End of 21-week treatment
| Intervention | partcipants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | Missing / Not Done | |
| Pregabalin | 15 | 35 | 24 | 11 | 4 | 2 | 0 | 2 |
Change in total HADS score between Baseline and Week 21. Each of the 14 items is scored 0, 1, 2 or 3 where a score of 3 corresponds to the most anxious/depressed. 7-item depression and 7-item anxiety subscales are summed; each resulting in a total score of 0-21. (NCT00288639)
Timeframe: Baseline, End of 21-week treatment
| Intervention | score on scale (Mean) | |
|---|---|---|
| HADS Depression Subscale (n=76) | HADS Anxiety Subscale (n=76) | |
| Pregabalin | -0.59 | -1.68 |
Percentage change from baseline=[(12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate)/ 8 week baseline period seizure frequency rate] x 100. Seizure frequencies per 28-day period: = (total # of partial seizures in period x 28 / (total # of days in period). (NCT00288639)
Timeframe: 8 week baseline period & 12 week treatment observation period
| Intervention | percentage change in events (Median) |
|---|---|
| Pregabalin | -33.33 |
Percentage change from baseline = ((21 weeks-8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. (NCT00288639)
Timeframe: 8 week baseline period and 21 week treatment period
| Intervention | percentage change in events (Median) |
|---|---|
| Pregabalin | -29.39 |
Percentage change from baseline = ((12 weeks - 8 weeks)/8 weeks)*100. Negative mean R-Ratios and associated 95% CIs that do not include zero indicate reduction in partial seizure frequency. (NCT00288639)
Timeframe: 8 week baseline observation period & 12 week treatment observation period
| Intervention | percentage change in events (Median) | |
|---|---|---|
| Baseline seizure frequency ≤3 per 28 days (n=43) | Baseline seizure frequency >3 per 28 days (n=49) | |
| Pregabalin | -33.33 | -21.99 |
Change from baseline = 12 week treatment observation period seizure frequency rate minus 8 week baseline period seizure frequency rate. (NCT00288639)
Timeframe: 8 week baseline period & 12 week treatment observation period
| Intervention | change in median partial seizures (Median) | ||
|---|---|---|---|
| Simple Partial Seizures (n=47) | Complex Partial Seizures (n=76) | Evolve to Secondary Generalized (n=30) | |
| Pregabalin | 0.00 | 0.00 | 0.00 |
Subjects recall sleep related activities over the previous 4 weeks. Low scores reflect greater impairment (except sleep adequacy, optimal sleep, &quantity). Range = 0 - 100 for Sleep Disturbance, Snoring, Awaken Short of Breath, Sleep Adequacy, Somnolence, & Sleep Problems Index. Quantity of Sleep Range = 0 - 24. Optimal Sleep Range 0 - 1. (NCT00288639)
Timeframe: Baseline, end of 21-week treatment
| Intervention | score on scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep Disturbance (n=72) | Snoring (n=76) | Awaken Short of Breath (n=77) | Quantity of Sleep (n=66) | Sleep Adequacy (n=77) | Somnolence (n=77) | Sleep Problems Index (n=72) | |
| Pregabalin | -3.95 | 7.89 | -1.82 | 0.05 | 4.29 | 0.52 | -2.81 |
The PGIC is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00288639)
Timeframe: End of 21-week treatment
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | Missing / Not Done | |
| Pregabalin | 14 | 36 | 17 | 9 | 3 | 1 | 0 | 13 |
Count of subjects seizure free during the period. (NCT00288639)
Timeframe: last 4 weeks & whole 12 week treatment observation period
| Intervention | participants (Number) | |
|---|---|---|
| During 12 week Observation period (n=84) | During the last 4 weeks of Obs. period (n=86) | |
| Pregabalin | 18 | 30 |
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Baseline (n=116, 118) | Week 8 (n=112, 113) | |
| Placebo | 17.83 | 15.43 |
| Pregabalin | 15.55 | 11.71 |
Clinical Global Impression of Change (CGIC): clinician's judgment of overall change in the patient's condition over a defined period on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse. (NCT00292188)
Timeframe: Week 8
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| very much improved | much improved | minimally improved | no change | minimally worse | much worse | very much worse | |
| Placebo | 6 | 18 | 26 | 61 | 9 | 3 | 1 |
| Pregabalin | 11 | 33 | 36 | 33 | 5 | 4 | 1 |
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety. (NCT00292188)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 9.94 |
| Placebo | 11.63 |
Hospital Anxiety and Depression Scale Anxiety Score (HADS-A) consists of 7 items that are assessed by a score of 0 = no anxiety to 3 = severe feeling of anxiety. The anxiety subscale determines a state of generalized anxiety (including anxious mood, restlessness, anxious thoughts, panic attacks). Score range = 0 to 21; higher scores indicate a greater intensity of anxiety (NCT00292188)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.52 |
| Placebo | 7.36 |
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment. (NCT00292188)
Timeframe: each day of Week 8
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.61 |
| Placebo | 5.23 |
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range:0 (no pain) to 10 (worst possible pain). Mean of scores available for each week. (NCT00292188)
Timeframe: Baseline through Week 8
| Intervention | score on scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 (n=125, 125) | Week 2 (n=121, 119) | Week 3 (n=113, 116) | Week 4 (n=108, 108) | Week 5 (n=106, 104) | Week 6 (n=104, 101) | Week 7 (n=99, 99) | Week 8 (n=97, 97) | |
| Placebo | 5.79 | 5.64 | 5.44 | 5.27 | 5.26 | 5.34 | 5.26 | 5.24 |
| Pregabalin | 5.54 | 5.37 | 4.91 | 4.95 | 4.80 | 4.76 | 4.74 | 4.64 |
Patient Global Impression of Change (PGIC): a patient-rated instrument that measures change in patient's overall status on a 7-point scale; range: 1 Very Much Improved to 7 Very Much Worse. (NCT00292188)
Timeframe: Week 8
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| very much improved | much improved | minimally improved | no change | minimally worse | much worse | very much worse | |
| Placebo | 6 | 22 | 26 | 52 | 10 | 7 | 2 |
| Pregabalin | 13 | 27 | 41 | 30 | 3 | 3 | 3 |
Based on weekly mean daily pain rating score (DPRS), responders were defined as subjects with a >= 30% and >=50% reduction in weekly mean scores from baseline until endpoint (Week 8). Endpoint was calculated as the mean of the last 7 available pain scores from the daily pain diary while in the double-blind treatment phase. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |
|---|---|---|
| 30% Responder | 50% Responder | |
| Placebo | 32 | 18 |
| Pregabalin | 50 | 30 |
Pain Treatment Satisfaction Scale (PTSS); Satisfaction with Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range:1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00292188)
Timeframe: Screening, Week 8
| Intervention | score on scale (Mean) | |
|---|---|---|
| Screening (n=112, 110) | Week 8 (n=122, 121) | |
| Placebo | 51.05 | 54.15 |
| Pregabalin | 50.33 | 62.36 |
Pain Treatment Satisfaction Scale (PTSS); Medication Characteristics: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00292188)
Timeframe: Screening, Week 8
| Intervention | score on scale (Mean) | |
|---|---|---|
| Screening (n=112, 110) | End of Treatment (Week 8) (n=122, 121) | |
| Placebo | 59.39 | 70.39 |
| Pregabalin | 57.44 | 71.52 |
Pain Treatment Satisfaction Scale (PTSS); Impact of Current Pain Medication: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00292188)
Timeframe: Screening, Week 8
| Intervention | score on a scale (Mean) | |
|---|---|---|
| Screening (n=113, 113) | End of Treatment (Week 8) (n=122, 121) | |
| Placebo | 53.60 | 42.56 |
| Pregabalin | 54.53 | 52.64 |
Pain Treatment Satisfaction Scale (PTSS); Efficacy: measure of patient satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00292188)
Timeframe: Screening, Week 8
| Intervention | score on scale (Mean) | |
|---|---|---|
| Screening (n=112, 110) | End of Treatment (Week 8) (n=122, 121) | |
| Placebo | 42.73 | 37.88 |
| Pregabalin | 43.23 | 53.21 |
Modified Brief Pain Inventory Short Form (m-BPI-sf): self-administered questionnaire to assess severity of pain (measured by 4 items)and impact of pain on daily functions (measured by 7 items)in past 24 hours. Items are rated on an 11-point scale ranging from 0 to 10, with higher scores indicating greater pain and/or interference due to pain. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | score on a scale (Mean) | |||
|---|---|---|---|---|
| pain interference index Baseline (n=125, 126) | pain interference index Week 8 (n=120, 121) | pain severity index Baseline (n= 122, 125) | pain severity index Week 8 (n=120, 120) | |
| Placebo | 4.69 | 4.17 | 5.72 | 5.21 |
| Pregabalin | 4.57 | 3.31 | 5.36 | 4.20 |
Medical Outcome Study (MOS) is a patient-rated questionnaire consisting of 12 items that assess key constructs of sleep (7 subscales as well as a 9-item overall sleep problems index. MOS-Sleep Scale is scored from 0 to 100. A higher score indicates more disturbance. (NCT00292188)
Timeframe: Week 8
| Intervention | score on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sleep Disturbance (n=117, 118) | Snoring (n=111, 118) | Awaken Short of Breath/Headache (n= 118, 117) | Sleep Quantity (n=117, 118) | Sleep Adequacy (n=119, 119) | Somnolence (n=116, 114) | Sleep Problems Index-6 (n=112, 111) | Sleep problems Index-9 (n=111, 107) | |
| Placebo | 46.45 | 37.87 | 20.66 | 6.48 | 44.61 | 32.33 | 51.72 | 42.98 |
| Pregabalin | 35.73 | 38.92 | 14.71 | 6.39 | 55.25 | 34.64 | 42.20 | 35.43 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 3 | 16 | 14 | 23 | 23 | 47 | 5 | 7 | 13 | 26 | 34 | 36 |
| Pregabalin | 5 | 3 | 13 | 24 | 39 | 42 | 4 | 10 | 8 | 22 | 34 | 42 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of the Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of the Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 4 | 14 | 14 | 29 | 26 | 39 | 7 | 5 | 16 | 27 | 33 | 33 |
| Pregabalin | 4 | 8 | 13 | 27 | 33 | 41 | 3 | 12 | 14 | 26 | 27 | 38 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | particpants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of the Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of the Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 6 | 12 | 7 | 15 | 35 | 51 | 3 | 11 | 6 | 23 | 27 | 51 |
| Pregabalin | 2 | 8 | 6 | 22 | 23 | 64 | 1 | 9 | 9 | 26 | 22 | 52 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of the Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 10 | 14 | 8 | 23 | 33 | 38 | 9 | 7 | 11 | 31 | 35 | 28 |
| Pregabalin | 7 | 7 | 6 | 40 | 30 | 36 | 3 | 11 | 13 | 28 | 36 | 29 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of the Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of the Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 1 | 15 | 15 | 25 | 27 | 43 | 4 | 5 | 13 | 27 | 30 | 42 |
| Pregabalin | 5 | 6 | 5 | 20 | 42 | 48 | 3 | 10 | 11 | 23 | 32 | 41 |
The number of subjects' responses to each of the 6 questions on the Medical Outcome Study Cognitive (MOS-Cog) subscale were summarized at baseline and Week 8. Category range: all of the time to none of the time. No formal statistical modeling was used. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: All of the Time | Baseline: Most of the Time | Baseline: A Good Bit of Time | Baseline: Some of the Time | Baseline: A Little of the Time | Baseline: None of the Time | Week 8: All of the Time | Week 8: Most of the Time | Week 8: A Good Bit of Time | Week 8: Some of the Time | Week 8: A Little of the Time | Week 8: None of the Time | |
| Placebo | 1 | 9 | 6 | 27 | 36 | 45 | 6 | 9 | 6 | 22 | 31 | 47 |
| Pregabalin | 2 | 6 | 3 | 31 | 33 | 51 | 4 | 6 | 12 | 28 | 31 | 39 |
11-point numerical scale with which the patient describes pain interference with sleep over past 24 hours; range: 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Endpoint weekly mean score: mean of last 7 available scores from daily sleep interference diary during double-blind treatment. (NCT00292188)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.93 |
| Placebo | 3.73 |
Neuropathic Pain Symptom Inventory (NPSI) includes 10 descriptors (scale 0-10) of different pain symptoms & 2 temporal items assessing the duration of spontaneous ongoing and paroxysmal pain. A total intensity score is calculated by sub grouping the questions into five pain dimensions, summing the five sub groups, and converting into a percentage. (NCT00292188)
Timeframe: Week 8
| Intervention | percentage score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 33.29 |
| Placebo | 37.12 |
Number of subjects responding to have had optimal sleep. Optimal sleep is 1 item in the Medical Outcome Study (MOS)sleep scale, a patient-reported measure consisting of twelve items that assess the key constructs of sleep. Subjects were asked to recall sleep-related activities over the past week. (NCT00292188)
Timeframe: Week 8
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 58 |
| Placebo | 45 |
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n=116, 118) | Week 8 (n=112, 113) | |
| Placebo | 38.76 | 33.62 |
| Pregabalin | 34.57 | 26.18 |
Hospital Anxiety and Depression Scale (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression (NCT00292188)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 12.04 |
| Placebo | 11.80 |
"Hospital Anxiety and Depression Scale Depression Score (HADS-D) consists of 7 items that are assessed by a score of 0 = no depression to 3 = severe feeling of depression. The depression subscale focuses on the state of lost interest and diminished pleasure response (lowering of hedonic tone). Score range = 0 to 21; higher scores indicate a greater intensity of depression" (NCT00292188)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 5.23 |
| Placebo | 6.20 |
Self-rated instrument to measure symptom severity and treatment outcome in post traumatic stress disorder (PTSD). Scale of 17 PTSD symptoms over previous week; frequency scale: 0 (not at all) to 4 (every day), and severity 0 (not at all distressing) to 4(extremely distressing). The total Davidson Trauma Scale score ranges from 0 to 136. (NCT00292188)
Timeframe: Baseline, Week 8
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n=124, 124) | Week 8 (n=118, 120) | |
| Placebo | 20.90 | 18.47 |
| Pregabalin | 18.27 | 14.16 |
Absolute Improvement in Sleep by assessing Mean Daily sleep interference scores as measured weekly starting at baseline and reported weekly through week 12 excluding the first week. This score is an 11 point scale the documents the pain interference in sleep in the preceding 24 hours. 0 is no interference and 10 is pain completely disrupted sleep in the previous 24 hours. During the study patients recorded a daily sleep interference score based on 11 point scale (0-10) with the higher number being the most sleep interference (NCT00310765)
Timeframe: Baseline and week 2 through week 12
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| baseline | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 open label no study medication | week 9 open label | week 10 open label | week 11 open label | week 12 open label | |
| Placebo | 4.66 | 3.4 | 3.26 | 3.54 | 3.06 | 2.74 | 3.18 | 3.30 | 1.70 | 1.25 | 1.18 | 0.56 |
| Pregabalin | 3.94 | 2.20 | 1.60 | 1.68 | 1.68 | 1.55 | 1.6 | 1.82 | 1.31 | 1.37 | 1.39 | 1.01 |
Patients were randomized to pregabalin or placebo 75 mg twice a day. Patients were allowed to double the dose on day 3 if adequate pain relief was not obtained. Abdominal pain reduction was measured on a Likert scale. A Likert scale assumes the intensity of pain is linear on a continuum from no pain at level 0 to severe pain at level 10. Patients were required to complete a daily dairy recording pain using the Likert 11-point numeric scale. The primary end point was a positive change in the daily pain diary of 2 points from each patient's baseline at weeks 8 after the completion of the blinded study and at week 12 during the open label portion of the study. After 7 weeks all patients are randomized to study drug pregabalin 150 to 300 mg daily for 4 additional weeks after a one week wash out with no medication. (NCT00310765)
Timeframe: Baseline and week 2 through week 12
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| baseline pain score | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 open label with no study medication | week 9 open label | week 10 open label | week 11 open label | week 12 open label | |
| Patients Treated With Placebo | 5.8 | 5.22 | 4.64 | 4.84 | 4.32 | 3.88 | 3.92 | 4.13 | 2.21 | 2.27 | 2.23 | 1.13 |
| Patients Treated With Pregabalin | 6.15 | 2.87 | 1.88 | 3.31 | 2.72 | 2.49 | 2.53 | 2.46 | 2.06 | 1.84 | 1.46 | 1.68 |
"EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state." (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.5 |
| Placebo | 0.5 |
"QANeP: assessment of sensory threshold: subject responds yes when monofilament stimulus is felt on area of maximum pain: 1 (lowest/softest 0.07 gram [g]) to 6 (highest 300 g) or 7 (not perceived); rated by lowest/softest filament felt when in contact with the skin. Summarized as change from baseline (mean at observation minus mean at baseline)." (NCT00313820)
Timeframe: Baseline, Week 12
| Intervention | scores on scale (Mean) |
|---|---|
| Pregabalin | 0.0 |
| Placebo | -0.1 |
SF-MPQ Part B VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Distance from left-hand end of line was measured and entered on Case Report Form (CRF) as score in mm. Higher score indicates greater level of pain. (NCT00313820)
Timeframe: Week 12
| Intervention | millimeters (Least Squares Mean) |
|---|---|
| Pregabalin | 48.5 |
| Placebo | 49.5 |
DSIS: subject rated 11-point numeric scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. Endpoint calculated as mean of last 7 available scores. (NCT00313820)
Timeframe: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
| Intervention | scores on scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (n=108, 108) | Week 2 (n=104, 106) | Week 3 (n=102, 105) | Week 6 (n=98, 102) | Week 9 (n=98, 97) | Week 12 (n=92, 92) | Endpoint [Week 12 or ET] (n=108, 108) | |
| Placebo | 4.2 | 4.0 | 3.9 | 3.7 | 3.4 | 3.2 | 3.1 |
| Pregabalin | 3.6 | 3.5 | 3.2 | 3.0 | 3.0 | 3.1 | 3.0 |
Subject rated pain scale: static mechanical allodynia (SMA) gentle constant mechanical pressure; dynamic mechanical allodynia (DMA) gentle stroking with foam brush; punctate hyperalgesia (PH) pinprick; cold allodynia (CA) touch with cool metal rod 13-17° celsius (C); cold hyperalgesia (CH) touch with cold metal rod 4° C; temporal summation to tactile stimuli (TSTS) repeated touching/tapping. 11-point numeric scale; range 0 (no pain) to 10 (worst possible pain). Reference area=mirror image of pain site (test area). Summarized as change from baseline (mean at observation minus mean at baseline). (NCT00313820)
Timeframe: Baseline, Week 12
| Intervention | scores on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| SMA (n=108, 107) | DMA (n=108, 107) | PH reference area (n=108, 107) | PH test area (n=108, 107) | TSTS (n=108, 106) | CA (n=108, 106) | CH reference area (n=107, 107) | CH test area (n=107, 106) | |
| Placebo | -0.5 | -0.6 | -0.2 | -0.0 | -0.5 | -0.3 | -0.2 | -0.9 |
| Pregabalin | -0.7 | -0.8 | -0.2 | -0.7 | -1.0 | -1.1 | 0.0 | -0.9 |
Weekly mean pain score measured by DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication. (NCT00313820)
Timeframe: Week 1, Week 2, Week 3, Week 6, Week 9, and Week 12
| Intervention | scores on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n=108, 108) | Week 2 (n=104, 106) | Week 3 (n=102, 105) | Week 6 (n=97, 102) | Week 9 (n=98, 97) | Week 12 [ET] (n=92, 92) | |
| Placebo | 6.0 | 5.8 | 5.6 | 5.4 | 5.2 | 4.9 |
| Pregabalin | 5.6 | 5.3 | 5.1 | 4.9 | 4.8 | 4.7 |
MOS: subject rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance (n=100, 97) | Snoring score (n=98, 97) | Awaken SOB or headache (n=99, 97) | Sleep quantity (100, 97) | Sleep adequacy (n=99, 97) | Somnolence (n=99, 97) | Overall sleep problems index (n=100, 97) | |
| Placebo | 31.9 | 32.9 | 15.0 | 6.6 | 58.9 | 37.8 | 32.4 |
| Pregabalin | 27.1 | 40.6 | 11.3 | 7.0 | 67.5 | 39.9 | 28.2 |
NPSI: subject rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score (0 to 100). Higher score indicates a greater intensity of pain. (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Burning Pain (n=108, 108) | Pressing Pain (n=108, 107) | Paroxysmal Pain (n=108, 108) | Evoked Pain (n=108, 108) | P/D (n=108, 108) | Total Score (n=108, 107) | |
| Placebo | 2.9 | 2.6 | 2.1 | 3.2 | 3.1 | 28.5 |
| Pregabalin | 2.6 | 2.7 | 1.9 | 2.8 | 2.7 | 25.7 |
30% Responder Yes = number of subjects with 30% reduction in mean pain score from baseline to observation; 30% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 30. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 30% Responder No indicates number of subjects that did not reach 30% reduction in mean pain score. (NCT00313820)
Timeframe: Baseline, Week 12
| Intervention | participants (Number) | |
|---|---|---|
| 30% Responders Yes | 30% Responders No | |
| Placebo | 35 | 73 |
| Pregabalin | 48 | 60 |
MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of subjects with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night. (NCT00313820)
Timeframe: Week 12
| Intervention | participants (Number) | |
|---|---|---|
| Optimal sleep = Yes | Optimal sleep = No | |
| Placebo | 42 | 55 |
| Pregabalin | 51 | 49 |
50% Responder Yes = number of subjects with 50% reduction in mean pain score from baseline to observation; 50% reduction calculated as [(T minus B) divided by B multiplied by 100] < = negative 50. T = endpoint mean pain score (obtained from last 7 available scores from DPRS); B = baseline mean pain score (obtained from average of last 7 daily scores from DPRS). 50% Responder No indicates number of subjects that did not reach 50% reduction in mean pain score. (NCT00313820)
Timeframe: Baseline, Week 12
| Intervention | participants (Number) | |
|---|---|---|
| 50 % Responders Yes | 50 % Responders No | |
| Placebo | 22 | 86 |
| Pregabalin | 26 | 82 |
Mean pain score obtained from last 7 available DPRS scores up to and including day of Week 12 visit or early termination (ET) equivalent. DPRS: subject rated 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. Self-assessment performed daily on awakening prior to taking study medication. (NCT00313820)
Timeframe: Up to Week 12
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.8 |
| Placebo | 5.0 |
PGIC: subject rated instrument to measure subject's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.9 |
| Placebo | 3.1 |
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 65.7 |
| Placebo | 62.7 |
HADS is subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) | |
|---|---|---|
| Week 12 [LOCF] Anxiety score | Week 12 [LOCF] Depression score | |
| Placebo | 6.5 | 6.5 |
| Pregabalin | 5.5 | 6.7 |
CGIC: clinician rated instrument that measures change in a subject's ovall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT00313820)
Timeframe: Week 12
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.8 |
| Placebo | 3.1 |
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries. (NCT00333866)
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
| Intervention | Units on a scale (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=183,179,174,178) | Week 2 (n=180,172,168,174) | Week 3 (n=174, 164, 159,163) | Week 4 (n=165,157,155,156) | Week 5 (n=163, 150, 152,148) | Week 6 (n=159,145,148,144) | Week 7 (n=155,140,144,133) | Week 8 (n=149,133,142,127) | Week 9 (n=146,128,141,126) | Week 10 (n=144,125,139,126) | Week 11 (n=143,123,137,121) | Week 12 (n=141,121,135,119) | Week 13 (n=140,120,133,118) | Week 14 (n=134,115,128,111) | Overall (n=183,179,174,178) | |
| Placebo | -0.38 | -0.62 | -0.75 | -0.73 | -0.82 | -0.84 | -0.91 | -0.99 | -1.11 | -1.14 | -1.09 | -1.22 | -1.05 | -1.08 | -0.91 |
| Pregabalin 300 mg | -1.20 | -1.48 | -1.42 | -1.52 | -1.67 | -1.56 | -1.50 | -1.60 | -1.64 | -1.75 | -1.65 | -1.62 | -1.66 | -1.73 | -1.57 |
| Pregabalin 450 mg | -1.08 | -1.43 | -1.56 | -1.67 | -1.69 | -1.76 | -1.83 | -1.95 | -1.94 | -2.03 | -1.92 | -1.95 | -1.93 | -1.95 | -1.76 |
| Pregabalin 600 mg | -1.23 | -1.59 | -1.90 | -2.01 | -1.99 | -2.15 | -2.20 | -2.25 | -2.24 | -2.34 | -2.24 | -2.29 | -2.26 | -2.29 | -2.07 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Functioning (n=184,184,177,186) | Physical Role Limitations (n=183,183,177,185) | Emotional Role Limitations (n=183,183,177,185) | Social Functioning (n=183,184,178,186) | Mental Health (n=183,184,178,186) | Bodily Pain (n=183,184,178,186) | Vitality (n=183,184,178,186) | General Health Perception (n=183,184,177,186) | Mental Component Score (n=182,183,176,184) | Physical Component Score (n=182,183,176,184) | |
| Placebo | 4.64 | 4.01 | -2.31 | 0.75 | -1.67 | 4.95 | 4.15 | 0.94 | -1.27 | 2.47 |
| Pregabalin 300 mg | 5.22 | 4.40 | 1.44 | 4.10 | 1.65 | 7.77 | 4.89 | 2.76 | 0.87 | 2.60 |
| Pregabalin 450 mg | 6.63 | 5.50 | 3.93 | 5.76 | 4.25 | 10.32 | 9.25 | 3.67 | 2.39 | 3.01 |
| Pregabalin 600 mg | 4.13 | 5.03 | 1.56 | 3.60 | 2.41 | 7.53 | 7.29 | 2.21 | 1.35 | 2.34 |
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep Disturbance (n=183,183,177,185) | Snoring (n=172,174,174,177) | Shortness of Breath, Headache (n=182,182,177,184) | Quantity of Sleep (n=182,182,175,182) | Sleep Adequacy (n=183,183,179,185) | Somnolence (n=182,182,177,184) | Overall Sleep Problem Index (n=181,181,174,184) | |
| Placebo | -5.99 | -0.03 | -0.67 | 0.41 | 7.62 | -0.10 | -4.83 |
| Pregabalin 300 mg | -13.18 | 1.17 | -9.62 | 0.61 | 10.19 | 0.67 | -9.19 |
| Pregabalin 450 mg | -19.26 | 4.89 | -12.59 | 0.91 | 16.76 | 0.61 | -13.07 |
| Pregabalin 600 mg | -18.70 | 5.87 | -9.91 | 0.76 | 11.97 | 1.92 | -11.72 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| HADS Anxiety (HADS-A) Total | HADS Depression (HADS-D) Total | |
| Placebo | -0.31 | -0.11 |
| Pregabalin 300 mg | -0.42 | -0.33 |
| Pregabalin 450 mg | -0.81 | -0.70 |
| Pregabalin 600 mg | -0.90 | 0.04 |
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| FIQ Physical Impairment (n=183,184,179,186) | FIQ Feel Good (n=182,184,178,183) | FIQ Work Missed (n=182,181,178,184) | FIQ Do Work (n=182,183,179,185) | FIQ Pain (n=183,184,179,185) | FIQ Fatigue (n=183,184,179,184) | FIQ Rested (n=183,184,179,185) | FIQ Stiffness (n=183,184,179,185) | FIQ Anxiety (n=183,184,179,185) | FIQ Depression (n=181,184,179,184) | |
| Placebo | -0.09 | -1.15 | -0.13 | -0.90 | -0.97 | -0.81 | -0.94 | -1.06 | -0.48 | -0.22 |
| Pregabalin 300 mg | -0.26 | -1.11 | -0.29 | -1.04 | -1.18 | -0.86 | -1.17 | -1.02 | -0.66 | -0.56 |
| Pregabalin 450 mg | -0.35 | -1.77 | -0.75 | -1.60 | -1.72 | -1.36 | -1.47 | -1.28 | -1.12 | -1.19 |
| Pregabalin 600 mg | -0.26 | -1.26 | -0.27 | -0.98 | -1.10 | -1.05 | -1.40 | -0.94 | -0.68 | -0.43 |
Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 30.8 |
| Pregabalin 300 mg | 33.5 |
| Pregabalin 450 mg | 44.0 |
| Pregabalin 600 mg | 32.4 |
Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | mm (Least Squares Mean) |
|---|---|
| Placebo | -10.30 |
| Pregabalin 300 mg | -12.86 |
| Pregabalin 450 mg | -17.75 |
| Pregabalin 600 mg | -11.74 |
Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.94 |
| Pregabalin 300 mg | -1.42 |
| Pregabalin 450 mg | -1.72 |
| Pregabalin 600 mg | -1.95 |
FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -6.94 |
| Pregabalin 300 mg | -8.11 |
| Pregabalin 450 mg | -12.79 |
| Pregabalin 600 mg | -8.38 |
Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.73 |
| Pregabalin 300 mg | -1.06 |
| Pregabalin 450 mg | -1.29 |
| Pregabalin 600 mg | -0.96 |
Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days). (NCT00333866)
Timeframe: Week 14
| Intervention | mg/day (Least Squares Mean) |
|---|---|
| Placebo | 460.65 |
| Pregabalin 300 mg | 449.14 |
| Pregabalin 450 mg | 508.53 |
| Pregabalin 600 mg | 724.42 |
MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). (NCT00333866)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.91 |
| Pregabalin 300 mg | -2.78 |
| Pregabalin 450 mg | -3.32 |
| Pregabalin 600 mg | -2.19 |
Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00333866)
Timeframe: Week 14
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 7 | 43 | 45 | 43 | 11 | 17 | 3 |
| Pregabalin 300 mg | 13 | 45 | 50 | 28 | 9 | 14 | 5 |
| Pregabalin 450 mg | 16 | 50 | 55 | 27 | 7 | 8 | 2 |
| Pregabalin 600 mg | 20 | 46 | 41 | 25 | 10 | 10 | 3 |
"Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 no pain to 100 worst possible pain. Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind." (NCT00346034)
Timeframe: Week 12 (end of treatment)
| Intervention | mm (Mean) |
|---|---|
| Pregabalin | -20.1 |
"Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 no pain to 100 worst possible pain. Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind." (NCT00346034)
Timeframe: Week 4
| Intervention | mm (Mean) |
|---|---|
| Pregabalin | -18.1 |
Mean deviation (MD) is a global index of visual field depression. The MD ranges from 0 decibels (no defect) to about -32 decibels (end-stage damage), higher scores indicate worse condition. It is derived from the Humphrey 24-2 SITA standard visual field analyzer. Change in mean deviation score from baseline to Week 12 or termination was computed for each participant. As planned, for each participant, the worst eye (eye with the greatest decrease in mean deviation) was used in the analysis and data is reported for same. (NCT00351611)
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)
| Intervention | Decibels (Least Squares Mean) |
|---|---|
| Pregabalin | -0.339 |
| Placebo | -0.214 |
Visual acuity best-corrected (with glasses or best possible glasses prescription) was measured using early treatment diabetic retinopathy study (ETDRS) charts. There were 2 ETDRS charts. The letters on chart A were read using the right eye and on chart B using the left eye. The participants started from the top of the chart to down. The participants read down the chart until they reached a row where a minimum of 3 letters on a line could not be read. The participants were scored by number of letters identified correctly. Range was from 0 to 70, with higher scores indicate better visual acuity. As planned, for each participant, the worst eye (eye with the greatest decrease in visual acuity) was used in the analysis and data is reported for same. (NCT00351611)
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)
| Intervention | Letters identified correctly (Least Squares Mean) |
|---|---|
| Pregabalin | -1.890 |
| Placebo | -0.990 |
In this primary outcome measure, percentage of participants is reported, with a decrease in the threshold value from baseline to Week 12 or termination in any 5 or more points (in either eye) at the p<0.05 level repeated in the same 5 points on subsequent computerized automated perimetry testing (Humphrey 24-2 SITA standard). It was derived from the Humphrey 24-2 SITA standard visual field analyzer. For each eye there were 52 test points. For each test point, the Humphrey analyzer determined the threshold value for sensitivity to light by the participant. In addition, for each of the 52 points, the test provided probabilities (p<0.05, p<0.02, etc.) that a participant with normal vision of the same age would have the same result, i.e., that the measured value at that point was at or below the respective percentile of the age-specific empiric distribution at that position of the field for normal participants. (NCT00351611)
Timeframe: Baseline, Week 12 or Early Termination (any time up to Week 12)
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 3.8 |
| Placebo | 5.6 |
The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome. (NCT00353704)
Timeframe: 120 minutes after surgery
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 11.7 |
| Placebo | 22.5 |
"Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as cumulated opioid consumption (milligram)" (NCT00353704)
Timeframe: 240 minutes
| Intervention | mg (Mean) |
|---|---|
| Pregabalin | 7.3 |
| Placebo | 16.0 |
DSST: subject-rated; evaluates aspects of cognition (includes attending to directions, processing speed, sustained attention, visual-motor integration, learning and psychomotor speed). Subject matches symbol (1 to 9) with corresponding number key (1 to 9); number of correct symbol-number pairs completed by subject over a 90-second test period determines DSST score. Change: mean at observation minus mean at baseline. Data summarized as change from baseline to endpoint. (NCT00368745)
Timeframe: Baseline, Endpoint (AF Week 6 )
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin 75 mg to 300 mg PO BID | 13.10 |
| Placebo 75 mg to 300 mg PO BID | 13.47 |
Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine benzodiazepine psychoactive toxicology assay (each visit Alprazolam Free phase); negative serum benzodiazepine alcohol assay (endpoint or LOCF). (NCT00368745)
Timeframe: Endpoint (Post Alprazolam Free Week 6 or LOCF Post Alprazolam Free Week 1)
| Intervention | participants (Number) |
|---|---|
| Pregabalin 75 mg to 300 mg PO BID | 20 |
| Placebo 75 mg to 300 mg PO BID | 10 |
Number of subjects benzodiazepine free: < 2 doses rescue medication; negative urine toxicology assay (each visit Alprazolam Free phase), negative urine alcohol assay (Alprazolam Free Week 6 = endpoint or LOCF). Relapse: > = 2 intakes rescue medication, positive urine and /or alcohol assays, unable to tolerate alprazolam taper, or discontinuation. (NCT00368745)
Timeframe: Alprazolam Free Week 6
| Intervention | participants (Number) |
|---|---|
| Pregabalin 75 mg to 300 mg PO BID | 21 |
| Placebo 75 mg to 300 mg PO BID | 12 |
The 25th percentile estimate of time until discontinuation is based on Kaplan-Meier estimates. Event day is the study day when the subject discontinued from study. (NCT00368745)
Timeframe: Baseline, Week 13 (Final Visit/Early Termination)
| Intervention | days (Number) |
|---|---|
| Pregabalin 75 mg to 300 mg PO BID | 51 |
| Placebo 75 mg to 300 mg PO BID | 33 |
The 25th percentile estimate of time until first use of rescue medication is based on Kaplan-Meier estimates. Event day is the study day when the subject first used rescue medication. Rescue medication: packet with 2 doses alprazolam to take only in the event subject experiences severe symptoms of benzodiazepine withdrawal or rebound anxiety. (NCT00368745)
Timeframe: Baseline, Week 13 (Final Visit/Early Termination)
| Intervention | days (Number) |
|---|---|
| Pregabalin 75 mg to 300 mg PO BID | 63 |
| Placebo 75 mg to 300 mg PO BID | 30 |
CGI-S: 7-point scale to assess global change in subject condition compared to baseline; range 1 (no evidence of illness) to 7 (among the most severely ill); higher score = more affected. Change from baseline: mean at observation minus mean at baseline. (NCT00368745)
Timeframe: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alprazolam Taper (AT) Week 1 (n=45, 40) | AT Week 2 (n=44, 37) | AT Week 3 (n=32, 27) | AT Week 4 (n=17, 11) | AT Week 5 (n=7, 5) | AT Week 6 (n=16, 9) | Alprazolam Free (AF) Week 1 (n=38, 28) | AF Week 2 (n=34, 24) | AF Week 3 (n=30, 26) | AF Week 4 (n=30, 19) | AF Week 5 (n=26, 18) | AF Week 6 (n=21, 15) | Endpoint [LOCF] (n=45, 41) | |
| Placebo 75 mg to 300 mg PO BID | 0.22 | 0.41 | -0.10 | -0.04 | -0.05 | 0.08 | 0.23 | -0.48 | -0.32 | -0.84 | -0.75 | -1.02 | 0.31 |
| Pregabalin 75 mg to 300 mg PO BID | -0.23 | -0.33 | -0.60 | -0.41 | -0.77 | -0.63 | -0.46 | -0.98 | -0.88 | -0.87 | -0.82 | -1.33 | -0.45 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); lower score indicates less affected. Change from baseline: mean at observation minus mean at baseline. (NCT00368745)
Timeframe: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (Alprazolam Free [AF] Week 6)
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alprazolam Taper (AT) Week 1 (n=46, 40) | AT Week 2 (n=45, 37) | AT Week 3 (n=33, 26) | AT Week 4 (n=18, 11) | AT Week 5 (n=8, 5) | AT Week 6 (n=17, 9) | Alprazolam Free (AF) Week 1 (n=39, 28) | AF Week 2 (n=35, 24) | AF Week 3 (n=31, 26) | AF Week 4 (n=31, 19) | AF Week 5 (n=27, 18) | AF Week 6 (n=22, 15) | Endpoint [LOCF] (n=46, 41) | |
| Placebo 75 mg to 300 mg PO BID | 0.67 | 2.17 | -0.21 | 1.91 | 2.86 | 2.41 | 2.40 | -1.14 | -2.47 | -3.58 | -3.34 | -4.77 | 2.77 |
| Pregabalin 75 mg to 300 mg PO BID | -0.82 | -1.72 | -2.59 | -1.47 | -2.36 | -1.26 | -0.43 | -2.15 | -3.46 | -3.58 | -3.85 | -5.62 | -2.01 |
CGI-I: 7-point scale to assess global change in subject condition compared to baseline; range 1 (very much improved) to 7 (very much worse); higher score = more affected. (NCT00368745)
Timeframe: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alprazolam Taper (AT) Week 1 (n=46, 39) | AT Week 2 (n=45, 37) | AT Week 3 (n=33, 27) | AT Week 4 (n=18, 11) | AT Week 5 (n=8, 5) | AT Week 6 (n=17, 9) | Alprazolam Free (AF) Week 1 (n=39, 28) | AF Week 2 (n=35, 24) | AF Week 3 (n=30, 26) | AF Week 4 (n=31, 19) | AF Week 5 (n=27, 18) | AF Week 6 (n=22, 15) | Endpoint [LOCF] (n= 46, 41) | |
| Placebo 75 mg to 300 mg PO BID | 3.90 | 3.98 | 3.47 | 3.01 | 3.44 | 3.86 | 3.90 | 3.27 | 2.93 | 2.46 | 2.77 | 2.18 | 3.52 |
| Pregabalin 75 mg to 300 mg PO BID | 3.52 | 3.17 | 2.88 | 3.09 | 2.63 | 3.00 | 2.93 | 2.39 | 2.15 | 2.20 | 2.29 | 1.52 | 2.57 |
PGI-I: subject rated 7-point scale measures change in overall status; range 1 (very much improved) to 7 (very much worse). (NCT00368745)
Timeframe: Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, and Endpoint (AF Week 6 )
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alprazolam Taper (AT) Week 1 (n=46, 40) | AT Week 2 (n= 45, 37) | AT Week 3 (n=33, 26) | AT Week 4 (n=18, 11) | AT Week 5 (n=8, 5) | AT Week 6 (n=17, 9) | Alprazolam Free (AF) Week 1 (n=39, 28) | AF Week 2 (n=35, 24) | AF Week 3 (n=31, 26) | AF Week 4 (n=30, 19) | AF Week 5 (n=27, 18) | AF Week 6 (n=22, 14) | Endpoint [LOCF] (n=46, 41) | |
| Placebo 75 mg to 300 mg PO BID | 3.82 | 4.03 | 3.31 | 2.98 | 3.75 | 3.38 | 3.45 | 2.94 | 2.92 | 2.73 | 2.70 | 2.48 | 3.74 |
| Pregabalin 75 mg to 300 mg PO BID | 3.16 | 3.13 | 2.93 | 3.12 | 2.91 | 2.93 | 2.95 | 2.34 | 2.28 | 2.43 | 2.32 | 1.53 | 2.71 |
Mean scores at each visit for PWC: 20-item physician-rated interview measures presence of anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception, and cognition); range 0 (not present) to 3 (severe). Total score: 0 to 60; higher score = more affected. Mean scores entered as post-hoc analysis as Mean change from baseline in PWS scores not analyzed: PWS not measured at baseline. (NCT00368745)
Timeframe: Baseline, Alprazolam Taper Weeks 1 through 6, Alprazolam Free Weeks 1 through 6, Endpoint (AF Week 6 )
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alprazolam Taper (AT) Week 1 (n=43, 40) | AT Week 2 (n=44,37) | AT Week 3 (n=33, 26) | AT Week 4 (n=18, 11) | AT Week 5 (n=7, 5) | AT Week 6 (n=17, 9) | Alprazolam Free (AF) Week 1 (n=39, 28) | AF Week 2 (n=33, 24) | AF Week 3 (n=30, 26) | AF Week 4 (n=30, 19) | AF Week 5 (n=27, 18) | AF Week 6 (n=22, 15) | Endpoint [LOCF] (n=46, 41) | |
| Placebo 75 mg to 300 mg PO BID | 8.50 | 10.00 | 9.41 | 9.04 | 9.58 | 12.55 | 10.70 | 6.43 | 7.16 | 6.99 | 8.25 | 5.51 | 10.28 |
| Pregabalin 75 mg to 300 mg PO BID | 6.32 | 6.37 | 6.56 | 5.63 | 7.30 | 6.82 | 6.78 | 4.71 | 6.86 | 7.43 | 7.87 | 2.40 | 6.48 |
Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit. (NCT00372528)
Timeframe: Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)
| Intervention | Seizures (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Month 6 to Month 12 (n = 20) | Month 12 to Month 18 (n = 18) | Month 18 to Month 24 (n = 19) | Month 24 to Month 30 (n = 18) | Month 30 to Month 36 (n = 18) | Month 36 to Month 42 (n = 17) | Month 42 to Month 48 (n = 11) | Month 54 or EOS (n = 19) | Follow-up (n = 14) | |
| Pregabalin | 35.10 | 29.70 | 27.80 | 32.50 | 29.30 | 28.70 | 24.80 | 22.90 | 6.40 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00372528)
Timeframe: Baseline up to Year 5 and follow-up (30 days after last dose)
| Intervention | Participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Pregabalin | 21 | 3 |
Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by the collection time period (up to 10 days). (NCT00380874)
Timeframe: Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.11 |
| Placebo | 1.27 |
Number of participants with persistent paresthesic, dyesthesic, and pain symptoms at chemotherapy Cycle 9 and last observation carried forward (LOCF) endpoint. Numeric rating scale of symptoms: >=1: mild symptoms to >=4: moderate severe symptoms. Subjects rated their average severity of symptoms over the last 24 hours every evening before bedtime. (NCT00380874)
Timeframe: Cycle 9 and Last Observation Carried Forward (LOCF) cycle endpoint
| Intervention | participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Paresthesia Cycle 9 (n=19,19) (>or=1) | Paresthesia LOCF endpoint (n=30,29) (>or=1) | Paresthesia Cycle 9 (n=19,19) (>or=2) | Paresthesia LOCF endpoint (n=30,29) (>or=2) | Paresthesia Cycle 9 (n=19,19) (>or=3) | Paresthesia LOCF endpoint (n=30,29) (>or=3) | Paresthesia Cycle 9 (n=19,19) (>or=4) | Paresthesia LOCF endpoint (n=30,29) (>or=4) | Dysesthesia Cycle 9 (n=19,19) (>or=1) | Dysesthesia LOCF endpoint (n=30,29) (>or=1) | Dysesthesia Cycle 9 (n=19,19) (>or=2) | Dysesthesia LOCF endpoint (n=30,29) (>or=2) | Dysesthesia Cycle 9 (n=19,19) (>or=3) | Dysesthesia LOCF endpoint (n=30,29) (>or=3) | Dysesthesia Cycle 9 (n=19,19) (>or=4) | Dysesthesia LOCF endpoint (n=30,29 (>or=4) | Pain Cycle 9 (n=19,19) (>or=1) | Pain LOCF endpoint (n=30,29;) (>or=1) | Pain Cycle 9 (n=19,19) (>or=2) | Pain LOCF endpoint (n=30,29) (>or=2) | Pain Cycle 9 (n=19,19) (>or=3) | Pain LOCF endpoint (n=30,29) (>or=3) | Pain Cycle 9 (n=19,19) (>or=4) | Pain LOCF endpoint (n=30,29) (>or=4) | |
| Placebo | 6 | 7 | 3 | 3 | 1 | 1 | 1 | 1 | 4 | 5 | 3 | 4 | 1 | 2 | 1 | 2 | 2 | 3 | 1 | 2 | 1 | 2 | 1 | 2 |
| Pregabalin | 7 | 8 | 4 | 5 | 2 | 3 | 1 | 2 | 10 | 11 | 5 | 6 | 3 | 4 | 1 | 2 | 6 | 6 | 2 | 2 | 1 | 1 | 0 | 0 |
Least squares mean of change: mean at cycle minus mean at Baseline. Paresthetic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of paresthesia (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint is defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). (NCT00380874)
Timeframe: Baseline to Cycle 9
| Intervention | score on scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 (n=25, 27) | Cycle 2 (n=26, 26) | Cycle 3 (n=24, 23) | Cycle 4 (n=25, 23) | Cycle 5 (n=24, 22) | Cycle 6 (n=21, 21) | Cycle 7 (n=17, 22) | Cycle 8 (n=16, 19) | Cycle 9 (n=16, 18) | |
| Placebo | 0.13 | 0.22 | 0.37 | 0.40 | 0.53 | 0.64 | 0.96 | 1.03 | 1.65 |
| Pregabalin | 0.03 | 0.35 | 0.53 | 0.64 | 1.03 | 0.74 | 0.93 | 0.83 | 0.92 |
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Pain Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of pain (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). (NCT00380874)
Timeframe: Baseline to Cycle 9, LOCF cycle endpoint
| Intervention | score on scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 (n=25,27) | Cycle 2 (n=25,26) | Cycle 3 (n=23,23) | Cycle 4 (n=25,23) | Cycle 5 (n=24,22) | Cycle 6 (n=21,21) | Cycle 7 (17,22) | Cycle 8 (n=16,19) | Cycle 9 (n=16, 18) | LOCF endpoint (n=26, 27) | |
| Placebo | 0.07 | 0.16 | 0.26 | 0.27 | 0.31 | 0.58 | 0.60 | 0.60 | 0.97 | 0.78 |
| Pregabalin | 0.02 | 0.29 | 0.47 | 0.62 | 0.85 | 0.54 | 0.92 | 0.92 | 0.86 | 0.65 |
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Dysesthesic Duration Adjusted Average Change (DAAC) endpoint was computed based on Numeric Rating Scale (NRS) of dysesthesis (collected 0=no pain; 1-3=mild pain; 4-6=moderate pain; 7-10=severe pain). DAAC endpoint was defined as the Area Under Curve (AUC) of the collected NRS over time, divided by collection time period (up to 10 days). (NCT00380874)
Timeframe: Baseline to Cycle 9, LOCF cycle endpoint
| Intervention | score on scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 (n=25,27) | Cycle 2 (n=26,26) | Cycle 3 (n=24,23) | Cycle 4 (n=25,23) | Cycle 5 (n=24,22) | Cycle 6 (n=21,21) | Cycle 7 (n=17,22) | Cycle 8 (n=16,19) | Cycle 9 (n=16, 18) | LOCF endpoint (n=26, 27) | |
| Placebo | 0.13 | 0.38 | 0.65 | 0.71 | 0.80 | 0.93 | 1.17 | 1.06 | 1.75 | 1.33 |
| Pregabalin | 0.09 | 0.75 | 0.91 | 1.01 | 1.54 | 0.88 | 1.17 | 1.33 | 1.24 | 1.36 |
Least squares (LS) mean of change: mean at cycle minus mean at Baseline. Neuropathic Pain Symptom Inventory (NPSI) = questionnaire designed to evaluate symptoms of neuropathic pain. 11-point numeric rating scale, range: 0 (no pain) to 10 (worst pain imaginable) best describing their average pain for last 24 hours. (NCT00380874)
Timeframe: Baseline to Cycle 9, Last Observation Carried Forward (LOCF) cycle endpoint
| Intervention | score on scale (Least Squares Mean) | |||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Burning spontaneous pain Cycle 3 (n=27,27) | Burning spontaneous pain Cycle 4 (n=28,23) | Burning spontaneous pain Cycle 5 (n=26,24) | Burning spontaneous pain Cycle 6 (n=24,24) | Burning spontaneous pain Cycle 7 (n=21,23) | Burning spontaneous pain Cycle 8 (n=19,21) | Burning spontaneous pain Cycle 9 (n=19,20) | Burning spontaneous pain LOCF endpoint (n=29,27) | Pressing spontaneous pain Cycle 2 (n=28,27) | Pressing spontaneous pain Cycle 3 (n=28,24) | Pressing spontaneous pain Cycle 4 (n=28,23) | Pressing spontaneous pain Cycle 5 (n=26,24) | Pressing spontaneous pain Cycle 6 (n=24,24) | Pressing spontaneous pain Cycle 7 (n=32,29) | Pressing spontaneous pain Cycle 8 (n=19,21) | Pressing spontaneous pain Cycle 9 (n=19,20 | Pressing spontaneous pain LOCF endpoint (n=29,27) | Paroxysmal pain Cycle 3 (n=27,24) | Paroxysmal pain Cycle 4 (n=28,24) | Paroxysmal pain Cycle 5 (n=25,24) | Paroxysmal pain Cycle 6 (n=22,23) | Paroxysmal pain Cycle 7(n=19,23) | Paroxysmal pain Cycle 8 (n=18,21) | Paroxysmal pain Cycle 9 (n=18,20) | Paroxysmal pain LOCF endpoint (n=28,27) | Evoke pain Cycle 2 (n=28,27) | Evoke pain Cycle 3 (n=28,23) | Evoke pain Cycle 4 (n=28,24) | Evoke pain Cycle 5 (n=26,24) | Evoke pain Cycle 6 (n=24,24) | Evoke pain Cycle 7 (n=21,22) | Evoke pain Cycle 8 (n=19,20) | Evoke pain Cycle 9 (n=19,20) | Evoke pain LOCF endpoint (n=29,27) | Paresthesia/dysesthesia pain Cycle 2 (n=28,27) | Paresthesia/dysesthesia pain Cycle 3(n=28,23) | Paresthesia/dysesthesia pain Cycle 4 (n=28,24) | Paresthesia/dysesthesia pain Cycle 5(n=26,24) | Paresthesia/dysesthesia pain Cycle 6 (n=24,23) | Paresthesia/dysesthesia pain Cycle 7 (n=21,22) | Paresthesia/dysesthesia pain Cycle 8 (n=19,21) | Paresthesia/dyesthesia pain Cycle 9 (n=18,20) | Paresthesia/dyesthesia pain LOCF endpt (n=29,27) | Total Score Cycle 2 (n=27,27) | Total Score Cycle 3 (n=27,24) | Total Score Cycle 4(n=27,23) | Total Score Cycle 5 (n=25,24) | Total Score Cycle 6(n=22,23) | Total Score Cycle 7 (n=18,23) | Total Score Cycle 8(n=18,20) | Total Score Cycle 9 (n=17,20) | Total Score Cycle LOCF Endpoint (n=28,27) | |
| Placebo | -0.02 | 0.15 | 0.19 | 0.14 | 0.40 | 0.23 | 0.59 | 0.35 | 0.05 | 0.01 | 0.20 | 0.06 | 0.09 | 0.30 | 0.12 | 0.14 | 0.08 | 0.02 | 0.13 | 0.017 | 0.21 | 0.35 | 0.32 | 0.38 | 0.20 | 0.04 | 0.07 | 0.28 | 0.29 | 0.66 | 0.40 | 0.36 | 0.59 | 0.43 | -0.00 | 0.14 | 0.06 | 0.20 | 0.32 | 0.48 | 0.58 | 0.85 | 0.52 | 0.00 | 0.00 | 0.01 | 0.01 | 0.02 | 0.02 | 0.02 | 0.03 | 0.02 |
| Pregabalin | 0.09 | 0.02 | 0.06 | 0.28 | 0.42 | 0.53 | 0.54 | 0.33 | -0.01 | 0.05 | 0.03 | 0.06 | 0.09 | 0.26 | 0.39 | 0.25 | 0.15 | 0.00 | 0.06 | 0.06 | 0.08 | 0.36 | 0.63 | 0.18 | 0.11 | 0.04 | 0.17 | 0.15 | 0.18 | 0.49 | 0.99 | 1.05 | 0.74 | 0.46 | 9.25 | 0.34 | 0.43 | 0.60 | 0.68 | 0.78 | 1.09 | 1.17 | 0.83 | 0.00 | 0.01 | 0.01 | 0.01 | 0.02 | 0.03 | 0.04 | 0.03 | 0.02 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline. (NCT00381095)
Timeframe: Baseline, Day 1 to End of Dose Adjustment or ET
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -0.72 |
| Placebo | -0.53 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline. (NCT00381095)
Timeframe: Baseline, Days 1 through 28 or ET
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -1.27 |
| Placebo | -1.03 |
HADS: participant rated questionnaire with 2 subscales. HADS-Anxiety assessed generalized anxiety (anxious mood/ restlessness/ anxious thoughts/panic attacks); HADS-Depression assessed lost interest/diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items which ranged from 0 (no presence of anxiety or depression) to 3 (severe feeling anxiety/depression). Total 0-21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Change was week x minus baseline. (NCT00381095)
Timeframe: Baseline, Week 4 or ET
| Intervention | Units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Anxiety Baseline (n= 72, 78) | Anxiety Change at Week 4 (n= 60, 60) | Anxiety Change at Week 4/LOCF (n=64, 65) | Depression Baseline (n= 72, 78) | Depression Change at Week 4 (n= 60, 60) | Depression Change at Week 4/LOCF (n=64, 65) | |
| Placebo | 11.60 | 0.80 | 0.71 | 10.15 | -0.57 | -0.57 |
| Pregabalin | 11.61 | 0.98 | 0.80 | 9.33 | 0.20 | 0.22 |
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely intereres) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. Change was score at each observation minus baseline score. (NCT00381095)
Timeframe: Baseline, Week 4 or ET
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n=71, 76) | Change at Week 4 (n=59, 58) | Change at Week 4/LOCF(n=64, 62) | |
| Placebo | 5.27 | -1.50 | -1.48 |
| Pregabalin | 4.92 | -1.83 | -1.66 |
m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index was the mean of item scores 1, 2, 3, and 4 (worst, least, average and current pain scores). Change was scores at observation minus scores at baseline. (NCT00381095)
Timeframe: Baseline, Week 4 or ET
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n=71, 77) | Change at Week 4 (n=59, 59) | Change at Week 4/LOCF (n=64, 63) | |
| Placebo | 5.03 | -1.41 | -1.35 |
| Pregabalin | 5.18 | -2.06 | -1.94 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT00381095)
Timeframe: Weeks 2 and 4 or ET
| Intervention | Units on a scale (Mean) | ||
|---|---|---|---|
| Week 2 (n=66,68) | Week 4 (n=59, 60) | LOCF/ET (n=69, 74) | |
| Placebo | 3.09 | 2.87 | 2.99 |
| Pregabalin | 2.97 | 2.73 | 2.88 |
DAAC from baseline in the daily worst pain based on the NRS Worst Pain at Reference Site score collected from participant's daily diary 14 days after dosing stabilized (fixed dosing date) up to Day 28. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). DAAC defined as AUC of daily worst pain score divided by pain measurement duration. Change was week x minus baseline. (NCT00381095)
Timeframe: Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -1.47 |
| Placebo | -1.15 |
DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline. (NCT00381095)
Timeframe: Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline (n=72, 79) | Change at Day 28 (n=72, 77) | |
| Placebo | 6.47 | -1.23 |
| Pregabalin | 6.28 | -1.53 |
Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 2 |
| Duloxetine | 9 |
| Gabapentin + Duloxetine | 6 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 59 |
| Duloxetine | 64 |
| Gabapentin + Duloxetine | 68 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 65 |
| Duloxetine | 68 |
| Gabapentin + Duloxetine | 72 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.59 |
| Duloxetine | -3.08 |
| Gabapentin + Duloxetine | -2.86 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.30 |
| Duloxetine | -2.71 |
| Gabapentin + Duloxetine | -2.49 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.12 |
| Duloxetine | -2.62 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Gabapentin + Duloxetine | -2.39 |
| Duloxetine | -2.62 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | beats per minute (Least Squares Mean) |
|---|---|
| Pregabalin | -1.30 |
| Duloxetine | 0.80 |
| Gabapentin + Duloxetine | 1.05 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | kilogram (Least Squares Mean) |
|---|---|
| Pregabalin | 1.00 |
| Duloxetine | -2.39 |
| Gabapentin + Duloxetine | -1.06 |
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | days (Median) |
|---|---|
| Pregabalin | 35.0 |
| Duloxetine | 28.0 |
| Gabapentin + Duloxetine | 28.0 |
A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.98 | -1.86 |
| Gabapentin + Duloxetine | 5.15 | -1.88 |
| Pregabalin | 4.61 | -1.63 |
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.57 |
| Duloxetine | -3.13 |
| Gabapentin + Duloxetine | -2.54 |
This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for <56 contiguous days prior to randomization. Prior use: use of gabapentin for >=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| de novo, baseline | de novo, week 1 | de novo, week 2 | de novo, week 3 | de novo, week 4 | de novo, week 5 | de novo, week 6 | de novo, week 7 | de novo, week 8 | de novo, week 9 | de novo, week 10 | de novo, week 11 | de novo, week 12 | prior use, baseline | prior use, week 1 | prior use, week 2 | prior use, week 3 | prior use, week 4 | prior use, week 5 | prior use, week 6 | prior use, week 7 | prior use, week 8 | prior use, week 9 | prior use, week 10 | prior use, week 11 | prior use, week 12 | |
| Duloxetine | 5.39 | -0.71 | -1.22 | -1.83 | -2.35 | -2.65 | -2.64 | -2.73 | -2.78 | -2.89 | -2.86 | -2.98 | -3.08 | 5.99 | -0.48 | -0.99 | -1.32 | -1.61 | -1.95 | -2.03 | -2.14 | -2.16 | -2.38 | -2.45 | -2.46 | -2.46 |
| Gabapentin + Duloxetine | 5.49 | -0.38 | -1.10 | -1.62 | -1.67 | -1.81 | -1.88 | -2.07 | -2.06 | -2.10 | -1.92 | -2.09 | -2.10 | 5.92 | -0.65 | -1.28 | -1.68 | -1.75 | -1.96 | -1.98 | -2.17 | -2.31 | -2.37 | -2.44 | -2.41 | -2.53 |
| Pregabalin | 5.24 | -0.22 | -0.39 | -0.71 | -0.84 | -0.95 | -1.09 | -1.08 | -1.26 | -1.21 | -1.42 | -1.48 | -1.62 | 5.91 | -0.30 | -0.70 | -1.18 | -1.64 | -1.72 | -1.92 | -1.93 | -1.89 | -2.04 | -2.14 | -2.27 | -2.39 |
(NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nausea | Peripheral Oedema | Insomnia | Somnolence | Anxiety | Dizziness | Dysuria | Headache | Hyperhidrosis | Sedation | Allergic Oedema | Anorgasmia | Increased Blood Creatine | Increased Blood Glucose | Bruxism | Cerebrovascular Accident | Chest Discomfort | Depression | Dermatitis | Diarrhoea | Dry mouth | Enterovirus Infection | Fatigue | Generalized Oedema | Facial Hypoaesthesia | Lacunar Infarction | Loss of Consciousness | Lymphoma | Mental Impairment | Muscular Weakness | Myoclonus | Pollakiuria | Pulomnary Embolism | Rash | Sleep Disorder | Urticaria | Vomiting | |
| Duloxetine | 4 | 0 | 4 | 2 | 1 | 0 | 2 | 2 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
| Gabapentin + Duloxetine | 4 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Pregabalin | 0 | 5 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | coefficient (Number) | ||
|---|---|---|---|
| Direct Treatment Effect | Indirect Treatment Effect | Total Treatment Effect | |
| Ordinary Coefficient | -0.449 | 0.014 | -0.435 |
Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): >34, male (m): >36. Alanine Aminotransferase (ALT): f:<69 years (yr) >34, ≥69yr >32; m: <69yr >43, ≥69yr >35. Total Bilirubin (TBili): >21. Gamma Glutamyl Transferase (GGT): f: <59yr >49, ≥59yr >50; m: <59yr >61, ≥59yr >50. Fasting Plasma Glucose (FPG): <59yr >6.4, ≥59yr >6.7. Hemoglobin A1C (HbA1C) >6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr >106, 50-70yr >123, 70-80yr >164, ≥80yr >221; m: 18-50yr >129, 50-70yr >131, 70-80yr >156, ≥80yr >187 (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| AST, n=113, n=116, n=109 | ALT, n=111, n=104, n=110 | TBili, n=119, n=121, n=116 | GGT, n=102, n=105, n=96 | FPG, n=33, n=30, n=36 | HbA1C, n=17, n=18, n=29 | AlkPhos, n=112, n=114, n=113 | |
| Duloxetine | 6 | 6 | 0 | 6 | 11 | 2 | 3 |
| Gabapentin + Duloxetine | 4 | 10 | 0 | 6 | 18 | 10 | 4 |
| Pregabalin | 4 | 3 | 2 | 2 | 7 | 6 | 4 |
"Elevated systolic blood pressure: >=130 millimeter mercury (mm Hg) + an increase of >=10 mm Hg if baseline <130 mm Hg.~Elevated diastolic blood pressure: >=85 mm Hg + an increase of >=10 mm Hg if baseline <85 mm Hg." (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) | |
|---|---|---|
| diastolic, n=94, n=98, n=100 | systolic, n=42, n=39, n=56 | |
| Duloxetine | 12 | 15 |
| Gabapentin + Duloxetine | 13 | 16 |
| Pregabalin | 11 | 20 |
"Treatment-emergent high body weight: weight at last visit >=107% of baseline weight.~Treatment-emergent low body weight: weight at last visit <=93% of baseline weight." (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) | |
|---|---|---|
| high | low | |
| Duloxetine | 1 | 10 |
| Gabapentin + Duloxetine | 3 | 8 |
| Pregabalin | 6 | 2 |
(NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | micromole/liter (Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 8.07 | -0.28 |
| Gabapentin + Duloxetine | 8.23 | -0.42 |
| Pregabalin | 8.43 | -0.51 |
The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Total | Item 1 | Item 2 | Item 3 | |
| Duloxetine | -3.47 | -1.21 | -1.12 | -1.17 |
| Gabapentin + Duloxetine | -4.54 | -1.95 | -1.53 | -1.54 |
| Pregabalin | -4.96 | -1.96 | -1.64 | -1.70 |
14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| male, total; n=62, n=67, n=66 | female, total; n=39; n=42, n=43 | male, pleasure; n=64, n=67, n=69 | female, pleasure; n=40, n=42, n=43 | male, desire/frequency; n=65, n=67, n=69 | female, desire/frequency; n=42, n=42, n=43 | male, desire/interest; n=65, n=67, n=70 | female, desire/interest; n=42, n=42, n=45 | male, arousal; n=65, n=67, n=70 | female, arousal; n=40, n=42, n=45 | male, orgasm; n=64, n=67, n=69 | female, orgasm; n=40, n=42, n=43 | |
| Duloxetine | 0.48 | 1.12 | -0.06 | 0.47 | 0.06 | 0.26 | -0.19 | 0.34 | 0.52 | 0.07 | 0.18 | -0.05 |
| Gabapentin + Duloxetine | 1.29 | -0.61 | 0.13 | -0.09 | 0.16 | 0.30 | 0.05 | 0.01 | 0.52 | -0.30 | 0.17 | -0.85 |
| Pregabalin | -0.53 | -0.01 | 0.08 | 0.15 | -0.02 | 0.21 | -0.27 | -0.17 | 0.17 | -0.11 | -0.39 | 0.31 |
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| total, n=122, n=126, n=128 | cognitive toxicity, n=126, n=129, n=128 | somatomotor toxicity, n=122, n=126, n=129 | |
| Duloxetine | -8.92 | -6.23 | -2.58 |
| Gabapentin + Duloxetine | -7.29 | -5.29 | -1.91 |
| Pregabalin | -6.27 | -5.12 | -1.36 |
The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| GTS, n=122, n=119, n=118 | QOS, n=121, n=118, n=118 | AFS, n=122, n=118, n=118 | BFW, n=124, n=115, n=118 | |
| Duloxetine | 17.40 | 7.39 | 8.14 | 21.04 |
| Gabapentin + Duloxetine | 14.75 | 9.64 | 11.86 | 14.33 |
| Pregabalin | 10.96 | 9.32 | 10.02 | 19.67 |
Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units/liter (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| baseline, AST, n=119, n=121, n=118 | change, AST, n=119, n=121, n=118 | baseline, ALT, n=120, n=122, n=120 | change, ALT, n=120, n=122, n=120 | baseline, GGT, n=121, n=123, n=120 | change, GGT, n=121, n=123, n=120 | baseline, AlkPhos, n=121, n=123, n=120 | change, AlkPhos, n=121, n=123, n=120 | |
| Duloxetine | 22.84 | -0.52 | 25.04 | -0.16 | 34.29 | -3.03 | 83.74 | 0.55 |
| Gabapentin + Duloxetine | 23.42 | -0.48 | 24.39 | 0.03 | 43.93 | -2.55 | 82.18 | 1.78 |
| Pregabalin | 22.55 | 1.12 | 23.88 | -0.13 | 40.80 | 1.17 | 84.97 | 2.80 |
(NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | percent (Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 7.51 | -0.01 |
| Gabapentin + Duloxetine | 7.16 | 0.07 |
| Pregabalin | 7.57 | -0.12 |
(NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | millimole/liter (Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 8.45 | 0.19 |
| Gabapentin + Duloxetine | 7.99 | 0.67 |
| Pregabalin | 8.24 | 0.16 |
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.47 | -1.16 |
| Gabapentin + Duloxetine | 4.40 | -1.13 |
| Pregabalin | 4.27 | -1.06 |
A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 Weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 6.87 | -3.02 |
| Gabapentin + Duloxetine | 7.00 | -2.64 |
| Pregabalin | 6.73 | -2.34 |
A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 5.03 | -2.24 |
| Gabapentin + Duloxetine | 5.36 | -2.19 |
| Pregabalin | 4.98 | -1.77 |
A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.18 | -1.55 |
| Gabapentin + Duloxetine | 4.07 | -1.54 |
| Pregabalin | 4.23 | -1.27 |
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 5.65 | -2.44 |
| Gabapentin + Duloxetine | 5.75 | -2.29 |
| Pregabalin | 5.53 | -1.80 |
The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.61 | -2.00 |
| Gabapentin + Duloxetine | 4.83 | -1.90 |
| Pregabalin | 4.25 | -1.62 |
A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 5.03 | -2.38 |
| Gabapentin + Duloxetine | 5.03 | -1.86 |
| Pregabalin | 4.24 | -1.51 |
A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 5.52 | -2.56 |
| Gabapentin + Duloxetine | 5.79 | -2.09 |
| Pregabalin | 5.25 | -1.88 |
A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.97 | -2.12 |
| Gabapentin + Duloxetine | 5.40 | -2.50 |
| Pregabalin | 4.91 | -2.29 |
A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 3.08 | -1.27 |
| Gabapentin + Duloxetine | 3.29 | -1.17 |
| Pregabalin | 2.96 | -0.97 |
A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.08 | -1.85 |
| Gabapentin + Duloxetine | 4.10 | -1.43 |
| Pregabalin | 3.42 | -1.46 |
A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 4.63 | -2.09 |
| Gabapentin + Duloxetine | 5.02 | -2.33 |
| Pregabalin | 4.38 | -1.82 |
Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | millimeter mercury (Least Squares Mean) | |
|---|---|---|
| Diastolic | Systolic | |
| Duloxetine | 2.24 | -3.08 |
| Gabapentin + Duloxetine | -0.79 | -2.08 |
| Pregabalin | 0.18 | -3.31 |
Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Increased blood creatinine | Increased blood glucose | |
| Duloxetine | 0 | 0 |
| Gabapentin + Duloxetine | 1 | 0 |
| Pregabalin | 0 | 1 |
14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| male, total, better; n=62, n=67, n=66 | male, total, same; n=62, n=67, n=66 | male, total, worse; n=62, n=67, n=66 | female, total, better; n=39, n=42, n=43 | female, total, same; n=39, n=42, n=43 | female, total, worse; n=39, n=42, n=43 | male, pleasure, better; n=64, n=67, n=69 | male, pleasure, same; n=64, n=67, n=69 | male, pleasure, worse; n=64, n=67, n=69 | female, pleasure, better; n=40, n=42, n=43 | female, pleasure, same; n=40, n=42, n=43 | female, pleasure, worse; n=40, n=42, n=43 | male, desire/frequency, better; n=65, n=67, n=69 | male, desire/frequency, same; n=65, n=67, n=69 | male, desire/frequency, worse; n=65, n=67, n=69 | female, desire/frequency, better; n=42, n=42, n=43 | female, desire/frequency, same; n=42, n=42, n=43 | female, desire/frequency, worse; n=42, n=42, n=43 | male, desire/interest, better; n=65, n=67, n=70 | male, desire/interest, same; n=65, n=67, n=70 | male, desire/interest, worse; n=65, n=67, n=70 | female, desire/interest, better; n=42, n=42, n=45 | female, desire/interest, same; n=42, n=42, n=45 | female, desire/interest, worse; n=42, n=42, n=45 | male, arousal, better; n=65, n=67, n=70 | male, arousal, same; n=65, n=67, n=70 | male, arousal, worse; n=65, n=67, n=70 | female, arousal, better; n=40, n=42, n=45 | female, arousal, same; n=40, n=42, n=45 | female, arousal, worse; n=40, n=42, n=45 | male, orgasm, better; n=64, n=67, n=69 | male, orgasm, same; n=64, n=67, n=69 | male, orgasm, worse; n=64, n=67, n=69 | female, orgasm, better; n=40, n=42, n=43 | female, orgasm, same; n=40, n=42, n=43 | female, orgasm, worse; n=40, n=42, n=43 | |
| Duloxetine | 26 | 9 | 32 | 23 | 5 | 14 | 11 | 40 | 16 | 16 | 21 | 5 | 20 | 29 | 18 | 12 | 21 | 9 | 18 | 19 | 30 | 18 | 14 | 10 | 24 | 29 | 14 | 18 | 10 | 14 | 18 | 31 | 18 | 17 | 13 | 12 |
| Gabapentin + Duloxetine | 31 | 11 | 24 | 18 | 7 | 18 | 21 | 32 | 16 | 6 | 32 | 5 | 24 | 23 | 22 | 12 | 24 | 7 | 26 | 17 | 27 | 16 | 17 | 12 | 23 | 33 | 14 | 15 | 16 | 14 | 17 | 29 | 23 | 11 | 16 | 16 |
| Pregabalin | 24 | 9 | 29 | 13 | 5 | 21 | 13 | 39 | 12 | 10 | 23 | 7 | 12 | 36 | 17 | 11 | 21 | 10 | 20 | 19 | 26 | 13 | 12 | 17 | 20 | 28 | 17 | 11 | 14 | 15 | 12 | 29 | 23 | 15 | 13 | 12 |
The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| hours worked, greater, n=86, n=90, n=83 | hours worked, same, n=86, n=90, n=83 | hours worked, lower, n=86, n=90, n=83 | hours volunteered, greater, n=86, n=91, n=82 | hours volunteered, same, n=86, n=91, n=82 | hours volunteered, lower, n=86, n=91, n=82 | psychiatric visits, greater, n=92, n=93, n=90 | psychiatric visits, same, n=92, n=93, n=90 | psychiatric visits, lower, n=92, n=93, n=90 | outpatient group visits, greater, n=91, n=92, n=91 | outpatient group visits, same, n=91, n=92, n=91 | outpatient group visits, lower, n=91, n=92, n=91 | outpatient ind. visits, greater, n=91, n=88, n=90 | outpatient ind. visits, same, n=91, n=88, n=90 | outpatient ind. visits, lower, n=91, n=88, n=90 | days of partial care, greater, n=93, n=95, n=90 | days of partial care, same, n=93, n=95, n=90 | days of partial care, lower, n=93, n=95, n=90 | nights of partial care, greater, n=92, n=95, n=91 | nights of partial care, same, n=92, n=95, n=91 | nights of partial care, lower, n=92, n=95, n=91 | ER visits-psychiatric, greater, n=93, n=94, n=91 | ER visits-psychiatric, same, n=93, n=94, n=91 | ER visits-psychiatric, lower, n=93, n=94, n=91 | ER visits-nonpsychiatric, greater,n=91, n=95, n=88 | ER visits-nonpsychiatric, same,n=91, n=95, n=88 | ER visits-nonpsychiatric, lower,n=91, n=95, n=88 | phone mental health, greater,n=94, n=95, n=90 | phone mental health, same,n=94, n=95, n=90 | phone mental health, lower,n=94, n=95, n=90 | nonpsychiatric visits, greater, n=89, n=94, n=83 | nonpsychiatric visits, same, n=89, n=94, n=83 | nonpsychiatric visits, lower, n=89, n=94, n=83 | unpaid care, greater, n=84, n=87, n=86 | unpaid care, same, n=84, n=87, n=86 | unpaid care, lower, n=84, n=87, n=86 | missed work caregiver, greater, n=6, n=9, n=5 | missed work caregiver, same, n=6, n=9, n=5 | missed work caregiver, lower, n=6, n=9, n=5 | paid care, greater, n=60, n=58, n=58 | paid care, same, n=60, n=58, n=58 | paid care, less, n=60, n=58, n=58 | |
| Duloxetine | 12 | 66 | 12 | 8 | 77 | 6 | 0 | 91 | 2 | 0 | 92 | 0 | 1 | 84 | 3 | 1 | 94 | 0 | 1 | 94 | 0 | 0 | 94 | 0 | 4 | 85 | 6 | 1 | 93 | 1 | 20 | 46 | 28 | 0 | 87 | 0 | 0 | 8 | 1 | 0 | 58 | 0 |
| Gabapentin + Duloxetine | 13 | 59 | 11 | 10 | 66 | 6 | 2 | 84 | 4 | 1 | 89 | 1 | 4 | 81 | 5 | 2 | 87 | 1 | 2 | 89 | 0 | 0 | 91 | 0 | 4 | 78 | 6 | 2 | 87 | 1 | 18 | 45 | 20 | 0 | 85 | 1 | 0 | 5 | 0 | 0 | 58 | 0 |
| Pregabalin | 10 | 65 | 11 | 7 | 66 | 13 | 2 | 88 | 2 | 0 | 90 | 1 | 3 | 84 | 4 | 2 | 91 | 0 | 1 | 91 | 0 | 0 | 91 | 2 | 3 | 83 | 5 | 1 | 92 | 1 | 24 | 44 | 21 | 2 | 82 | 0 | 0 | 6 | 0 | 0 | 60 | 0 |
The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| better, total; n=122, n=126, n=128 | same, total; n=122, n=126, n=128 | worse, total; n=122, n=126, n=128 | better, cognitive toxicity; n=126, n=129, n=128 | same, cognitive toxicity; n=126, n=129, n=128 | worse, cognitive toxicity; n=126, n=129, n=128 | better, somatomotor toxicity; n=122, n=126, n=129 | same, somatomotor toxicity; n=122, n=126, n=129 | worse, somatomotor toxicity; n=122, n=126, n=129 | |
| Duloxetine | 84 | 5 | 37 | 80 | 6 | 43 | 74 | 19 | 33 |
| Gabapentin + Duloxetine | 86 | 4 | 38 | 82 | 5 | 41 | 74 | 19 | 36 |
| Pregabalin | 68 | 8 | 46 | 75 | 9 | 42 | 60 | 15 | 47 |
Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| baseline | change | |
| Duloxetine | 6.02 | -2.58 |
| Gabapentin + Duloxetine | 5.74 | -2.40 |
| Pregabalin | 5.74 | -2.12 |
This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | days (Median) |
|---|---|
| Pregabalin | 56.0 |
| Duloxetine | 35.0 |
| Gabapentin + Duloxetine | 28.0 |
Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow. (NCT00385671)
Timeframe: baseline through 12 weeks
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 38 |
| Duloxetine | 51 |
| Gabapentin + Duloxetine | 36 |
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). (NCT00385671)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 3.03 |
| Duloxetine | 3.01 |
| Gabapentin + Duloxetine | 2.83 |
This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries. (NCT00385671)
Timeframe: baseline, 12 weeks
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 48 |
| Duloxetine | 50 |
| Gabapentin + Duloxetine | 47 |
Score range for awaken short of breath or with headache is 0-100. Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.99 |
| Pregabalin 150 mg/Day | 6.70 |
| Pregabalin 300 mg/Day | 6.70 |
| Pregabalin 600 mg/Day | 4.95 |
Score range for overall sleep problem index is 0-100. Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 29.22 |
| Pregabalin 150 mg/Day | 25.19 |
| Pregabalin 300 mg/Day | 26.03 |
| Pregabalin 600 mg/Day | 26.78 |
Sleep Quantity subscale is scored from 0-24 indicating the number of hours of sleep. Higher scores indicate more of the attribute named in the subscale. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 6.58 |
| Pregabalin 150 mg/Day | 6.59 |
| Pregabalin 300 mg/Day | 6.85 |
| Pregabalin 600 mg/Day | 6.79 |
Score range for sleep adequacy is 0-100. Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 63.37 |
| Pregabalin 150 mg/Day | 67.38 |
| Pregabalin 300 mg/Day | 73.67 |
| Pregabalin 600 mg/Day | 69.37 |
Score range for sleep disturbance is 0-100.Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 31.99 |
| Pregabalin 150 mg/Day | 23.09 |
| Pregabalin 300 mg/Day | 23.75 |
| Pregabalin 600 mg/Day | 20.65 |
Score range for snoring is 0-100.Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 22.28 |
| Pregabalin 150 mg/Day | 26.58 |
| Pregabalin 300 mg/Day | 25.24 |
| Pregabalin 600 mg/Day | 31.99 |
Score range for Somnolence is 0-100. Higher scores indicate more of the attribute. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 30.23 |
| Pregabalin 150 mg/Day | 34.16 |
| Pregabalin 300 mg/Day | 41.45 |
| Pregabalin 600 mg/Day | 44.46 |
Number of participants who reported Optimal Sleep (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | participants (Number) |
|---|---|
| Placebo | 37 |
| Pregabalin 150 mg/Day | 26 |
| Pregabalin 300 mg/Day | 48 |
| Pregabalin 600 mg/Day | 44 |
Patient Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Mean) |
|---|---|
| Placebo | 3.6 |
| Pregabalin 150 mg/Day | 3.3 |
| Pregabalin 300 mg/Day | 2.9 |
| Pregabalin 600 mg/Day | 3.0 |
Present pain intensity score range from 0-5. Higher scores indicate more severe pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 2.21 |
| Pregabalin 150 mg/Day | 2.01 |
| Pregabalin 300 mg/Day | 1.78 |
| Pregabalin 600 mg/Day | 1.90 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 47.47 |
| Pregabalin 150 mg/Day | 48.09 |
| Pregabalin 300 mg/Day | 54.54 |
| Pregabalin 600 mg/Day | 52.50 |
Sensory score range from 0-33. Higher scores indicate more severe pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 8.97 |
| Pregabalin 150 mg/Day | 8.42 |
| Pregabalin 300 mg/Day | 7.11 |
| Pregabalin 600 mg/Day | 6.97 |
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to endpoint. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | participants (Number) |
|---|---|
| Placebo | 15 |
| Pregabalin 150 mg/Day | 21 |
| Pregabalin 300 mg/Day | 32 |
| Pregabalin 600 mg/Day | 30 |
Participants not reporting hyperalgesia. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | participants (Number) |
|---|---|
| Placebo | 66 |
| Pregabalin 150 mg/Day | 55 |
| Pregabalin 300 mg/Day | 66 |
| Pregabalin 600 mg/Day | 65 |
Participants not reporting allodynia. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | participants (Number) |
|---|---|
| Placebo | 65 |
| Pregabalin 150 mg/Day | 52 |
| Pregabalin 300 mg/Day | 63 |
| Pregabalin 600 mg/Day | 66 |
Affective score range from 0-12. Higher scores indicate more severe pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 2.43 |
| Pregabalin 150 mg/Day | 2.14 |
| Pregabalin 300 mg/Day | 1.72 |
| Pregabalin 600 mg/Day | 1.82 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 9
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.17 |
| Pregabalin 150 mg/Day | 2.44 |
| Pregabalin 300 mg/Day | 2.38 |
| Pregabalin 600 mg/Day | 2.22 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 10
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.08 |
| Pregabalin 150 mg/Day | 4.86 |
| Pregabalin 300 mg/Day | 4.18 |
| Pregabalin 600 mg/Day | 4.56 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 11
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.16 |
| Pregabalin 150 mg/Day | 2.43 |
| Pregabalin 300 mg/Day | 2.37 |
| Pregabalin 600 mg/Day | 2.27 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.10 |
| Pregabalin 150 mg/Day | 2.49 |
| Pregabalin 300 mg/Day | 2.30 |
| Pregabalin 600 mg/Day | 2.14 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 7
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.19 |
| Pregabalin 150 mg/Day | 2.55 |
| Pregabalin 300 mg/Day | 2.36 |
| Pregabalin 600 mg/Day | 2.21 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 6
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.24 |
| Pregabalin 150 mg/Day | 2.63 |
| Pregabalin 300 mg/Day | 2.37 |
| Pregabalin 600 mg/Day | 2.33 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 5
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.26 |
| Pregabalin 150 mg/Day | 2.74 |
| Pregabalin 300 mg/Day | 2.39 |
| Pregabalin 600 mg/Day | 2.41 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 4
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.35 |
| Pregabalin 150 mg/Day | 2.79 |
| Pregabalin 300 mg/Day | 2.54 |
| Pregabalin 600 mg/Day | 2.36 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 10
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.16 |
| Pregabalin 150 mg/Day | 2.46 |
| Pregabalin 300 mg/Day | 2.39 |
| Pregabalin 600 mg/Day | 2.28 |
Scores range from 0-10. Higher scores indicate more severe interference with sleep. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.20 |
| Pregabalin 150 mg/Day | 2.44 |
| Pregabalin 300 mg/Day | 2.39 |
| Pregabalin 600 mg/Day | 2.26 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 9
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.08 |
| Pregabalin 150 mg/Day | 4.87 |
| Pregabalin 300 mg/Day | 4.22 |
| Pregabalin 600 mg/Day | 4.50 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.04 |
| Pregabalin 150 mg/Day | 4.89 |
| Pregabalin 300 mg/Day | 4.23 |
| Pregabalin 600 mg/Day | 4.47 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 7
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.14 |
| Pregabalin 150 mg/Day | 4.90 |
| Pregabalin 300 mg/Day | 4.24 |
| Pregabalin 600 mg/Day | 4.48 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 6
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.29 |
| Pregabalin 150 mg/Day | 5.02 |
| Pregabalin 300 mg/Day | 4.31 |
| Pregabalin 600 mg/Day | 4.54 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 5
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.29 |
| Pregabalin 150 mg/Day | 5.15 |
| Pregabalin 300 mg/Day | 4.42 |
| Pregabalin 600 mg/Day | 4.55 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week4
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.43 |
| Pregabalin 150 mg/Day | 5.14 |
| Pregabalin 300 mg/Day | 4.57 |
| Pregabalin 600 mg/Day | 4.50 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 3
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.50 |
| Pregabalin 150 mg/Day | 2.81 |
| Pregabalin 300 mg/Day | 2.60 |
| Pregabalin 600 mg/Day | 2.43 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 2
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.56 |
| Pregabalin 150 mg/Day | 2.89 |
| Pregabalin 300 mg/Day | 2.76 |
| Pregabalin 600 mg/Day | 2.49 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 13
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.08 |
| Pregabalin 150 mg/Day | 2.33 |
| Pregabalin 300 mg/Day | 2.27 |
| Pregabalin 600 mg/Day | 2.19 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 12
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.06 |
| Pregabalin 150 mg/Day | 2.36 |
| Pregabalin 300 mg/Day | 2.28 |
| Pregabalin 600 mg/Day | 2.21 |
Clinical Global Impression Change is scaled from 1 to 7. 1=very much improved, 7=very much worse. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Mean) |
|---|---|
| Placebo | 3.3 |
| Pregabalin 150 mg/Day | 3.1 |
| Pregabalin 300 mg/Day | 2.7 |
| Pregabalin 600 mg/Day | 2.7 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 3
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.59 |
| Pregabalin 150 mg/Day | 5.18 |
| Pregabalin 300 mg/Day | 4.63 |
| Pregabalin 600 mg/Day | 4.60 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 2
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.75 |
| Pregabalin 150 mg/Day | 5.27 |
| Pregabalin 300 mg/Day | 4.76 |
| Pregabalin 600 mg/Day | 4.73 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 13
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 4.97 |
| Pregabalin 150 mg/Day | 4.70 |
| Pregabalin 300 mg/Day | 4.16 |
| Pregabalin 600 mg/Day | 4.36 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 12
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.00 |
| Pregabalin 150 mg/Day | 4.71 |
| Pregabalin 300 mg/Day | 4.15 |
| Pregabalin 600 mg/Day | 4.37 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 11
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.12 |
| Pregabalin 150 mg/Day | 4.88 |
| Pregabalin 300 mg/Day | 4.18 |
| Pregabalin 600 mg/Day | 4.47 |
Weekly mean pain score is defined as the mean of the last 7 daily diary pain ratings. Scores range from 0-10 (11 points ordinal)with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week 1
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.96 |
| Pregabalin 150 mg/Day | 5.45 |
| Pregabalin 300 mg/Day | 5.21 |
| Pregabalin 600 mg/Day | 5.23 |
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.12 |
| Pregabalin 150 mg/Day | 4.81 |
| Pregabalin 300 mg/Day | 4.26 |
| Pregabalin 600 mg/Day | 4.49 |
Endpoint mean pain score is defined as the mean of the last 7 daily pain diary rating while taking the study medication, up to and including day after last dose. Scores range from 0-10 (11 points ordinal) with higher scores indicating increased pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 4.99 |
| Expected Pregabalin Exposure of 300 mg/Day | 4.35 |
| Expected Pregabalin Exposure of 600 mg/Day | 4.34 |
Weekly mean sleep interference scores is defined as the mean of the last 7 daily diary interference with sleep ratings. Scores range from 0-10 (11 points ordinal) with higher scores indicating more severe interference with sleep. (NCT00394901)
Timeframe: week 1
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.79 |
| Pregabalin 150 mg/Day | 3.00 |
| Pregabalin 300 mg/Day | 2.97 |
| Pregabalin 600 mg/Day | 2.81 |
Visual Analogue Scale Score range from 0-100mm. Higher scores indicate more severe pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | mm (Least Squares Mean) |
|---|---|
| Placebo | 50.02 |
| Pregabalin 150 mg/Day | 47.80 |
| Pregabalin 300 mg/Day | 41.99 |
| Pregabalin 600 mg/Day | 42.59 |
Total score range from 0-45. Higher scores indicate more severe pain. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 11.39 |
| Pregabalin 150 mg/Day | 10.56 |
| Pregabalin 300 mg/Day | 8.84 |
| Pregabalin 600 mg/Day | 8.78 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 54.16 |
| Pregabalin 150 mg/Day | 59.80 |
| Pregabalin 300 mg/Day | 61.58 |
| Pregabalin 600 mg/Day | 58.31 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 75.28 |
| Pregabalin 150 mg/Day | 77.71 |
| Pregabalin 300 mg/Day | 82.69 |
| Pregabalin 600 mg/Day | 77.11 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 67.96 |
| Pregabalin 150 mg/Day | 77.35 |
| Pregabalin 300 mg/Day | 74.63 |
| Pregabalin 600 mg/Day | 69.42 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 69.99 |
| Pregabalin 150 mg/Day | 76.14 |
| Pregabalin 300 mg/Day | 75.41 |
| Pregabalin 600 mg/Day | 73.02 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 76.16 |
| Pregabalin 150 mg/Day | 79.68 |
| Pregabalin 300 mg/Day | 76.93 |
| Pregabalin 600 mg/Day | 77.20 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 61.91 |
| Pregabalin 150 mg/Day | 65.90 |
| Pregabalin 300 mg/Day | 68.90 |
| Pregabalin 600 mg/Day | 66.67 |
Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00394901)
Timeframe: Week13/discontinuation
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 52.36 |
| Pregabalin 150 mg/Day | 57.66 |
| Pregabalin 300 mg/Day | 56.19 |
| Pregabalin 600 mg/Day | 56.30 |
Self-administered questionnaire: change from Baseline in mean pain interference with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. 11-point scale from 0 (does not interfere) to 10 (completely interferes). Change = observation mean minus Baseline mean. (NCT00407511)
Timeframe: Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF)
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Week 8 (n=102) | Week 12 (n=98) | EOT/LOCF (n=102) | |
| Pregabalin | -3.8 | -4.2 | -4.0 |
11 point Likert scale; range: 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Weekly pain score = mean pain score from last 7 post-Baseline days preceding observation visit or last 7 days on study drug for early termination. Change = mean at observation minus mean at Baseline. (NCT00407511)
Timeframe: Week 4, Week 8, Week 12
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Week 4 (n=110) | Week 8 (n=100) | Week 12 (n=96) | |
| Pregabalin | -3.2 | -3.9 | -4.2 |
Daily sleep interference measured on an 11-point Likert scale. Range: 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change = mean at observation minus mean at Baseline. Evaluations recorded in patient's daily sleep diaries. (NCT00407511)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (n=120) | Week 2 (n=118) | Week 3 (n=114) | Week 4 (n=110) | Week 5 (n=104 | Week 6 (n=103) | Week 7 (n=100) | Week 8 (n=100) | Week 9 (n=97) | Week 10 (n=99) | Week 11 (n=98) | Week 12 (n=96) | EOT/LOCF (n=120) | |
| Pregabalin | -1.0 | -1.8 | -2.5 | -2.8 | -3.0 | -3.1 | -3.3 | -3.4 | -3.5 | -3.5 | -3.5 | -3.4 | -3.1 |
100-mm line (Visual Analog Scale) marked by the subject to measure their degree of anxiety over past 24 hours. Range: 0 = not at all anxious to 100 = extremely anxious. Change = mean score at observation minus mean score at Baseline. (NCT00407511)
Timeframe: Baseline, Week 8, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Week 8 (n=99) | Week 12 (n=97) | EOT/LOCF (n=101) | |
| Pregabalin | -39.2 | -41.4 | -40.5 |
Self-administered questionnaire: change from Baseline in mean pain severity index over past 24 hours; 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level). Change = mean score at observation minus mean score at Baseline. (NCT00407511)
Timeframe: Baseline, Week 8, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Week 8 (n=102) | Week 12 (n=98) | EOT/LOCF (n=102) | |
| Pregabalin | -4.2 | -4.7 | -4.6 |
11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline. (NCT00407511)
Timeframe: Baseline, End of Treatment
| Intervention | scores on scale (Mean) |
|---|---|
| Pregabalin | -3.8 |
Satisfaction with current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4. (NCT00407511)
Timeframe: Baseline, Week 8, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | |||
|---|---|---|---|---|
| Baseline (n=78) | Week 8 (n=100) | Week 12 (n=97) | EOT/LOCF (n=105) | |
| Pregabalin | 52.56 | 85.92 | 88.56 | 88.08 |
Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). Score=[(5-mean of non-missing items)*100]/4. (NCT00407511)
Timeframe: Baseline, Week 8, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | |||
|---|---|---|---|---|
| Baseline (n=78) | Week 8 (n=100) | Week 12 (n=97) | EOT/LOCF (n=105) | |
| Pregabalin | 62.34 | 90.38 | 91.66 | 91.40 |
7-point investigator rating scale of change in participant's status since beginning study medication. Range: 1 (very much improved) to 7 (very much worse). (NCT00407511)
Timeframe: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much Worse | Very much worse | |
| Pregabalin | 41 | 55 | 5 | 2 | 0 | 0 | 0 |
7-point participant rating scale for change observed in their overall status since beginning of study medication. Range: 1 (very much improved) to 7 (very much worse) (NCT00407511)
Timeframe: End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Pregabalin | 37 | 53 | 12 | 1 | 0 | 0 | 0 |
100 mm line (Visual Analog Scale) marked by subject; Intensity of pain range (over past week): 0 = no pain to 100 = worst possible pain. Change = observation mean minus Baseline mean. (NCT00407511)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF
| Intervention | scores on scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (n = 120) | Week 2 (n = 116) | Week 3 (n = 116) | Week 4 (n = 109) | Week 8 (n = 102) | Week 12 (n = 98) | EOT/LOCF (n = 120) | |
| Pregabalin | -18.8 | -28.5 | -34.9 | -41.0 | -46.6 | -49.0 | -45.9 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 104, 106) | Change from baseline at endpoint (n = 99, 99) | |
| Placebo | 0.4 | -0.1 |
| Pregabalin | 0.4 | -0.1 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 0.5 | -0.1 |
| Pregabalin | 0.5 | -0.1 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 0.4 | -0.1 |
| Pregabalin | 0.4 | -0.1 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 1- Burning pain (n = 100, 99) | 2- Squeezing pain (n = 100, 99) | 3- Pain like pressure (n = 100, 99) | 5- Electric shocks (n = 100, 99) | 6- Stabbing pain (n = 100, 99) | 8- By light touching (n = 100, 99) | 9- By pressure (n = 100, 99) | 10- By something cold (n = 100, 99) | 11- Pins and needles (n = 99, 99) | 12- Tingling (n = 99, 99) | |
| Placebo | -1.00 | -0.41 | -0.20 | -0.68 | -0.52 | -0.94 | -1.10 | -0.52 | -0.62 | -0.83 |
| Pregabalin | -1.39 | -1.04 | -0.73 | -1.77 | -1.13 | -0.78 | -1.22 | -0.89 | -1.01 | -0.99 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 104, 106) | Change from baseline at endpoint (n = 99, 99) | |
| Placebo | 0.5 | -0.1 |
| Pregabalin | 0.5 | -0.1 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 0.3 | -0.1 |
| Pregabalin | 0.4 | -0.1 |
Participant rated questionnaire used to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each of the relevant dimensions and a total score of 0-100. Higher score indicates a greater intensity of pain. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 0.4 | -0.0 |
| Pregabalin | 0.4 | -0.1 |
Participant rated pain scale. The pain produced by the applied stimulus (dynamic mechanical allodynia - gentle stroking with foam brush) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 83, 82) | Change from baseline at endpoint (n = 79, 75) | |
| Placebo | 2.3 | -0.3 |
| Pregabalin | 2.7 | -0.6 |
Participant rated pain scale. The pain produced by the applied stimulus (static mechanical allodynia - gentle constant mechanical pressure) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 83, 82) | Change from baseline at endpoint (n = 79, 75) | |
| Placebo | 2.6 | -0.3 |
| Pregabalin | 2.9 | -1.0 |
Participant rated pain scale. The pain produced by the applied stimulus (Cold allodynia - touch with cool metal rod 13-17 degrees celsius was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 83, 82) | Change from baseline at endpoint (n = 79, 72) | |
| Placebo | 2.7 | 0.4 |
| Pregabalin | 2.5 | -0.1 |
Participant rated pain scale. The pain produced by the applied stimulus (Cold hyperalgesia - touch with cold metal rod 4 degrees celsius) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 83, 82) | Change from baseline at endpoint (n = 79, 72) | |
| Placebo | 2.8 | 0.4 |
| Pregabalin | 2.8 | -0.1 |
Participant rated pain scale. The pain produced by the applied stimulus (Punctata hyperalgesia - pinprick) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n=83,82) | Change from baseline at endpoint (n=79,75) | |
| Placebo | 3.4 | -0.4 |
| Pregabalin | 3.9 | -1.0 |
Participant rated pain scale. The pain produced by the applied stimulus (Temporal summation to tactile stimuli - repeated touching/tapping) was rated on an 11 point numerical rating scale (0=no pain, 10=worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 83, 82) | Change from baseline at endpoint (n = 79, 75) | |
| Placebo | 3.9 | -0.8 |
| Pregabalin | 4.1 | -0.5 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint | |
| Placebo | 6.5 | -1.2 |
| Pregabalin | 6.5 | -1.9 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 1 through16
| Intervention | score on scale (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n = 111, 108) | Change at Week 1 (n = 111, 107) | Change at Week 2 (n = 110, 105) | Change at Week 3 (n = 107, 105) | Change at Week 4 (n = 107, 103) | Change at Week 5 (n = 105, 101) | Change at Week 6 (n = 105, 99) | Change at Week 7 (n = 103, 98) | Change at Week 8 (n = 101, 97) | Change at Week 9 (n = 98, 97) | Change at Week 10 (n = 97, 91) | Change at Week 11 (n = 96, 90) | Change at Week 12 (n = 96, 91) | Change at Week 13 (n = 93, 91) | Change at Week 14 (n = 93, 92) | Change at Week 15 (n = 93, 92) | Change at Week 16 (n = 89, 90) | |
| Placebo | 6.51 | -0.38 | -0.62 | -0.86 | -1.03 | -1.07 | -1.22 | -1.34 | -1.32 | -1.37 | -1.32 | -1.43 | -1.44 | -1.39 | -1.34 | -1.41 | -1.36 |
| Pregabalin | 6.44 | -0.85 | -1.26 | -1.35 | -1.64 | -1.87 | -1.89 | -2.02 | -1.96 | -1.99 | -2.03 | -2.04 | -1.90 | -2.02 | -2.00 | -2.09 | -2.17 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 105) | Change from baseline at endpoint (n = 105, 104) | |
| Placebo | 5.2 | -1.0 |
| Pregabalin | 4.9 | -2.0 |
Pain related sleep interference was assessed on an 11 point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). (NCT00407745)
Timeframe: Baseline, Week 1 through 16
| Intervention | score on scale (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n = 111, 107) | Change at Week 1 (n = 111, 106) | Change at Week 2 (n = 110, 104) | Change at Week 3 (n = 107, 104) | Change at Week 4 (n = 107, 102) | Change at Week 5 (n = 105, 100) | Change at Week 6 (n = 105, 98) | Change at Week 7 (n = 103, 97) | Change at Week 8 (n = 101, 96) | Change at Week 9 (n = 98, 96) | Change at Week 10 (n = 97, 90) | Change at Week 11 (n = 96, 89) | Change at Week 12 (n = 96, 90) | Change at Week 13 (n = 93, 90) | Change at Week 14 (n = 93, 91) | Change at Week 15 (n = 93, 91) | Change at Week 16 (n = 89, 89) | |
| Placebo | 5.18 | -0.26 | -0.49 | -0.61 | -0.90 | -0.91 | -0.99 | -1.10 | -1.11 | -1.11 | -1.12 | -1.20 | -1.20 | -1.19 | -1.18 | -1.11 | -1.17 |
| Pregabalin | 4.86 | -0.96 | -1.29 | -1.36 | -1.59 | -1.81 | -1.86 | -1.98 | -1.97 | -2.03 | -2.18 | -2.08 | -2.07 | -2.08 | -2.09 | -2.15 | -2.25 |
The PGIC is a participant-rated instrument measuring change in the participant's overall status on a 7-point scale: 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| 1-Very much improved | 2-Much improved | 3-Minimally improved | 4-No change | 5-Minimally worse | 6-Much worse | 7-Very much worse | |
| Placebo | 2 | 25 | 24 | 40 | 5 | 3 | 0 |
| Pregabalin | 7 | 33 | 38 | 19 | 2 | 0 | 1 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 104) | Change from baseline at endpoint (n = 100, 97) | |
| Placebo | 51.2 | -8.0 |
| Pregabalin | 51.9 | -17.3 |
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.66 |
| Placebo | -1.07 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 49 |
| Placebo | 30 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 48 |
| Placebo | 33 |
Mean weekly score was calculated as the average of the available daily diary pain score values for the week. Pain score was measured on an 11-point numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 31 |
| Placebo | 16 |
NPSI - Temporal item which assesses the duration (number of hours during the last 24 hours) of spontaneous ongoing pain. Improved duration would be a decrease in the number of hours of spontaneous ongoing pain during the last 24 hours compared to baseline. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 39 |
| Placebo | 28 |
NPSI - Temporal item which assesses the paroxysmal pain (number of pain attacks during the last 24 hours). Improvement in the number of attacks would be a decrease in the number of paroxysms during the last 24 hours compared to baseline. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 48 |
| Placebo | 38 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 6.9 | -0.8 |
| Pregabalin | 6.7 | -1.4 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 6.3 | -0.5 |
| Pregabalin | 5.2 | -1.0 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 105) | Change from baseline at endpoint (n = 100, 98) | |
| Placebo | 12.8 | -0.2 |
| Pregabalin | 15.0 | -6.2 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 104) | Change from baseline at endpoint (n = 100, 97) | |
| Placebo | 43.8 | 5.7 |
| Pregabalin | 42.3 | 11.6 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 104,105) | Change from baseline at endpoint (n = 100, 98) | |
| Placebo | 6.2 | 0.2 |
| Pregabalin | 5.9 | 0.6 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 104) | Change from baseline at endpoint (n = 100, 97) | |
| Placebo | 35.6 | -4.7 |
| Pregabalin | 31.2 | 2.2 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 105) | Change from baseline at endpoint (n = 100, 97) | |
| Placebo | 39.7 | -4.9 |
| Pregabalin | 36.3 | -0.8 |
Participant rated questionnaire to assess sleep quality and quantity. Consists of a 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline (n = 105, 103) | Change from baseline at endpoint (n = 100, 95) | |
| Placebo | 45.9 | -5.8 |
| Pregabalin | 45.7 | -10.8 |
"The Modified Brief Pain Inventory (mBPI-10) Interference Scale is a self administered questionnaire that assessed pain interference with functional activities over the past week. The items were measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the pain interference index, was calculated by averaging the 10 items that comprised the scale." (NCT00407745)
Timeframe: Baseline, Week 16
| Intervention | score on scale (Mean) | |
|---|---|---|
| Baseline | Change from baseline at endpoint (n = 100, 99) | |
| Placebo | 4.9 | -1.1 |
| Pregabalin | 4.7 | -1.6 |
Negative values indicate a decrease in seizure frequency; positive values reflect an increase in seizure frequency. (NCT00407797)
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)
| Intervention | percent change (Mean) | |
|---|---|---|
| <= 6 seizures at Baseline (n=50) | > 6 seizures at Baseline (n=71) | |
| Pregabalin | -57.9 | -46.5 |
28-day seizure rate (at observation period [obs]) = [(number of seizures obs ) divided by (duration of period based on observed last dosing date and Visit 3 [Week 9] date)] * 28. Percent change = [(28-day seizure rate obs minus 28-day seizure rate at baseline [b]) divided by 28-day seizure rate b] * 100. Negative values indicate a decrease in seizure frequency and positive values reflect an increase in seizure frequency. (NCT00407797)
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)
| Intervention | percent change (Mean) |
|---|---|
| Pregabalin | -51.2 |
Percent change from Baseline = [(28-day seizure rate at 21 weeks minus 28-day seizure rate at baseline [b]) divided by (28-day seizure rate b) * 100. Negative values indicate a decrease in seizure frequency, positive values reflect an increase in seizure frequency. (NCT00407797)
Timeframe: Week 21 or End of Treatment (early termination)
| Intervention | percent change (Mean) |
|---|---|
| Pregabalin | -36.0 |
(NCT00407797)
Timeframe: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
| Intervention | percent of participants (Number) |
|---|---|
| Pregabalin | 63.6 |
(NCT00407797)
Timeframe: Week 17 through Week 21 (or Last 4 Weeks of Treatment after Week 9)
| Intervention | percent of participants (Number) |
|---|---|
| Pregabalin | 48.8 |
Seizure-free = no seizures during last 4 weeks of observation period (100 percent reduction in seizures from baseline). (NCT00407797)
Timeframe: Week 17 to Week 21 (or Last 4 Weeks of Treatment after Week 9)
| Intervention | percent of participants (Number) |
|---|---|
| Pregabalin | 40.5 |
Seizure-free = no seizures during observation period (100 percent reduction in seizures from baseline). (NCT00407797)
Timeframe: Week 9 to Week 21 or Early Termination (end of treatment)
| Intervention | percent of participants (Number) |
|---|---|
| Pregabalin | 20.7 |
Response ratio (RR) = comparison between baseline 28-seizure frequency with the 12 week observation phase. RR = [(28-day seizure rate in observation period [obs] minus 28-day seizure rate at baseline [b] ) divided by (28-day seizure rate obs plus 28-day seizure rate b)] * 100. Range: -100 to 100; negative values for the RR indicate reductions in seizures. (NCT00407797)
Timeframe: Week 9 to Week 21 or End of Treatment (early termination)
| Intervention | ratio (Mean) |
|---|---|
| Pregabalin | -45.1 |
Participant rated questionnaire with 2 subscales: HADS-A assesses generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D: state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale has 7 items; range: 0 (no anxiety or depression) to 3 (severe anxiety or depression). Total score 0 to 21 for each subscale; higher score = greater severity of symptoms. Negative value = reduction from baseline (b), positive value = increase from b. Change = (HADS score at observation period minus HADS score at b) divided by HADS score b. (NCT00407797)
Timeframe: Week 21, LOCF
| Intervention | scores on scale (Mean) | |||
|---|---|---|---|---|
| Week 21: Anxiety | LOCF: Anxiety | Week 21: Depression | LOCF: Depression | |
| Pregabalin | -1.4 | -1.4 | -0.8 | -0.7 |
Participant rated questionnaire to assess sleep quality and quantity; 9-item overall sleep problems index and 7 subscales. Sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy subscale scores (s) rated 1 (all the time) to 6 (none of the time); transformed s; total range (r): 0 to 100; higher s = greater intensity of attribute; negative values (v) = reduction from baseline (b), positive v = increase from b. Sleep Quantity score r: 0-24 hours. Higher s = greater quantity of sleep. Change = (MOS score at observation period minus MOS score at b) divided by MOS score b. (NCT00407797)
Timeframe: Week 21, LOCF
| Intervention | scores on scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 21: Sleep Disturbance | LOCF: Sleep Disturbance | Week 21: Snoring | LOCF: Snoring | Week 21: Awaken Short of Breath | LOCF: Awaken Short of Breath | Week 21: Adequacy | LOCF: Adequacy | Week 21: Somnolence | LOCF: Somnolence | Week 21: 9-Item Overall Sleep Problem Index | LOCF: 9-Item Overall Sleep Problem Index | Week 21: Sleep Quantity | LOCF: Sleep Quantity | |
| Pregabalin | -3.8 | -4.0 | 1.4 | 2.2 | 0.7 | 0.3 | 4.2 | 4.0 | 0.4 | -0.8 | -2.2 | -2.5 | 0.4 | 0.4 |
Optimal Sleep subscale of the MOS subject rated questionnaire to assess sleep quality and quantity. Optimal Sleep (1 of 7 subscales) was derived from sleep quantity: average hours of sleep each night during the past week. Number of subjects with response: YES=1 (optimal sleep: quantity of sleep was 7 or 8 hours per night) or No= 0 (no optimal sleep). Negative value indicates a decrease in attribute; positive value indicates an increase in attribute. Change = (MOS score at observation period minus MOS score at baseline [b]) divided by MOS score b. (NCT00407797)
Timeframe: Week 21, LOCF
| Intervention | scores on scale (Mean) | |
|---|---|---|
| Week 21 | LOCF | |
| Pregabalin | 0.1 | 0.1 |
Patient General Impression to Change (PGIC): participant rated instrument to measure participant's change in overall status since beginning study medication on a 7-point scale; range: 1 (very much improved) to 7 (very much worse). Not done = participant did not complete the PGIC. (NCT00407797)
Timeframe: Week 21, LOCF
| Intervention | percent of participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 21: Very Much Improved | Week 21: Much Improved | Week 21: Minimally Improved | Week 21: No Change | Week 21: Minimally Worse | Week 21: Much Worse | Week 21: Very Much Worse | Week 21: Not Done | LOCF: Very Much Improved | LOCF: Much Improved | LOCF: Minimally Improved | LOCF: No Change | LOCF: Minimally Worse | LOCF: Much Worse | LOCF: Very Much Worse | LOCF: Not Done | |
| Pregabalin | 22.4 | 52.6 | 13.8 | 4.3 | 1.7 | 1.7 | 0.9 | 2.6 | 20.7 | 51.1 | 12.6 | 4.4 | 1.5 | 1.5 | 0.7 | 7.4 |
Change: score at each study week minus score at baseline. HAM-A, a clinician-rated interview, measures presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety. (NCT00413010)
Timeframe: Baseline, Weeks 1 through Week 8
| Intervention | score on scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 (n=164;n=169) | Week 2 (n=166;n=163) | Week 3 (n=157;n=160) | Week 4 (n=153;n=150) | Week 5 (n=135;n=130) | Week 6 (n=122;n=125) | Week 8 (n=126;n=127) | |
| Placebo | -3.1 | -5.2 | -5.5 | -7.0 | -7.6 | -8.0 | -8.0 |
| Pregabalin | -4.4 | -6.3 | -7.0 | -8.3 | -8.4 | -9.2 | -9.3 |
Change: score at each study week minus score at baseline. HAM-D, clinician-rated interview, measures presence of depressive symptoms in 17 areas (symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels, & weight loss). Total score ranges from 0 to 52; higher scores indicate more depression. (NCT00413010)
Timeframe: Weeks 1 through Week 8
| Intervention | score on scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Week 1 n=165,168 | Week 2 n=165,164 | Week 3 n=156,160 | Week 4 n=153, 149 | Week 5 n=135, 130 | Week 6 n=122, 125 | Week 8 n= 126, 127 | |
| Placebo | -1.3 | -2.4 | -2.8 | -3.3 | -3.9 | -3.8 | -3.8 |
| Pregabalin | -2.1 | -3.1 | -3.5 | -4.7 | -4.3 | -4.7 | -4.8 |
CGI-S is a clinician-rated instrument measuring the severity of a subject's symptoms on a 7-point categorical scale. Scores range from 1 (not at all ill) to 7 (among the most extremely ill patients). Higher score indicates that the subject is more ill. (NCT00413010)
Timeframe: Week 8
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Normal, not ill at all | Borderline, mentally ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill | Not assessed | |
| Placebo | 18 | 37 | 63 | 48 | 8 | 1 | 0 | 1 |
| Pregabalin | 28 | 49 | 49 | 46 | 2 | 2 | 0 | 0 |
Responders = YES if subjects achieved a >= 50% decrease in HAM-A total score from Baseline to respective study week. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; higher score indicates greater anxiety. (NCT00413010)
Timeframe: Weeks 1 through Week 8
| Intervention | participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 Responder: Yes | Week 1 Responder: No | Week 2 Responder: Yes | Week 2 Responder: No | Week 3 Responder: Yes | Week 3 Responder: No | Week 4 Responder: Yes | Week 4 Responder: No | Week 5 Responder: Yes | Week 5 Responder: No | Week 6 Responder: Yes | Week 6 Responder: No | Week 8 Responder: Yes | Week 8 Responder: No | Week 8 (LOCF) Responder: Yes | Week 8 (LOCF) Responder: No | |
| Placebo | 8 | 161 | 26 | 137 | 23 | 137 | 46 | 104 | 46 | 84 | 48 | 77 | 47 | 80 | 62 | 114 |
| Pregabalin | 21 | 143 | 39 | 127 | 51 | 106 | 64 | 89 | 58 | 77 | 57 | 65 | 63 | 63 | 84 | 93 |
Responders = YES using CGI-I if score indicated much improved or very much improved at the last study week. CGI-I is a clinician-rated instrument that measures change in subject's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00413010)
Timeframe: Week 1 through Week 8
| Intervention | participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1: Yes | Week 1: No | Week 2: Yes | Week 2: No | Week 3: Yes | Week 3: No | Week 4: Yes | Week 4: No | Week 5: Yes | Week 5: No | Week 6: Yes | Week 6: No | Week 8: Yes | Week 8: No | Week 8 (LOCF): Yes | Week 8 (LOCF): No | |
| Placebo | 49 | 120 | 74 | 89 | 76 | 86 | 88 | 61 | 81 | 50 | 76 | 49 | 82 | 45 | 110 | 66 |
| Pregabalin | 62 | 101 | 94 | 72 | 93 | 62 | 97 | 55 | 89 | 45 | 83 | 38 | 80 | 43 | 113 | 61 |
Participant in remission defined as HAM-A total score of <= 7. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges 0 - 56; higher score indicates greater anxiety. (NCT00413010)
Timeframe: Week 1 through Week 8
| Intervention | participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 Remission: Yes | Week 1 Remission: No | Week 2 Remission: Yes | Week 2 Remission: No | Week 3 Remission: Yes | Week 3 Remission: No | Week 4 Remission: Yes | Week 4 Remission: No | Week 5 Remission: Yes | Week 5 Remission: No | Week 6 Remission: Yes | Week 6 Remission: No | Week 8 Remission: Yes | Week 8 Remission: No | Week 8 (LOCF) Remission: Yes | Week 8 (LOCF) Remission: No | |
| Placebo | 5 | 164 | 15 | 148 | 18 | 142 | 29 | 121 | 30 | 100 | 32 | 93 | 31 | 96 | 42 | 134 |
| Pregabalin | 12 | 152 | 22 | 144 | 32 | 125 | 43 | 110 | 39 | 96 | 37 | 85 | 40 | 86 | 55 | 122 |
Change from baseline: average across visit weeks using mixed model. HAM-A=clinician-rated interview measuring presence of anxiety-related symptoms in 14 areas including anxiety, tension, depressed mood, palpitations, breathing difficulties, sleep disturbances, & restlessness. Total score ranges from 0 to 56; higher score indicates greater anxiety. (NCT00413010)
Timeframe: Baseline, 8 weeks
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin | -7.6 |
| Placebo | -6.4 |
Time to sustained improvement was defined as time to 50% or greater reduction in HAM-A total score from Baseline, which was sustained for the remainder of the study. HAM-A is a clinician-rated interview measuring the presence of anxiety-related symptoms in 14 areas. Total score ranges from 0 to 56; a higher score indicates greater anxiety. (NCT00413010)
Timeframe: Week 8
| Intervention | days (Median) |
|---|---|
| Pregabalin | 57 |
Number of subjects with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Subjects are counted only once per treatment in each row. (NCT00424372)
Timeframe: 52 weeks
| Intervention | subjects (Number) | ||||
|---|---|---|---|---|---|
| Subjects with adverse events | Subjects with serious adverse events | Subjects with severe adverse events | Subjects discontinued due to adverse events | Dose reduced or temporary discontinuation | |
| Pregabalin | 124 | 14 | 5 | 17 | 34 |
Ranges: 0-100 mm. Larger scale indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. (NCT00424372)
Timeframe: 52 weeks
| Intervention | mm (Mean) | |||
|---|---|---|---|---|
| Baseline | Week 52 | Endpoint | Change from Baseline to Endpoint | |
| Pregabalin | 62.0 | 28.3 | 33.7 | -28.3 |
Score ranges: 0-45. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. (NCT00424372)
Timeframe: 52 weeks
| Intervention | score on scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Week 52 | Endpoint | Change from Baseline to Endpoint | |
| Pregabalin | 14.7 | 6.1 | 8.2 | -6.5 |
Score ranges: 0-33. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. (NCT00424372)
Timeframe: 52 weeks
| Intervention | score on scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Week 52 | Endpoint | Change from Baseline to Endpoint | |
| Pregabalin | 11.3 | 5.1 | 6.7 | -4.8 |
Score ranges: 0-5. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. (NCT00424372)
Timeframe: 52 weeks
| Intervention | score on scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Week 52 | Endpoint | Change from Baseline to Endpoint | |
| Pregabalin | 2.8 | 1.4 | 1.7 | -1.1 |
Score ranges: 0-12. Higher scores indicate more severe pain. Baseline: The last evaluation on or before Day 1 of double-blind for subjects that took pregabalin in double-blind and last visit <= Day 1 of open-label for subjects that took placebo in double-blind. Endpoint: The last evaluation during dose adjustment/maintenance step of open-label. (NCT00424372)
Timeframe: 52 weeks
| Intervention | score on scale (Mean) | |||
|---|---|---|---|---|
| Baseline | Week 52 | Endpoint | Change from Baseline to Endpoint | |
| Pregabalin | 3.4 | 1.0 | 1.7 | -1.8 |
Tmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | hours (Median) |
|---|---|
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | 1.00 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | 0.967 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | 1.13 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | 1.00 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | 0.450 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | 1.00 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | 1.00 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | 1.98 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | 1.00 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | 0.583 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | 2.00 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 4.00 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | 4.05 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 1.00 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | hours (Mean) |
|---|---|
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | 2.64 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | 3.78 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | 3.76 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | 3.22 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | 3.88 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | 2.70 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | 3.83 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | 3.08 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | 4.77 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | 4.02 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | 3.13 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 6.54 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | 5.80 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 3.85 |
Area under the curve from time zero to the end of dosing interval (AUCtau), where dosing interval was 12 hours, for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12 hours post-dose on Day 8
| Intervention | (microgram*hour/milliliter)/(mg/kg) (Geometric Mean) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 7.614 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 7.563 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 7.595 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 7.962 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 8.203 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 11.64 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 9.571 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 7.59 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 10.20 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 13.07 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 9.642 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 14.4 |
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | milliliter/minute (mL/min) (Geometric Mean) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 19.00 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 17.70 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 18.54 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 34.18 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 30.49 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 58.23 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 49.49 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 63.7 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 90.56 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 78.38 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 85.87 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 73.1 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t1/2 for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | hours (Mean) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 4.433 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 3.397 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 3.263 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 3.90 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 3.523 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 3.520 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 4.287 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 4.113 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | NA |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 4.960 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 3.953 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 5.643 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 6.61 |
Full physical examination included examination of the abdomen, breasts, lungs, lymph nodes, mouth, genitourinary, musculoskeletal and neurological systems, skin, extremities, head, heart, ears, eyes, neck, nose, ocular fundi, throat and thyroid gland. The neurological exam was performed by a pediatric neurologist or qualified investigator. (NCT00437281)
Timeframe: Baseline up to 7 days post-last dose of study medication
| Intervention | participants (Number) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 |
| Placebo (Age Cohort: 1 to 23 Months) | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 |
| Placebo (Age Cohort: 2 to 6 Years) | 1 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 1 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | 1 |
| Placebo (Age Cohort: 7 to 11 Years) | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 1 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 |
| Placebo (Age Cohort: 12 to 16 Years) | 0 |
Cmax for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | (microgram/milliliter)/(mg/kg) (Geometric Mean) |
|---|---|
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | 1.51 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | 1.81 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | 1.18 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | 1.52 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | 1.93 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | 1.50 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | 1.70 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | 1.54 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | 1.31 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | 2.29 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | 1.24 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 1.28 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | 1.81 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 1.79 |
Cmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | (microgram/milliliter)/(mg/kg) (Geometric Mean) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1.468 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1.577 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1.496 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1.601 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | NA |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1.856 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 2.350 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 1.660 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0.945 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | NA |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 1.762 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 2.538 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 1.355 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 1.94 |
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). AUC (0 - ∞) for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). Results are normalized to individual participant's Day 8 dose. (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | (microgram*hour/milliliter)/(mg/kg) (Geometric Mean) |
|---|---|
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | 6.70 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | 8.10 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | 7.05 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | 7.02 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | 8.30 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | 6.38 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | 8.76 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | 9.16 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | 10.0 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | 10.1 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | 8.00 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 15.9 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | 13.8 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 10.6 |
Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning is reported (single-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months) | 31.5 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months) | 24.7 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months) | 20.1 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months) | 28.0 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years) | 32.3 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years) | 60.1 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years) | 38.8 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years) | 45.5 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years) | 58.2 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years) | 45.8 |
| Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years) | 64.8 |
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 54.3 |
| Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years) | 99.6 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 90.0 |
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for open-label treatment included events between Day 8 and 28 days after the open-label dose that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. (NCT00437281)
Timeframe: Day 8 up to 28 days after open-label dose of study medication
| Intervention | adverse events (Number) | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Placebo (Age Cohort: 1 to 23 Months) | 2 | 1 | 0 |
| Placebo (Age Cohort: 12 to 16 Years) | 0 | 0 | 0 |
| Placebo (Age Cohort: 2 to 6 Years) | 1 | 1 | 0 |
| Placebo (Age Cohort: 7 to 11 Years) | 0 | 1 | 1 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 1 | 0 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1 | 0 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 | 0 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 | 1 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 | 0 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 | 0 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 | 0 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 | 0 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 | 0 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 | 0 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 | 1 | 1 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0 | 0 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 | 0 | 0 |
Analysis for severity of AEs was performed separately for double-blind and open-label treatment. AE = any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AEs were classified as mild, moderate and severe based on severity assessment: Mild = no interference with participant's usual function; Moderate = some interference with participant's usual function; Severe = significant interference with participant's usual function. Treatment-emergent events for double-blind treatment included events between baseline and Day 7 that were absent before treatment or that worsened relative to pretreatment state. Participants may experience more than 1 AE. (NCT00437281)
Timeframe: Baseline to Day 7
| Intervention | adverse events (Number) | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Placebo (Age Cohort: 1 to 23 Months) | 1 | 1 | 0 |
| Placebo (Age Cohort: 12 to 16 Years) | 0 | 0 | 0 |
| Placebo (Age Cohort: 2 to 6 Years) | 13 | 3 | 0 |
| Placebo (Age Cohort: 7 to 11 Years) | 2 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 2 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 11 | 4 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 5 | 0 | 0 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 3 | 0 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | 4 | 1 | 1 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 2 | 3 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 5 | 0 | 0 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | 5 | 2 | 3 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0 | 1 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0 | 1 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1 | 2 | 0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0 | 2 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 2 | 1 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 2 | 1 | 1 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 4 | 0 | 0 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 3 | 0 | 0 |
Tmax for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24 hours post-dose on Day 8
| Intervention | hours (Median) |
|---|---|
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 0.617 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1.05 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months) | 1.12 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months) | 2.49 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 0.500 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1.67 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 2.62 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 1.00 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0.583 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 1.00 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 4.00 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | 0.790 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0.500 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | 0.583 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 2.09 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years) | 2.15 |
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received matching placebo from Day 1 to Day 7 and pregabalin on Day 8 morning was to be reported (single-dose participants). (NCT00437281)
Timeframe: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years) | 42.6 |
| Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years) | 73.8 |
Renal clearance is the volume of plasma from which the drug is completely removed by the kidney in a given amount of time. CLr for participants who received pregabalin from Day 1 to Day 8 morning is reported (multiple-dose participants). (NCT00437281)
Timeframe: 0 to 12 hours post-dose, 12 to 24 hours post-dose on Day 8
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months) | 21.0 |
| Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years) | 8.77 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years) | 48.4 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years) | 11.5 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years) | 24.75 |
| Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years) | 55.9 |
| Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years) | 36.9 |
| Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years) | NA |
| Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years) | 69.16 |
VAS-Anxiety was administered to measure pre-operative anxiety. Score: 0 = no anxiety to 100 = worst imaginable anxiety. (NCT00442546)
Timeframe: Day 1, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours prior to surgery
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Day 1 (n=83, 79, 78) | 1 hour (n=68, 67, 59) | 2 hours (n=75, 76, 63) | 3 hours (n=52, 58, 63) | 4 hours (n=19, 17, 20) | 5 hours (n=3, 4, 8) | |
| Placebo | 6.992 | 6.085 | 6.454 | 7.313 | 10.133 | -15.145 |
| Pregabalin (150 mg) | 6.133 | 6.974 | 3.792 | 7.477 | 8.218 | 71.190 |
| Pregabalin (300 mg) | 7.103 | 3.272 | 6.818 | 7.588 | 0.109 | 29.819 |
Total cumulative dose calculated as mg of oral morphine equivalent and included opioids given by any route (patient controlled analgesia [PCA] pump, parenteral bolus or oral). Results for daily total not including pregabalin (not an opioid). Statistical model included main effect of treatment group and center. 1 subject at 144 h, 300 mg=non-missing data. Due to small sample size (N=1, 300 mg; N=5, other groups) and large opioid consumption for another subject in same center, least squares mean (300 mg, 144 h) is negative. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, 192 hours, 216 hours
| Intervention | mg of oral morphine equivalent (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| 24 hours (n=85, 86, 84) | 48 hours (n=82, 81, 83) | 72 hours (n=60, 60, 60) | 96 hours (n=32, 39, 35) | 120 hours (n=12, 6, 13) | 144 hours (n=5, 1, 5) | |
| Placebo | 167.854 | 122.830 | 52.895 | 35.332 | 27.559 | 73.956 |
| Pregabalin (150 mg) | 151.790 | 86.402 | 55.654 | 31.976 | 27.520 | 33.956 |
| Pregabalin (300 mg) | 152.306 | 93.846 | 48.713 | 24.758 | 14.235 | -64.544 |
"Subject rated scale for average pain intensity over the last 24 hours. Pain was assessed using the question How much pain do you have right now? Scores range from 0 (no pain) to 10 (most possible pain)." (NCT00442546)
Timeframe: 4, 8, 12, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104, 112, 120, 128, 136, 144, 152, 160, 168, 176, 184, and 192 hours during the hospital stay
| Intervention | scores on a scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4 hours (n=84, 84, 78) | 8 hours (n=82, 79, 75) | 12 hours (n=66, 68, 64) | 24 hours (n=87, 88, 82) | 32 hours (n=79, 78, 69) | 40 hours (n=62, 55, 55) | 48 hours (n=78, 72, 70) | 56 hours (n=62, 56, 57) | 64 hours (n=46, 37, 45) | 72 hours (n=51, 45, 45) | 80 hours (n=19, 24, 24) | 88 hours (n=16, 13, 20) | 96 hours (n=16, 14, 20) | 104 hours (n=7, 3, 7) | |
| Placebo | 4.363 | 5.119 | 4.784 | 4.836 | 4.345 | 3.902 | 3.785 | 3.760 | 4.578 | 3.826 | 4.285 | 3.914 | 2.658 | 1.829 |
| Pregabalin (150 mg) | 4.940 | 5.083 | 4.779 | 4.500 | 4.450 | 3.720 | 4.095 | 4.015 | 4.220 | 3.971 | 5.312 | 4.265 | 3.525 | 3.501 |
| Pregabalin (300 mg) | 3.554 | 4.529 | 4.068 | 4.545 | 4.507 | 3.821 | 4.069 | 3.358 | 3.492 | 3.271 | 2.403 | 2.767 | 2.532 | 2.680 |
Subject rated scale for average pain intensity over the last 24 hours. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. (NCT00442546)
Timeframe: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 12 hours (n=29, 28, 28) | 24 hours (n=81, 79, 74) | 48 hours (n=78, 82, 75) | 72 hours (n=56, 51, 55) | 96 hours (n=20, 21, 26) | 120 hours (n=5, 3, 9) | Week 2 (n=79, 72, 71) | Week 4 (n=76, 65, 67) | Week 6/ET (n=60, 54, 59) | |
| Placebo | 6.748 | 4.918 | 4.515 | 4.186 | 4.741 | 4.287 | 3.987 | 3.163 | 2.389 |
| Pregabalin (150 mg) | 5.712 | 4.961 | 4.518 | 4.281 | 4.842 | 4.211 | 3.691 | 2.956 | 2.374 |
| Pregabalin (300 mg) | 4.845 | 4.614 | 4.309 | 3.740 | 3.126 | 2.940 | 3.974 | 2.845 | 2.385 |
Subject rated scale for worst pain over the last 24 hours. Scores ranged from 0 (no pain) to 10 (pain as bad as you can imagine). Weekly mean scores were calculated post-discharge. (NCT00442546)
Timeframe: 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours, 168 hours, and 192 hours during the hospital stay, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 12 hours (n=29, 28, 28) | 24 hours (n=82, 79, 74) | 48 hours (n=78, 82, 75) | 72 hours (n=56, 52, 55) | 96 hours (n=20, 21, 26) | 120 hours (n=5, 3, 9) | Week 2 (n=79, 72, 72) | Week 4 (n=76, 65, 67) | Week 6/ET (n=61, 55, 59) | |
| Placebo | 8.770 | 7.201 | 7.079 | 5.964 | 6.556 | 7.056 | 5.396 | 4.280 | 3.350 |
| Pregabalin (150 mg) | 7.217 | 7.477 | 7.041 | 6.322 | 6.703 | 5.915 | 5.255 | 4.134 | 3.455 |
| Pregabalin (300 mg) | 7.002 | 7.290 | 6.740 | 5.977 | 4.711 | 4.346 | 5.592 | 4.043 | 3.425 |
NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. (NCT00442546)
Timeframe: Month 3, Month 6 (phone call)
| Intervention | scores on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Burning Spontaneous Pain, Month 3, (n=23, 24, 29) | Burning Spontaneous Pain, Month 6, (n=22, 15, 15) | Pressing Spontaneous Pain, Month 3, (n=23, 24, 29) | Pressing Spontaneous Pain, Month 6, (n=22, 15, 15) | Paroxysmal Pain, Month 3, (n=23, 24, 29) | Paroxysmal Pain, Month 6, (n=22, 15, 15) | Evoked Pain, Month 3, (n=23, 24, 29) | Evoked Pain, Month 6, (n=22, 15, 15) | Paresthesia/Dysesthesia, Month 3, (n=23, 24, 29) | Paresthesia/Dysesthesia, Month 6, (n=22, 15, 15) | Total Score, Month 3, (n=23, 24, 29) | Total Score, Month 6, (n=22, 15, 15) | |
| Placebo | 0.828 | 0.667 | 0.948 | 0.633 | 1.086 | 0.533 | 0.931 | 0.711 | 0.690 | 0.033 | 0.045 | 0.027 |
| Pregabalin (150 mg) | 1.348 | 1.091 | 1.457 | 1.409 | 0.804 | 1.205 | 1.174 | 0.636 | 0.848 | 0.773 | 0.058 | 0.051 |
| Pregabalin (300 mg) | 0.792 | 1.400 | 0.958 | 1.333 | 1.688 | 1.133 | 1.319 | 1.667 | 0.604 | 0.500 | 0.055 | 0.061 |
The Global Evaluation of Study Medication is a subject-administered single item instrument that records the subject's overall impression (global evaluation) of the study medication by asking the following question: how would you rate the study medication you received for pain? The subject chooses based on a scale of 1 (poor), 2 (fair), 3 (good), or 4 (excellent). (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, and Week 6/ET
| Intervention | participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Discharge, Excellent (n=85, 84, 78) | Discharge, Good (n=85, 84, 78) | Discharge, Fair (n=85, 84, 78) | Discharge, Poor (n=85, 84, 78) | Week 2, Excellent (n=22, 20, 18) | Week 2, Good (n=22, 20, 18) | Week 2, Fair (n=22, 20, 18) | Week 2, Poor (n=22, 20, 18) | Week 4, Excellent (n=30, 27, 19) | Week 4, Good (n=30, 27, 19) | Week 4, Fair (n=30, 27, 19) | Week 4, Poor (n=30, 27, 19) | Week 6/ET, Excellent (n=32, 31, 40) | Week 6/ET, Good (n=32, 31, 40) | Week 6/ET, Fair (n=32, 31, 40) | Week 6/ET, Poor (n=32, 31, 40) | |
| Placebo | 19 | 39 | 12 | 8 | 5 | 9 | 1 | 3 | 7 | 8 | 3 | 1 | 5 | 19 | 7 | 9 |
| Pregabalin (150 mg) | 31 | 31 | 14 | 9 | 6 | 11 | 3 | 2 | 13 | 11 | 4 | 2 | 3 | 17 | 6 | 6 |
| Pregabalin (300 mg) | 27 | 46 | 6 | 5 | 10 | 4 | 4 | 2 | 9 | 12 | 3 | 3 | 7 | 9 | 5 | 10 |
The NRS-Sleep: subject rated 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]) rating how pain has interfered with sleep during the past 24 hours. Weekly mean scores were calculated post hospital discharge. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours 120 hours, 144 hours, 168 hours, and 192 hours post-surgery, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 hours (n=86, 86, 81) | 48 hours (n=82, 82, 77) | 72 hours (n=59, 58, 59) | 96 hours (n=20, 21, 24) | 120 hours (n=6, 4, 7) | Week 2 (n=80, 73, 71) | Week 4 (n=76, 65, 67) | Week 6/ET (n=61, 56, 57) | |
| Placebo | 5.481 | 4.027 | 3.645 | 3.213 | 1.328 | 4.256 | 3.532 | 2.748 |
| Pregabalin (150 mg) | 4.452 | 3.830 | 2.926 | 4.087 | 3.194 | 3.837 | 3.181 | 2.484 |
| Pregabalin (300 mg) | 3.671 | 3.408 | 2.609 | 1.645 | 7.237 | 4.128 | 3.042 | 2.592 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5F: Subject response to 'how, during the past 24 hours, pain has interfered with your sleep'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 3.307 | 3.587 | 2.668 | 2.070 | 1.499 | 0.778 |
| Pregabalin (150 mg) | 2.696 | 3.139 | 2.478 | 1.847 | 1.276 | 1.963 |
| Pregabalin (300 mg) | 2.642 | 3.015 | 2.166 | 1.701 | 0.941 | 1.005 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5E: Subject response to 'how, during the past 24 hours, pain has interfered with your relations with other people'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 2.624 | 1.671 | 1.187 | 0.898 | 1.364 | 0.626 |
| Pregabalin (150 mg) | 1.837 | 1.566 | 1.004 | 0.544 | 0.253 | 0.802 |
| Pregabalin (300 mg) | 1.716 | 1.370 | 1.162 | 0.845 | 0.861 | 1.060 |
The analysis was performed by Kaplan-Meier method with log-rank test. (NCT00442546)
Timeframe: time from end of surgery up to 192 hours post surgery
| Intervention | hours (Mean) |
|---|---|
| Pregabalin (150 mg) | 106.802 |
| Pregabalin (300 mg) | 112.966 |
| Placebo | 95.531 |
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. (NCT00442546)
Timeframe: Week 2, Week 4, Week 6/ET
| Intervention | mg (Least Squares Mean) | |||
|---|---|---|---|---|
| Acetylsalicylic Acid, Week 2 (n=6, 1, 2) | Paracetamol, Week 2 (n=7, 13, 7) | Paracetamol, Week 4 (n=5, 12, 6) | Paracetamol, Week 6/ET (n=6, 14, 5) | |
| Placebo | 992.613 | 630.787 | 593.498 | 1385.873 |
| Pregabalin (150 mg) | 498.613 | 603.496 | 792.434 | 1128.952 |
| Pregabalin (300 mg) | 797.463 | 665.574 | 779.226 | 1098.840 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5D: Subject response to 'how, during the past 24 hours, pain has interfered with your normal work (work outside the home and housework)'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=82, 77, 72) | Week 2 (n=86, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 4.873 | 3.831 | 2.895 | 2.040 | 2.264 | 1.029 |
| Pregabalin (150 mg) | 4.879 | 4.010 | 2.833 | 2.133 | 1.797 | 1.627 |
| Pregabalin (300 mg) | 4.738 | 3.539 | 2.500 | 2.152 | 1.731 | 1.349 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5B: Subject response to 'how, during the past 24 hours, pain has interfered with your mood'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 3.354 | 2.554 | 1.530 | 1.325 | 1.334 | 0.369 |
| Pregabalin (150 mg) | 2.588 | 2.640 | 1.590 | 1.053 | 0.632 | 1.201 |
| Pregabalin (300 mg) | 2.418 | 2.115 | 1.511 | 1.171 | 0.956 | 0.832 |
The OR-SDS assessed subject-reported levels of frequency, severity and degree of bother for 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, retching and vomiting. The overall composite score was the average across frequency, severity, and degree of bother scores. Total possible score: 0 (better) to 4.34 (worse). (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 hours (n=72, 69, 69) | 48 hours (n=83, 86, 77) | 72 hours (n=81, 77, 73) | 96 hours (n=49, 53, 54) | 120 hours (n=19, 17, 23) | Discharge (n=86, 85, 82) | Week 2 (n=87, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 66, 71) | |
| Placebo | 0.778 | 0.838 | 0.703 | 0.637 | 0.471 | 0.615 | 0.469 | 0.329 | 0.229 |
| Pregabalin (150 mg) | 0.669 | 0.743 | 0.630 | 0.567 | 0.453 | 0.530 | 0.482 | 0.354 | 0.230 |
| Pregabalin (300 mg) | 0.727 | 0.722 | 0.637 | 0.593 | 0.393 | 0.575 | 0.467 | 0.384 | 0.355 |
The analysis was performed by Kaplan-Meier method with log-rank test. (NCT00442546)
Timeframe: time from end of surgery up to 192 hours post surgery
| Intervention | hours (Mean) |
|---|---|
| Pregabalin (150 mg) | 75.709 |
| Pregabalin (300 mg) | 73.906 |
| Placebo | 78.451 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5A: Subject response to 'how, during the past 24 hours, pain has interfered with your general activity. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 4.764 | 3.524 | 2.427 | 2.028 | 1.969 | 1.410 |
| Pregabalin (150 mg) | 3.794 | 3.254 | 2.470 | 2.109 | 1.861 | 1.738 |
| Pregabalin (300 mg) | 4.499 | 3.526 | 2.417 | 1.902 | 1.547 | 1.717 |
CMEs were defined using OR-SDS (assesses subject-reported levels of severity concerning 10 symptoms associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion and retching/vomiting). CME = any symptom rated as severe or very severe, with the exception of confusion. Confusion was defined as a CME if the severity score was at least moderate. Total score = the sum of CMEs across symptoms. Each CME = 1 point. Total CME score ranges from 0 to 9. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, and Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 hours (n=72, 69, 69) | 48 hours (n=83, 86, 87) | 72 hours (n=81, 77, 73) | 96 hours (n=49, 53, 54) | 120 hours (n=19, 17, 23) | Discharge (n=86, 85, 82) | Week 2 (n=87, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 66, 71) | |
| Placebo | 0.772 | 0.789 | 0.613 | 0.284 | 0.246 | 0.352 | 0.171 | 0.032 | 0.051 |
| Pregabalin (150 mg) | 0.822 | 0.814 | 0.647 | 0.440 | 0.178 | 0.429 | 0.328 | 0.116 | 0.059 |
| Pregabalin (300 mg) | 0.817 | 0.834 | 0.570 | 0.489 | 0.350 | 0.502 | 0.311 | 0.236 | 0.260 |
TUG: time taken in seconds to rise from a standard arm chair, walk to a line on the floor 3 meters away, turn, return and sit down again. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Week 2, Week 4, Week 6/ET
| Intervention | seconds (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 hours (n=45, 47, 46) | 48 hours (n=69, 70, 64) | 72 hours (n=46, 46, 46) | 96 hours (n=14, 14, 22) | 120 hours (n=5, 2, 5) | Week 2 (n=78, 71, 72) | Week 4 (n=73, 65, 63) | Week 6/ET (n=75, 60, 63) | |
| Placebo | 82.964 | 86.842 | 80.142 | 70.271 | 34.078 | 21.678 | 16.535 | 13.813 |
| Pregabalin (150 mg) | 76.153 | 80.027 | 66.228 | 110.780 | 52.591 | 22.322 | 18.072 | 12.694 |
| Pregabalin (300 mg) | 79.973 | 79.548 | 68.373 | 43.021 | NA | 21.332 | 18.145 | 15.140 |
The OR-SDS was used to assess subject-reported levels of severity concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom severity was rated as: 1=slight, 2=moderate, 3=severe, or 4=very severe. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible severity score: 0 (less severe) to 4 (more severe). (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 hours (n=72, 69, 69) | 48 hours (n=83, 86, 77) | 72 hours (n=81, 77, 73) | 96 hours (n=49, 53, 54) | 120 hours (n=19, 17, 23) | Discharge (n=86, 85, 82) | Week 2 (n=87, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 66, 71) | |
| Placebo | 0.621 | 0.695 | 0.562 | 0.535 | 0.391 | 0.488 | 0.364 | 0.247 | 0.175 |
| Pregabalin (150 mg) | 0.579 | 0.642 | 0.539 | 0.509 | 0.366 | 0.451 | 0.390 | 0.269 | 0.182 |
| Pregabalin (300 mg) | 0.590 | 0.624 | 0.534 | 0.502 | 0.334 | 0.495 | 0.375 | 0.308 | 0.282 |
Total dose for in-hospital visits was the total dose for the day. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours
| Intervention | mg (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Acetylsalicylic Acid, 72 hours (n=3, 1, 1) | Ketorolac, 24 hours, (n=1, 4, 3) | Ketorolac, 48 hours, (n=2, 8, 4) | Paracetamol, 24 hours (n=14, 20, 16) | Paracetamol, 48 hours (n=22, 25, 17) | Paracetamol, 72 hours (n=12, 13, 16) | |
| Placebo | 1425.825 | 27.189 | 23.473 | 1380.481 | 1263.337 | 1128.355 |
| Pregabalin (150 mg) | 235.175 | 32.961 | 20.553 | 1311.246 | 1357.030 | 446.050 |
| Pregabalin (300 mg) | 1442.025 | 53.432 | 21.863 | 1363.086 | 1368.880 | 877.916 |
The OR-SDS was used to assess subject-reported level of degree of bother concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom degree of bother was rated as: 1=not at all, 2=a little bit, 3=somewhat, 4=quite a bit, or 5=very much. Average score for each symptom was calculated by taking the mean of patient-reported score. Total possible degree of bother score: 0 (less degree of bother) to 5 (greater degree of bother). (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 hours (n=72, 69, 69) | 48 hours (n=83, 86, 77) | 72 hours (n=81, 77, 73) | 96 hours (n=49, 53, 54) | 120 hours (n=19, 17, 23) | Discharge (n=86, 85, 82) | Week 2 (n=87, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 66, 71) | |
| Placebo | 0.836 | 0.918 | 0.822 | 0.703 | 0.574 | 0.697 | 0.533 | 0.354 | 0.274 |
| Pregabalin (150 mg) | 0.671 | 0.810 | 0.686 | 0.572 | 0.565 | 0.575 | 0.527 | 0.395 | 0.260 |
| Pregabalin (300 mg) | 0.788 | 0.769 | 0.694 | 0.623 | 0.439 | 0.616 | 0.506 | 0.433 | 0.401 |
The OR-SDS was used to assess subject-reported levels of frequency concerning 10 symptoms known to be associated with opioid medication usage: fatigue, drowsiness, inability to concentrate, nausea, dizziness, constipation, itching, difficulty with urination, confusion, and retching/vomiting. Symptom frequency was rated as: 1=rarely, 2=occasionally, 3=frequently, or 4=almost constantly. The average score for each symptom was calculated by taking the mean of patient-reported score. Total possible frequency score: 0 (less frequent) to 4 (more frequent). (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 hours (n=72, 69, 69) | 48 hours (n=83, 86, 76) | 72 hours (n=81, 77, 73) | 96 hours (n=49, 53, 54) | 120 hours (n=19, 17, 23) | Discharge (n=86, 85, 81) | Week 2 (n=87, 78, 79) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 66, 71) | |
| Placebo | 0.888 | 0.908 | 0.726 | 0.676 | 0.446 | 0.664 | 0.513 | 0.391 | 0.239 |
| Pregabalin (150 mg) | 0.767 | 0.782 | 0.669 | 0.623 | 0.427 | 0.567 | 0.535 | 0.402 | 0.249 |
| Pregabalin (300 mg) | 0.808 | 0.779 | 0.688 | 0.656 | 0.405 | 0.619 | 0.525 | 0.415 | 0.386 |
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Discharge (n=84, 84, 80) | Week 2 (n=22, 20, 18) | Week 4 (n=30, 27, 19) | Week 6/ET (n=32, 31, 40) | |
| Placebo | 73.577 | 75.713 | 78.823 | 67.015 |
| Pregabalin (150 mg) | 74.156 | 78.669 | 78.723 | 66.887 |
| Pregabalin (300 mg) | 75.705 | 82.724 | 78.886 | 69.367 |
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Discharge (n=84, 84, 80) | Week 2 (n=22, 20, 18) | Week 4 (n=30, 27, 19) | Week 6/ET (n=32, 31, 40) | |
| Placebo | 81.556 | 84.583 | 84.323 | 76.908 |
| Pregabalin (150 mg) | 85.733 | 91.880 | 88.492 | 82.339 |
| Pregabalin (300 mg) | 85.732 | 87.869 | 90.571 | 84.571 |
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Discharge (n=84, 84, 80) | Week 2 (n=22, 20, 18) | Week 4 (n=30, 27, 19) | Week 6/ET (n=32, 31, 40) | |
| Placebo | 77.550 | 80.148 | 81.572 | 71.962 |
| Pregabalin (150 mg) | 79.897 | 85.274 | 83.608 | 74.618 |
| Pregabalin (300 mg) | 80.706 | 85.294 | 84.728 | 76.925 |
The degree of passive (movement of the knee with the aid of physical therapist or designee) knee flexion and extension tolerated by each subject was recorded. Passive ROM in the sitting position was assessed with a goniometer. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
| Intervention | degrees (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 hours (n=81, 76, 73) | 48 hours (n=78, 80, 70) | 72 hours (n=53, 50, 53) | 96 hours (n=17, 17, 24) | 120 hours (n=5, 3, 6) | Week 2 (n=79, 71, 73) | Week 4 (n=72, 62, 65) | Week 6/ET (n=74, 60, 66) | |
| Placebo | 64.991 | 76.813 | 80.984 | 80.287 | 79.218 | 93.642 | 101.932 | 108.944 |
| Pregabalin (150 mg) | 66.720 | 77.714 | 84.154 | 86.471 | 92.160 | 94.767 | 104.548 | 110.318 |
| Pregabalin (300 mg) | 71.523 | 81.322 | 88.119 | 91.460 | 97.160 | 96.973 | 107.703 | 111.348 |
The degree of active (patient moving the knee) knee flexion and extension tolerated by each subject was recorded. Active ROM in the sitting position was assessed with a goniometer. (NCT00442546)
Timeframe: 24 hours, 48 hours, 72 hours, 96 hours, and 120 hours post surgery, Week 2, Week 4, Week 6/ET
| Intervention | degrees (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 hours (n=74, 71, 68) | 48 hours (n=76, 78, 67) | 72 hours (n=52, 52, 50) | 96 hours (n=17, 17, 24) | 120 hours (n=6, 3, 6) | Week 2 (n=73, 67, 69) | Week 4 (n=65, 63, 62) | Week 6/ET (n=67, 54, 63) | |
| Placebo | 55.738 | 69.178 | 75.588 | 74.194 | 81.765 | 87.992 | 96.921 | 103.980 |
| Pregabalin (150 mg) | 54.877 | 69.981 | 76.516 | 78.624 | 80.694 | 89.917 | 98.883 | 105.352 |
| Pregabalin (300 mg) | 60.744 | 73.370 | 79.535 | 79.500 | 72.694 | 90.332 | 102.237 | 106.252 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5C: Subject response to 'how, during the past 24 hours, pain has interfered with your walking ability'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 4.982 | 3.425 | 2.442 | 1.742 | 1.928 | 1.126 |
| Pregabalin (150 mg) | 4.918 | 3.297 | 2.646 | 2.004 | 1.439 | 1.573 |
| Pregabalin (300 mg) | 4.728 | 3.344 | 2.108 | 1.886 | 1.907 | 1.391 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Q5G: Subject response to 'how, during the past 24 hours, pain has interfered with your enjoyment of life'. Scale: 0 = does not interfere to 10 = completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 3.744 | 2.953 | 1.768 | 1.696 | 1.368 | 0.663 |
| Pregabalin (150 mg) | 3.487 | 2.945 | 2.152 | 1.535 | 0.944 | 1.657 |
| Pregabalin (300 mg) | 3.769 | 2.802 | 2.042 | 1.720 | 1.467 | 1.658 |
m-BPI-sf questionnaire (7-items) assessed pain interference with functional activities during the past 24 hours. Pain interference index = average of pain interference question (Q) 5A to 5G. Questions were asked as follows: how, during the past 24 hours, has pain interfered with general activity (Q5A), mood (Q5B), walking ability (Q5C), normal work (outside home and housework) (Q5D), relations with other people (Q5E), sleep (Q5F), enjoyment of life (Q5G). Scale: 0=does not interfere to 10=completely interferes. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, Week 6/ET, Month 3, Month 6
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Discharge (n=83, 80, 74) | Week 2 (n=86, 78, 80) | Week 4 (n=77, 69, 67) | Week 6/ET (n=78, 67, 71) | Month 3 (n=30, 32, 35) | Month 6 (n=31, 25, 27) | |
| Placebo | 3.887 | 3.037 | 2.094 | 1.662 | 1.629 | 0.852 |
| Pregabalin (150 mg) | 3.427 | 2.969 | 2.162 | 1.597 | 1.139 | 1.513 |
| Pregabalin (300 mg) | 3.488 | 2.814 | 1.996 | 1.637 | 1.335 | 1.300 |
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, and Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Discharge (n=12, 17, 15) | Week 2 (n=6, 4, 4) | Week 4 (n=4, 3, 4) | Week 6/ET (n=2, 5, 6) | |
| Placebo | 1.821 | 1.833 | 2.478 | 3.878 |
| Pregabalin (150 mg) | 1.845 | 2.333 | 1.149 | 1.526 |
| Pregabalin (300 mg) | 1.654 | 1.667 | 2.433 | 4.174 |
Measure of subject satisfaction with treatment for acute or chronic pain. Response range: 1 (strongly agree) to 5 (strongly disagree). Mean scores were calculated and transformed onto a scale of 0-100, range: 0 = worst possible satisfaction to 100 = best possible satisfaction with pain treatment. (NCT00442546)
Timeframe: Discharge, Week 2, Week 4, and Week 6/ET
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Discharge (n=12, 17, 15) | Week 2 (n=6, 4, 4) | Week 4 (n=4, 3, 4) | Week 6/ET (n=2, 5, 6) | |
| Placebo | 2.051 | 1.833 | 2.537 | 3.900 |
| Pregabalin (150 mg) | 2.260 | 2.333 | 1.418 | 2.067 |
| Pregabalin (300 mg) | 1.696 | 1.667 | 2.612 | 4.233 |
The amount of opioid use was calculated as mg of oral morphine equivalent and included opioids administered by any route (PCA pump, parenteral bolus, or oral). Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. This outcome measure does not include pregabalin as it is not an opioid. (NCT00442546)
Timeframe: Week 2, Week 4, Week 6/Early Termination (ET)
| Intervention | mg of oral morphine equivalent (Least Squares Mean) | ||
|---|---|---|---|
| Week 2 (n=41, 40, 36) | Week 4 (n=33, 33, 30) | Week 6/ET (n=24, 28, 22) | |
| Placebo | 26.119 | 34.271 | 35.036 |
| Pregabalin (150 mg) | 30.255 | 37.130 | 38.686 |
| Pregabalin (300 mg) | 27.692 | 37.507 | 35.945 |
"The presence of persistent pain was evaluated on the 11-point VRS. The subject answered the question: how much pain did you experience in the last 24 hours in your operated knee? A zero score of VRS was the only number considered as a no. Any positive score (1-10) of VRS was consider as yes." (NCT00442546)
Timeframe: Month 3, Month 6 (phone call)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Month 3, Yes (n=65, 59, 61) | Month 3, No (n=65, 59, 61) | Month 6, Yes (n=64, 62, 61) | Month 6, No (n=64, 62, 61) | |
| Placebo | 27 | 34 | 14 | 47 |
| Pregabalin (150 mg) | 22 | 43 | 19 | 45 |
| Pregabalin (300 mg) | 22 | 37 | 15 | 47 |
Week 4 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. (NCT00442546)
Timeframe: Week 4
| Intervention | mg (Median) |
|---|---|
| Pregabalin (150 mg) | 650.000 |
| Placebo | 22.100 |
Week 6 total daily dose was calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. (NCT00442546)
Timeframe: Week 6/ET
| Intervention | mg (Least Squares Mean) |
|---|---|
| Pregabalin (150 mg) | 513.163 |
Weeks 2, 4, and 6 total daily doses were calculated by adding the cumulative doses during the 2 week period prior to the visit and dividing them by the number of days in the period. (NCT00442546)
Timeframe: Week 2, Week 4, Week 6/ET
| Intervention | mg (Least Squares Mean) |
|---|---|
| Pregabalin (150 mg) | 862.350 |
| Placebo | 983.850 |
"The mBPI-SF is a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the Worst Pain item of the m-BPI-sf scale (11 point Likert scale; range: 0 [no pain] to 10 [pain as bad as you can imagine]), subjects were asked to rate their pain by marking an X in one of the ten boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuroaxial block." (NCT00442546)
Timeframe: 48 hours after surgery
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin (150 mg) | 7.041 |
| Pregabalin (300 mg) | 6.740 |
| Placebo | 7.079 |
Participants with significant heart rate values with the criteria > 1.5 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below. (NCT00448916)
Timeframe: Visit 1 to 12 Months
| Intervention | Participants (Number) | |
|---|---|---|
| > 1.5 * ULN | < 0.9 * LLN | |
| Pregabalin: 1-23 Months | 0 | 5 |
| Pregabalin: 12-16 Years | 0 | 0 |
| Pregabalin: 2-6 Years | 0 | 2 |
| Pregabalin: 7-11 Years | 0 | 1 |
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10*3/mm*3): <0.5 LLN or >1.75 ULN; white blood cell (WBC) count (X10E9/L): <0.6 LLN or >1.5 ULN; lymphocytes-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; total neutrophils-Abs (10*3/mm*3): <0.8 LLN or >1.2 ULN; and eosinophils-Abs: >1.2 ULN. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Platelets: <0.5xLLN (N=16,15,12,11) | Platelets: >1.75xULN (N=16,15,12,11) | WBC count: <0.6xLLN (N=15,15,12,11) | WBC count: >1.5xULN (N=15,15,12,11) | Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11) | Lymphocytes-Abs: >1.2xULN (N=15,15,12,11) | Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11) | Total neutrophils-Abs: >1.2xULN (N=15,15,12,11) | Eosinophils-Abs: >1.2xULN (N=15,15,12,11) | Hemoglobin: <0.8xLLN(N=15,15,12,11) | Hematocrit: <0.8xLLN (N=15,15,12,11) | Red blood cell count: <0.8xLLN (N=15,15,12,11) | Basophils: >1.2xULN (N=15,15,12,11) | Monocytes: >1.2xULN (N=15,15,12,11) | |
| Pregabalin: 1-23 Months | 1 | 1 | 1 | 0 | 0 | 1 | 3 | 1 | 3 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 1 | 0 | 2 | 0 | 0 | 0 | 4 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 7-11 Years | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
"Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-<480; 480-<500; ≥500 msec) and maximum QTcF interval (450-<480; 480-<500; ≥500 msec) values were calculated.~Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below." (NCT00448916)
Timeframe: Week 1 to 12 Months
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR interval: ≥ 200 msec | PR interval: ≥50% increase from Baseline | PR interval: ≥25% increase from Baseline | QRS interval: ≥ 200 msec | QRS interval: ≥25% increase from Baseline | QT interval: ≥ 500 msec | QTcB interval: 450-<480 msec | QTcB interval: 480-<500 msec | QTcB interval: ≥ 500 msec | QTcF interval: 450-<480 msec | QTcF interval: 480-<500 msec | QTcF interval: ≥ 500 msec | |
| Pregabalin: 1-23 Months | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 7-11 Years | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
"Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as abnormal and no abnormalities in the sites were reported as normal. Any change from the previous physical examination results were noted." (NCT00448916)
Timeframe: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 (N=16,13,11,10) | Month 1 (N=14,13,10,10) | Month 6 (N=11,10,6,7) | Month 12/Eary Termination (N=16,12,12,9) | Follow-up (N=6,4,9,6) | |
| Pregabalin: 1-23 Months | 2 | 1 | 1 | 1 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 1 | 0 |
| Pregabalin: 2-6 Years | 1 | 1 | 1 | 2 | 0 |
| Pregabalin: 7-11 Years | 0 | 0 | 0 | 1 | 1 |
Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE. (NCT00448916)
Timeframe: 28 Days
| Intervention | Participants (Number) |
|---|---|
| Pregabalin: 1-23 Months | NA |
| Pregabalin: 2-6 Years | NA |
| Pregabalin: 7-11 Years | NA |
| Pregabalin: 12-16 Years | NA |
Weight was recorded in kilograms and weight change from Baseline was reported. (NCT00448916)
Timeframe: Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up
| Intervention | Kg (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Day 9 (N=16,14,12,11) | Week 1 (N=16,13,11,10) | Month 1 (N=14,13,10,10) | Month 2 (N=11,12,8,9) | Month 4 (N=11,10,7,9) | Month 6 (N=11,10,6,7) | Month 9 (N=9,10,6,5) | Month 12/Early Termination (N=15,12,11,8) | |
| Pregabalin: 1-23 Months | 0.1 | 0.3 | 0.4 | 1.0 | 1.3 | 1.8 | 2.4 | 1.8 |
| Pregabalin: 12-16 Years | 0.4 | 1.2 | 2.4 | 3.0 | 4.1 | 5.9 | 7.3 | 6.6 |
| Pregabalin: 2-6 Years | 0.1 | 0.4 | 0.8 | 1.2 | 1.3 | 1.4 | 2.3 | 2.4 |
| Pregabalin: 7-11 Years | -0.1 | 1.5 | 2.1 | 3.8 | 5.2 | 5.9 | 6.3 | 6.0 |
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (>2.0 times upper limit of the reference range) (u/L) were noted. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) |
|---|---|
| Pregabalin: 1-23 Months | 0 |
| Pregabalin: 2-6 Years | 1 |
| Pregabalin: 7-11 Years | 1 |
| Pregabalin: 12-16 Years | 4 |
Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or > 1.25 times upper limit of normal (ULN) or < 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below. (NCT00448916)
Timeframe: Visit 1 to 12 Months
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| ≥ 20% increase from Baseline | ≥ 20% decrease from Baseline | > 1.25 * ULN | < 0.9 * LLN | |
| Pregabalin: 1-23 Months | 12 | 5 | 1 | 0 |
| Pregabalin: 12-16 Years | 3 | 3 | 0 | 0 |
| Pregabalin: 2-6 Years | 5 | 7 | 1 | 0 |
| Pregabalin: 7-11 Years | 8 | 3 | 0 | 3 |
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alanine Aminotransferase: >3.0xULN (N=15,15,12,11) | Blood Urea Nitrogen: >1.3xULN | Albumin: <0.8xLLN (N=15,15,12,11) | Albumin: >1.2xULN (N=15,15,12,11) | Potassium: <0.9xLLN (N=15,15,12,11) | Potassium: >1.1xULN (N=15,15,12,11) | Magnesium: <0.9xLLN (N=15,15,12,11) | Magnesium: >1.1xULN (N=15,15,12,11) | Phosphate: <0.8xLLN (N=15,15,12,11) | Phosphate: >1.2xULN (N=15,15,12,11) | Bicarbonate (venous): <0.9xLLN (N=15,15,12,11) | Bicarbonate (venous): >1.1xULN (N=15,15,12,11) | Glucose: <0.6xLLN (N=15,15,12,11) | Glucose: >1.5xULN (N=15,15,12,11) | Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10) | Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10) | IGF Binding Protein: <0.9xLLN (N=12,13,11,10) | IGF Binding Protein: >1.1xULN (N=12,13,11,10) | Lipid profile cholesterol/triglycerides(N=1,4,0,1) | |
| Pregabalin: 1-23 Months | 0 | 2 | 0 | 2 | 0 | 1 | 0 | 1 | 0 | 0 | 9 | 0 | 1 | 0 | 0 | 5 | 0 | 4 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 1 | 5 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 11 | 0 | 1 | 0 | 0 | 8 | 0 | 2 | 0 |
| Pregabalin: 7-11 Years | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 7 | 0 | 0 | 0 | 1 | 4 | 0 | 5 | 0 |
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): <0.8 LLN or >1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): <0.8 LLN or >1.2 ULN. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| T4 (free): <0.8xLLN (N=13,13,11,10) | T4 (free): >1.2xULN (N=13,13,11,10) | TSH: <0.8xLLN (N=14,12,11,10) | TSH: >1.2xULN (N=14,12,11,10) | |
| Pregabalin: 1-23 Months | 0 | 0 | 1 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 1 | 0 | 0 | 0 |
| Pregabalin: 7-11 Years | 0 | 0 | 0 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Participants with AEs | Participants with serious AEs | Participants with severe AEs | |
| Pregabalin: 1-23 Months | 14 | 8 | 7 |
| Pregabalin: 12-16 Years | 9 | 1 | 1 |
| Pregabalin: 2-6 Years | 13 | 3 | 4 |
| Pregabalin: 7-11 Years | 11 | 0 | 0 |
Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined. (NCT00448916)
Timeframe: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 (N=16,13,11,10) | Month 1 (N=14,13,10,10) | Month 6 (N=11,10,6,7) | Month 12/Early Termination (N=16,11,12,9) | Follow-up (N=6,4,9,6) | |
| Pregabalin: 1-23 Months | 1 | 0 | 0 | 0 | 0 |
| Pregabalin: 12-16 Years | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 0 | 0 | 0 | 0 | 0 |
| Pregabalin: 7-11 Years | 0 | 0 | 0 | 0 | 0 |
Height was recorded in centimeters. (NCT00448916)
Timeframe: Month 12/Early Termination
| Intervention | cm (Mean) |
|---|---|
| Pregabalin: 1-23 Months | 83.3 |
| Pregabalin: 2-6 Years | 109.9 |
| Pregabalin: 7-11 Years | 145.6 |
| Pregabalin: 12-16 Years | 167.3 |
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted. (NCT00448916)
Timeframe: 12 Months
| Intervention | Participants (Number) |
|---|---|
| Pregabalin: 1-23 Months | 1 |
| Pregabalin: 2-6 Years | 1 |
| Pregabalin: 7-11 Years | 0 |
| Pregabalin: 12-16 Years | 1 |
BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2. (NCT00448916)
Timeframe: Month 12/Early Termination
| Intervention | Kg/m^2 (Mean) |
|---|---|
| Pregabalin: 1-23 Months | 16.2 |
| Pregabalin: 2-6 Years | 18.0 |
| Pregabalin: 7-11 Years | 20.6 |
| Pregabalin: 12-16 Years | 24.8 |
Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or > 1.25 times ULN or < 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below. (NCT00448916)
Timeframe: Visit 1 to 12 Months
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| ≥ 30% increase from Baseline | ≥ 30% decrease from Baseline | > 1.25 * ULN | < 0.9 * LLN | |
| Pregabalin: 1-23 Months | 2 | 2 | 0 | 0 |
| Pregabalin: 12-16 Years | 1 | 0 | 0 | 0 |
| Pregabalin: 2-6 Years | 3 | 1 | 0 | 0 |
| Pregabalin: 7-11 Years | 1 | 0 | 0 | 1 |
"m-BPI-sf: participant rated 11-point Likert rating scale ranging from 0 (no pain) to 10 (worst pain possible). Pain severity index is the mean of item scores 2, 3, and 4 (pain right now, worst pain, and average pain level).~LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata." (NCT00468845)
Timeframe: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
| Intervention | Units on a scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n=149, 147, 155) | Discharge (n=140, 141, 138) | Day 7 (n=122, 121, 125) | Day 14 (n=129, 124, 130) | Day 28 (n=141, 142, 143) | |
| Placebo | 0 | 2.53 | 2.20 | 1.61 | 0.83 |
| Pregabalin 150mg | 0 | 2.62 | 2.05 | 1.19 | 0.79 |
| Pregabalin 300 mg | 0 | 2.60 | 2.16 | 1.63 | 0.98 |
Post-discharge worst pain as measured in daily participant diaries NRS an 11 point Likert scale that ranged from 0 (no pain) to 10 (pain as bad as you can imagine). LS Means from ANOVA model with terms of treatment, pooled center, salpingo-oophorectomy strata and baseline worst pain score. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| Discharge (n=140, 143, 138) | Day 7 (n=123, 121, 125) | Day 14 (n=129, 125, 130) | Day 28 (n=141, 142, 143) | |
| Placebo | 4.2 | 3.5 | 2.5 | 1.4 |
| Pregabalin 150mg | 4.3 | 3.2 | 1.8 | 1.2 |
| Pregabalin 300 mg | 4.4 | 3.4 | 2.4 | 1.7 |
Participant sat upright from supine position, followed by 120 second (sec) rest period, during which participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Day 1 (day of surgery), up to 7 days PS, Discharge, 2 and 4 weeks PS
| Intervention | Units on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 24 Hours PS (n=147, 141, 149) | 48 Hours PS (n=142, 141, 142) | 72 Hours PS (n=83, 90, 75) | 96 Hours PS (n=29, 31, 26) | 120 Hours PS (n=14, 15, 12) | 144 Hours PS (n=2, 5, 5) | Discharge (n=141, 135, 144) | Day 14 (n=126, 120, 128) | Day 28 (n=138, 138, 142) | |
| Placebo | 5.28 | 3.67 | 3.20 | 3.20 | 2.36 | 2.00 | 2.42 | 1.30 | 0.76 |
| Pregabalin 150mg | 5.21 | 3.57 | 2.80 | 2.31 | 2.89 | 1.86 | 2.67 | 1.08 | 0.70 |
| Pregabalin 300 mg | 5.53 | 3.71 | 3.04 | 3.20 | 2.84 | 1.26 | 2.99 | 1.37 | 0.91 |
Pain reported by participants at rest (numeric rating scale (NRS) - Current Pain) on an 11 point Likert scale 0 (no pain) - 10 (worst pain). Pain at rest during the hospital stay was assessed just before each Pain with Movement assessment. Assessment performed 3 times each day of hospital stay, with 1 of daily assessments at 24 (+/- 2 ) hour intervals from end of surgery. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 8, 16, 24, 32, 40, 48 hours PS
| Intervention | Units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| 8 Hours PS (n=123, 125, 126) | 16 Hours PS (n=94, 88, 107) | 24 Hours PS (n=151, 147, 154) | 32 Hours PS (n=127, 127, 136) | 40 Hours PS (n=93, 97, 100) | 48 Hours PS (n=142, 143, 140) | |
| Placebo | 5.47 | 4.30 | 3.93 | 3.55 | 2.98 | 2.65 |
| Pregabalin 150mg | 5.13 | 4.06 | 3.79 | 3.37 | 2.97 | 2.60 |
| Pregabalin 300 mg | 5.39 | 4.55 | 3.76 | 3.31 | 2.71 | 2.26 |
Chronic post-operative pain as a result of abdominal hysterectomy as reported by participants on PS questionaire of pain within last 24 hours in area affected by surgery. (NCT00468845)
Timeframe: 3 and 6 Months PS
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Months 3 PS (n =136, 127, 138) | Months 6 PS (n =138, 127, 141) | |
| Placebo | 10.1 | 4.3 |
| Pregabalin 150mg | 12.5 | 6.5 |
| Pregabalin 300 mg | 17.3 | 6.3 |
The integrated analgesic score (a combination of opioid use and either worst pain, or pain at rest, or pain caused by sitting, or pain caused by forced expiration as defined by Silverman et al 1993) was the sum of percent differences from mean rank for pain and opioids and ranged from -200 to 200 where lower values represent improvement. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 0-24, 24-48, 48-72 hours PS
| Intervention | Units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| 0-24 Hours PS (n=150, 145, 151) | 24-48 Hours PS (n=141, 142, 139) | 48-72 Hours PS (n=81, 89, 74) | |
| Placebo | 3.36 | 5.48 | 19.85 |
| Pregabalin 150mg | -6.58 | -5.51 | 3.23 |
| Pregabalin 300 mg | -11.66 | -18.84 | -6.93 |
Pain characteristics in participants who reported pain (mBPI-sf, NPSI); NPSI a participant rated questionnaire to evaluate different symptoms of neuropathic pain, burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia at discharge. NPSI Total Score ranged from 0 to 0.5; NPSI subscales pain ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS)
| Intervention | Units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Total subscale(n=132, 131, 136) | Burning Spontaneous subscale (n=139, 145, 143) | Pressing Spontaneous subscale (n=139, 145, 143) | Paroxysmal pain subscale (n=138, 140, 143) | Evoked Pain subscale (n=134, 135, 142) | Paresthesia/dysesthesia (n=136, 140, 141) | |
| Placebo | 0.076 | 1.75 | 1.57 | 1.18 | 2.27 | 0.91 |
| Pregabalin 150mg | 0.073 | 1.86 | 1.74 | 1.08 | 2.14 | 0.46 |
| Pregabalin 300 mg | 0.070 | 1.80 | 1.60 | 0.95 | 2.27 | 0.67 |
The amounts of non-opioid rescue medications, ibuprofen, used by the participants during the study, including anti-emetic medications. (NCT00468845)
Timeframe: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS
| Intervention | Grams (g) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 Hours PS (n=150, 147, 155) | 48 Hours PS (n=150, 147, 154) | 72 Hours PS (n=150, 147, 149) | 1st Week PS (n=142, 142, 145) | 2nd Week PS (n=140, 135, 143) | 3rd Week PS (n=132, 124, 134) | 4th Week PS (n=95, 94, 103) | Till Discharge (n=147, 143, 147) | |
| Placebo | 0.01 | 0.12 | 0.24 | 0.97 | 1.88 | 2.83 | 3.84 | 0.26 |
| Pregabalin 150mg | 0.01 | 0.08 | 0.14 | 0.51 | 1.22 | 1.95 | 2.42 | 0.18 |
| Pregabalin 300 mg | 0.03 | 0.15 | 0.27 | 0.87 | 1.94 | 2.99 | 4.30 | 0.38 |
The amounts of non-opioid rescue medications, paracetamol, used by the participants during the study, including anti-emetic medications. (NCT00468845)
Timeframe: 24, 48, 72 hours PS, Discharge (day 3 up to day 7 PS), Week 1, 2, 3, 4 PS,
| Intervention | Grams (g) (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 Hours PS (n=150, 147, 155) | 48 Hours PS (n=150, 147, 154) | 72 Hours PS (n=150, 147,149) | 1st Week PS (n=142, 142, 145) | 2nd Week PS (n=139, 135, 143) | 3rd Week PS (n=131, 124, 134) | 4th Week PS (n=95, 94, 103) | Till Discharge (n=147, 143, 147) | |
| Placebo | 1.22 | 3.55 | 5.68 | 12.63 | 19.70 | 24.35 | 25.63 | 6.05 |
| Pregabalin 150mg | 1.16 | 3.23 | 5.07 | 10.76 | 17.89 | 23.56 | 27.10 | 5.45 |
| Pregabalin 300 mg | 1.21 | 3.20 | 5.08 | 10.57 | 16.79 | 22.12 | 25.62 | 5.78 |
Impact of current pain medication response scale: 0 (worst possible response) to 100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS), Day 28 PS
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Discharge (n=139, 141, 140) | Day 28 (n=133, 135, 141) | |
| Placebo | 72.82 | 69.05 |
| Pregabalin 150mg | 72.73 | 76.41 |
| Pregabalin 300 mg | 66.28 | 69.53 |
Satisfaction with current pain medication ranged from 0 (worst possible response) to100 (best possible response). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS), Day 28 PS
| Intervention | Units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Medication Subscale/Discharge (n=138, 137, 139) | Medication Subscale/Day 28 (n=133, 134, 137) | Characteristic Subscale/Discharge (n=138,136,138) | Characteristic Subscale/Day 28 (n=133, 133, 137) | Efficacy Subscale/Discharge (n=138, 137, 139) | Efficacy Subscale/Day 28 (n=133, 134, 136) | |
| Placebo | 76.71 | 78.26 | 79.58 | 81.69 | 73.77 | 74.82 |
| Pregabalin 150mg | 79.43 | 82.52 | 82.15 | 84.82 | 76.68 | 80.20 |
| Pregabalin 300 mg | 78.45 | 80.16 | 81.88 | 83.16 | 75.04 | 76.92 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 1 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 16.2 | 45.5 | 30.5 | 7.8 |
| Pregabalin 150mg | 13.3 | 56.0 | 26.7 | 4.0 |
| Pregabalin 300 mg | 17.6 | 47.3 | 29.1 | 6.1 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 14 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 31.3 | 33.6 | 24.4 | 10.7 |
| Pregabalin 150mg | 40.0 | 42.3 | 11.5 | 6.2 |
| Pregabalin 300 mg | 42.9 | 37.3 | 16.7 | 3.2 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 2 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 16.2 | 47.0 | 29.1 | 7.7 |
| Pregabalin 150mg | 21.9 | 49.1 | 25.4 | 3.5 |
| Pregabalin 300 mg | 17.6 | 54.6 | 21.8 | 5.9 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 28 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 34.3 | 35.0 | 23.8 | 7.0 |
| Pregabalin 150mg | 42.4 | 41.7 | 9.4 | 6.5 |
| Pregabalin 300 mg | 40.1 | 34.5 | 16.2 | 9.2 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 3 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 17.6 | 50.0 | 29.4 | 2.9 |
| Pregabalin 150mg | 15.9 | 52.3 | 31.8 | 0 |
| Pregabalin 300 mg | 17.5 | 47.5 | 30.0 | 5.0 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 4 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 14.3 | 42.9 | 28.6 | 14.3 |
| Pregabalin 150mg | 17.6 | 52.9 | 29.4 | 0 |
| Pregabalin 300 mg | 5.3 | 57.9 | 31.6 | 5.3 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 5 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 14.3 | 42.9 | 28.6 | 14.3 |
| Pregabalin 150mg | 0 | 71.4 | 28.6 | 0 |
| Pregabalin 300 mg | 7.7 | 53.8 | 38.5 | 0 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 7 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 25.2 | 39.4 | 26.0 | 9.4 |
| Pregabalin 150mg | 36.6 | 38.2 | 15.4 | 9.8 |
| Pregabalin 300 mg | 36.9 | 37.7 | 17.2 | 8.2 |
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. (NCT00468845)
Timeframe: Day 28 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Superficial Incision SSI | Deep Incision SSI | Organ/space SSI | Non-infectious Wound Healing | |
| Placebo | 1.2 | 0 | 0.6 | 0 |
| Pregabalin 150mg | 1.9 | 0 | 0 | 2.5 |
| Pregabalin 300 mg | 1.9 | 0 | 0 | 2.5 |
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. (NCT00468845)
Timeframe: Day 14 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Superficial Incision SSI | Deep Incision SSI | Organ/space SSI | Non-infectious Wound Healing | |
| Placebo | 2.4 | 0 | 0 | 0.6 |
| Pregabalin 150mg | 5.0 | 0.6 | 0.6 | 4.4 |
| Pregabalin 300 mg | 2.5 | 0 | 0 | 2.5 |
Time-normalized AUC of pain reported by participants with movement caused by PEF test. Pain reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 48 +/- 4 hours PS
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 150mg | 4.45 |
| Pregabalin 300 mg | 4.64 |
| Placebo | 4.61 |
Time-normalized AUC of pain with movement caused by sitting reported by participants. Participant sat upright from supine position, followed by a 120sec rest period, during which the participant asked to rate pain with movement. Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. Current pain reported on 11 point Likert scale 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 48 +/- 4 hours PS
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 150mg | 4.87 |
| Pregabalin 300 mg | 5.01 |
| Placebo | 4.87 |
Incision length (cm) correlated with worst pain. Worst pain ranged from 0 (no pain) to 10 (worst pain imaginable). LS Means adjusted for treatment, pooled center, salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Day 1
| Intervention | Centimeter (cm) (Least Squares Mean) |
|---|---|
| Pregabalin 150mg | 7.1074 |
| Pregabalin 300 mg | 7.2324 |
| Placebo | 7.4437 |
Mean time from end of surgery to actual hospital discharge. Participant was expected to remain at the hospital for a minimum of 2 days following surgery. (NCT00468845)
Timeframe: Day 1 up to Day 7 PS
| Intervention | Hours (Mean) |
|---|---|
| Pregabalin 150mg | 79.339 |
| Pregabalin 300 mg | 85.221 |
| Placebo | 78.740 |
Mean time from end of surgery to meet protocol defined hospital discharge criteria: participant no longer received parental opioids, was able to dress and mobilize without assistance, and had normal intake of food and fluids. (NCT00468845)
Timeframe: Day 1 up to Day 7 PS
| Intervention | Hours (Mean) |
|---|---|
| Pregabalin 150mg | 57.670 |
| Pregabalin 300 mg | 60.751 |
| Placebo | 58.745 |
"Modified Brief Pain Inventory - Short Form (m-BPI-sf): participant rated 11-point Likert rating scale ranged from 0 (no pain) to 10 (worst pain imaginable).~Least Square (LS) Means adjusted for treatment, pooled center and salpingo-oophorectomy strata." (NCT00468845)
Timeframe: Day 2 (24 hours post surgery [PS])
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 150mg | 7.1 |
| Pregabalin 300 mg | 7.2 |
| Placebo | 7.4 |
Participant anxiety reported on Visual Anxiety Scale (VAS), 0 (not at all anxious) to 100 (extremely anxious). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata (NCT00468845)
Timeframe: Surgery day before first dose and 1 hour after first dose, Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
| Intervention | Units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Surgery Day (prior to first dose)(n=149, 144, 151) | Surgery Day (1 hour after dosing)(n=138, 139, 146) | Day 1 PS (n=150, 149, 154) | Day 2 PS (n=112, 120, 118) | Day 3 PS (n=44, 40, 35) | Day 4 PS (n=17, 20, 15) | Day 5 PS (n=7, 13, 7) | Discharge (n=143, 144, 148) | |
| Placebo | 33.3 | 30.9 | 18.6 | 13.8 | 13.9 | 9.3 | 15.1 | 8.8 |
| Pregabalin 150mg | 31.9 | 29.5 | 15.6 | 12.6 | 17.2 | 9.0 | 11.6 | 10.2 |
| Pregabalin 300 mg | 28.4 | 29.7 | 16.1 | 13.4 | 11.2 | 4.2 | 4.5 | 8.3 |
Post-discharge average pain as measured in daily participant diaries NRS an 11 point Likert scale ranged from 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Day 2, 3, 4, 5, 6, 7, PS; week 2, 3, 4 PS
| Intervention | Units on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Day 2 PS (n=29, 21, 25) | Day 3 PS (n=97, 94, 98) | Day 4 PS (n=126, 114, 125) | Day 5 PS (n=133, 117, 133) | Day 6 PS (n=133, 125, 138) | Day 7 PS (n=132, 130, 135) | 2nd Week PS (Average) (n=134, 131, 139) | 3rd Week PS (Average) (n=114, 110, 114) | 4th Week PS (Average) (n=87, 87, 82) | |
| Placebo | 3.1 | 2.8 | 2.8 | 2.6 | 2.4 | 2.2 | 1.7 | 1.3 | 1.2 |
| Pregabalin 150mg | 3.9 | 3.0 | 2.7 | 2.5 | 2.3 | 2.1 | 1.7 | 1.3 | 1.2 |
| Pregabalin 300 mg | 4.3 | 3.2 | 2.9 | 2.6 | 2.5 | 2.3 | 2.0 | 1.7 | 1.6 |
m-BPI-sf: participant-rated 11 point Likert rating scale ranging from 0 (does not interfere) to 10 (completely interferes) with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life) in past 24 hours. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Baseline, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
| Intervention | Units on a scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n=149, 147, 154) | Discharge (n=133, 131, 130) | Day 7 (n=121, 119, 123) | Day 28 (n=140, 141, 142) | Day 14 (n=129, 123, 126) | |
| Placebo | 0 | 2.90 | 2.52 | 1.07 | 1.68 |
| Pregabalin 150mg | 0 | 2.57 | 1.96 | 0.85 | 1.20 |
| Pregabalin 300 mg | 0 | 2.62 | 2.09 | 1.01 | 1.41 |
Change from baseline= PEF at x hours minus PEF at baseline; possible values ranged from 0-900 liters/minute (higher values indicated better lung function). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Baseline, every 8 hours (up to 232 hours) PS, and Discharge (Day 3-7 PS flexible)
| Intervention | L/min (Least Squares Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=116, 114, 121) | 8 Hours PS (n=84, 79, 83) | 16 Hours PS (n=72, 62, 76) | 24 Hours PS (n=115, 112, 117) | 32 Hours PS (n=104, 105, 106) | 40 Hours PS (n=70, 73, 79) | 48 Hours PS (n=108, 112, 111) | 56 Hours PS (n=78, 85, 82) | 64 Hours PS (n=52, 51, 54) | 72 Hours PS (n=61, 68, 60) | 80 Hours PS (n=30, 24, 24) | 88 Hours PS (n=18, 15, 19) | 96 Hours PS (n=20, 22, 21) | 104 Hours PS (n=9, 12, 12) | 112 Hours PS (n=5, 10, 9) | 120 Hours PS (n=10, 12, 10) | 128 Hours PS (n=4, 9, 7) | |
| Placebo | 0 | -41.29 | -36.48 | -29.46 | -28.92 | -25.07 | -21.70 | -21.12 | -17.18 | -20.81 | -8.17 | -9.71 | 2.36 | -4.94 | -11.61 | -6.98 | -14.32 |
| Pregabalin 150mg | 0 | -39.25 | -37.37 | -28.92 | -24.53 | -24.18 | -16.71 | -17.11 | -15.04 | -18.12 | -17.23 | -10.08 | -1.45 | -12.79 | -15.61 | -12.36 | -6.72 |
| Pregabalin 300 mg | 0 | -35.35 | -36.49 | -26.53 | -25.66 | -25.70 | -13.62 | -15.40 | -14.20 | -12.97 | -3.01 | -2.30 | 5.26 | 0.69 | 8.49 | -8.14 | -4.76 |
Current pain with movement caused by peak expiratory flow (PEF) test as reported by participant on 11 point Likert scale 0 (no pain) to 10 (worst pain). Assessment performed 3 times each day of hospital stay, with 1 daily assessment at 24 (+/- 2) hour interval from end of surgery. PEF test performed 3 times, with 120sec rest periods in between. At beginning of each rest period, participant asked to rate pain caused by forced expiration. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Day 1, up to 7 days PS, 2 and 4 weeks PS
| Intervention | Units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| 24 hours PS (n=146, 142, 148) | 48 hours PS (n=141, 143, 140) | 72 hours PS (n=83, 90, 74) | 96 hours PS (n=28, 31, 25) | 120 hours PS (n=13, 14, 11) | 144 hours PS (n=2, 5, 3) | |
| Placebo | 4.97 | 3.46 | 3.04 | 3.28 | 1.45 | 1.67 |
| Pregabalin 150mg | 4.83 | 3.22 | 2.62 | 1.88 | 1.97 | 3.67 |
| Pregabalin 300 mg | 4.92 | 3.47 | 2.69 | 3.05 | 2.10 | 0.67 |
Time-normalized AUC of pain reported by participants on 11 point Likert scale 0 (no pain) to 10 (worst pain). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 48 +/- 4 hours PS
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 150mg | 3.62 |
| Pregabalin 300 mg | 3.58 |
| Placebo | 3.76 |
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. (NCT00468845)
Timeframe: Day 7 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Superficial Incision SSI | Deep Incision SSI | Organ/space SSI | Non-infectious Wound Healing | |
| Placebo | 0.6 | 0 | 0 | 0.6 |
| Pregabalin 150mg | 1.9 | 0.6 | 0 | 3.8 |
| Pregabalin 300 mg | 2.5 | 0 | 0 | 1.9 |
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Superficial Incision SSI | Deep Incision SSI | Organ/space SSI | Non-infectious Wound Healing | |
| Placebo | 0.6 | 0 | 0 | 0 |
| Pregabalin 150mg | 3.1 | 0 | 0 | 0 |
| Pregabalin 300 mg | 1.2 | 0 | 0 | 1.2 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Day 1
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 20.0 | 35.0 | 30.0 | 15.0 |
| Pregabalin 150mg | 14.3 | 42.9 | 39.3 | 3.6 |
| Pregabalin 300 mg | 3.1 | 62.5 | 31.3 | 3.1 |
Participant satisfaction with study medication using the Global Evaluation of Study Medication questionaire. Participants overall impression (global evaluation) of the study medication was recorded by the participant by answering the following question: How would you rate the study medication you received for pain? Excellent 4; Good 3; Fair 2; Poor 1. (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Placebo | 26.4 | 39.9 | 25.0 | 8.8 |
| Pregabalin 150mg | 29.6 | 48.6 | 16.9 | 4.9 |
| Pregabalin 300 mg | 26.2 | 51.0 | 17.9 | 4.8 |
Pre-specified adverse events of wound healing complications based on Center for Disease Control and Prevention, 1999, guidelines for prevention of surgical site infection (SSI) wound healing complications included: superficial incisional SSI, deep incisional SSI, organ/space SSI or non-infections wound healing complication. (NCT00468845)
Timeframe: Day 1 up to Day 28 PS
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Superficial Incision SSI | Deep Incision SSI | Organ/space SSI | Non-infectious Wound Healing | |
| Placebo | 0 | 0 | 0 | 0 |
| Pregabalin 150mg | 0 | 0 | 0 | 0 |
| Pregabalin 300 mg | 1.2 | 0 | 0 | 0 |
"Participant rated questionnaire assessed current health for 6 domains: mobility/self-care/ usual activities/pain/discomfort/anxiety and depression. Scoring developed by EuroQol Group assigned a utility value for each domain in the profile. Scores ranged from 1 better health (no problems) to 3 worst health (eg, confined to bed). Score transformed and resulted in a total score range -0.594 to 1.000; higher score=better health state. Health profile scores estimated using Dolan computational algorithms 1997 and 2001. LS Means adjusted for treatment/pooled center/salpingo-oophorectomy strata." (NCT00468845)
Timeframe: Discharge (day 3 up to day 7 PS) and day 28 PS
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| EQ-5D 1997, Discharge (n=138, 141, 138) | EQ-5D 1997, Day 28 (n=140, 143, 142) | EQ-5D 2001, Discharge (n=138, 141, 138) | EQ-5D 2001, Day 28 (n=140, 143, 142) | |
| Placebo | 0.58 | 0.78 | 0.60 | 0.78 |
| Pregabalin 150mg | 0.57 | 0.81 | 0.59 | 0.81 |
| Pregabalin 300 mg | 0.61 | 0.78 | 0.62 | 0.78 |
Sleep interference post surgery measured daily in participant diaries; NRS of how pain interfered with sleep during the last 24 hours, ranged from 0 (does not interfere) to 10 (completely interferes). LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Daily post hospital discharge ( Day 2-7 PS), Week 2, 3, 4 PS
| Intervention | Units on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Day 2 PS (n=21, 18, 20) | Day 3 PS (n=88, 89, 87) | Day 4 PS (n=122, 111, 119) | Day 5 PS (n=133, 117, 132) | Day 6 PS (n=133, 127, 138) | Day 7 PS (n=132, 131, 138) | 2nd Week PS (Average) (n=134, 131, 139) | 3rd Week PS (Average) (n=115, 112, 113) | 4th Week PS (Average) (n=87, 87, 81) | |
| Placebo | 3.2 | 2.6 | 2.5 | 2.5 | 2.1 | 2.1 | 1.5 | 1.0 | 0.9 |
| Pregabalin 150mg | 2.4 | 2.6 | 2.3 | 2.1 | 1.7 | 1.7 | 1.3 | 1.0 | 1.0 |
| Pregabalin 300 mg | 3.6 | 2.3 | 2.5 | 2.2 | 1.9 | 2.0 | 1.7 | 1.3 | 1.4 |
Functional mobility test performed once a day at 24 hour intervals from surgery after the pain with movement assessment. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Day 1, 2, 3, 4, 5 PS and Discharge (day 3 up to day 7 PS)
| Intervention | Seconds (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Day 1 PS (n=85, 85, 93) | Day 2 PS (n=107, 105, 105) | Day 3 PS (n=43, 35, 31) | Day 4 PS (n=16, 18, 13) | Day 5 PS (n=7, 10, 7) | Discharge (n=130, 134, 134) | |
| Placebo | 38.54 | 29.25 | 31.38 | 40.43 | 32.18 | 26.40 |
| Pregabalin 150mg | 39.77 | 31.82 | 34.07 | 42.26 | 31.27 | 28.11 |
| Pregabalin 300 mg | 42.79 | 33.06 | 33.48 | 37.31 | 23.06 | 30.05 |
Total CME score calculated by summing the number of Clinically Meaningful Events (CMEs) across symptoms. CME for each symptom will be defined using the Opioid-Related Symptom Distress Scale (OR-SDS) a participant rated scale of symptoms within the last 24 hours. Total CME score could range from 0 to 9. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: Surgery Day, Day 1, 2, 3, 4, 5 PS, Discharge (day 3 up to day 7 PS), Day 7, 14, 28 PS
| Intervention | Units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Surgery Day (n=26, 25, 32) | Day 1 PS (n=148, 147, 154) | Day 2 PS (n=108, 116, 114) | Day 3 PS (n=38, 36, 32) | Day 4 PS (n=14, 16, 11) | Day 5 PS (n=5, 9, 6) | Discharge (n=133, 132, 133) | Day 7 PS (n=119, 117, 120) | Day 14 PS (n=119, 116, 124) | Day 28 PS (n=129, 135, 136) | |
| Placebo | 0.9 | 1.2 | 0.7 | 0.3 | 0.3 | 0.3 | 0.3 | 0.2 | 0.1 | 0.2 |
| Pregabalin 150mg | 0.9 | 1.1 | 0.6 | 0.5 | 0.0 | 0.4 | 0.4 | 0.2 | 0.1 | 0.0 |
| Pregabalin 300 mg | 0.8 | 1.1 | 0.6 | 0.7 | 0.4 | 0.1 | 0.4 | 0.4 | 0.2 | 0.2 |
Total cumulative dose was calculated as milligram (mg) of morphine equivalent and included opioids administered by any route. LS Means adjusted for treatment, pooled center and salpingo-oophorectomy strata. (NCT00468845)
Timeframe: 24, 48 Hours PS, Discharge (day 3 up to day 7 PS)
| Intervention | milligram (mg) (Least Squares Mean) | ||
|---|---|---|---|
| 24 hours PS (n=150, 147, 153) | 48 hours PS (n=150, 147, 151) | Till Discharge (n=147, 143, 144) | |
| Placebo | 124.44 | 168.31 | 195.32 |
| Pregabalin 150mg | 113.38 | 148.67 | 164.28 |
| Pregabalin 300 mg | 111.27 | 144.95 | 167.01 |
Percentage of participants experiencing any of the following (could have had more than 1): 1) episode of SE; 2) SGTC seizure if none had been experienced within 2 years of study entry; 3) 28-day study seizure rate during DBP >2 times the Max 28-day study seizure rate during BLP; 4) 2-day study seizure rate during the DBP >2 times the Max 2-day study seizure rate during BLP; or 5) unacceptable clinically significant increase in frequency/intensity of seizure activity (NCT00524030)
Timeframe: Week 2 up to Week 18
| Intervention | Percentage of Participants (Number) | |||||
|---|---|---|---|---|---|---|
| Status Epilepticus | SGTC Seizure (not experienced in previous 2 years) | 28-Day Seizure Rate >2 times Max Baseline Rate | 2-Day Seizure Rate >2 times Max Baseline Rate | Increased Frequency/Intensity of Seizure Activity | Total | |
| Pregabalin 150 mg/Day | 0 | 0 | 13.0 | 13.0 | 17.4 | 39.1 |
| Pregabalin 600 mg/Day | 1.0 | 2.9 | 10.8 | 7.8 | 14.7 | 28.4 |
(NCT00524030)
Timeframe: Week 2 to Week 20
| Intervention | Days (Mean) |
|---|---|
| Pregabalin 150 mg/Day | 73.8 |
| Pregabalin 600 mg/Day | 78.0 |
(NCT00524030)
Timeframe: Randomization up to Week 20
| Intervention | Percentage of Participants (Number) |
|---|---|
| Pregabalin 150 mg/Day | 53.6 |
| Pregabalin 600 mg/Day | 58.3 |
Participants who discontinued due to: episode of SE; SGTC seizure if none within 2 years of study entry; 28-day study seizure rate during DBP >2 times Max 28-day study seizure rate during BLP; 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate, defined as (1-KM product limit estimate for survival function) * 100% (NCT00524030)
Timeframe: Week 2 up to Week 18
| Intervention | Percentage of Participants (Number) |
|---|---|
| Pregabalin 150 mg/Day | 37.7 |
Participants who discontinued due to: episode of status epilepticus (SE); secondarily generalized tonic-clonic (SGTC) seizure if none within 2 years of study entry; 28-day study seizure rate during double-blind phase (DBP) greater than (>)2 times maximum (Max) 28-day study seizure rate during baseline phase (BLP); 2-day study seizure rate during DBP >2 times Max 2-day study seizure rate during BLP; or unacceptable clinically significant increase in frequency/intensity of seizure activity. Determined as exit rate:(1-Kaplan-Meier [KM] product limit estimate for survival function) * 100% (NCT00524030)
Timeframe: Week 2 up to Week 18
| Intervention | Percentage of Participants (Number) |
|---|---|
| Pregabalin 600 mg/Day | 31.9 |
Percentage of participants predicted to exit the study due to any seizure exit criteria at Day 126. The exit rate at Day 126 was predicted using the final model (log normal distribution with respect to treatment group) and the parameter estimates. (NCT00524030)
Timeframe: Day 126
| Intervention | Percentage of Participants (Number) |
|---|---|
| Pregabalin 150 mg/Day | 37.2 |
| Pregabalin 600 mg/Day | 26.3 |
Percentage of participants who were seizure-free during the last 28 days on double-blind study medication (monotherapy phase, Days 112-140), during the monotherapy portion of the double-blind treatment phase (Days 56-140), and during all of the double-blind treatment phase (Days 1-140) (NCT00524030)
Timeframe: Day 1 up to Day 140
| Intervention | Percentage of Participants (Number) | ||
|---|---|---|---|
| Last 28 Days of Monotherapy (Days 112-140) | Monotherapy (Days 56-140) | Entire Double-Blind Treatment (Days 1-140) | |
| Pregabalin 150 mg/Day | 17.9 | 7.1 | 0 |
| Pregabalin 600 mg/Day | 12.5 | 6.7 | 1.7 |
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. (NCT00537238)
Timeframe: Baseline, Week 16
| Intervention | percent change (Median) |
|---|---|
| Pregabalin | -53.93 |
| Levetiracetam | -57.28 |
Participants who had at least 50% reduction in 28-day seizure rate from baseline to the end of the maintenance phase were considered as responders. The 28-day seizure rate was calculated as number of partial seizures in the period divided by difference of number of days in the period and number of missing diary day entries in the period, multiplied by 28. (NCT00537238)
Timeframe: Baseline up to Week 16
| Intervention | proportion of participants (Number) |
|---|---|
| Pregabalin | 0.59 |
| Levetiracetam | 0.59 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales:sleep disturbance,snoring,awakened short of breath,sleep adequacy,somnolence (range:0-100);sleep quantity (range:0-24),optimal sleep(yes/no), and 9 item index measures of sleep disturbance provide composite scores:sleep problem summary,overall sleep problem. Except adequacy,optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score[RS] minus lowest possible score divided by possible RS range*100);total score range:0-100;higher score=more intensity of attribute. (NCT00537238)
Timeframe: Baseline, Week 16
| Intervention | units on a scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Sleep Disturbance (n=253, 253) | Baseline: Snoring (n=253, 254) | Baseline: Awaken Short of Breath (n=253, 254) | Baseline: Quantity of Sleep (n=252, 252) | Baseline: Adequacy of Sleep (n=253, 254) | Baseline: Somnolence (n=253, 254) | Baseline: Sleep Problem Index (9) (n=253, 253) | Week 16: Sleep Disturbance (n=230, 241) | Week 16: Snoring (n=230, 240) | Week 16: Awaken Short of Breath (n=230, 241) | Week 16: Quantity of Sleep (n=230, 241) | Week 16: Adequacy of Sleep (n=230, 241) | Week 16: Somnolence (n=230, 241) | Week 16: Sleep Problem Index (9) (n=230, 241) | |
| Levetiracetam | 28.10 | 32.42 | 17.26 | 7.82 | 64.40 | 33.77 | 29.49 | 23.61 | 23.75 | 14.27 | 7.75 | 66.46 | 32.29 | 26.00 |
| Pregabalin | 27.06 | 30.72 | 15.72 | 7.77 | 62.96 | 34.85 | 29.62 | 21.97 | 33.77 | 15.15 | 7.89 | 63.46 | 31.56 | 26.64 |
BPRS-A:18-item clinician rated scale assesses somatic concern,anxiety, emotional withdrawal,conceptual disorganization,hallucinatory behavior(HB), guilt feelings,suspiciousness,disorientation,tension,mannerisms and posturing,grandiosity,depressive mood,hostility,motor retardation,uncooperativeness,unusual thought content,blunted affect,excitement. Items rated on 7-point scale 1 (not reported) to 7 (very severe). Total score=sum of items(range 18-126), core score=sum of conceptual disorganization, suspiciousness, HB, unusual thought content(range 4-28). Higher total/core score=more impairment. (NCT00537238)
Timeframe: Baseline, Week 7, 10, 13, 16 and Follow-up (Day 7 of taper phase)
| Intervention | units on a scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Total BPRS-A Score (n=253, 254) | Baseline: Core BPRS-A Score (n=253, 254) | Change at Week 7: Total BPRS-A Score (n=217, 225) | Change at Week 7: Core BPRS-A Score (n=216, 225) | Change at Week 10: Total BPRS-A Score (n=217, 219) | Change at Week 10: Core BPRS-A Score (n=217, 219) | Change at Week 13: Total BPRS-A Score (n=209, 214) | Change at Week 13: Core BPRS-A Score (n=209, 214) | Change at Week 16: Total BPRS-A Score (n=235, 241) | Change at Week 16: Core BPRS-A Score (n=235, 241) | Change at Follow-up: Total BPRS-A Score(n=178,189) | Change at Follow-up: Core BPRS-A Score(n=178,189) | |
| Levetiracetam | 26.09 | 5.01 | -1.70 | -0.22 | -2.42 | -0.34 | -2.68 | -0.38 | -1.92 | -0.26 | -1.42 | -0.11 |
| Pregabalin | 27.26 | 5.18 | -2.16 | -0.34 | -2.64 | -0.40 | -2.99 | -0.51 | -2.70 | -0.40 | -2.77 | -0.37 |
Change was calculated as (proportion of SGTC seizure rate divided by all partial seizure rates during double blind phase) minus (proportion of SGTC seizure rate divided by all partial seizure rates at baseline). Negative values indicated reductions in seizures. (NCT00537238)
Timeframe: Baseline, Week 16
| Intervention | percentage of all partial seizure/28days (Mean) | |
|---|---|---|
| Baseline (n=107, 111) | Change at Week 16 (n=102, 101) | |
| Levetiracetam | 38.94 | 6.33 |
| Pregabalin | 39.41 | 3.93 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00537238)
Timeframe: Baseline, Week 16
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline: HADS-A (n=253, 253) | Baseline: HADS-D (n=253, 253) | Week 16: HADS-A (n=228, 241) | Week 16: HADS-D (n=228, 241) | |
| Levetiracetam | 7.34 | 6.00 | 6.06 | 5.42 |
| Pregabalin | 7.25 | 6.22 | 6.32 | 5.41 |
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the maintenance phase. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. (NCT00537238)
Timeframe: Baseline up to Week 16
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| All Partial Seizure | Simple Partial Seizure | Complex Partial Seizure | SGTC Seizure | |
| Levetiracetam | 27.6 | 66.2 | 59.0 | 79.0 |
| Pregabalin | 19.9 | 65.7 | 49.3 | 80.6 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. (NCT00537238)
Timeframe: Baseline, Week 16
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Baseline (n=252, 252) | Week 16 (n=230, 241) | |
| Levetiracetam | 55.6 | 50.2 |
| Pregabalin | 56.0 | 58.3 |
Seizure free for 28 days was defined as participants who have not experienced any seizure (simple partial, complex partial and SGTC) for at least 28 consecutive days from their last seizure until the end of the MP. Same participant could be seizure free for a specific type of seizure but not necessarily for the other types of seizure. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| All Partial Seizure (n=189, 182) | Simple Partial (n=74, 66) | Complex Partial (n=126, 123) | SGTC (n=95, 91) | |
| Gabapentin | 34.1 | 36.4 | 40.7 | 42.9 |
| Pregabalin | 30.7 | 29.7 | 37.3 | 46.3 |
Participants who had at least 75% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 75% responders. If percent change from baseline <= -75 then 75% responder rate = 1 (yes) otherwise responder rate = 0 (no). Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + SGTC). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| All Partial Seizure (n=238, 240) | Simple Partial (n=87, 88) | Complex Partial (n=161, 158) | SGTC (n=112, 114) | |
| Gabapentin | 34.2 | 33.0 | 36.1 | 43.9 |
| Pregabalin | 33.6 | 36.8 | 37.3 | 38.4 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity (range:0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem. Except adequacy, optimal sleep and quantity, higher scores=more impairment. Scores transformed (actual raw score [RS] minus lowest possible score divided by possible RS range*100); total score range:0-100; higher score=more intensity of attribute. (NCT00537940)
Timeframe: Baseline, Week 21
| Intervention | Units on a scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Sleep Disturbance (n=238, 240) | Baseline: Snoring (n=238, 240) | Baseline: Awaken Short of Breath (n=238, 240) | Baseline: Quantity of Sleep (n=238, 240) | Baseline: Adequacy of Sleep (n=238, 240) | Baseline: Somnolence (n=238, 240) | Baseline: Sleep Problem Index (9) (n=238, 240) | Week 21: Sleep Disturbance (n=212, 210) | Week 21: Snoring (n=212, 210) | Week 21: Awaken Short of Breath (n=212, 210) | Week 21: Quantity of Sleep (n=212, 210) | Week 21: Adequacy of Sleep (n=212, 210) | Week 21: Somnolence (n=212, 210) | Week 21: Sleep Problem Index (9) (n=212, 210) | |
| Gabapentin | 26.43 | 28.09 | 19.61 | 7.59 | 63.67 | 29.31 | 28.15 | 25.31 | 26.12 | 18.20 | 8.77 | 64.53 | 29.98 | 27.54 |
| Pregabalin | 29.68 | 29.28 | 23.64 | 7.56 | 61.30 | 32.29 | 31.60 | 24.99 | 28.07 | 16.26 | 8.79 | 63.87 | 32.04 | 27.88 |
Participants who had at least 50% reduction in seizure frequency from Baseline to double-blind treatment (TP + MP) were considered as 50% responders. If percent change from baseline <= -50 then responder rate = 1 (yes) otherwise responder rate = 0 (no). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| All Partial Seizure (n=238, 240) | Simple Partial (n=87, 88) | Complex Partial (n=161, 158) | SGTC (n=112, 114) | |
| Gabapentin | 58.3 | 53.4 | 55.1 | 60.5 |
| Pregabalin | 56.3 | 55.2 | 56.5 | 50.9 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep. Participants responded whether their sleep was optimal or not by choosing yes or no. Percentage of participants with optimal sleep are reported. (NCT00537940)
Timeframe: Baseline, Week 21
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Baseline (n=238, 240) | Week 21 (n=212, 210) | |
| Gabapentin | 58.8 | 58.6 |
| Pregabalin | 49.2 | 51.4 |
The seizures were recorded by the participants, by a family member, by a caregiver, or by a legal guardian and documented in a daily seizure diary. Participant's 28-day seizure frequency of all partial seizure was assessed during double blind (TP + MP) phase compared with baseline. Total partial seizure is defined as the total number of (simple partial seizure + complex partial seizure + secondary generalized tonic clonic seizure [SGTC]). (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | percent change (Median) |
|---|---|
| Pregabalin | -58.65 |
| Gabapentin | -57.43 |
HADS: participant rated questionnaire with 2 subscales. Hospital Anxiety and Depression Scale - anxiety (HADS-A) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); Hospital Anxiety and Depression Scale - depression (HADS-D) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00537940)
Timeframe: Baseline, Week 21
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Baseline HADS-A (n=238, 240) | HADS- A Change at Week 21/ET (n=212, 210) | Baseline HADS-D (n=238, 240) | HADS-D Change at Week 21/ET (n=212, 210) | |
| Gabapentin | 7.60 | -0.83 | 5.65 | -0.42 |
| Pregabalin | 7.82 | -0.92 | 5.94 | -0.59 |
Change in SGTC = (Proportion of SGTC/All Partial Seizure rate during at the double-blind phase) - (Proportion of SGTC/All Partial Seizure rate at Baseline). Negative values indicate reduction from baseline. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | percentage of all partial seizure/28days (Mean) | |
|---|---|---|
| Baseline (n=114, 114) | Change from Baseline at Double Blind (n=104, 98) | |
| Gabapentin | 59.60 | -2.17 |
| Pregabalin | 56.53 | 1.59 |
SGTC Responder is defined as a participant who shows reduction from Baseline to double-blind phase in proportion of 28-Day SGTC Seizure Rate to 28-Day All Partial Seizure Rate. (NCT00537940)
Timeframe: 6 weeks Baseline, 21 weeks through End of MP for 27 weeks
| Intervention | percentage of responders (Number) |
|---|---|
| Pregabalin | 30.8 |
| Gabapentin | 39.8 |
GESM is a self-administered overall impression (global evaluation) of study medication received for pain; 4 categories: poor, fair, good, and excellent. (NCT00551135)
Timeframe: 24 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| 24 h PS: Poor (n=100, 96, 101, 99) | 24 h PS: Fair (n=100, 96, 101, 99) | 24 h PS: Good (n=100, 96, 101, 99) | 24 h PS: Excellent (n=100, 96, 101, 99) | EOT: Poor (n=99, 99, 100, 100) | EOT: Fair (n=99, 99, 100, 100) | EOT: Good (n=99, 99, 100, 100) | EOT: Excellent (n=99, 99, 100, 100) | |
| Placebo | 15 | 32 | 40 | 12 | 18 | 19 | 32 | 31 |
| Pregabalin 150 mg | 8 | 28 | 46 | 14 | 10 | 19 | 37 | 33 |
| Pregabalin 300 mg | 7 | 25 | 42 | 27 | 6 | 14 | 30 | 50 |
| Pregabalin 50 mg | 10 | 29 | 45 | 16 | 9 | 14 | 45 | 31 |
"Number of participants who answered yes to the Post-Surgery Contact question: From the time you were discharged from the hospital, did you have to contact any type of physician because of pain, difficulty getting up and walking about, or difficulty with passing urine?" (NCT00551135)
Timeframe: 24 and 72 hours (h) post surgery (PS)
| Intervention | participants (Number) | |
|---|---|---|
| 24 h PS | 72 h PS | |
| Placebo | 0 | 1 |
| Pregabalin 150 mg | 2 | 3 |
| Pregabalin 300 mg | 1 | 1 |
| Pregabalin 50 mg | 0 | 1 |
NPSI: a 12-item self-administered questionnaire to assess the characteristics of neuropathic pain on average in the last 24 hours. 5 subscale scores include: burning spontaneous (spont.) pain, pressing spont. pain, paroxysmal pain, evoked pain, and paresthesia or dysesthesia (paresth/dysesth) (range: 0 [no pain] to 10 [worst pain imaginable]); total score calculated from the 5 pain subscores (range: 0 to 0.5), higher scores meaning worse pain. (NCT00551135)
Timeframe: 1, 3, and 6 months (mo) post surgery (PS)
| Intervention | scores on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NPSI total score 1 mo PS (n=20, 24, 19, 26) | NPSI total score 3 mo PS (n=3, 5, 5, 3) | Burning spont. pain 1 mo PS (n=20, 24, 19, 26) | Burning spont. pain 3 mo PS (n=3, 5, 5, 3) | Pressing spont. pain 1 mo PS (n=20, 24, 19, 26) | Pressing spont. pain 3 mo PS (n=3, 5, 5, 3) | Paroxysmal pain 1 mo PS (n=20, 24, 19, 26) | Paroxysmal pain 3 mo PS (n=3, 5, 5, 3) | Evoked pain 1 mo PS (n=20, 24, 19, 26) | Evoked pain 3 mo PS (n=3, 5, 5, 3) | Paresth/dysesth 1 mo PS (n=20, 24, 19, 26) | Paresth/dysesth 3 mo PS (n=3, 5, 5, 3) | |
| Placebo | 0.04 | 0.04 | 0.77 | 1.00 | 0.69 | 0.67 | 0.71 | 1.33 | 1.05 | 0.44 | 0.46 | 0.50 |
| Pregabalin 150 mg | 0.03 | 0.02 | 1.04 | 0.00 | 0.50 | 0.50 | 0.56 | 0.20 | 0.76 | 1.3 | 0.35 | 0.20 |
| Pregabalin 300 mg | 0.05 | 0.05 | 1.11 | 0.40 | 1.03 | 2.30 | 1.05 | 0.70 | 1.44 | 1.73 | 0.32 | 0.10 |
| Pregabalin 50 mg | 0.03 | 0.02 | 0.30 | 1.00 | 0.43 | 0.50 | 0.95 | 0.33 | 0.82 | 0.22 | 0.10 | 0.50 |
Investigator-assigned mutually exclusive categories of: 1) no surgical wound complication, 2) superficial incisional surgical site infection, 3) deep incisional surgical site infection, 4) organ or space surgical site infection, or 5) non-infectious wound healing complication. (NCT00551135)
Timeframe: Day 7 post surgery (PS) and up to 30 days PS
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| No surgical wound complication | Superficial incisional surgical site infection | Deep incisional surgical site infection | Organ/space surgical site infection | Non-infectious wound healing complication | |
| Placebo | 101 | 1 | 0 | 0 | 1 |
| Pregabalin 150 mg | 102 | 0 | 0 | 0 | 1 |
| Pregabalin 300 mg | 99 | 1 | 0 | 0 | 1 |
| Pregabalin 50 mg | 102 | 1 | 0 | 0 | 2 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by coughing (coughing two times while sitting); range: 0 (no pain) to 10 (worst pain) (NCT00551135)
Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | scores on scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2 h BS (n=102, 99, 101, 101) | 1 h PS (n=95, 91, 93, 90) | 2 h PS (n=96, 93, 99, 97) | 3 h PS (n=100, 99, 100, 100) | Day 2 PS (n=102, 98, 101, 100) | Day 3 PS (n=102, 98, 101, 100) | Day 4 PS (n=101, 99, 99, 101) | Day 5 PS (n=101, 99, 98, 100) | Day 6 PS (n=100, 99, 98, 99) | Day 7 PS (n=96, 93, 91, 93) | EOT (n=101, 99, 100, 100) | |
| Placebo | 2.1 | 1.8 | 4.6 | 4.3 | 3.9 | 5.2 | 4.5 | 3.9 | 3.8 | 3.2 | 2.7 | 2.3 |
| Pregabalin 150 mg | 1.8 | 1.5 | 4.8 | 4.3 | 4.1 | 5.1 | 4.5 | 3.6 | 3.1 | 2.8 | 2.5 | 2.0 |
| Pregabalin 300 mg | 2.2 | 1.6 | 3.7 | 3.8 | 3.8 | 4.5 | 4.3 | 3.6 | 3.2 | 2.9 | 2.5 | 2.3 |
| Pregabalin 50 mg | 2.4 | 1.4 | 4.4 | 4.1 | 3.8 | 4.6 | 4.3 | 3.6 | 2.8 | 2.6 | 2.4 | 1.9 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by sitting (sitting in a standardized fashion after being in a fully supine position); range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | scores on scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2 h BS (n=102, 99, 101, 101) | 1 h PS (n=92, 91, 91, 91) | 2 h PS (n=96, 93, 100, 96) | 3 h PS (n=100, 98, 101, 101) | Day 2 PS (n=102, 98, 101, 100) | Day 3 PS (n=102, 98, 100, 101) | Day 4 PS (n=101, 99, 99, 101) | Day 5 PS (n=101, 99, 98, 100) | Day 6 PS (n=100, 99, 98, 99) | Day 7 PS (n=96, 93, 91, 93) | EOT (n=101, 99, 100, 100) | |
| Placebo | 1.1 | 0.9 | 4.1 | 3.5 | 3.1 | 3.7 | 2.8 | 2.3 | 2.0 | 1.7 | 1.5 | 1.2 |
| Pregabalin 150 mg | 1.2 | 0.6 | 4.1 | 3.7 | 3.3 | 3.6 | 3.0 | 2.2 | 1.8 | 1.6 | 1.5 | 1.3 |
| Pregabalin 300 mg | 1.0 | 0.8 | 3.1 | 3.2 | 2.9 | 3.4 | 3.0 | 2.4 | 1.9 | 1.8 | 1.8 | 1.3 |
| Pregabalin 50 mg | 1.3 | 0.7 | 3.6 | 3.3 | 2.7 | 3.5 | 2.7 | 2.2 | 1.7 | 1.6 | 1.5 | 1.0 |
NRS: a self-administered questionnaire to rate pain. A single item asks to rate pain with movement caused by walking (rising from sitting position and walking approximately 5 meters or 16 feet at a moderate pace); range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, and 7 PS; and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | scores on scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | 2 h BS (n=102, 98, 101, 101) | 1 h PS (n=69, 62, 63, 60) | 2 h PS (n=84, 76, 84, 80) | 3 h PS (n=96, 91, 93, 94) | Day 2 PS (n=102, 98, 101, 100) | Day 3 PS (n=102, 98, 100, 101) | Day 4 PS (n=101, 99, 99, 101) | Day 5 PS (n=101, 99, 98, 100) | Day 6 PS (n=100, 99, 98, 99) | Day 7 PS (n=96, 93, 91, 93) | EOT (n=101, 99, 100, 100) | |
| Placebo | 2.0 | 1.2 | 3.7 | 3.6 | 3.3 | 3.9 | 2.9 | 2.2 | 1.9 | 1.6 | 1.3 | 1.2 |
| Pregabalin 150 mg | 1.6 | 1.1 | 3.9 | 3.4 | 3.6 | 3.8 | 3.0 | 2.2 | 1.8 | 1.6 | 1.4 | 1.2 |
| Pregabalin 300 mg | 1.9 | 1.2 | 2.9 | 3.1 | 3.0 | 3.3 | 2.8 | 2.1 | 1.8 | 1.7 | 1.5 | 1.3 |
| Pregabalin 50 mg | 1.9 | 1.2 | 3.2 | 3.3 | 3.1 | 3.3 | 2.7 | 2.2 | 1.7 | 1.5 | 1.3 | 1.1 |
Total cumulative dose of naproxen calculated in milligrams (mg) from the end of surgery up to and including Day 7 after surgery. (NCT00551135)
Timeframe: End of Surgery through Day 7 post surgery
| Intervention | mg (Least Squares Mean) |
|---|---|
| Pregabalin 50 mg | 3938.81 |
| Pregabalin 150 mg | 3930.57 |
| Pregabalin 300 mg | 3892.96 |
| Placebo | 3770.07 |
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 PS
| Intervention | scores on scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 h BS (n=102, 99, 101, 101) | 1 h PS (n=102, 97, 100, 100) | 2 h PS (n=102, 99, 101, 101) | 3 h PS (n=102, 99, 101, 101) | Day 2 PS (n=101, 99, 100, 101) | Day 3 PS (n=102, 99, 100, 100) | Day 4 PS (n=101, 99, 99, 101) | Day 5 PS (n=101, 98, 98, 100) | Day 6 PS (n=100, 99, 98, 98) | Day 7 PS (n=96, 93, 90, 93) | Day 8 PS (n=60, 62, 53, 60) | Day 9 PS (n=21, 24, 25, 22) | Day 10 PS (n=11, 11, 13, 11) | |
| Placebo | 0.7 | 3.8 | 3.0 | 2.7 | 3.3 | 2.3 | 1.8 | 1.7 | 1.5 | 1.3 | 1.1 | 1.5 | 0.9 |
| Pregabalin 150 mg | 0.7 | 3.7 | 3.2 | 2.7 | 3.3 | 2.7 | 2.0 | 1.8 | 1.4 | 1.4 | 1.2 | 1.0 | 1.0 |
| Pregabalin 300 mg | 0.8 | 2.9 | 2.7 | 2.6 | 3.3 | 2.2 | 1.9 | 1.8 | 1.4 | 1.3 | 1.2 | 0.6 | 0.9 |
| Pregabalin 50 mg | 0.9 | 3.3 | 3.1 | 2.5 | 3.2 | 2.5 | 2.0 | 1.4 | 1.3 | 1.2 | 1.3 | 0.4 | 0.5 |
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours: range of 0 (no pain) to 10 (worst imaginable pain). (NCT00551135)
Timeframe: 24 hours post surgery
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin 50 mg | 5.2 |
| Pregabalin 150 mg | 5.4 |
| Pregabalin 300 mg | 4.7 |
| Placebo | 5.4 |
Total cumulative dose of opioids and tramadol administered by any route during surgery and postoperatively. Dose of tramadol calculated as milligrams (mg) of oral morphine equivalent. (NCT00551135)
Timeframe: 24, 48, and 72 hours (h) post surgery (PS), and Days 4, 5, 6, and 7 PS
| Intervention | mg (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| 24 h PS (n=102, 99, 101, 101) | 48 h PS (n=102, 99, 101, 101) | 72 h PS (n=102, 99, 101, 101) | Day 4 PS (n=102, 99, 101, 101) | Day 5 PS (n=102, 99, 101, 101) | Day 6 PS (n=101, 99, 99, 100) | Day 7 PS (n=99, 99, 97, 100) | |
| Placebo | 16.03 | 19.79 | 22.20 | 23.97 | 25.57 | 26.90 | 28.15 |
| Pregabalin 150 mg | 9.44 | 14.10 | 16.99 | 18.65 | 20.46 | 21.57 | 22.23 |
| Pregabalin 300 mg | 6.58 | 9.73 | 12.34 | 14.18 | 14.64 | 15.81 | 16.16 |
| Pregabalin 50 mg | 10.29 | 13.15 | 14.59 | 15.35 | 16.09 | 15.99 | 15.88 |
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). The Total Distinct CME score is the sum of CMEs across symptoms (range: 0 [none] to 10 [10 CMEs]); the Cumulative Total Distinct (CT Distinct) CME score is the sum of Total Distinct CME scores at observation and prior observations. The Total CME score is the same as the Total Distinct CME score except that only 1 CME is counted if both nausea and vomiting (or retching) occur (range: 0 [none] to 9 [9 CMEs]). (NCT00551135)
Timeframe: 3, 24, and 72 hours (h) Post-Surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | scores on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Total CME 3 h PS (n=98, 97, 98, 98) | Total CME 24 h PS (n=97, 97, 98, 97) | Total CME 72 h PS (n=98, 96, 96, 96) | Total CME EOT (n=100, 98, 99, 97) | CT Distinct CME 3 h PS (n=98, 97, 98, 98) | CT Distinct CME 24 h PS (n=93, 95, 96, 94) | CT Distinct CME 72 h PS (n=91, 92, 93, 92) | CT Distinct CME EOT (n=90, 92, 93, 89) | |
| Placebo | 0.2 | 0.2 | 0.1 | 0.1 | 0.2 | 0.4 | 0.5 | 0.6 |
| Pregabalin 150 mg | 0.2 | 0.3 | 0.1 | 0.1 | 0.2 | 0.4 | 0.5 | 0.5 |
| Pregabalin 300 mg | 0.1 | 0.4 | 0.2 | 0.1 | 0.1 | 0.4 | 0.5 | 0.6 |
| Pregabalin 50 mg | 0.2 | 0.2 | 0.1 | 0.0 | 0.2 | 0.3 | 0.3 | 0.3 |
OR-SDS: a self-administered assessment of 10 common opioid-related side effects (symptoms). A CME is a severe or very severe symptom (or moderate or greater severity symptom of confusion). For individual symptom categories, the number of subjects who experienced at least one CME. Concentrate (concentr). (NCT00551135)
Timeframe: 3, 24, and 72 hours (h) post surgery (PS), and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fatigue 3 h PS (n=99, 98, 98, 100) | Fatigue 24 h PS (n=99, 97, 100, 97) | Fatigue 72 h PS (n=101, 97, 98, 98) | Fatigue EOT (n=100, 98, 100, 98) | Drowsiness 3 h PS (n=99, 98, 98, 100) | Drowsiness 24 h PS (n=98, 98, 99, 97) | Drowsiness 72 h PS (n=100, 98, 98, 98) | Drowsiness EOT (n=100, 98, 100, 97) | Inability to concentr 3 h PS (n=100, 97, 98, 99) | Inability to concentr 24 h PS (n=99, 98, 100, 97) | Inability to concentr 72 h PS (101, 98, 98, 97) | Inability to concentr EOT (n=100, 98, 100, 99) | Nausea 3 h PS (n=101, 97, 99, 100) | Nausea 24 h PS (n=100, 99, 101, 98) | Nausea 72 h PS (n=101, 99, 99, 98) | Nausea EOT (n=101, 98, 100, 99) | Dizziness 3 h PS (n=101, 97, 99, 100) | Dizziness 24 h PS (n=100, 98, 99, 98) | Dizziness 72 h PS (n=101, 98, 97, 98) | Dizziness EOT (n=101, 98, 100, 99) | Constipation 3 h PS (n=101, 98, 99, 100) | Constipation 24 h PS (n=99, 99, 100, 98) | Constipation 72 h PS (n=99, 97, 98, 98) | Constipation EOT (n=101, 98, 99, 99) | Itching 3 h PS (n=100, 98, 99, 100) | Itching 24 h PS (n=100, 99, 101, 98) | Itching 72 h PS (n=100, 99, 99, 97) | Itching EOT (n=101, 98, 100, 98) | Difficulty Urinating 3 h PS (n=101, 98, 99, 99) | Difficulty Urinating 24 h PS (n=100, 99, 100, 98) | Difficulty Urinating 72 h PS (n=100, 99, 99, 98) | Difficulty Urinating EOT (n= 101, 98, 100, 99) | Confusion 3 h PS (n=101, 98, 99, 100) | Confusion 24 h PS (n=101, 99, 99, 98) | Confusion 72 h PS (n=100, 99, 99, 98) | Confusion EOT (n=101, 98, 100, 99) | Retching/Vomiting 3 h PS (n=101, 98, 99, 100) | Retching/Vomiting 24 h PS (n=101, 99, 100, 98) | Retching/Vomiting 72 h PS (n=101, 99, 99, 98) | Retching/Vomiting EOT (n=101, 98, 100, 99) | |
| Placebo | 2 | 2 | 1 | 3 | 4 | 3 | 3 | 3 | 2 | 2 | 1 | 1 | 4 | 1 | 0 | 1 | 6 | 1 | 0 | 0 | 1 | 5 | 7 | 2 | 0 | 1 | 1 | 1 | 1 | 3 | 0 | 0 | 2 | 1 | 2 | 2 | 3 | 1 | 0 | 1 |
| Pregabalin 150 mg | 2 | 3 | 0 | 0 | 4 | 7 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 4 | 0 | 0 | 1 | 3 | 0 | 0 | 0 | 4 | 7 | 2 | 1 | 0 | 1 | 0 | 3 | 4 | 0 | 0 | 3 | 1 | 1 | 2 | 0 | 2 | 0 | 0 |
| Pregabalin 300 mg | 2 | 6 | 1 | 0 | 4 | 8 | 1 | 2 | 0 | 2 | 1 | 0 | 1 | 3 | 0 | 2 | 5 | 6 | 1 | 1 | 0 | 7 | 10 | 5 | 0 | 1 | 0 | 0 | 2 | 5 | 3 | 3 | 3 | 2 | 3 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin 50 mg | 4 | 2 | 0 | 0 | 5 | 2 | 1 | 0 | 1 | 1 | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 2 | 0 | 1 | 1 | 4 | 4 | 1 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | 1 | 2 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
"Number of participants who reported surgery-related pain at assessment (by answering 'yes' to a single question: In the last 24 hours, have you had pain in the area affected by your surgery?)" (NCT00551135)
Timeframe: 1, 3, and 6 months (mo) post surgery (PS)
| Intervention | participants (Number) | ||
|---|---|---|---|
| 1 month PS (n=98, 98, 98, 99) | 3 month PS (n=98, 97, 97, 97) | 6 month PS (n=98, 97, 97, 97) | |
| Placebo | 26 | 3 | 0 |
| Pregabalin 150 mg | 24 | 5 | 1 |
| Pregabalin 300 mg | 19 | 5 | 1 |
| Pregabalin 50 mg | 20 | 3 | 1 |
NRS: a self-administered questionnaire to rate pain. AUC from 1 h PS through 48 h PS for ratings of pain caused by movements of sitting, walking, and coughing; Range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: 1 hour through 48 hours post surgery
| Intervention | scores on scale (Least Squares Mean) | ||
|---|---|---|---|
| Sitting (n=100, 99, 101, 101) | Walking (n=97, 91, 95, 96) | Coughing (n=101, 99, 100, 101) | |
| Placebo | 155.57 | 161.74 | 220.34 |
| Pregabalin 150 mg | 158.90 | 162.70 | 219.69 |
| Pregabalin 300 mg | 148.25 | 143.40 | 199.13 |
| Pregabalin 50 mg | 146.22 | 143.82 | 202.93 |
NRS: a self-administered questionnaire to rate pain. A single item asks participant to rate pain on average in the last 24 hours; range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: 2 hours (h) before surgery (BS); 1, 2, and 3 h post surgery (PS); Days 1, 2, 3, 4, 5, 6, and 7 PS
| Intervention | scores on scale (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2 h BS (n=102, 99, 101, 101) | 1 h PS (n=101, 96, 99, 99) | 2 h PS (n=101, 97, 101, 99) | 3 h PS (n=102, 99, 101, 101) | Day 1 PS (n=101, 99, 101, 99) | Day 2 PS (n=102, 99, 99, 100) | Day 3 PS (n=102, 98, 98 101) | Day 4 PS (n=101, 99, 97, 100) | Day 5 PS (n=101, 99, 98, 100) | Day 6 PS (n=98, 96, 91, 96) | Day 7 PS (n=63, 66, 56, 62) | |
| Placebo | 1.4 | 3.2 | 3.1 | 3.2 | 3.4 | 2.9 | 2.5 | 1.9 | 1.8 | 1.6 | 1.3 |
| Pregabalin 150 mg | 1.3 | 3.0 | 3.2 | 3.2 | 3.4 | 3.1 | 2.5 | 2.0 | 1.8 | 1.5 | 1.5 |
| Pregabalin 300 mg | 1.3 | 2.5 | 2.8 | 2.9 | 2.9 | 2.9 | 2.4 | 2.1 | 1.7 | 1.7 | 1.4 |
| Pregabalin 50 mg | 1.3 | 2.8 | 3.0 | 2.8 | 3.4 | 2.9 | 2.5 | 1.9 | 1.6 | 1.4 | 1.6 |
DSIRS: self-administered 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Performed daily on awakening, prior to taking study medication. (NCT00551135)
Timeframe: Days 2, 3, 4, 5, 6, 7, 8, 9, and 10 post surgery (PS)
| Intervention | scores on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Day 2 PS (n=102, 99, 101, 101) | Day 3 PS (n=102, 98, 100, 101) | Day 4 PS (n=101, 99, 99, 101) | Day 5 PS (n=101, 98, 98, 100) | Day 6 PS (n=100, 99, 98, 99) | Day 7 PS (n=98, 96, 92, 96) | Day 8 PS (n=61, 65, 54, 61) | Day 9 PS (n=21, 24, 25, 24) | Day 10 PS (n=11, 11, 13, 11) | |
| Placebo | 3.18 | 2.11 | 1.48 | 1.44 | 1.13 | 1.00 | 0.63 | 1.01 | 0.72 |
| Pregabalin 150 mg | 2.61 | 2.01 | 1.40 | 1.22 | 0.98 | 0.90 | 0.90 | 1.01 | 1.16 |
| Pregabalin 300 mg | 2.17 | 1.50 | 1.27 | 1.09 | 0.81 | 0.72 | 0.59 | 0.40 | 0.08 |
| Pregabalin 50 mg | 2.86 | 2.13 | 1.52 | 1.03 | 0.94 | 1.04 | 1.00 | 0.14 | 0.15 |
m-BPI-sf: a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. Pain interference index score is mean of 7 individual item scores for interference of pain with functional activities (general activity, mood, walking ability, relations with other people, sleep, normal work, and enjoyment of life); range: 0 (does not interfere) to 10 (completely interferes with functional activities). Pain severity index score is mean of 4 individual item scores for pain severity (pain right now, and worst, least, and average pain); range: 0 (no pain) to 10 (worst imaginable pain). (NCT00551135)
Timeframe: 1, 3, and 6 months (mo) post surgery (PS)
| Intervention | scores on a scale (Mean) | |||
|---|---|---|---|---|
| Pain Severity 1 mo PS (n=20, 24, 19, 26) | Pain Severity 3 mo PS (n=3, 5, 5, 3) | Pain Interference 1 mo PS (n=20, 24, 19, 26) | Pain Interference 3 mo PS (n=3, 5, 5, 3) | |
| Placebo | 0.76 | 0.42 | 0.51 | 0.00 |
| Pregabalin 150 mg | 0.81 | 0.75 | 0.71 | 0.20 |
| Pregabalin 300 mg | 1.43 | 1.55 | 1.29 | 1.34 |
| Pregabalin 50 mg | 0.86 | 0.58 | 0.39 | 0.14 |
The PCS is a self-administered questionnaire with 13 items, each scored from 0 (not at all) to 4 (all the time) for extent to which participant catastrophizes postoperative pain. Total score is sum of scores for all questions (range: 0 to 52); Subscale scores: Rumination (sum of scores for 4 items; range: 0 to 16); Magnification (sum of scores for 3 items; range: 0 to 12); and Helplessness (sum of scores for 6 items; range: 0 to 24); higher scores mean a greater extent of pain catastrophizing. (NCT00551135)
Timeframe: 3 hours (h) post surgery (PS) and End of Treatment (EOT [Day 7 PS or Early Termination])
| Intervention | scores on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Total score change: 3 h PS (n=99, 98, 98, 99) | Total score change: EOT (n=97, 96, 98, 96) | Rumination change: 3 h PS (n=99, 98, 98, 99) | Rumination change: EOT (n=97, 96, 98, 96) | Magnification change: 3 h PS (n=99, 98, 99, 99) | Magnification change: EOT (n=97, 96, 99, 96) | Helplessness change: 3 h PS (n=99, 98, 99, 99) | Helplessness change: EOT (n=97, 96, 99, 96) | |
| Placebo | -1.5 | -5.7 | -0.4 | -1.9 | -0.7 | -1.4 | -0.5 | -2.5 |
| Pregabalin 150 mg | -2.8 | -5.8 | -0.7 | -1.8 | -0.9 | -1.7 | -1.3 | -2.3 |
| Pregabalin 300 mg | -3.6 | -6.3 | -1.1 | -2.2 | -1.1 | -1.6 | -1.4 | -2.5 |
| Pregabalin 50 mg | -3.5 | -6.2 | -1.0 | -2.3 | -0.9 | -1.5 | -1.5 | -2.4 |
PCSS and MCSS are component summary scores from the self-administered SF-12v2 acute health quality of life, norm-based survey. PCSS range: 4.95 to 76.13; MCSS range: -0.79 to 79.69; lowest scores mean very much below and highest scores mean very much above the general population average. (NCT00551135)
Timeframe: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| PCSS at baseline (n=101, 99, 100, 100) | PCSS change at EOT (n=99, 99, 99, 98) | MCSS at baseline (n=101, 99, 100, 100) | MCSS change at EOT (n=99, 99, 99, 98) | |
| Placebo | 44.89 | -8.21 | 56.18 | 1.50 |
| Pregabalin 150 mg | 48.14 | -7.06 | 54.58 | 2.68 |
| Pregabalin 300 mg | 46.44 | -6.92 | 54.81 | 3.27 |
| Pregabalin 50 mg | 46.43 | -6.86 | 54.48 | 2.65 |
EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate a single index value: the Health State Profile Score; range: 0.0 (death) to 1.0 (perfect health), higher scores indicating better health state. (NCT00551135)
Timeframe: Baseline and End of Treatment (EOT [Day 7 post surgery or Early Termination])
| Intervention | scores on scales (Least Squares Mean) | |
|---|---|---|
| Baseline (n=101, 99, 100, 100) | Change at EOT (n=97, 98, 99, 98) | |
| Placebo | 0.66 | -0.04 |
| Pregabalin 150 mg | 0.68 | -0.01 |
| Pregabalin 300 mg | 0.65 | -0.01 |
| Pregabalin 50 mg | 0.66 | -0.01 |
Anxiety VAS is a single-item self-administered continuous measure of anxiety using a 100-millimeter (mm) line on which the subject is asked to place a mark indicating the intensity of current anxiety. The score is the distance in mm from the left-most point on the line to the subject's mark; range: 0 (Not at all anxious) at the left-most point to 100 (Extremely anxious) at the right-most point. Performed prior to blood draws. (NCT00551135)
Timeframe: Baseline; 2 hours (h) before surgery (BS); 1, 2, and 3 h PS; Days 2, 3, 4, 5, 6, 7, 8, and 9 PS
| Intervention | scores on a scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=101, 98, 100, 100) | 2 h BS (n=101, 98, 100, 99) | 1 h PS (n=100, 96, 99, 99) | 2 h PS (n=101, 98, 100, 100) | 3 h PS (n=101, 98, 100, 100) | Day 2 PS (n=101, 98, 100, 100) | Day 3 PS (n=101, 97, 99, 100) | Day 4 PS (n=101, 98, 98, 101) | Day 5 PS (n=101, 98, 97, 99) | Day 6 PS (n=100, 98, 97, 97) | Day 7 PS (n=97, 93, 89, 95) | Day 8 PS (n=61, 64, 53, 58) | Day 9 PS (n=21, 24, 23, 22) | |
| Placebo | 16.4 | 4.2 | -3.2 | -6.1 | -6.4 | -5.8 | -9.3 | -11.4 | -12.7 | -12.8 | -12.4 | -14.7 | -12.8 |
| Pregabalin 150 mg | 19.4 | 3.2 | -3.5 | -7.6 | -8.3 | -10.4 | -12.7 | -15.3 | -15.0 | -15.0 | -15.2 | -15.4 | -16.4 |
| Pregabalin 300 mg | 18.4 | 1.4 | -5.2 | -7.1 | -9.0 | -7.5 | -11.3 | -12.1 | -12.4 | -13.6 | -13.3 | -15.5 | -14.7 |
| Pregabalin 50 mg | 20.2 | 0.2 | -6.4 | -8.4 | -8.7 | -7.9 | -9.1 | -11.1 | -12.3 | -12.5 | -13.0 | -13.6 | -16.6 |
NRS: a self-administered questionnaire to rate pain. AUC for a single item asking participant to rate current pain at rest (preceding pain with movement); range: 0 (no pain) to 10 (worst pain). (NCT00551135)
Timeframe: 1 through 48 hours post surgery (PS)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Pregabalin 50 mg | 133.8 |
| Pregabalin 150 mg | 141.3 |
| Pregabalin 300 mg | 132.3 |
| Placebo | 135.1 |
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row. (NCT00553280)
Timeframe: 53 weeks
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Participants with adverse events | Participants with serious adverse events | Participants with severe adverse events | Participants discontinued due to adverse events | Dose reduced or temporary discontinuation | |
| Pregabalin | 114 | 21 | 7 | 17 | 43 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. (NCT00553280)
Timeframe: From baseline to 52 weeks or study discontinuation (Study Endpoint)
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -1.2 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. (NCT00553280)
Timeframe: From baseline to 52 weeks or study discontinuation (Study Endpoint)
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -0.7 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. (NCT00553280)
Timeframe: From baseline to 52 weeks or study discontinuation (Study Endpoint)
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -3.5 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. (NCT00553280)
Timeframe: From baseline to 52 weeks or study discontinuation (Study Endpoint)
| Intervention | mm (Mean) |
|---|---|
| Pregabalin | -25.4 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. (NCT00553280)
Timeframe: From baseline to 52 weeks or study discontinuation (Study Endpoint)
| Intervention | score on scale (Mean) |
|---|---|
| Pregabalin | -4.7 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep disturbance ranges from 0-100. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -9.03 |
| Pregabalin 300 mg/Day | -15.40 |
| Pregabalin 600 mg/Day | -12.81 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep shortness of breath or headache ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.63 |
| Pregabalin 300 mg/Day | -3.02 |
| Pregabalin 600 mg/Day | -4.47 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for sleep adequacy ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 12.08 |
| Pregabalin 300 mg/Day | 17.69 |
| Pregabalin 600 mg/Day | 21.73 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for somnolence ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -2.96 |
| Pregabalin 300 mg/Day | 0.83 |
| Pregabalin 600 mg/Day | 4.83 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 10.34 |
| Pregabalin 300 mg/Day | 11.84 |
| Pregabalin 600 mg/Day | 12.89 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 2.31 |
| Pregabalin 300 mg/Day | 3.29 |
| Pregabalin 600 mg/Day | 4.40 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.84 |
| Pregabalin 300 mg/Day | 5.33 |
| Pregabalin 600 mg/Day | 7.81 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 2.70 |
| Pregabalin 300 mg/Day | 2.43 |
| Pregabalin 600 mg/Day | 3.86 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 4.13 |
| Pregabalin 300 mg/Day | 5.05 |
| Pregabalin 600 mg/Day | 6.35 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 4.38 |
| Pregabalin 300 mg/Day | 2.28 |
| Pregabalin 600 mg/Day | 3.97 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 3.00 |
| Pregabalin 300 mg/Day | 8.06 |
| Pregabalin 600 mg/Day | 11.16 |
The mean change from baseline in Short-Form 36-Item Health Survey Scores at study endpoint. Short-Form 36-Item Health Survey is scored from 0-100 with higher scores reflecting better patient status. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 5.28 |
| Pregabalin 300 mg/Day | 4.20 |
| Pregabalin 600 mg/Day | 12.87 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Affective score ranges from 0-12. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.83 |
| Pregabalin 300 mg/Day | -1.43 |
| Pregabalin 600 mg/Day | -1.39 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Present pain intensity score ranges from 0-5. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.59 |
| Pregabalin 300 mg/Day | -0.80 |
| Pregabalin 600 mg/Day | -0.96 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Sensory score ranges from 0-33. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -2.82 |
| Pregabalin 300 mg/Day | -4.60 |
| Pregabalin 600 mg/Day | -4.95 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for snoring ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -6.00 |
| Pregabalin 300 mg/Day | -5.96 |
| Pregabalin 600 mg/Day | -1.56 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1.~Change from baseline: Score at Week 1 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 1
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.39 |
| Pregabalin 300 mg/Day | -0.82 |
| Pregabalin 600 mg/Day | -1.14 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11.~Change from baseline: Score at Week 11 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 11
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.32 |
| Pregabalin 300 mg/Day | -1.95 |
| Pregabalin 600 mg/Day | -2.09 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12.~Change from baseline: Score at Week 12 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 12
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.36 |
| Pregabalin 300 mg/Day | -2.01 |
| Pregabalin 600 mg/Day | -2.13 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13.~Change from baseline: Score at Week 13 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 13
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.38 |
| Pregabalin 300 mg/Day | -2.04 |
| Pregabalin 600 mg/Day | -2.12 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10.~Change from baseline: Score at Week 10 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 10
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.23 |
| Pregabalin 300 mg/Day | -1.93 |
| Pregabalin 600 mg/Day | -2.10 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2.~Change from baseline: Score at Week 2 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 2
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.57 |
| Pregabalin 300 mg/Day | -1.17 |
| Pregabalin 600 mg/Day | -1.80 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3.~Change from baseline: Score at Week 3 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 3
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.80 |
| Pregabalin 300 mg/Day | -1.40 |
| Pregabalin 600 mg/Day | -1.93 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4.~Change from baseline: Score at Week 4 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 4
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.89 |
| Pregabalin 300 mg/Day | -1.53 |
| Pregabalin 600 mg/Day | -2.00 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5.~Change from baseline: Score at Week 5 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 5
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.91 |
| Pregabalin 300 mg/Day | -1.57 |
| Pregabalin 600 mg/Day | -2.07 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6.~Change from baseline: Score at Week 6 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 6
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.94 |
| Pregabalin 300 mg/Day | -1.72 |
| Pregabalin 600 mg/Day | -2.06 |
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.20 |
| Pregabalin 300 mg/Day | -1.82 |
| Pregabalin 600 mg/Day | -1.94 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8.~Change from baseline: Score at Week 8 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 8
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.18 |
| Pregabalin 300 mg/Day | -1.85 |
| Pregabalin 600 mg/Day | -2.12 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7.~Change from baseline: Score at Week 7 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 7
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.04 |
| Pregabalin 300 mg/Day | -1.76 |
| Pregabalin 600 mg/Day | -2.13 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Total score ranges from 0-45. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -3.68 |
| Pregabalin 300 mg/Day | -6.03 |
| Pregabalin 600 mg/Day | -6.36 |
The mean change from baseline in Short-Form McGill Pain Questionnaire Scores at study endpoint. Visual Analogue Scale Score ranges from 0-100 mm. Higher scores indicate more severe pain. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | mm (Least Squares Mean) |
|---|---|
| Placebo | -16.92 |
| Pregabalin 300 mg/Day | -24.19 |
| Pregabalin 600 mg/Day | -24.41 |
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr). (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.27 |
| Expected Exposure Pregabalin 300 mg/Day | -1.93 |
| Expected Exposure Pregabalin 600 mg/Day | -1.90 |
Clinical Global Impression of Change is a clinician-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation
| Intervention | score on scale (Mean) |
|---|---|
| Placebo | 3.3 |
| Pregabalin 300 mg/Day | 2.9 |
| Pregabalin 600 mg/Day | 2.7 |
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | participants (Number) |
|---|---|
| Placebo | 29 |
| Pregabalin 300 mg/Day | 39 |
| Pregabalin 600 mg/Day | 16 |
The Patient Global Impression of Change is a patient-rated instrument that measures change in patient's overall status on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00553475)
Timeframe: Week 13 or up to discontinuation
| Intervention | score on scale (Mean) |
|---|---|
| Placebo | 3.4 |
| Pregabalin 300 mg/Day | 3.2 |
| Pregabalin 600 mg/Day | 2.8 |
"The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9.~Change from baseline: Score at Week 9 minus score at baseline" (NCT00553475)
Timeframe: From baseline to Week 9
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -1.20 |
| Pregabalin 300 mg/Day | -1.93 |
| Pregabalin 600 mg/Day | -2.06 |
The mean change from baseline in the weekly mean sleep interference score at study endpoint. Score range is from 0-10. Higher scores indicate more severe interference with sleep. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -0.74 |
| Pregabalin 300 mg/Day | -1.59 |
| Pregabalin 600 mg/Day | -1.36 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for overall sleep problems index ranges from 0-100. Higher scores indicate more of the attribute. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | -7.91 |
| Pregabalin 300 mg/Day | -11.45 |
| Pregabalin 600 mg/Day | -9.73 |
The mean change from baseline in Medical Outcomes Study - Sleep Scale Scores at study endpoint. Score for quantity of sleep ranges from 0-24. Higher scores indicate more of the attribute named in the subscale. (NCT00553475)
Timeframe: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
| Intervention | score on scale (Least Squares Mean) |
|---|---|
| Placebo | 0.37 |
| Pregabalin 300 mg/Day | 0.69 |
| Pregabalin 600 mg/Day | 0.54 |
Epidural medication consumption was recorded for each 4-h interval from the completion of surgery to the time that the epidural was discontinued (same as the time to achieve hospital discharge criteria). Because the discontinuation time varied from patient to patient (as they achieved physical therapy criteria), the average hourly consumption (total analgesic used divided by the total infusion time) was used as the measure of epidural drug use. (NCT00558753)
Timeframe: 36 h
| Intervention | mL/h (Mean) |
|---|---|
| 1 Placebo | 6.40 |
| 2 Pregabalin | 5.77 |
(NCT00558753)
Timeframe: 1-30 days
| Intervention | Degrees (Least Squares Mean) | |||
|---|---|---|---|---|
| Day 1 | Day 2 | Day 3 | Day 30 | |
| 1 Placebo | 75.6 | 76.7 | 80.4 | 103.0 |
| 2 Pregabalin | 77.8 | 81.0 | 84.2 | 107.2 |
Patients will be evaluated in blinded fashion for lower extremity Complex Regional Pain Syndrome(CRPS) at pre-op, 1, 3, and 6 months postsurgery based initially on telephone interviews. An S-LANSS score of 12 or more was an indication of chronic neuropathic pain. Patients with an Self-report version of the Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS) score of 12 or more at 6 mo came to the physician's office for a standardized physical examination, which included the S-LANSS examination items (allodynia and hyperalgesia) directly assessed by the physician, plus a pinprick evaluation. (NCT00558753)
Timeframe: 3 and 6 months post-surgery
| Intervention | participants (Number) | |
|---|---|---|
| Neuropathic pain at 3 Month Follow up | Neuropathic pain at 6 Month Follow up | |
| 1 Placebo | 10 | 6 |
| 2 Pregabalin | 0 | 0 |
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine) (NCT00570310)
Timeframe: Baseline and 6 Weeks
| Intervention | Units on a Scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.14 |
| Placebo | 1.57 |
Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization) (NCT00570310)
Timeframe: 6 Weeks
| Intervention | Days (Least Squares Mean) |
|---|---|
| Pregabalin | 15.54 |
| Placebo | 7.87 |
The LifeShirt System, developed by VivoMetrics, is a lightweight vest with embedded sensors that continuously collect information on a range of cardiopulmonary parameters. It was used to collect and store the respiratory rate, posture, activity level, QRS complexes, and R-R intervals via a 3-axis accelerometer and a 3-lead, single channel electrocardiogram. (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | Beats Per Minute (Mean) |
|---|---|
| Placebo | -2.94 |
| Pregabalin | -3.49 |
Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | Intervals more than 50 ms (Mean) |
|---|---|
| Placebo | 15.97 |
| Pregabalin | -2.25 |
The Beck Depression Inventory Scale measures symptoms of depression, score range, 0-63 (higher score=greater severity of depressive symptoms) (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 1.21 |
| Pregabalin | -1.20 |
Heart Rate Variability parameters generated by the frequency domain analysis included: Low Frequency / High Frequency (LF/HF), as well as normalized LF (normalized LF=LF/[total power-VLF]) and normalized HF (normalized HF=HF/[total power-VLF]). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | Ratio (Mean) | ||
|---|---|---|---|
| Low frequency/High frequency | Normalized low frequency | Normalized high frequency | |
| Placebo | 0.37 | 0.0066 | -0.038 |
| Pregabalin | -1.30 | -0.049 | 0.039 |
Heart rate variability parameters generated by the frequency domain analysis included: total power (area under the curve) over all frequencies, very low frequency (VLF, 0-0.04 Hz),low frequency (LF, 0.04-0.15 Hz), and high frequency (HF,0.15-0.4 Hz). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | Hertz (Hz) (Mean) | ||
|---|---|---|---|
| Total Power | Low Frequency | High Frequency | |
| Placebo | 45.29 | 32.41 | -12.19 |
| Pregabalin | -140.99 | -67.06 | -41.37 |
(NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | mm Hg (Mean) | |
|---|---|---|
| Systolic Blood Pressure (mm Hg) | Diastolic Blood Pressure (mm Hg) | |
| Placebo | -7.63 | -4.41 |
| Pregabalin | -8.98 | -4.93 |
Heart rate variability parameters yielded by time domain analysis included the mean of all R-R intervals (ANN), standard deviation of all R-R intervals (SDNN), root mean square of successive differences (RMSSD), and standard deviation of the averages of R-R intervals for all 5-minute segments within the block (SDANN). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | milliseconds (Mean) | |||
|---|---|---|---|---|
| ANN | SDNN | SDANN | RMSSD | |
| Placebo | 21.47 | 3.42 | 0.68 | 0.58 |
| Pregabalin | 65.44 | -0.55 | 1.38 | -0.51 |
The Sheehan Disability Scale was used to evaluate functional impairment in work/school, social and family life, score range, 0-10; the 3 items can be summed into a single dimensional measure of global functional impairment that ranges from 0(unimpaired) to 30 (highly impaired). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Disability scale - Global functioning score | Disability scale - Work/school disability | Disability scale - Social disability | Disability scale - Family disability | |
| Placebo | -1.67 | -0.42 | -0.58 | -0.67 |
| Pregabalin | -7.73 | -2.93 | -2.13 | -2.67 |
Anxiety symptoms were measured using the Spielberger State-Trait Anxiety Inventory Scale (STAI) for symptoms of anxiety. State anxiety: score range, 20-80 (higher score=greater levels of state anxiety). Trait anxiety: score range, 20-80 (higher score=greater levels of trait anxiety). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | units on a scale (Mean) | |
|---|---|---|
| State Anxiety | Trait Anxiety | |
| Placebo | 0.57 | 1 |
| Pregabalin | 1.2 | -3.67 |
Pain severity was evaluated using the Visual Analog Scale, the Modified Brief Pain Inventory-Short Form, and the Neuropathy Pain Scale. The Visual Analog Scale was scored within a range of 0-100 with 0=no pain and 100=the worst imaginable pain. The Brief Pain Inventory is made up of two parts: total pain and pain interference. The total pain score is the sum of most, least, average, and now pain scored within a range of 0-10 with 0=no pain and 10=pain as bad as you can imagine. The pain interference score is the sum of affective and activity interference - how pain interfered with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. It was scored within a range of 0-10 with 0=pain does not interfere and 10=pain completely interferes. The Neuropathy Pain Scale total is the sum of 10 items -cold, sharp, deep, dull, hot, intense, itchy, sensitive, surface, and unpleasant pain scored within a range of 0-10 with 0=no pain and 10=most pain. (NCT00573261)
Timeframe: baseline and end of 4 week intervention
| Intervention | units on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visual analog pain rating | Brief pain inventory - Total Pain | Brief pain inventory - Most Pain | Brief pain inventory - Least Pain | Brief pain inventory - Average Pain | Brief pain inventory - Now pain | Pain interference | Affective interference | Activity Interference | Neuropathy pain scale (total) | Cold pain | Sharp pain | Deep pain | Dull pain | Hot pain | Intense pain | Itchy pain | Sensitive pain | Surface pain | Unpleasant pain | |
| Placebo | -21.29 | -1.36 | -1.07 | -0.071 | -0.64 | 0.43 | -1.43 | -0.071 | -1.36 | -10.31 | -1.23 | -0.92 | -0.23 | 0 | -1.77 | -1.38 | 0 | -2.31 | -1.46 | -1.00 |
| Pregabalin | -43.27 | -9.13 | -3.33 | -1.20 | -2.87 | -1.73 | -13.93 | -5.27 | -8.67 | -27.33 | -2.13 | -2.53 | -3.00 | -2.07 | -2.53 | -3.13 | -4.07 | -1.60 | -3.20 | -3.07 |
Heart rate variability parameters yielded by time domain analysis included the number of N-N intervals that differ by more than 50 milliseconds from adjacent intervals divided by the total number of all N-N intervals (pNN50). (NCT00573261)
Timeframe: baseline and at end of a 4-week intervention
| Intervention | Ratio (Mean) |
|---|---|
| Placebo | 0.011 |
| Pregabalin | 0.0015 |
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. (NCT00596466)
Timeframe: Baseline up to Week 28
| Intervention | Participants (Number) | |
|---|---|---|
| Non-serious AEs | Serious AEs (SAEs) | |
| Pregabalin | 30 | 3 |
Pre-defined criteria were established for each laboratory test (hematology, blood chemistry and urinalysis) to define the values that would be identified as of potential clinical importance. (NCT00596466)
Timeframe: Baseline up to Week 28
| Intervention | Participants (Number) |
|---|---|
| Pregabalin | 17 |
Criteria for clinical chemistry abnormalities included total bilirubin: greater than (>) 1.5*upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase: >3.0*ULN; total protein, albumin: <0.8*LLN or >1.2*ULN; blood urea nitrogen, creatinine: >1.3*ULN; uric acid: >1.2*ULN; sodium: <0.95*LLN or >1.05*ULN; potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN. Clinical significance was judged by investigator. (NCT00599638)
Timeframe: Baseline up to Week 7
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin + PF-00489791 | 0 |
| Pregabalin | 0 |
| Placebo | 0 |
Criteria for hematology abnormalities included Hemoglobin: <0.8*lower limit of normal (LLN) and hematocrit: <0.8*LLN. Clinical significance was judged by investigator. (NCT00599638)
Timeframe: Baseline up to Week 7
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin + PF-00489791 | 0 |
| Pregabalin | 0 |
| Placebo | 0 |
Urinalysis abnormalities criteria included: urine specific gravity: <1.003 to >1.030; urine pH: <4.5 to >8; urine glucose, urine ketones, urine proteins, urine blood/hemoglobin: >=1. Clinical significance was judged by investigator. (NCT00599638)
Timeframe: Baseline up to Week 7
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin + PF-00489791 | 0 |
| Pregabalin | 0 |
| Placebo | 0 |
Vital signs abnormalities included sitting, standing: systolic, diastolic blood pressure and heart rate. Clinical significance was judged by investigator. (NCT00599638)
Timeframe: Baseline up to Week 7
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin + PF-00489791 | 0 |
| Pregabalin | 2 |
| Placebo | 1 |
Participants marked intensity of the pain on a scale, ranging from 0 millimeters (mm) = no pain to 100 mm = worst possible pain, where higher scores indicate more pain. (NCT00599638)
Timeframe: Baseline, Week 4
| Intervention | mm (Mean) | |
|---|---|---|
| Baseline | Week 4 | |
| Placebo | 67.92 | 55.92 |
| Pregabalin | 65.92 | 63.79 |
| Pregabalin + PF-00489791 | 66.48 | 60.88 |
The PGIC is a participant-rated instrument that measures change in the participants' overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse), lower scores indicated more improvement. PGIC was evaluated using 3 categories: improvement (scores 1-3), no change (score 4), and worsening (scores 5-7). In this outcome measure percentage of participants with categories: improved, no change and worsening, based on PGIC score were reported. Cumulative data at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week6]) was calculated and reported. (NCT00599638)
Timeframe: End of treatment period (included both Week 2 and Week 6)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Improved | No Change | Worse | |
| Placebo | 39.13 | 43.48 | 17.39 |
| Pregabalin | 77.78 | 18.52 | 3.70 |
| Pregabalin + PF-00489791 | 77.42 | 16.13 | 6.45 |
"Pain was assessed by using a daily pain rating scale that consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain intensity. Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily. The mean pain score was defined as the mean of the last 7 daily pain ratings scale scores while taking study medication, at end of each treatment period: Period 1 (Week 2) and Period 2 (Week 6), respectively. Mean pain score had a score range of 0 (no pain) to 10 (worst possible pain), higher scores indicate more pain. Cumulative data of mean pain scores at end of treatment for both the periods was calculated and reported in terms of adjusted mean and standard error." (NCT00599638)
Timeframe: End of treatment period (included both Week 2 and Week 6)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin + PF-00489791 | 4.32 |
| Pregabalin | 4.22 |
| Placebo | 5.57 |
Participant rated 10-item questionnaire to evaluate different symptoms of neuropathic pain (spontaneous pain like [item 1 to 3]: burning, squeezing, pressure; painful attack like [item 4 to 5]: electric shock, stabbing; pain provoked on [item 6 to 8]: light touching, pressure, contact with something cold; abnormal sensations like [item 9 to 10]: pins and needles, tingling). Each item was rated on an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity of pain). Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. Cumulative data of NPSI scale at end of treatment for both the periods (Period 1 [Week 2] and Period 2 [Week 6]) was calculated and reported in terms of adjusted mean and standard error. (NCT00599638)
Timeframe: End of treatment period (included both Week 2 and Week 6)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin + PF-00489791 | 25.71 |
| Pregabalin | 25.87 |
| Placebo | 35.25 |
Criteria for ECG abnormalities: Maximum QTc (corrected QT) interval, QTcB (Bazett's correction formula) and QTcF (Fridericia's correction formula): 450 to less than (<) 480 milliseconds (msec), 480 to <500 msec and greater than equal to (>=) 500 msec; Maximum QTc interval increase from baseline: >=30 to <60 and >=60 (msec); PR interval: >=300 msec and percent change >=25 or 50 percent; QRS complex: percent change >=25 or 50 percent. Clinical significance was judged by investigator. (NCT00599638)
Timeframe: Baseline up to Week 7
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin + PF-00489791 | 1 |
| Pregabalin | 0 |
| Placebo | 0 |
Time (in hours) to first patient controlled analgesic (PCA) pump use after surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg. (NCT00601458)
Timeframe: First 24 hours following surgery
| Intervention | Hours (Median) |
|---|---|
| Pregabalin 300 mg | 7.3 |
| Naproxen Sodium 550 mg | 9.1 |
| Placebo | 5.8 |
Total dose (amount) of hydromorphone via patient controlled analgesic (PCA) pump required in the 24 hours post-surgery in each of the treatment arms: placebo, pregabalin 300 mg or naproxen 550 mg. (NCT00601458)
Timeframe: First 24 hours following surgery
| Intervention | milligrams (Geometric Mean) |
|---|---|
| Pregabalin 300 mg | 2.94 |
| Naproxen Sodium 550 mg | 2.07 |
| Placebo | 5.96 |
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change). (NCT00610155)
Timeframe: Day 8, 22, 36
| Intervention | percent signal change (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACC | AIC_L | AIC_R | MIC_L | MIC_R | PIC_L | PIC_R | Amyg_L | Amyg_R | S1 | S2 | SensTHAL | MRF | NucCun | PAG | |
| Placebo | 0.2 | 20.2 | 20.2 | 9.0 | 0.7 | 0.8 | 6.3 | -3.4 | -3.8 | 14.6 | 13.5 | 6.7 | -1.7 | -1.8 | -5.0 |
| Pregabalin | -22.3 | -13.5 | -10.6 | -7.6 | -9.2 | -14.9 | -17.2 | -14.3 | -10.3 | -31.6 | -0.4 | 3.9 | 1.5 | 1.0 | 1.6 |
| Tramadol | -3.7 | 18.2 | 10.3 | 9.7 | 2.8 | -8.1 | 2.4 | 1.5 | 2.0 | -4.5 | 9.6 | -2.8 | -6.6 | -8.2 | -12.0 |
BOLD brain activation signals in pre-defined ROI. ROI were ACC; AIC_L; AIC_R; MIC_L; MIC_R; PIC_L; PIC_R; Amyg_L; Amyg_R; S1; S2; SensTHAL; MRF; NucCun; PAG. Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis, signal change is unit less measure but is approximated to percent signal change here by grand scaling (dividing effects by 10000 to get percent signal change). (NCT00610155)
Timeframe: Day 8, 22, 36
| Intervention | percent signal change (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACC | AIC_L | AIC_R | MIC_L | MIC_R | PIC_L | PIC_R | Amyg_L | Amyg_R | S1 | S2 | SensTHAL | MRF | NucCun | PAG | |
| Placebo | 83.3 | 118.7 | 104.0 | 100.4 | 92.0 | 34.2 | 91.8 | 36.4 | 67.0 | 27.7 | 74.5 | 10.4 | 37.7 | 40.5 | 44.6 |
| Pregabalin | 102.2 | 92.1 | 121.7 | 93.4 | 106.6 | 31.2 | 75.3 | 29.7 | 77.5 | -49.0 | 73.6 | 19.4 | 34.3 | 38.7 | 63.3 |
| Tramadol | 92.5 | 103.4 | 104.6 | 105.2 | 71.1 | 44.6 | 95.5 | 24.9 | 57.2 | 37.7 | 94.6 | 0.8 | 25.5 | 27.7 | 53.6 |
"Participants answered: Please rate your pain from 0-10 that best describes the intensity of pain right now. PPIS assessed on 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain)." (NCT00610155)
Timeframe: Day 8, 22, 36
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 5.54 |
| Tramadol | 4.13 |
| Placebo | 5.83 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning using 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). The daily pain scores for an average of the last 7 days and an average of last 3 days were calculated. (NCT00610155)
Timeframe: Day -35 through Day 36
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Last 7 days | Last 3 days | |
| Placebo | 6.40 | 6.33 |
| Pregabalin | 5.57 | 5.46 |
| Tramadol | 5.28 | 5.10 |
BOLD brain activation signals in pre-defined region of interest(ROI):anterior cingulate cortex(ACC);left,right anterior cortex([AIC_L ],[AIC_R]);left,right mid-insular cortex([MIC_L],[MIC_R]);left,right posterior insular cortex([PIC_L],[PIC_R]);left,right amygdala([Amyg_L],[Amyg_R]);primary,secondary somatosensory cortex([S1],[S2]);sensory part of thalamus(SensTHAL);midbrain reticular formation(MRF);nucleus cuneiformis(NucCun);periaqueductal gray(PAG). Prior to ROI analysis, a prelimanary anlysis was performed, wherein it was concluded that ROI analysis was to be carried out for DMAa, DMAc amd TH only. In voxel BOLD analysis,signal change is unit less measure but approximated to percent signal change by grand scaling(effects divided by 10000 to get percent signal change). (NCT00610155)
Timeframe: Day 8, 22, 36
| Intervention | percent signal change (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ACC | AIC_L | AIC_R | MIC_L | MIC_R | PIC_L | PIC_R | Amyg_L | Amyg_R | S1 | S2 | SensTHAL | MRF | NucCun | PAG | |
| Placebo | 7.4 | 30.8 | 17.1 | 30.0 | 18.3 | -0.3 | 6.5 | 8.5 | 21.7 | -2.9 | 10.8 | 9.6 | 11.7 | 12.9 | 2.5 |
| Pregabalin | -17.3 | 8.1 | 11.1 | 3.8 | 8.6 | -6.8 | -13.6 | -5.7 | -1.4 | -28.5 | 2.5 | 8.0 | 7.0 | 1.1 | -3.8 |
| Tramadol | 18.6 | 23.3 | 21.9 | 23.4 | 13.4 | -5.8 | 2.9 | 5.5 | 20.3 | -4.1 | -3.2 | 16.5 | 6.4 | -0.9 | -15.3 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | -12.0 |
| Pregabalin Low Dose | -5.9 |
| Lorazepam | -9.7 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=109,30,94,29,99,30) | Discontinuation Week 2 (n=106,29,84,26,93,30) | |
| Lorazepam, Lorazepam | 8.0 | 7.1 |
| Lorazepam, Placebo | 4.6 | 4.6 |
| Pregabalin High Dose, Placebo | 4.9 | 4.1 |
| Pregabalin High Dose, Pregabalin High Dose | 6.8 | 7.9 |
| Pregabalin Low Dose, Placebo | 7.4 | 7.1 |
| Pregabalin Low Dose, Pregabalin Low Dose | 5.1 | 5.7 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=58,52,48) | Discontinuation Week 2 (n=54,49,44) | |
| Lorazepam | 8.8 | 8.3 |
| Pregabalin High Dose | 9.6 | 9.0 |
| Pregabalin Low Dose | 9.4 | 9.9 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | -2.3 |
| Pregabalin Low Dose | -2.1 |
| Lorazepam | -2.1 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected (NCT00624780)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | -2.4 |
| Pregabalin High Dose, Placebo | -2.3 |
| Pregabalin Low Dose, Pregabalin Low Dose | -2.4 |
| Pregabalin Low Dose, Placebo | -2.0 |
| Lorazepam, Lorazepam | -2.5 |
| Lorazepam, Placebo | -2.2 |
Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | participants (Number) |
|---|---|
| Pregabalin High Dose | 3 |
| Pregabalin Low Dose | 1 |
| Lorazepam | 2 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | -15.6 |
| Pregabalin Low Dose | -14.9 |
| Lorazepam | -16.0 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | -16.6 |
| Pregabalin High Dose, Placebo | -19.1 |
| Pregabalin Low Dose, Pregabalin Low Dose | -18.3 |
| Pregabalin Low Dose, Placebo | -16.0 |
| Lorazepam, Lorazepam | -16.7 |
| Lorazepam, Placebo | -18.7 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | -17.4 |
| Pregabalin Low Dose | -16.0 |
| Lorazepam | -16.7 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | -18.7 |
| Pregabalin High Dose, Placebo | -17.5 |
| Pregabalin Low Dose, Pregabalin Low Dose | -18.2 |
| Pregabalin Low Dose, Placebo | -14.9 |
| Lorazepam, Lorazepam | -19.0 |
| Lorazepam, Placebo | -17.5 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | -2.0 |
| Pregabalin Low Dose | -2.7 |
| Lorazepam | -3.2 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | 2.1 |
| Pregabalin Low Dose | 2.0 |
| Lorazepam | 1.6 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 2 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | 2.8 |
| Pregabalin High Dose, Placebo | -1.0 |
| Pregabalin Low Dose, Pregabalin Low Dose | 1.7 |
| Pregabalin Low Dose, Placebo | 1.8 |
| Lorazepam, Lorazepam | 2.2 |
| Lorazepam, Placebo | -0.1 |
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00624780)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose | 1.9 |
| Pregabalin Low Dose | 1.9 |
| Lorazepam | 1.9 |
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. (NCT00624780)
Timeframe: Week 24
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | 1.7 |
| Pregabalin High Dose, Placebo | 1.9 |
| Pregabalin Low Dose, Pregabalin Low Dose | 1.6 |
| Pregabalin Low Dose, Placebo | 2.3 |
| Lorazepam, Lorazepam | 1.5 |
| Lorazepam, Placebo | 2.0 |
Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | participants (Number) |
|---|---|
| Pregabalin High Dose | 1 |
| Pregabalin Low Dose | 5 |
| Lorazepam | 1 |
Rebound anxiety was defined as a rapid return of the participant's original symptoms following drug discontinuation, that were worse compared to baseline. This was characterized by a HAM-A score at the Discontinuation Week 1 or Week 2 greater than or equal to the baseline value. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | participants (Number) |
|---|---|
| Pregabalin High Dose, Pregabalin High Dose | 4 |
| Pregabalin High Dose, Placebo | 0 |
| Pregabalin Low Dose, Pregabalin Low Dose | 0 |
| Pregabalin Low Dose, Placebo | 1 |
| Lorazepam, Lorazepam | 6 |
| Lorazepam, Placebo | 0 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline (n=15,19,21) | Change at Discontinuation Week 1 (n=15,19,18) | |
| Lorazepam | 24.4 | -9.9 |
| Pregabalin High Dose | 25.8 | -7.7 |
| Pregabalin Low Dose | 24.9 | -5.9 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Discontinuation Week 1 | |
| Lorazepam | 24.6 | -15.8 |
| Pregabalin High Dose | 25.0 | -15.3 |
| Pregabalin Low Dose | 24.7 | -15.3 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Discontinuation Week 1 | |
| Lorazepam, Lorazepam | 24.6 | -16.2 |
| Lorazepam, Placebo | 24.9 | -19.1 |
| Pregabalin High Dose, Placebo | 24.2 | -18.7 |
| Pregabalin High Dose, Pregabalin High Dose | 25.5 | -17.6 |
| Pregabalin Low Dose, Placebo | 24.9 | -16.5 |
| Pregabalin Low Dose, Pregabalin Low Dose | 24.7 | -18.4 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n=14,19,21) | Change at Discontinuation Week 1 (n=14,19,18) | Change at Discontinuation Week 2 (n=13,15,16) | |
| Lorazepam | 16.4 | -5.9 | -5.4 |
| Pregabalin High Dose | 13.6 | -3.4 | -4.7 |
| Pregabalin Low Dose | 17.6 | -3.3 | -2.7 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n=57,51,52) | Change at Discontinuation Week 1 (n=57,51,49) | Change at Discontinuation Week 2 (n=53,48,44) | |
| Lorazepam | 14.8 | -7.6 | -8.0 |
| Pregabalin High Dose | 17.4 | -8.5 | -8.3 |
| Pregabalin Low Dose | 17.1 | -9.3 | -8.7 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n=109,30,94,29,99,30) | Change at DC Week 1 (n=109,30,94,29,99,30) | Change at DC Week 2 (n=106,29,84,26,92,30) | |
| Lorazepam, Lorazepam | 16.8 | -8.7 | -9.6 |
| Lorazepam, Placebo | 14.9 | -10.4 | -10.3 |
| Pregabalin High Dose, Placebo | 17.8 | -12.9 | -13.8 |
| Pregabalin High Dose, Pregabalin High Dose | 17.8 | -11.0 | -9.8 |
| Pregabalin Low Dose, Placebo | 17.4 | -9.9 | -10.2 |
| Pregabalin Low Dose, Pregabalin Low Dose | 16.1 | -11.0 | -10.8 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Last visit on treatment (n=15,18,20) | Change at Discontinuation Week 1 (n=15,18,18) | Change at Discontinuation Week 2 (n=14,15,16) | |
| Lorazepam | 16.1 | -2.4 | -2.2 |
| Pregabalin High Dose | 16.1 | 2.0 | -2.3 |
| Pregabalin Low Dose | 21.6 | -2.3 | -3.5 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Last visit on treatment (n=58,52,50) | Change at Discontinuation Week 1 (n=58,52,48) | Change at Discontinuation Week 2 (n=54,49,44) | |
| Lorazepam | 6.7 | 2.3 | 1.5 |
| Pregabalin High Dose | 8.0 | 1.7 | 1.5 |
| Pregabalin Low Dose | 8.5 | 0.9 | 1.5 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Last visit on treatment (n=109,30,93,29,100,30) | Change at DC Week 1 (n=109,30,93,28,99,30) | Change at DC Week 2 (n=107,29,84,26,94,30) | |
| Lorazepam, Lorazepam | 5.6 | 3.0 | 2.2 |
| Lorazepam, Placebo | 5.5 | 0.3 | 0.6 |
| Pregabalin High Dose, Placebo | 5.5 | -0.0 | -0.8 |
| Pregabalin High Dose, Pregabalin High Dose | 6.3 | 1.6 | 2.5 |
| Pregabalin Low Dose, Placebo | 8.3 | 0.6 | 1.5 |
| Pregabalin Low Dose, Pregabalin Low Dose | 5.6 | 0.7 | 1.2 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Last visit on treatment (n=15,18,20) | Change at Discontinuation Week 1 (n=15,18,18) | |
| Lorazepam | 13.1 | -4.2 |
| Pregabalin High Dose | 10.1 | 0.1 |
| Pregabalin Low Dose | 16.8 | -2.8 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Last visit on treatment | Change at Discontinuation Week 1 | |
| Lorazepam | 5.0 | 2.3 |
| Pregabalin High Dose | 7.2 | 1.9 |
| Pregabalin Low Dose | 6.5 | 1.4 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Last visit on treatment, Week 1 post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Last visit on treatment | Change at Discontinuation Week 1 | |
| Lorazepam, Lorazepam | 5.3 | 3.0 |
| Lorazepam, Placebo | 4.7 | -0.1 |
| Pregabalin High Dose, Placebo | 4.9 | 0.0 |
| Pregabalin High Dose, Pregabalin High Dose | 5.2 | 1.7 |
| Pregabalin Low Dose, Placebo | 6.5 | 1.0 |
| Pregabalin Low Dose, Pregabalin Low Dose | 3.9 | 1.1 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00624780)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Lorazepam | 4.4 | 2.3 |
| Pregabalin High Dose | 4.6 | 2.3 |
| Pregabalin Low Dose | 4.5 | 2.5 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected (NCT00624780)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Week 24 | |
| Lorazepam, Lorazepam | 4.4 | 1.9 |
| Lorazepam, Placebo | 4.5 | 2.4 |
| Pregabalin High Dose, Placebo | 4.5 | 2.2 |
| Pregabalin High Dose, Pregabalin High Dose | 4.7 | 2.3 |
| Pregabalin Low Dose, Placebo | 4.5 | 2.5 |
| Pregabalin Low Dose, Pregabalin Low Dose | 4.5 | 2.1 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=15,19,18) | Discontinuation Week 2 (n=14,15,16) | |
| Lorazepam | 14.1 | 14.6 |
| Pregabalin High Dose | 18.1 | 13.9 |
| Pregabalin Low Dose | 19.0 | 18.6 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation [DC] occurred after Week 15 to Week 24)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=109,30,94,28,99,30) | Discontinuation Week 2 (n=107,29,84,26,94,30) | |
| Lorazepam, Lorazepam | 8.4 | 7.9 |
| Lorazepam, Placebo | 7.07 | 6.1 |
| Pregabalin High Dose, Placebo | 5.5 | 5.0 |
| Pregabalin High Dose, Pregabalin High Dose | 7.9 | 8.9 |
| Pregabalin Low Dose, Placebo | 8.4 | 9.2 |
| Pregabalin Low Dose, Pregabalin Low Dose | 6.3 | 6.5 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Week 12 | |
| Lorazepam | 24.5 | 7.9 |
| Pregabalin High Dose | 25.3 | 8.0 |
| Pregabalin Low Dose | 24.9 | 8.9 |
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); total possible range 0 to 56. Lower score indicates less affected. (NCT00624780)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Week 24 | |
| Lorazepam, Lorazepam | 24.7 | 5.7 |
| Lorazepam, Placebo | 24.1 | 6.6 |
| Pregabalin High Dose, Placebo | 24.6 | 7.1 |
| Pregabalin High Dose, Pregabalin High Dose | 25.6 | 7.0 |
| Pregabalin Low Dose, Placebo | 25.1 | 10.2 |
| Pregabalin Low Dose, Pregabalin Low Dose | 24.8 | 6.5 |
DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | participants (Number) | |
|---|---|---|
| Newly developed DESS | Worsened DESS | |
| Lorazepam | 3 | 0 |
| Pregabalin High Dose | 6 | 0 |
| Pregabalin Low Dose | 0 | 0 |
DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | participants (Number) | |
|---|---|---|
| Newly developed DESS | Worsened DESS | |
| Lorazepam | 36 | 1 |
| Pregabalin High Dose | 40 | 1 |
| Pregabalin Low Dose | 38 | 2 |
DESS adverse events, a subset of Treatment Emergent Signs and Symptoms (TESS), were defined as those spontaneously reported adverse events that developed or existed prior to but worsened during Discontinuation Week 1 and 2. (NCT00624780)
Timeframe: 2 weeks post-treatment discontinuation (discontinuation occurred after Week 15 to Week 24)
| Intervention | participants (Number) | |
|---|---|---|
| Newly developed DESS | Worsened DESS | |
| Lorazepam, Lorazepam | 50 | 5 |
| Lorazepam, Placebo | 7 | 0 |
| Pregabalin High Dose, Placebo | 5 | 0 |
| Pregabalin High Dose, Pregabalin High Dose | 78 | 2 |
| Pregabalin Low Dose, Placebo | 17 | 1 |
| Pregabalin Low Dose, Pregabalin Low Dose | 35 | 2 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and Week 12, for period 1, and between Week 13 and Week 24, for period 2, that were absent before treatment or that worsened relative to pretreatment state. (NCT00624780)
Timeframe: Baseline up to Week 12 (period 1), Week 13 up to Week 24 (period 2)
| Intervention | participants (Number) | |
|---|---|---|
| Period 1 (n=154,52,154,52,153,50) | Period 2 (n=121,39,112,38,114,39) | |
| Lorazepam, Lorazepam | 95 | 52 |
| Lorazepam, Placebo | 35 | 20 |
| Pregabalin High Dose, Placebo | 37 | 26 |
| Pregabalin High Dose, Pregabalin High Dose | 103 | 62 |
| Pregabalin Low Dose, Placebo | 40 | 18 |
| Pregabalin Low Dose, Pregabalin Low Dose | 100 | 62 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred prior to Week 9)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=15,19,18) | Discontinuation Week 2 (n=14,15,16) | |
| Lorazepam | 9.1 | 10.6 |
| Pregabalin High Dose | 10.2 | 8.2 |
| Pregabalin Low Dose | 14.3 | 14.1 |
PWC: 20 item physician rated interview measuring anxiolytic drug withdrawal-related signs and symptoms (gastrointestinal, mood, sleep, motor, somatic, perception and cognition); range 0 (not present) to 3 (severe); total score range: 0 to 60; higher score = more affected. (NCT00624780)
Timeframe: Week 1, 2 post-treatment discontinuation (discontinuation occurred from Week 9 to Week 15)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Discontinuation Week 1 (n=58,52,49) | Discontinuation Week 2 (n=54,49,44) | |
| Lorazepam | 7.3 | 6.9 |
| Pregabalin High Dose | 9.1 | 8.9 |
| Pregabalin Low Dose | 8.0 | 8.3 |
Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis. (NCT00631696)
Timeframe: Baseline, Week 12 (last observation in the Week 12 window)
| Intervention | percent motility (Mean) | |
|---|---|---|
| Baseline | Change to Week 12 | |
| Placebo | 61.38 | -2.71 |
| Pregabalin | 61.95 | -3.94 |
FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis. (NCT00631696)
Timeframe: Baseline, Week 12 (last observation in the Week 12 window)
| Intervention | IU/L (Mean) | |
|---|---|---|
| Baseline | Change to Week 12 | |
| Placebo | 3.68 | 0.08 |
| Pregabalin | 3.17 | -0.05 |
Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution. (NCT00631696)
Timeframe: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 9.2 |
| Placebo | 3.2 |
FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. (NCT00631696)
Timeframe: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
| Intervention | IU/L (Mean) | |
|---|---|---|
| Baseline | Change to EOS | |
| Placebo | 3.68 | 0.22 |
| Pregabalin | 3.17 | 0.14 |
FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis. (NCT00631696)
Timeframe: Baseline, Week 26 (last observation in the Week 26 window)
| Intervention | IU/L (Mean) | |
|---|---|---|
| Baseline | Change to Week 26 | |
| Placebo | 3.69 | 0.21 |
| Pregabalin | 3.20 | 0.16 |
Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. (NCT00631696)
Timeframe: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
| Intervention | percent motility (Mean) | |
|---|---|---|
| Baseline | Change to EOS | |
| Placebo | 61.4 | -1.8 |
| Pregabalin | 61.9 | -3.2 |
Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis. (NCT00631696)
Timeframe: Baseline, Week 26 (last observation in the Week 26 window)
| Intervention | percent motility (Mean) | |
|---|---|---|
| Baseline | Change to Week 26 | |
| Placebo | 61.2 | -1.8 |
| Pregabalin | 61.8 | -2.6 |
End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. (NCT00631696)
Timeframe: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
| Intervention | nanograms per deciliter (ng/dL) (Mean) | |
|---|---|---|
| Baseline | Change to EOS | |
| Placebo | 481.8 | 0.8 |
| Pregabalin | 518.2 | 10.4 |
Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis. (NCT00631696)
Timeframe: Baseline, Week 12 (last observation in the Week 12 window)
| Intervention | ng/dL (Mean) | |
|---|---|---|
| Baseline | Change to Week 12 | |
| Placebo | 481.8 | 0.0 |
| Pregabalin | 518.2 | -14.8 |
Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis. (NCT00631696)
Timeframe: Baseline, Week 26 (last observation in the Week 26 window)
| Intervention | ng/dL (Mean) | |
|---|---|---|
| Baseline | Change to Week 26 | |
| Placebo | 474.6 | 2.6 |
| Pregabalin | 517.9 | 13.8 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill. (NCT00638443)
Timeframe: 10 days
| Intervention | meters (Mean) |
|---|---|
| Pregabalin | 237.49 |
| Diphenhydramine | 261.55 |
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. (NCT00638443)
Timeframe: 10 days
| Intervention | minutes (Mean) |
|---|---|
| Pregabalin | 2.52 |
| Diphenhydramine | 3.06 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity multiplied by the amount of time the subject walked. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale * minutes (Mean) |
|---|---|
| Pregabalin | 100.59 |
| Diphenhydramine | 95.26 |
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 52.31 |
| Diphenhydramine | 46.31 |
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 2.40 |
| Diphenhydramine | 2.94 |
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 1.82 |
| Diphenhydramine | 1.53 |
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference). (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 3.70 |
| Diphenhydramine | 3.58 |
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 37.77 |
| Diphenhydramine | 36.49 |
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 2.75 |
| Diphenhydramine | 2.83 |
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled). (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 12.98 |
| Diphenhydramine | 11.48 |
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity. (NCT00638443)
Timeframe: 10 days
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 3.09 |
| Diphenhydramine | 2.94 |
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes. (NCT00638443)
Timeframe: 10 days
| Intervention | minutes (Mean) |
|---|---|
| Pregabalin | 2.36 |
| Diphenhydramine | 3.15 |
Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| >= 0% reduction from baseline | >= 10% reduction from baseline | >= 20% reduction from baseline | >= 30% reduction from baseline | >= 40% reduction from baseline | >= 50% reduction from baseline | >= 60% reduction from baseline | >= 70% reduction from baseline | >= 80% reduction from baseline | >= 90% reduction from baseline | 100% reduction from baseline | |
| GEn 1200 mg/Day | 55 | 43 | 36 | 31 | 28 | 26 | 21 | 17 | 11 | 5 | 4 |
| GEn 2400 mg/Day | 50 | 42 | 34 | 25 | 19 | 15 | 11 | 6 | 5 | 2 | 1 |
| GEn 3600 mg/Day | 101 | 91 | 78 | 66 | 55 | 46 | 41 | 25 | 17 | 8 | 5 |
| PGB 300 mg/Day | 55 | 42 | 36 | 28 | 20 | 14 | 9 | 5 | 4 | 3 | 3 |
| Placebo | 103 | 86 | 73 | 57 | 46 | 35 | 26 | 15 | 11 | 4 | 3 |
Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.08 |
| GEn 1200 mg/Day | -2.43 |
| GEn 2400 mg/Day | -2.10 |
| GEn 3600 mg/Day | -2.63 |
| PGB 300 mg/Day | -1.65 |
Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.38 |
| GEn 1200 mg/Day | -2.32 |
| GEn 2400 mg/Day | -2.36 |
| GEn 3600 mg/Day | -2.52 |
| PGB 300 mg/Day | -2.17 |
"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used." (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.19 |
| GEn 1200 mg/Day | -2.24 |
| GEn 2400 mg/Day | -2.10 |
| GEn 3600 mg/Day | -2.66 |
| PGB 300 mg/Day | -1.65 |
"Current pain is defined as the participant's assessment of pain intensity right now. Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used." (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.90 |
| GEn 1200 mg/Day | -2.08 |
| GEn 2400 mg/Day | -1.95 |
| GEn 3600 mg/Day | -2.40 |
| PGB 300 mg/Day | -1.50 |
Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | milligrams (Least Squares Mean) |
|---|---|
| Placebo | -261.99 |
| GEn 1200 mg/Day | -171.64 |
| GEn 2400 mg/Day | -102.51 |
| GEn 3600 mg/Day | -228.54 |
| PGB 300 mg/Day | -246.07 |
Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.07 |
| GEn 1200 mg/Day | -2.35 |
| GEn 2400 mg/Day | -2.06 |
| GEn 3600 mg/Day | -2.54 |
| PGB 300 mg/Day | -1.50 |
Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.33 |
| GEn 1200 mg/Day | -2.35 |
| GEn 2400 mg/Day | -2.25 |
| GEn 3600 mg/Day | -2.88 |
| PGB 300 mg/Day | -1.62 |
Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.99 |
| GEn 1200 mg/Day | -2.15 |
| GEn 2400 mg/Day | -2.04 |
| GEn 3600 mg/Day | -2.71 |
| PGB 300 mg/Day | -1.83 |
Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.25 |
| GEn 1200 mg/Day | -2.24 |
| GEn 2400 mg/Day | -2.25 |
| GEn 3600 mg/Day | -3.00 |
| PGB 300 mg/Day | -1.86 |
Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.35 |
| GEn 1200 mg/Day | -2.54 |
| GEn 2400 mg/Day | -2.45 |
| GEn 3600 mg/Day | -3.01 |
| PGB 300 mg/Day | -2.24 |
The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) | |
|---|---|---|
| SF-36 Physical Component Summary Score | SF-36 Mental Component Summary Score | |
| GEn 1200 mg/Day | 3.5 | 0.4 |
| GEn 2400 mg/Day | 3.7 | 1.5 |
| GEn 3600 mg/Day | 4.6 | 1.6 |
| PGB 300 mg/Day | 3.7 | 0.7 |
| Placebo | 3.1 | 2.5 |
"The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit." (NCT00643760)
Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | participants (Number) |
|---|---|
| Placebo | 39 |
| GEn 1200 mg/Day | 20 |
| GEn 2400 mg/Day | 22 |
| GEn 3600 mg/Day | 50 |
| PGB 300 mg/Day | 17 |
"The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of very much improved or much improved. EOMT response is defined as the score recorded at the Week 13/Withdrawal visit." (NCT00643760)
Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | participants (Number) |
|---|---|
| Placebo | 46 |
| GEn 1200 mg/Day | 22 |
| GEn 2400 mg/Day | 24 |
| GEn 3600 mg/Day | 53 |
| PGB 300 mg/Day | 62 |
Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization. (NCT00643760)
Timeframe: Any time post-baseline until date of last dose of study medication (up to Week 13)
| Intervention | days (Median) |
|---|---|
| Placebo | 24 |
| GEn 1200 mg/Day | 25 |
| GEn 2400 mg/Day | 22 |
| GEn 3600 mg/Day | 15 |
| PGB 300 mg/Day | 29 |
The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Tension/Anxiety Domain Score | Depression/Rejection Domain Score | Anger/Hostility Domain Score | Vigor/Activity Domain Score | Fatigue/Inertia Domain Score | Confusion/Bewilderment Domain Score | |
| GEn 1200 mg/Day | -0.6 | -0.2 | -0.8 | -0.1 | -0.5 | 0.2 |
| GEn 2400 mg/Day | -0.7 | -0.6 | -0.5 | 0.1 | -1.1 | -0.1 |
| GEn 3600 mg/Day | -0.9 | -0.3 | -0.3 | 0.7 | -1.1 | 0.0 |
| PGB 300 mg/Day | -0.3 | 0.4 | -0.3 | -0.4 | -0.1 | -0.2 |
| Placebo | -1.0 | -0.5 | -0.5 | 0.6 | -0.8 | -0.3 |
The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| NPS 10 Score | NPS 8 Score | NPS Non-Allodynic Score | NPS 4 Score | |
| GEn 1200 mg/Day | -18.43 | -17.83 | -18.89 | -20.90 |
| GEn 2400 mg/Day | -22.24 | -21.84 | -22.86 | -25.15 |
| GEn 3600 mg/Day | -25.49 | -25.14 | -26.35 | -27.84 |
| PGB 300 mg/Day | -16.16 | -16.19 | -15.63 | -16.06 |
| Placebo | -18.92 | -18.73 | -19.37 | -20.54 |
The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. (NCT00643760)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)
| Intervention | scores on a scale (Least Squares Mean) | ||
|---|---|---|---|
| SF-MPQ Total Score | SF-MPQ Sensory Score | SF-MPQ Affective Score | |
| GEn 1200 mg/Day | -6.55 | -4.83 | -1.65 |
| GEn 2400 mg/Day | -6.75 | -5.31 | -1.45 |
| GEn 3600 mg/Day | -7.56 | -5.50 | -2.07 |
| PGB 300 mg/Day | -4.01 | -2.73 | -1.26 |
| Placebo | -5.85 | -4.25 | -1.63 |
The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. (NCT00643760)
Timeframe: Baseline and EOMT
| Intervention | scores on a scale (Least Squares Mean) | |
|---|---|---|
| Brief Pain Inventory Severity of Pain | Brief Pain Inventory Interference of Pain | |
| GEn 1200 mg/Day | -2.3 | -2.0 |
| GEn 2400 mg/Day | -2.4 | -2.1 |
| GEn 3600 mg/Day | -2.8 | -2.5 |
| PGB 300 mg/Day | -1.7 | -1.9 |
| Placebo | -2.1 | -2.0 |
The Quality of Life in Essential Tremor Questionnaire (QUEST), Hamilton Anxiety scale (HAM-A) and Hotel Dieu-16 (HD-16) were scored as per published guidelines [7], [8] and [9]. The QUEST rates patient perception as influenced by tremor across 5 domains. A QUEST score will be between 0 and 120 with 0 = no essential tremor and 120 = severe essential tremor. The HAM-A rates the severity of anxiety symptomatology across 14 parameters. Scores of 14-17 = mild anxiety, 18-24 = moderate anxiety, and 25-30 = severe anxiety; The HD-16 rates insomnia-related quality of life across five domains. An HD-16 score of 73.1 - 248.5 = severe insomnia, 61-73.1 = mild insomnia, and 0 - 61 = good sleeper. For the scales, HAM-A, QUEST and HD-16, higher scores represent increased symptom severity or diminished quality of life. CGI-C was scored as follows: 1 = very much improved, 2=much improved, 3=mildly improved, 4=no change, 5=mildly worse, 6= much worse, and 7= very much worse. (NCT00646451)
Timeframe: baseline to 6 weeks
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| QUEST | HAM-A | HD-16 | CGI-C | |
| Placebo | -9.7 | 4.1 | -38.6 | 3.8 |
| Pregabalin | 8.0 | 1.1 | 32.2 | 3.9 |
"Change from baseline in the overall TRS score obtained at the final evaluation (end of study). The overall TRS score will be derived from the three TRS subscales. The minimum and maximum score for part A is 0-80, part B is 0-36, and part C is 0-28 giving a maximum score of 144. TRS part A rates the severity of resting, postural and action tremor in upper and lower extremities, face, tongue, voice, head and trunk. Part B rates the severity of upper extremity tremor while writing, drawing, and pouring liquid. Part C rates functional disability of tremor while speaking, eating, drinking, maintaining hygiene, dressing, and working. Higher scores represent increased symptom severity or diminished quality of life.~." (NCT00646451)
Timeframe: baseline to 6 weeks
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| TRS Part A | TRS Part B | TRS Part C | Total TRS | |
| 1-Pregabalin | 2.4 | 6.7 | 4.5 | 5.1 |
| 2-Placebo | -0.2 | 3.6 | -1.5 | 0.3 |
Total activity score: Day (8 am to 8 pm) at end of treatment. Accelerometer measured physical activity by monitoring degree and intensity of body motion. Data is reported as activity counts. Subject activity was collected hourly for the variables: peak, average, and total activity. Higher score indicates greater activity (no activity = 0; total possible score was not defined). (NCT00654940)
Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Pregabalin | 300000 |
| Placebo | 270000 |
Daily Pain Rating Scale by treatment and sequence using an 11-point Likert scale: range 0 (no pain) to 10 (worst possible pain) over the past 24 hours. Self-assessment was performed daily on rising from bed (for the final time in the case of interrupted sleep). Average daily pain score: mean of the previous 7 days daily pain scores. Baseline was defined as the mean of the last 7 pre-treatment pain scores for each period. End of treatment was defined as the mean of the last 7 on treatment pain scores for each period. (NCT00654940)
Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to Week 2 [End of Treatment] for each treatment period)
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Baseline | Treatment Week 2 | Change from Baseline | |
| Period 1: Placebo | 5.24 | 5.08 | -0.16 |
| Period 1: Pregabalin | 6.03 | 5.40 | -0.63 |
| Period 2: Placebo | 5.96 | 6.11 | 0.16 |
| Period 2: Pregabalin | 5.31 | 4.38 | -0.93 |
NPSI at end of treatment: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100. (NCT00654940)
Timeframe: Week 0 to Week 2, Week 4 to Week 6 (Baseline to End of Treatment in Treatment Periods 1 and 2)
| Intervention | scores on scale (Mean) | |||
|---|---|---|---|---|
| Week 0 (Baseline: Treatment Period 1) | Week 2 (End of Treatment: Treatment Period 1) | Week 4 (Baseline: Treatment Period 2) | Week 6 (End of Treatment: Treatment Period 2) | |
| Placebo/Pregabalin | 5.25 | 4.91 | 5.27 | 3.00 |
| Pregabalin/Placebo | 5.31 | 5.31 | 4.33 | 4.75 |
Incidence of post-thoracotomy pain syndrome (persistent continuous or intermittent chest pain with resting pain score > 4 on a 10 point NRS scale) (NCT00663962)
Timeframe: 2 months postoperatively
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 0 |
| Placebo | 0 |
Clinical Global Impression - Improvement Scale (CGI-I): 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 6 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved. (NCT00676403)
Timeframe: Week 6
| Intervention | participants (Number) | |
|---|---|---|
| Week 6: Responders (n=21, 20, 22, 18, 23, 20) | Week 6: Non-Responders | |
| Placebo | 13 | 8 |
| Pregabalin 100 mg | 15 | 7 |
| Pregabalin 150 mg | 11 | 7 |
| Pregabalin 300 mg | 17 | 6 |
| Pregabalin 450 mg | 18 | 2 |
| Pregabalin 50 mg | 12 | 8 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores = better health status. Recall period: month prior to the assessment. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Functioning | Role-Physical | Bodily Pain | General Health | Vitality | Social Functioning | Role-Emotional | Mental Health | Summary Physical Score | Summary Emotional Score | |
| Placebo | 3.6 | 1.1 | 6.9 | 6.5 | 7.4 | 7.8 | -2.1 | 2.9 | 4.5 | 3.7 |
| Pregabalin 100 mg | 2.4 | 7.5 | 12.9 | 4.0 | 9.9 | 4.8 | 7.8 | 3.6 | 6.7 | 6.7 |
| Pregabalin 150 mg | -0.4 | 7.7 | 16.9 | 7.5 | 18.5 | 4.4 | 1.0 | 7.6 | 8.2 | 8.2 |
| Pregabalin 300 mg | 2.9 | 0.9 | 13.3 | 3.6 | 11.7 | 9.5 | 8.1 | 3.7 | 5.6 | 8.5 |
| Pregabalin 450 mg | 3.6 | 9.6 | 18.1 | 5.9 | 13.9 | 15.6 | 12.7 | 10.7 | 9.7 | 13.5 |
| Pregabalin 50 mg | 0.5 | 7.0 | 15.8 | 5.2 | 11.1 | 8.3 | 6.7 | 1.0 | 7.4 | 6.9 |
"Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Self-evaluated change in health status: 5 Likert-type response categories ranging from much worse now to much better now. Recall period: month prior to the assessment." (NCT00676403)
Timeframe: Baseline, Week 6
| Intervention | participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Much Worse than 1 Year Ago | Baseline: Somewhat Worse than 1 Year Ago | Baseline: About the Same as 1 Year Ago | Baseline: Somewhat Better than 1 Year Ago | Baseline: Much Better than 1 Year Ago | Week 6: Much Worse than 1 Year Ago | Week 6: Somewhat Worse than 1 Year Ago | Week 6: About the Same as 1 Year Ago | Week 6: Somewhat Better than 1 Year Ago | Week 6: Much Better than 1 Year Ago | |
| Placebo | 0 | 4 | 15 | 2 | 1 | 1 | 2 | 11 | 4 | 3 |
| Pregabalin 100 mg | 1 | 3 | 15 | 3 | 1 | 0 | 2 | 10 | 4 | 6 |
| Pregabalin 150 mg | 2 | 4 | 14 | 0 | 0 | 0 | 4 | 11 | 1 | 1 |
| Pregabalin 300 mg | 3 | 1 | 14 | 5 | 1 | 2 | 3 | 12 | 4 | 2 |
| Pregabalin 450 mg | 2 | 3 | 12 | 2 | 2 | 0 | 1 | 10 | 5 | 4 |
| Pregabalin 50 mg | 3 | 6 | 9 | 1 | 1 | 0 | 3 | 12 | 2 | 2 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Somnolence Subscale score range: 0-100; higher score indicates less somnolence. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -7.4 | -13.9 | -14.0 | -11.7 |
| Pregabalin 100 mg | -9.8 | -11.1 | -11.8 | -14.8 |
| Pregabalin 150 mg | -14.3 | -18.8 | -16.2 | -21.7 |
| Pregabalin 300 mg | -11.2 | -11.3 | -16.9 | -13.4 |
| Pregabalin 450 mg | -10.7 | -12.6 | -12.6 | -13.9 |
| Pregabalin 50 mg | -13.8 | -18.2 | -20.4 | -26.3 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality over the past week. Comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Snoring Subscale score (1 item): range 0-100, lower score indicates less snoring. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -2.4 | -1.5 | -3.2 | -2.1 |
| Pregabalin 100 mg | -8.6 | -11.4 | -4.0 | -6.6 |
| Pregabalin 150 mg | 0.7 | -8.7 | -7.5 | -2.0 |
| Pregabalin 300 mg | -2.9 | -3.3 | 2.8 | 1.0 |
| Pregabalin 450 mg | -9.2 | -12.2 | -3.5 | -7.5 |
| Pregabalin 50 mg | 5.2 | -0.8 | 4.4 | 2.5 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Quantity (1 item) subscale score range: 0-24 hours. Change from Baseline in number of hours slept. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline,, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | 0.4 | 0.5 | 0.6 | 0.6 |
| Pregabalin 100 mg | 0.5 | 0.6 | 0.7 | 0.7 |
| Pregabalin 150 mg | 0.9 | 1.2 | 1.4 | 1.3 |
| Pregabalin 300 mg | 0.4 | 0.7 | 1.1 | 0.7 |
| Pregabalin 450 mg | 0.7 | 1.1 | 1.1 | 1.2 |
| Pregabalin 50 mg | 0.7 | 0.8 | 1.0 | 0.9 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep quantity and quality over the past week; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Disturbance Subscale score (4 items): range 0-100; lower score indicates less disturbance. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -9.0 | -15.7 | -22.0 | -19.3 |
| Pregabalin 100 mg | -21.1 | -23.0 | -28.3 | -25.3 |
| Pregabalin 150 mg | -23.0 | -26.1 | -32.4 | -33.4 |
| Pregabalin 300 mg | -17.7 | -35.3 | -34.2 | -31.4 |
| Pregabalin 450 mg | -26.3 | -32.1 | -37.4 | -40.2 |
| Pregabalin 50 mg | -18.2 | -25.1 | -18.5 | -29.2 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Adequacy Subscale score range: 0-100; higher scores indicates greater sleep adequacy. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | 5.2 | 15.6 | 15.6 | 16.8 |
| Pregabalin 100 mg | 5.3 | 19.6 | 20.8 | 27.0 |
| Pregabalin 150 mg | 13.7 | 21.9 | 24.7 | 26.8 |
| Pregabalin 300 mg | 9.8 | 14.0 | 26.6 | 19.2 |
| Pregabalin 450 mg | 16.1 | 29.5 | 34.6 | 31.1 |
| Pregabalin 50 mg | 16.1 | 31.0 | 23.9 | 34.6 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Optimal Sleep subscale is derived from sleep quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours of sleep per night. (NCT00676403)
Timeframe: Week 1, Week 2, Week 4, Week 6
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | 6 | 8 | 11 | 12 |
| Pregabalin 100 mg | 7 | 11 | 11 | 11 |
| Pregabalin 150 mg | 9 | 9 | 10 | 10 |
| Pregabalin 300 mg | 6 | 12 | 14 | 9 |
| Pregabalin 450 mg | 11 | 12 | 11 | 13 |
| Pregabalin 50 mg | 10 | 6 | 12 | 11 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week ; comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Awaken Short of Breath or with Headache subscale score range: 0-100; lower score indicates less difficulty. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -7.3 | -9.1 | -9.9 | -7.4 |
| Pregabalin 100 mg | -5.3 | -8.8 | -8.9 | -4.9 |
| Pregabalin 150 mg | -9.2 | -12.1 | -9.9 | -11.5 |
| Pregabalin 300 mg | -8.6 | -8.2 | -9.1 | -3.0 |
| Pregabalin 450 mg | 1.4 | -1.1 | -9.2 | -8.2 |
| Pregabalin 50 mg | -1.7 | -4.3 | -2.5 | -0.9 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Composite index scores are sleep problems Index I (6 items) and sleep problems Index II (9 items). 9-Item Sleep Problems Index range: 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -8.1 | -15.5 | -18.2 | -16.8 |
| Pregabalin 100 mg | -14.2 | -19.0 | -22.0 | -22.2 |
| Pregabalin 150 mg | -17.8 | -22.5 | -25.2 | -28.3 |
| Pregabalin 300 mg | -14.4 | -23.3 | -27.0 | -22.3 |
| Pregabalin 450 mg | -18.8 | -24.6 | -29.1 | -29.4 |
| Pregabalin 50 mg | -15.9 | -23.5 | -19.3 | -27.5 |
RLS QoL: subject-rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period is the month prior to the assessment. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6
| Intervention | scores on scales (Least Squares Mean) |
|---|---|
| Placebo | 15.0 |
| Pregabalin 50 mg | 19.6 |
| Pregabalin 100 mg | 22.4 |
| Pregabalin 150 mg | 20.8 |
| Pregabalin 300 mg | 15.9 |
| Pregabalin 450 mg | 20.5 |
IRLS: Subject-rated instrument to assess RLS symptom severity and impact on daily living; 10 items yielding 2 subscale scores and 1 global (total) score. Subscale scores: symptom severity (6 items) and impact on daily living (3 items), with item 5 (daytime somnolence due to RLS) loaded equally on both subscales. Global score: calculated from all 10 items. Subscale score ranges: symptom severity 0-24, impact of daily living 0-12; global score range: 0-40. Lower scores reflect lower severity and better quality of life. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 6
| Intervention | scores on scale (Least Squares Mean) |
|---|---|
| Placebo | -7.73 |
| Pregabalin 50 mg | -11.83 |
| Pregabalin 100 mg | -11.76 |
| Pregabalin 150 mg | -16.02 |
| Pregabalin 300 mg | -12.89 |
| Pregabalin 450 mg | -16.26 |
MOS-SS: subject-rated instrument used to assess the key constructs of sleep over the past week; assesses sleep quantity and quality and is comprised 12 items yielding 7 subscale scores and 2 composite index scores. Sleep Problems Index I (6 items): composite index score range 0-100; lower score indicates fewer sleep problems. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 4 | Week 6 | |
| Placebo | -9.2 | -14.8 | -17.2 | -15.5 |
| Pregabalin 100 mg | -10.4 | -15.7 | -19.6 | -21.1 |
| Pregabalin 150 mg | -14.9 | -20.3 | -23.3 | -26.1 |
| Pregabalin 300 mg | -13.9 | -20.1 | -24.4 | -18.8 |
| Pregabalin 450 mg | -16.2 | -24.1 | -28.9 | -27.6 |
| Pregabalin 50 mg | -12.5 | -22.0 | -17.9 | -25.0 |
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Total wake time after sleep onset subscale (in minutes): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Reduction = improvement. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
| Intervention | minutes (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Placebo | -23.8 | -29.5 | -34.3 | -30.4 | -28.7 | -34.2 |
| Pregabalin 100 mg/Day | -28.5 | -36.5 | -32.0 | -36.5 | -30.7 | -34.2 |
| Pregabalin 150 mg/Day | -29.0 | -41.9 | -45.9 | -46.0 | -59.6 | -54.0 |
| Pregabalin 300 mg/Day | -32.2 | -39.8 | -42.3 | -43.6 | -42.5 | -41.1 |
| Pregabalin 50 mg/Day | -37.9 | -47.0 | -51.4 | -50.7 | -55.4 | -57.0 |
| Pregablin 450 mg/Day | -32.6 | -46.3 | -42.9 | -46.8 | -55.1 | -55.5 |
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Quality of sleep subscale: visual analog scale ranging from 1 (very poor) to 100 (excellent) completed by the subject 30 minutes after waking; recall period is the night before. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
| Intervention | scores on scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Placebo | 5.0 | 11.3 | 13.8 | 13.2 | 14.7 | 13.9 |
| Pregabalin 100 mg | 15.2 | 18.7 | 18.6 | 22.0 | 19.9 | 23.5 |
| Pregabalin 150 mg | 15.9 | 24.2 | 26.8 | 28.2 | 30.9 | 30.5 |
| Pregabalin 300 mg | 11.5 | 23.4 | 23.6 | 24.2 | 26.0 | 23.1 |
| Pregabalin 450 mg | 17.2 | 24.0 | 25.4 | 23.8 | 31.1 | 28.8 |
| Pregabalin 50 mg | 18.8 | 23.3 | 23.0 | 23.8 | 28.7 | 27.6 |
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Number of awakenings subscale: numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Fewer awakenings reflect better quality of sleep. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
| Intervention | awakenings (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Placebo | -0.5 | -0.7 | -0.7 | -0.9 | -0.8 | -1.0 |
| Pregabalin 100 mg | -1.0 | -1.3 | -1.0 | -1.2 | -1.0 | -1.1 |
| Pregabalin 150 mg | -1.2 | -1.3 | -1.3 | -1.5 | -1.6 | -1.5 |
| Pregabalin 300 mg | -0.7 | -1.3 | -1.2 | -1.1 | -1.2 | -1.0 |
| Pregabalin 450 mg | -0.8 | -1.1 | -1.4 | -1.2 | -1.5 | -1.2 |
| Pregabalin 50 mg | -0.9 | -1.0 | -1.0 | -1.1 | -1.3 | -1.0 |
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Hours of sleep subscale reflects change in hours of sleep from baseline. Numerical rating completed by the subject 30 minutes after waking; recall period is the night before. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
| Intervention | hours (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Placebo | 0.23 | 0.36 | 0.36 | 0.27 | 0.37 | 0.19 |
| Pregabalin 100 mg | 0.29 | 0.52 | 0.53 | 0.46 | 0.43 | 0.42 |
| Pregabalin 150 mg | 0.55 | 0.81 | 0.89 | 0.93 | 0.97 | 0.95 |
| Pregabalin 300 mg | 0.45 | 0.76 | 0.72 | 0.65 | 0.61 | 0.44 |
| Pregabalin 450 mg | 0.72 | 1.07 | 1.32 | 1.03 | 1.43 | 1.11 |
| Pregabalin 50 mg | 0.57 | 0.65 | 0.61 | 0.81 | 1.03 | 0.84 |
Subjective Sleep Questionnaire (SSQ): subject-rated instrument used to assess sleep behavior; measures sleep quantity and quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, and quality of sleep. Latency subscale (time to fall asleep [in minutes]): numerical rating completed by the subject 30 minutes after waking; recall period is the night before. Lower score reflects greater ease (shorter time) in falling asleep. Change from baseline = score at observation minus score at baseline. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6
| Intervention | minutes (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Placebo | -9.8 | -8.9 | -14.6 | -13.6 | -15.9 | -12.4 |
| Pregabalin 100 mg | -13.2 | -17.2 | -13.1 | -20.4 | -17.6 | -19.5 |
| Pregabalin 150 mg | -10.4 | -16.3 | -17.8 | -18.2 | -24.0 | -25.1 |
| Pregabalin 300 mg | -9.1 | -13.0 | -17.8 | -18.2 | -13.4 | -10.1 |
| Pregabalin 450 mg | -20.2 | -34.3 | -33.7 | -37.1 | -36.1 | -34.9 |
| Pregabalin 50 mg | -16.3 | -20.7 | -18.9 | -20.4 | -26.8 | -25.4 |
CGI-S Scale: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00676403)
Timeframe: Baseline, Week 1, Week 2, Week 4, Week 6, Last Observation Carried Forward (LOCF)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Normal, Not at All Ill | Baseline: Borderline, Mentally Ill | Baseline: Mildly Ill | Baseline: Moderately Ill | Baseline: Markedly Ill | Baseline: Severely Ill | Baseline: Among the Most Extremely Ill | Week 1: Normal, Not at All Ill | Week 1: Borderline, Mentally Ill | Week 1: Mildly Ill | Week 1: Moderately Ill | Week 1: Markedly Ill | Week 1: Severely Ill | Week 1: Among the Most Extremely Ill | Week 2: Normal, Not at All Ill | Week 2: Borderline, Mentally Ill | Week 2: Mildly Ill | Week 2: Moderately Ill | Week 2: Markedly Ill | Week 2: Severely Ill | Week 2: Among the Most Extremely Ill | Week 4: Normal, Not at All Ill | Week 4: Borderline, Mentally Ill | Week 4: Mildly Ill | Week 4: Moderately Ill | Week 4: Markedly Ill | Week 4: Severely Ill | Week 4: Among the Most Extremely Ill | Week 6: Normal, Not at All Ill | Week 6: Borderline, Mentally Ill | Week 6: Mildly Ill | Week 6: Moderately Ill | Week 6: Markedly Ill | Week 6: Severely Ill | Week 6: Among the Most Extremely Ill | LOCF: Normal | LOCF: Borderline, Mentally Ill | LOCF: Mildly Ill | LOCF: Moderately Ill | LOCF: Markedly Ill | LOCF: Severely Ill | LOCF: Among the Most Extremely Ill | |
| Placebo | 0 | 0 | 1 | 6 | 7 | 8 | 1 | 1 | 0 | 4 | 10 | 4 | 4 | 0 | 0 | 3 | 10 | 3 | 3 | 3 | 1 | 1 | 4 | 8 | 4 | 3 | 2 | 0 | 1 | 3 | 11 | 2 | 2 | 2 | 0 | 1 | 3 | 12 | 2 | 2 | 2 | 1 |
| Pregabalin 100 mg | 0 | 0 | 2 | 8 | 7 | 6 | 0 | 1 | 1 | 5 | 5 | 5 | 3 | 0 | 1 | 2 | 9 | 5 | 4 | 1 | 0 | 2 | 2 | 11 | 6 | 1 | 1 | 0 | 4 | 4 | 7 | 5 | 2 | 0 | 0 | 4 | 4 | 7 | 5 | 2 | 1 | 0 |
| Pregabalin 150 mg | 0 | 0 | 4 | 5 | 5 | 7 | 1 | 1 | 1 | 8 | 7 | 1 | 2 | 0 | 2 | 3 | 7 | 6 | 0 | 1 | 0 | 5 | 2 | 5 | 5 | 1 | 1 | 0 | 4 | 4 | 7 | 3 | 0 | 0 | 0 | 4 | 4 | 9 | 5 | 0 | 0 | 0 |
| Pregabalin 300 mg | 0 | 0 | 2 | 11 | 3 | 8 | 0 | 0 | 4 | 5 | 6 | 3 | 5 | 0 | 3 | 6 | 4 | 5 | 3 | 1 | 0 | 4 | 6 | 4 | 5 | 2 | 2 | 0 | 6 | 4 | 7 | 1 | 4 | 1 | 0 | 6 | 4 | 7 | 1 | 4 | 2 | 0 |
| Pregabalin 450 mg | 0 | 0 | 2 | 6 | 5 | 10 | 0 | 3 | 2 | 7 | 8 | 2 | 1 | 0 | 7 | 2 | 8 | 3 | 0 | 0 | 0 | 8 | 5 | 4 | 2 | 1 | 0 | 0 | 7 | 5 | 6 | 1 | 1 | 0 | 0 | 7 | 6 | 7 | 1 | 1 | 1 | 0 |
| Pregabalin 50 mg | 0 | 0 | 1 | 9 | 8 | 3 | 1 | 1 | 1 | 6 | 8 | 3 | 2 | 0 | 2 | 4 | 5 | 5 | 3 | 1 | 0 | 2 | 2 | 7 | 6 | 2 | 2 | 0 | 3 | 3 | 6 | 5 | 2 | 1 | 0 | 3 | 3 | 6 | 6 | 2 | 2 | 0 |
The primary efficacy variable was the change from baseline on the NRS. The primary time point was the average pain score during the last data-analysis-interval of week 8. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The primary efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. (NCT00696787)
Timeframe: Baseline and 8 weeks
| Intervention | units on scale (Mean) |
|---|---|
| Placebo | -1.98 |
| DVS SR | -1.60 |
| Pregabalin | -1.70 |
The efficacy variable was the change from baseline on the numeric rating scale (NRS). The time point was the average pain score during the last data-analysis-interval of week 8, data analysis interval. The baseline score was the average of the NRS scores across the last 7 days of the screening period (just prior to the start of the placebo run-in). The efficacy variable was the pain severity score measured on an 11 point NRS on which 0=no pain and 10=worst possible pain. (NCT00696787)
Timeframe: Baseline and 8 weeks
| Intervention | units on scale (Mean) |
|---|---|
| Placebo | -2.00 |
| DVS SR | -1.64 |
| Pregabalin | -1.45 |
Endpoints for this analysis will be median change from baseline to after week 6 of treatment. Hot Flash Related Daily Interference Scale is used to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. Responses to the questionnaire are recorded on a 0 to 10 scale. Lower scores are better. (NCT00702949)
Timeframe: Baseline, after week 6 of treatment.
| Intervention | units on a scale (Median) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Work | Social Activities | Leisure Activities | Sleep | Mood | Concentration | Relations | Sexuality | Enjoy Life | Overall QOL | |
| Placebo | -1 | 0 | 0 | -1 | 0 | -1 | 0 | 0 | -1 | 0 |
| Pregabalin150 | -1.5 | -1.5 | -1 | -3 | -1 | -1 | 0 | 0 | -2 | -1.5 |
| Pregabalin75 | -1.0 | -1 | -1 | -2 | -1 | -1 | -1 | 0 | -1 | -1.5 |
Hot flash activity will be analyzed in a number of ways. For the this analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin75 | -9.7 |
| Placebo | -6.1 |
Hot flash activity will be analyzed in a number of ways. For the this analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the lower dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | percent change (Median) |
|---|---|
| Pregabalin75 | -64.9 |
| Placebo | -50.1 |
The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | Hot flashes per day (Median) |
|---|---|
| Pregabalin75 | -4.6 |
| Pregabalin150 | -4.9 |
| Placebo | -2.9 |
Hot flash activity will be analyzed in a number of ways. For the primary analysis, the numerical change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin150 | -9.6 |
| Placebo | -6.1 |
The analysis of daily average hot flash frequency will follow as specified for the primary analysis. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | percent change (Median) |
|---|---|
| Pregabalin75 | -58.5 |
| Pregabalin150 | -61.1 |
| Placebo | -36.3 |
Hot flash activity will be analyzed in a number of ways. For the primary analysis, the percent change-from-baseline to hot flash score after week 6 of treatment will be compared between the highest dose treatment arm and the placebo arm. A hot flash score is computed for each patient by assigning points (1=mild, 2=moderate, 3=severe, 4=very severe) to each hot flash based on patient-reported severity, adding the points for each day, and averaging across each week of the study. Abbreviations for the analysis population description: Eligible patients (EPs). Evaluable for primary (EFP). Off-study for adverse event (AE). Do not have 6 weeks of data (NODATA). (NCT00702949)
Timeframe: Baseline, after week 6 of treatment
| Intervention | percent change (Median) |
|---|---|
| Pregabalin150 | -71.0 |
| Placebo | -50.1 |
A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire weekly. This patient diary contains several questions related to potential side effects and side benefits of pregabalin measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity, providing numbers representing the worst median changes from baseline minus Maximum (Week 1-6) Symptom Experience Diary Distributions). (NCT00702949)
Timeframe: Baseline, 6 weeks during treatment.
| Intervention | units on a scale (Median) | |||||
|---|---|---|---|---|---|---|
| Concern about weight gain | Concern about sleepiness | Concern about dizziness | Concern about coordination | Concern about concentration | Concern about blurred/double vision | |
| Placebo | 1.0 | 1.0 | 0 | 0.0 | 0.0 | 0.0 |
| Pregabalin150 | 2.0 | 2.0 | 2.0 | 1.0 | 1.0 | 1.0 |
| Pregabalin75 | 1.0 | 1.0 | 1.0 | 0.0 | 1.0 | 0.0 |
Region of Interest (ROI) analysis of contrast of doses (high and low) of pregabalin vs placebo on brain activity at rest and during emotional stimuli using fMRI and clinical scales. (NCT00706836)
Timeframe: Week 1, 2, 3 (Cross-over Design)
| Intervention | % signal change L amygdala + anticipn (Mean) |
|---|---|
| Pregabalin Low Dose (Crossover) | 0.6 |
| Pregabalin High Dose (Crossover) | -0.1 |
| Placebo (Crossover) | 0.6 |
Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 24 hours after initial dose (0-24hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain. (NCT00729690)
Timeframe: 24 hours
| Intervention | Area (NRS*hr) (Mean) |
|---|---|
| 1 Multi-Dose Pregabalin | 70.4 |
| 2 Single-dose Pregabalin | 59.6 |
| 3 Placebo | 73.4 |
Numerical Response scale NRS(0-10) Pain scores were collected every 4 hours after the initial dose and the Area Under the Curve (AUC) calculated. Calculated for the 1st 12 hours after initial dose (0-12hr). AUC measured in NRS pain score points per hour (NRS*hr). Larger AUC values indicate higher levels of reported pain. (NCT00729690)
Timeframe: 12 hours Post dose
| Intervention | Area (NRS*hr) (Mean) |
|---|---|
| 1 Multi-Dose Pregabalin | 30.1 |
| 2 Single-dose Pregabalin | 22.7 |
| 3 Placebo | 27.7 |
The degree of active knee flexion (ROM) tolerated by the patient will be assessed at days 1 and 2 post-surgery. Active flexion is the unassisted moment of the joint by the subject. On postoperative (PostOp) day 2 (NCT00729690)
Timeframe: PostOp day 2
| Intervention | Degrees (Mean) |
|---|---|
| 1 Multi-Dose Pregabalin | 78.1 |
| 2 Single-dose Pregabalin | 80.5 |
| 3 Placebo | 80.5 |
Passive flexion is the moment of the joint with the assistance of a clinician (The clinician or therapist physically hold and moves the knee through it's range of motion). (NCT00729690)
Timeframe: PostOp day 2
| Intervention | Degrees (Mean) |
|---|---|
| 1 Multi-Dose Pregabalin | 86.5 |
| 2 Single-dose Pregabalin | 88.2 |
| 3 Placebo | 87.1 |
Single voxel spectra obtained from the anterior and posterior right insula at rest to compare ratios for Gln/Cr, Glu/Cr, and combined Glutamate + Glutamine (Glx/Cr) for pregabalin and placebo. Gln, Glu, Glx calculated as ratios to the internal standard creatine. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | ratio (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glu/Cr ratio posterior insula - pre-dose | Glu/Cr ratio posterior insula - post-dose | Gln/Cr ratio posterior insula - pre-dose | Gln/Cr ratio posterior insula - post-dose | Glx/Cr ratio posterior insula - pre-dose | Glx/Cr ratio posterior insula - post-dose | Glu/Cr ratio anterior insula - pre-dose | Glu/Cr ratio anterior insula - post-dose | Gln/Cr ratio anterior insula - pre-dose | Gln/Cr ratio anterior insula - post-dose | Glx/Cr ratio anterior insula - pre-dose | Glx/Cr ratio anterior insula - post-dose | |
| Placebo | 1.13253 | 1.17129 | 0.52635 | 0.51553 | 1.65894 | 1.68747 | 1.23788 | 1.18524 | 0.47882 | 0.47541 | 1.71671 | 1.66124 |
| Pregabalin | 1.1751 | 1.1046 | 0.5311 | 0.4857 | 1.70624 | 1.5903 | 1.22731 | 1.2393 | 0.53144 | 0.5290 | 1.75888 | 1.7684 |
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 8.6641 |
| Placebo | 9.4722 |
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by the participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12). Total (overall) score was sum of items 1 to 15, range 0 to 45; higher scores indicated higher pain/impact. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 10.0862 |
| Placebo | 11.2774 |
SF-MPQ was completed to assess pain over the past week and to assess present pain and consists of 15 pain descriptors: sensory dimension of pain experience (sum of items 1 to 11) and affective dimension (sum of items 12 to 15). Each descriptor was ranked by participant on a 4-point intensity scale (0=none to 3=severe) and totaled in each subclass (sensory range 0 to 33; affective range 0 to 12); higher scores indicated higher pain/impact. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.4100 |
| Placebo | 1.8173 |
"PCS is a participant rated 13-item instrument to measure the presence and severity of catastrophizing. Scored 0 (not at all) to 4 (all the time) to statements such as When I'm in pain…I worry all the time about whether the pain will end. All 13 statements start with When I'm in pain…. Total score ranged from 0 to 52; higher scores reflected greater impairment. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier." (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 11.4050 |
| Placebo | 12.0041 |
A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.1750 |
| Placebo | 3.8705 |
A participant rated questionnaire with 2 subscales. HADS-A assessed state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assessed state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicated greater severity of anxiety and depression symptoms. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.3896 |
| Placebo | 5.1558 |
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The individual daily pain score was defined as the final score recorded in the last pain diary of the treatment period 24 hours prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.3110 |
| Placebo | 5.0527 |
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 7 day average pain score was defined as the mean daily pain NRS value for the last 7 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.1014 |
| Placebo | 4.7038 |
The daily pain diary consisted of the mBPI item regarding participant-rated average of pain over the past 24 hours. Scored on an 11-point numeric scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The 3 day average pain score was defined as the mean daily pain NRS value for the last 3 days prior to fMRI scanning visit. Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.3467 |
| Placebo | 4.7745 |
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined Region of Interest (ROI) brain regions in response to blunt pressure pain; acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kilograms [kg] pressure/equal stimulus conditions, and high pain pressure/up to 10 kg). Estimated as magnitude (percent change) of the betas representing brain signal activation associated with pressure induced pain. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | percent change (Least Squares Mean) | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anterior Cingulate | Brodman Area (BA) 22 | BA40 | Left (L)_Anterior Insula (anIns) | L_Amygdala | L_Cerebellum | L_DLPFC | L_Mid Insula | L_Mid Temporal Pole | L_Orbito Front | Periaqueductal gray (PAG) | Posterior Insula (pIns) | L_Posterior Cingulate | L_Precuneus | L_Putamen | L_Secondary Somatosensory Area (S2) | Right (R)_DLPFC | R_Anterior Insula | R_Amygdala | R_BA23_base | R_Inferior Parietal Lobule (IPL)_base | R_Insula_base | R_Mid Insula | R_Mid Front_DLPFC | R_Mid Temporal Pole | R_Orbito Front | L_PAG | R_Posterior Insula | Posterior Insula | R_Posterior Cingulate | R_Precuneus | R_Precuneus_base | Superior Temporal | R_Premotor | R_Putamen | R_Primary Somatosensory Area (S1) | R_Thalamus | Precuneus | |
| Placebo | -0.024 | 0.029 | 0.026 | 0.044 | 0.041 | 0.021 | 0.023 | 0.100 | -0.044 | -0.136 | 0.016 | 0.002 | -0.083 | -0.084 | 0.037 | 0.111 | 0.101 | 0.002 | 0.076 | -0.017 | -0.015 | 0.034 | 0.028 | 0.083 | -0.036 | -0.056 | 0.011 | -0.024 | -0.002 | -0.093 | -0.070 | -0.038 | 0.026 | -0.022 | 0.032 | 0.037 | 0.018 | -0.078 |
| Pregabalin | 0.008 | -0.050 | -0.047 | 0.073 | -0.040 | -0.056 | -0.002 | -0.011 | -0.024 | 0.033 | 0.014 | 0.001 | -0.132 | -0.057 | 0.081 | -0.016 | -0.004 | 0.080 | -0.077 | 0.005 | -0.042 | -0.010 | 0.015 | -0.011 | -0.048 | -0.046 | 0.034 | 0.063 | 0.050 | -0.175 | -0.070 | -0.040 | -0.039 | -0.022 | 0.088 | -0.048 | 0.010 | -0.066 |
BOLD fMRI imaging modality to assess brain activation signals across the whole brain in defined ROI brain regions in response to checkerboard visual stimuli (flashing at 8 hertz [Hz]). Reported as percent change between the pre-dose (baseline) and post-dose values. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | percent change in BOLD signal (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Right (R) anterior mid insula cortex | Left (L) mid insula cortex | R inferior parietal lobule, Brodman area 40 | L inferior parietal lobule, Brodman area 40 | Right primary somatosensory cortex | Left primary somatosensory cortex | Left supplementary motor area | |
| Placebo | -0.05 | 0.00 | 0.05 | 0.02 | -0.01 | 0.06 | 0.30 |
| Pregabalin | 0.32 | 0.23 | 0.27 | 0.28 | 0.14 | 0.21 | 0.02 |
"BP cuff evoked allodynia assessed based on participant response to the following question When I take your blood pressure, tell me if the cuff's pressure is painful. A standard BP cuff was inflated at approximately 10 millimeters of mercury (mm Hg) per second up to 180 mm Hg or to point when participant experienced pain; performed 3 times on each arm whether or not pain was reported. If no pain elicited at 180 mm Hg, it was recorded that no sphygmomanometry-evoked allodynia occurred. If pain was reported, value (in mm Hg) at which pain first occured was recorded for each of the assessments." (NCT00760474)
Timeframe: Day 58
| Intervention | mm Hg (Mean) | |
|---|---|---|
| Mean Left Arm BP Cuff Pressure | Mean Right Arm BP Cuff Pressure | |
| All Study Treatment: Pregabalin, Placebo | 107.92 | 129.31 |
Resting state brain activity assessed for correlation of brain seed region (pIns, anIns) to ROI connectivity at baseline (pre-dose) and post-dose (pre minus post) measured using z-score (mean of 0, standard deviation [SD] of 1); range approximately -3 to +3. Positive (+) z-scores reflect greater connectivity (+correlation between seed region and ROI). Negative (-) z-scores reflect -connectivity (anti-correlation between seed region and ROI). ROIs include PCC and IPL from within the default mode network (DMN). DMN is a constellation of regions in which connectivity is augmented in fibromyalgia. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | z-score (Mean) | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| pIns_Posterior cingulate (PCC) pre-dose | pIns_PCC post-dose | pIns_primary motor region (M1) pre-dose | pIns_M1 post-dose | pIns_cerebellum pre-dose | pIns_cerebellum post-dose | pIns_Left (L) IPL 3a pre-dose | pIns_L IPL 3a post-dose | pIns_L IPL 3b pre-dose | pIns_L IPL 3b post-dose | pIns_Right (R) IPL 3b pre-dose | pIns_R IPL 3b post-dose | pIns_cuneus pre-dose | pIns_cuneus post-dose | anIns_L IPL pre-dose | anIns_L IPL post-dose | anIns_R IPL pre-dose | anIns_R IPL post-dose | anIns_S2 pre-dose | anIns_S2 post-dose | anIns_cuneus pre-dose | anIns_cuneus post-dose | |
| Placebo | 1.5405 | 1.2409 | 1.3267 | 1.3771 | 1.4439 | 1.0704 | -0.9296 | -1.2977 | 1.7390 | 0.9930 | 0.7420 | 0.9081 | 1.8543 | 2.3324 | 1.9982 | 2.6797 | 1.7848 | 2.6194 | 1.6799 | 2.4225 | 1.7550 | 1.1899 |
| Pregabalin | 1.1647 | 2.1504 | 3.1486 | 3.2605 | 0.3984 | 0.0213 | 0.2025 | -0.3792 | 0.6552 | 1.5614 | 0.8310 | 0.9766 | 2.1363 | 3.0410 | 2.1404 | 2.6493 | 2.6956 | 1.2863 | 1.6592 | 3.1466 | 2.5103 | 1.8042 |
Participant rated severity of pain upon application of 4 kilograms (kg) pressure via dolorimeter at the bilateral epicondyle tender points (2 tender points, 2 centimeters distal to the epicondyles) described in the American College of Rheumatology (ACR) classification criteria and scored on a 0 (no pain) to 10 (worst possible pain) rating scale. Each arm was to be assessed for any pain (one point on each arm) with the application of pressure. (NCT00760474)
Timeframe: Day 58
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Pain Severity Left Epicondyle | Pain Severity Right Epicondyle | |
| All Study Treatment: Pregabalin, Placebo | 6.25 | 5.72 |
Minimum and maximum pain unpleasantness acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (neutral) to 20 (very intolerable). Baseline and Post-dose data for Period 1 and Period 2 summarized as LS Mean. Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline/Pre-dose (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) | |
|---|---|---|
| Minimum pain unpleasantness | Maximum pain unpleasantness | |
| Placebo | 3.4258 | 11.2742 |
| Pregabalin | 3.3924 | 10.1576 |
Minimum and maximum pain intensity acquired during resting state (no evoked pain) and during evoked pain (thumb pressure device with non-painful pressure, 2 kg pressure/equal stimulus conditions, and high pain pressure/up to 10 kg) measured during fMRI and scored from 0 (no pain sensation) to 20 (extremely intense). Baseline and Post-dose data for Period 1 and Period 2 summarized as Least Squares Mean (LS Mean). Any observation with a studentized residual >3 or <-3 was considered an outlier. (NCT00760474)
Timeframe: Baseline (Day 8, Day 37), Post-dose (Period 1/Day 22, Period 2/Day 51)
| Intervention | scores on a scale (Least Squares Mean) | |
|---|---|---|
| Minimum pain intensity | Maximum pain intensity | |
| Placebo | 3.4725 | 15.6117 |
| Pregabalin | 4.1184 | 14.5701 |
Time to response=first visit achieving a 30% reduction of weekly mean 24-hour APS score. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The number of days at which 50% of the participants at risk had at least 30% response was reported. (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | time (days) (Number) |
|---|---|
| Placebo | 36 |
| Pregabalin | 30 |
| LY545694 21 mg | 30 |
| LY545694 49 mg | 30 |
| LY545694 105 mg | 30 |
"Percentage of participants who reported hypoglycemic (lower than normal level of blood glucose) episodes was summarized as other non-serious adverse events (AEs) from the Investigations system organ class (preferred term = hypoglycemia). A listing of AEs is located in the Reported Adverse Event module." (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 1.12 |
| LY545694 21 mg | 0.00 |
| LY545694 49 mg | 0.00 |
| LY545694 105 mg | 2.13 |
PGI-I measured the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranged from 1 (very much better) to 7 (very much worse). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Week 5
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | 2.58 |
| Pregabalin | 2.28 |
| LY545694 21 mg | 2.37 |
| LY545694 49 mg | 2.63 |
| LY545694 105 mg | 2.41 |
"The total number of TEAEs (serious and non-serious) that first occurred or worsened during the treatment period) from the Nervous system disorders system organ class was summarized. A listing of serious AEs (SAEs) and other non-serious AEs is located in the Reported Adverse Event module." (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | participants (Number) |
|---|---|
| Placebo | 17 |
| Pregabalin | 22 |
| LY545694 21 mg | 16 |
| LY545694 49 mg | 24 |
| LY545694 105 mg | 23 |
This scale measured the number of participants with a 30% reduction in weekly mean 24-hour APS score from baseline to endpoint. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | participants (Number) |
|---|---|
| Placebo | 38 |
| LY545694 21 mg | 18 |
| LY545694 49 mg | 21 |
| LY545694 105 mg | 21 |
The EQ-5D was a generic, multidimensional, health-related, quality-of-life instrument. The profile allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 was generated for each domain. For each participant, the outcome rating on the 5 domains was mapped to a single index through an algorithm. The index ranged between 0 and 1, with the higher score indicating a better health state perceived by the participant. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | 0.09 |
| Pregabalin | 0.09 |
| LY545694 21 mg | 0.11 |
| LY545694 49 mg | 0.05 |
| LY545694 105 mg | 0.07 |
This scale measured worst pain APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.27 |
| Pregabalin | -2.87 |
| LY545694 21 mg | -2.57 |
| LY545694 49 mg | -2.77 |
| LY545694 105 mg | -2.67 |
This scale measured night pain APS scores. Data were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.31 |
| Pregabalin | -2.75 |
| LY545694 21 mg | -2.25 |
| LY545694 49 mg | -2.54 |
| LY545694 105 mg | -2.21 |
This scale measured 24-hour APS scores. Data were recorded daily (preferably at bedtime) on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Least Squares (LS) Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.08 |
| LY545694 21 mg | -2.22 |
| LY545694 49 mg | -2.45 |
| LY545694 105 mg | -2.42 |
Pulse rate was measured in beats per minute (bpm). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | beats per minute (bpm) (Least Squares Mean) |
|---|---|
| Placebo | -1.06 |
| Pregabalin | -3.60 |
| LY545694 21 mg | 0.87 |
| LY545694 49 mg | 1.47 |
| LY545694 105 mg | 1.66 |
Clearance is the volume of plasma cleared of study drug LY545694 (CLp) and metabolite compound 645838 (CLm) per unit time. The original PK/pharmacodynamic (PD) relationship outcome measure analysis was not conducted; therefore, only PK data were reported. (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | Liters per hour (L/hr) (Geometric Mean) |
|---|---|
| LY545694 Clearance (CLp) | 79.1 |
| Compound 645838 (CLm) | 39.8 |
SF-MPQ consisted of 11 sensory descriptors describing pain that were rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. Three pain scores were derived from the sum of the intensity rank values of the words chosen for sensory descriptors. The SF-MPQ sensory subscale was the sum of the 11 scores (ranged from 0 to 33, with 33 being the worst). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -8.20 |
| Pregabalin | -8.60 |
| LY545694 21 mg | -8.93 |
| LY545694 49 mg | -8.95 |
| LY545694 105 mg | -7.89 |
The SF-36 Health Status Survey was a generic, health-related scale assessing participants' quality of life on 8 domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health) and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | 7.51 |
| Pregabalin | 10.70 |
| LY545694 21 mg | 8.16 |
| LY545694 49 mg | 5.78 |
| LY545694 105 mg | 6.33 |
The SDS was completed by the participant and was used to assess the effect of the participant's symptoms on work/social/family life. Total scores ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.96 |
| Pregabalin | -2.58 |
| LY545694 21 mg | -2.63 |
| LY545694 49 mg | -1.97 |
| LY545694 105 mg | -3.04 |
The QIDS was a 16-item patient-rated measure of depressive symptomatology. Each item had a 0 to 3 point scale. The total score ranged from 0 to 27 with higher scores indicative of greater severity. QIDS was calculated by summing the scores from the 9 symptom domains of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) major depressive disorder criteria: depressed mood, loss of interest or pleasure, concentration/decision making, self outlook, suicidal ideation, energy/fatigability, sleep, weight/appetite change, and psychomotor changes. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.96 |
| Pregabalin | -1.49 |
| LY545694 21 mg | -0.69 |
| LY545694 49 mg | -0.46 |
| LY545694 105 mg | 0.20 |
NeuroQoL had 29 items: 13 assessed specific somatic experiences (pain, lost/reduced feeling, and diffuse sensory-motor symptoms); 14 assessed specific functional, social, and emotional experiences (restrictions in daily living activities, disruptions in social relationships, and emotional distress); 2 items assessed QoL and overall satisfaction. Items reported on a 5-point scale (never/not at all to all of the time/very much). Higher mean scores=more severe symptoms/greater disruption in functioning. First 27 items also associate with 3-point bothersome/importance scale (1=none to 3=very). (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.56 |
| Pregabalin | -0.49 |
| LY545694 21 mg | -0.58 |
| LY545694 49 mg | -0.59 |
| LY545694 105 mg | -0.31 |
CGI-S measured severity of illness at the time of assessment compared with start of treatment. Scores ranged from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.07 |
| Pregabalin | -1.02 |
| LY545694 21 mg | -1.28 |
| LY545694 49 mg | -1.07 |
| LY545694 105 mg | -1.03 |
Average BPI-I measured self-reported degree of pain interference on function. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -2.73 |
| Pregabalin | -2.81 |
| LY545694 21 mg | -2.31 |
| LY545694 49 mg | -2.73 |
| LY545694 105 mg | -2.30 |
ASQ consisted of 21 items (including a single item to assess overall sleep quality) and 3 subscales: Sleep Onset and Maintenance (items 1-3, 5-6, 9, 11); Sleep Experience (items 4, 7, 8, 10, 12); and Awakening Experience (items 13-20). Each item was scored on a 5-point Likert scale, ranging from 0 (no sleep at all) to 5 (a lot of sleep). Each subscale was calculated as the mean of the individual items comprising the subscale. A total ASQ score was calculated as the mean of the subscale scores; higher scores represent better sleep. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | 0.76 |
| Pregabalin | 0.88 |
| LY545694 21 mg | 0.67 |
| LY545694 49 mg | 0.51 |
| LY545694 105 mg | 0.55 |
"The Columbia Suicide Severity Rating Scale (C-SSRS) captured occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors and ideations were provided. Suicidal behavior = a yes answer to any 1 of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation = a yes answer to any 1 of 5 suicidal ideation questions, which included the wish to be dead and 4 different categories of active suicidal ideation." (NCT00785577)
Timeframe: Baseline through week 5
| Intervention | participants (Number) | |
|---|---|---|
| Suicidal behaviors | Suicidal ideations | |
| LY545694 105 mg | 0 | 1 |
| LY545694 21 mg | 0 | 1 |
| LY545694 49 mg | 0 | 0 |
| Placebo | 0 | 1 |
| Pregabalin | 0 | 0 |
"The number of participants by treatment group who had abnormal high or low laboratory values was reported by the investigator and summarized as serious adverse events (SAEs) from the Investigations system organ class during the treatment phase of the study. A listing of SAEs is located in the Reported Adverse Event module." (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Alanine aminotransferase (ALT) abnormal | Aspartate aminotransferase (AST) abnormal | |
| LY545694 105 mg | 1 | 1 |
| LY545694 21 mg | 0 | 0 |
| LY545694 49 mg | 0 | 0 |
| Placebo | 0 | 0 |
| Pregabalin | 0 | 0 |
The number of participants having QTcF and QTcB change ≥ 30 msec was summarized. (NCT00785577)
Timeframe: Baseline through 5 weeks
| Intervention | participants (Number) | |
|---|---|---|
| QTcB ≥30 msec | QTcF ≥30 msec | |
| LY545694 105 mg | 1 | 1 |
| LY545694 21 mg | 2 | 1 |
| LY545694 49 mg | 1 | 0 |
| Placebo | 4 | 3 |
| Pregabalin | 0 | 0 |
Participant discontinuation in the study due to serious and other non-serious AEs was measured during both the therapy (double-blind) phase and 1-week washout (follow-up) phase. A listing of serious and other non-serious AEs is located in the Reported Adverse Event module. (NCT00785577)
Timeframe: Baseline through 6 weeks
| Intervention | participants (Number) | |
|---|---|---|
| Therapy (Double-blind) Phase | 1-Week Washout (Follow-up) Phase | |
| LY545694 105 mg | 17 | 1 |
| LY545694 21 mg | 14 | 0 |
| LY545694 49 mg | 10 | 1 |
| Placebo | 5 | 0 |
| Pregabalin | 7 | 0 |
This scale first asked if the participant was experiencing hazy or blurry vision or if he/she had difficulty focusing. If the answer was yes, follow-up questions rated the degree to which the issue impaired his/her ability to do work or to read. (NCT00785577)
Timeframe: Week 5
| Intervention | participants (Number) | |
|---|---|---|
| YES | NO | |
| LY545694 105 mg | 4 | 26 |
| LY545694 21 mg | 3 | 23 |
| LY545694 49 mg | 3 | 32 |
| Placebo | 8 | 71 |
| Pregabalin | 8 | 29 |
Participants' systolic blood pressure and diastolic blood pressure were measured in millimeters of mercury (mmHg). LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | millimeters of mercury (mmHg) (Least Squares Mean) | |
|---|---|---|
| Systolic Blood Pressure (mmHg) | Diastolic Blood Pressure (mmHg) | |
| LY545694 105 mg | 0.08 | 0.77 |
| LY545694 21 mg | 0.22 | -0.07 |
| LY545694 49 mg | -0.24 | 1.88 |
| Placebo | -1.82 | -0.87 |
| Pregabalin | -3.18 | -3.60 |
BPI-S measured self-reported severity of pain. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and current pain. LS Means were adjusted for baseline, investigator, treatment, visit, a treatment-by-visit interaction, and a baseline-by-visit interaction. (NCT00785577)
Timeframe: Baseline, 5 weeks
| Intervention | units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| BPI-S Worst Pain | BPI-S Least Pain | BPI-S Average Pain | BPI-S Current Pain | |
| LY545694 105 mg | -3.13 | -1.54 | -2.25 | -2.51 |
| LY545694 21 mg | -3.49 | -1.99 | -2.79 | -2.66 |
| LY545694 49 mg | -2.94 | -2.09 | -2.50 | -2.98 |
| Placebo | -2.57 | -1.76 | -2.08 | -2.44 |
| Pregabalin | -3.54 | -2.44 | -2.92 | -3.06 |
100 mm line (VAS) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. Change = observation mean minus baseline mean. (NCT00806026)
Timeframe: Baseline, Week 12
| Intervention | mm (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | -3.20 |
| Pramipexole 0.25 mg | -2.64 |
| Pramipexole 0.5 mg | -2.75 |
| Placebo | -2.20 |
WPAI: 6 question participant rated questionnaire to determine degree to which SHP affected work productivity while at work and outside of work. Four scores are derived: percentage of absenteeism and presenteeism (reduced productivity while at work), overall work impairment score combining absenteeism and presenteeism, percentage of impairment in activities performed outside of work. Score range: 0 (not affected/no impairment) to 10 (completely affected/impaired). WPAI outcomes expressed as impairment percentages with higher numbers indicating greater impairment and less productivity. (NCT00806026)
Timeframe: Week 12
| Intervention | Percentage of impairment (Mean) | ||
|---|---|---|---|
| Overall work (n= 10, 7, 11, 10) | Activity (n= 18, 22, 25, 20) | Work time missed (n= 10, 7, 11, 10) | |
| Placebo | 14.60 | 23.00 | 1.50 |
| Pramipexole 0.25 mg | 5.70 | 20.90 | 0.00 |
| Pramipexole 0.5 mg | 9.10 | 22.80 | 0.00 |
| Pregabalin 300 mg | 6.00 | 12.20 | 0.00 |
MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Sleep adequacy data was reported at week 12 and not for first 12 weeks (average). Subscale scores range: 0-100; exception quantity of sleep (range 0-24 hours). With exception of sleep quantity and sleep adequacy, higher scores reflect poorer sleep outcomes. (NCT00806026)
Timeframe: Week 12
| Intervention | Units on a Scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sleep disturbance (n = 175, 169, 178, 171) | Snoring (n = 172, 169, 178, 170) | Awakening short of breath (n = 175, 169, 178, 171) | Sleep adequacy (n = 128, 120, 133, 125 ) | Somnolence (n = 175, 169, 178, 171) | Sleep quantity (n = 175, 169, 178, 171) | Sleep problem index I (n = 175, 169, 178, 171) | Sleep problem index II (n = 175, 169, 178, 171) | |
| Placebo | 38.60 | 24.60 | 9.60 | 50.00 | 26.00 | 6.50 | 35.00 | 36.30 |
| Pramipexole 0.25 mg | 39.30 | 25.80 | 12.30 | 54.80 | 27.60 | 6.50 | 35.30 | 36.60 |
| Pramipexole 0.5 mg | 34.40 | 25.80 | 13.80 | 55.20 | 25.50 | 6.60 | 33.40 | 34.10 |
| Pregabalin 300 mg | 30.50 | 29.00 | 10.50 | 61.30 | 23.90 | 6.80 | 29.40 | 30.70 |
"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being (physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health); 2 summary scores (physical and mental component); and self evaluated change in health status (summary of health status). The score for subscale scores and 2 summary score is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Summary of health status is a 5-point Likert scale ranging from 0=much worse now to 4=much better now. Higher subscale and summary score reflect better health status." (NCT00806026)
Timeframe: Week 12
| Intervention | Units on a Scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Physical functioning | Role physical | Bodily pain | General health | Vitality | Social functioning | Role emotional | Mental health | Summary physical score | Summary mental score | Summary of health status | |
| Placebo | 83.00 | 81.50 | 65.50 | 72.80 | 59.30 | 86.80 | 87.00 | 78.70 | 75.70 | 78.00 | 3.10 |
| Pramipexole 0.25 mg | 81.90 | 79.60 | 65.20 | 69.80 | 59.00 | 84.50 | 83.90 | 74.60 | 74.20 | 75.50 | 3.10 |
| Pramipexole 0.5 mg | 82.40 | 79.10 | 69.00 | 70.50 | 59.80 | 84.00 | 84.60 | 76.10 | 75.30 | 76.10 | 3.20 |
| Pregabalin 300 mg | 83.70 | 81.20 | 73.30 | 73.60 | 62.40 | 87.20 | 85.10 | 77.40 | 78.00 | 78.00 | 3.10 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline
| Intervention | minutes (Mean) |
|---|---|
| Pregabalin 300 mg | 90.60 |
| Pramipexole 0.25 mg | 100.20 |
| Pramipexole 0.5 mg | 83.90 |
| Placebo | 79.50 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Quality of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Quality of sleep subscale score ranges from 0-100. Higher score indicates better quality of sleep. (NCT00806026)
Timeframe: Week 12
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin 300 mg | 66.50 |
| Pramipexole 0.25 mg | 57.40 |
| Pramipexole 0.5 mg | 60.20 |
| Placebo | 57.70 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Number of awakenings subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Number of awakenings subscale score ranges from 0-30. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12
| Intervention | awakenings (Mean) |
|---|---|
| Pregabalin 300 mg | 1.10 |
| Pramipexole 0.25 mg | 1.70 |
| Pramipexole 0.5 mg | 1.50 |
| Placebo | 1.80 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Latency subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Latency subscale score ranges from 0-840 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Week 12
| Intervention | minutes (Mean) |
|---|---|
| Pregabalin 300 mg | 41.60 |
| Pramipexole 0.25 mg | 43.10 |
| Pramipexole 0.5 mg | 35.90 |
| Placebo | 47.70 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). Hours of sleep subscale: numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Hours of sleep subscale score ranges from 0-16 hours. Higher value indicates better sleep. (NCT00806026)
Timeframe: Week 12
| Intervention | hours (Mean) |
|---|---|
| Pregabalin 300 mg | 7.00 |
| Pramipexole 0.25 mg | 6.70 |
| Pramipexole 0.5 mg | 6.80 |
| Placebo | 6.70 |
ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Week 12
| Intervention | Units on a Scale (Mean) |
|---|---|
| Pregabalin 300 mg | 0.90 |
| Pramipexole 0.25 mg | 1.60 |
| Pramipexole 0.5 mg | 1.30 |
| Placebo | 1.40 |
The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline
| Intervention | Units on a Scale (Mean) |
|---|---|
| Pregabalin 300 mg | 49.30 |
| Pramipexole 0.25 mg | 51.90 |
| Pramipexole 0.5 mg | 58.40 |
| Placebo | 50.00 |
RLS QoL: Participant rated instrument used to assess the impact of RLS on quality of life and health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, traveling, sexual activity, and work) yielding a summary score ranging from 0-100. Higher scores reflect better quality of life. (NCT00806026)
Timeframe: Week 12
| Intervention | Units on Scale (Mean) |
|---|---|
| Pregabalin 300 mg | 77.75 |
| Pramipexole 0.25 mg | 73.33 |
| Pramipexole 0.5 mg | 75.48 |
| Placebo | 73.23 |
International Restless Legs Syndrome Study Group Rating Scale (IRLS) is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline
| Intervention | Units on a Scale (Mean) |
|---|---|
| Pregabalin 300 mg | 22.30 |
| Pramipexole 0.25 mg | 22.40 |
| Pramipexole 0.5 mg | 22.10 |
| Placebo | 22.40 |
Augmentation was worsening of RLS symptoms, attributable to a specific long-term therapeutic intervention for RLS. Percentage of participants with augmentation was evaluated by centralized evaluation board using a set of assessment criteria for potential augmentation which included structured interview for diagnosis of augmentation during RLS treatment (SIDA-RLS), augmentation severity rating scale (ASRS), clinical judgment. ASRS measures severity of augmentation and consist of three items to be completed by clinician. Clinician would score participants' answers by comparing post-baseline evaluations to those at baseline. ASRS total score range: 0-24, with higher score indicating more severe augmentation. (NCT00806026)
Timeframe: Baseline up to Week 52
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin 300 mg | 1.70 |
| Pramipexole 0.25 mg | 6.60 |
| Pramipexole 0.5 mg | 9.00 |
"CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. Responders were defined as participants who report CGI-I score of very much improved or much improved." (NCT00806026)
Timeframe: Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin 300 mg | 71.40 |
| Pramipexole 0.25 mg | 51.20 |
| Pramipexole 0.5 mg | 62.70 |
| Placebo | 46.80 |
MOS-SS: Participant rated instrument to assess sleep quantity, quality; comprised of 12 items yielding 7 subscale scores: sleep disturbance, snoring, awakening short of breath/ headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, 2 composite index scores: sleep problems Index I, II. Optimal sleep subscale scores range: 0-1; Optimal sleep = 1 if 'Average hours sleep' = 7 or 8, is 0 if 'Average hours sleep' is non-missing and less than 7, and is missing if 'Average hours sleep' is missing. Higher scores reflect better sleep outcomes. (NCT00806026)
Timeframe: Week 12
| Intervention | Participants (Number) |
|---|---|
| Pregabalin 300 mg | 84 |
| Pramipexole 0.25 mg | 64 |
| Pramipexole 0.5 mg | 77 |
| Placebo | 68 |
100 millimeter (mm) line (Visual Analog Scale) marked by participant. Intensity of pain range (over past week): 0 mm = no pain to 100 mm = worst possible pain. (NCT00806026)
Timeframe: Baseline
| Intervention | mm (Mean) |
|---|---|
| Pregabalin 300 mg | 4.20 |
| Pramipexole 0.25 mg | 4.30 |
| Pramipexole 0.5 mg | 4.00 |
| Placebo | 4.10 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal-not ill at all) to 7 (among the most extremely ill participants). Higher score = more affected. (NCT00806026)
Timeframe: Week 12
| Intervention | Units on a Scale (Mean) |
|---|---|
| Pregabalin 300 mg | 2.90 |
| Pramipexole 0.25 mg | 3.50 |
| Pramipexole 0.5 mg | 3.10 |
| Placebo | 3.70 |
IRLS is psychometrically and clinically valid and reliable clinician-administered instrument used to assess the severity of RLS. It assesses RLS symptom severity and impact on daily living and is comprised of 10 items, scored on 0 to 4 scale, where lower score indicates lower symptom severity/impact on living. Two subscale scores are symptom severity (6 items) ranging from 0-24 (lower score indicates lower symptom severity) and impact on daily living (3 items) ranging from 0-12 (lower score indicates lower impact on living). Item 3 is unrelated to the other items. The global score is calculated from all 10 items, range from 0 to 40, where lower scores reflect lower severity and better quality of life. (NCT00806026)
Timeframe: Baseline, Week 12
| Intervention | Units on a Scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | -11.80 |
| Pramipexole 0.25 mg | -7.90 |
| Pramipexole 0.5 mg | -10.50 |
| Placebo | -7.30 |
SSQ: Participant-rated instrument used to assess previous night's sleep profile. It is used to measure sleep quantity and quality and is comprised of 5 items yielding 5 subscale scores: latency (1 item), hours of sleep (1 item), number of awakenings (1 item), total WASO (1 item), quality of sleep (1 item). WASO is time spent awake from sleep onset to final awakening. Total WASO subscale (in minutes): numerical rating completed by the participant 30 minutes after waking; recall period is the night before. Total WASO subscale score ranges from 0-1440 minutes. Lower value indicates better sleep. (NCT00806026)
Timeframe: Baseline, Week 12
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | -49.86 |
| Pramipexole 0.25 mg | -33.69 |
| Pramipexole 0.5 mg | -37.18 |
| Placebo | -32.61 |
The RLS-NDI is a participant-rated instrument designed to assess daytime performance as related to RLS and the participant's previous night's sleep. The instrument consists of 14 items that encompass 5 domains: tiredness; emotional functioning; social functioning; cognitive functioning; and activities of daily living. There is also 1 global item assessing overall well -being. Each item is scored on a 0-10 numeric rating scale. Total score is the sum of scores from question 1 to 14. The total score ranges from 0 to 140 where higher scores indicate a more severe impact. (NCT00806026)
Timeframe: Baseline, Week 12
| Intervention | Units on a Scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | -8.10 |
| Pramipexole 0.25 mg | -4.30 |
| Pramipexole 0.5 mg | -14.50 |
| Placebo | -6.60 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 1.9 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 7.2 |
"The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | mm (Mean) |
|---|---|
| Pregabalin | -13.1 |
"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Physical Functioning | Feel Good | Work Missed | Difficulty Working | Pain | Fatigue | Morning Tiredness | Stiffness | Anoxiouness | Depression | |
| Pregabalin | -0.2 | -0.4 | -0.5 | -0.7 | -1.0 | -0.3 | -0.6 | -0.7 | -0.3 | -0.2 |
Any untoward medical occurrence in a participant who received study drug was considered an adverse event (AE), without regard to possibility of causal relationship. Treatment-emergent adverse events: those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; lifethreatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. (NCT00830128)
Timeframe: Up to 53 weeks
| Intervention | Participants (Number) | |
|---|---|---|
| All-causality adverse events (AEs) | All-causality SAEs | |
| Pregabalin | 102 | 3 |
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Number of participants with response = YES if sleep quantity is 7 or 8 hours per night or response = NO if sleep quantity is < 7 hours per night. (NCT00830128)
Timeframe: Week 52 or Study Discontinuation
| Intervention | Paticipants (Number) | |
|---|---|---|
| Yes | No | |
| Pregabalin | 26 | 80 |
"FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment.~Change = mean FIQ scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -4.9 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -3.0 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means worse symptoms.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -3.7 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score means greater quantity of sleep.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | hours (Mean) |
|---|---|
| Pregabalin | 0.3 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep adequacy.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 4.2 |
"MOS: patient rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score means greater sleep disturbance.~Change = mean scores at observation minus mean scores at baseline." (NCT00830128)
Timeframe: Baseline, Week 52 or Study Discontinuation
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | -9.6 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.94 |
| Pregabalin | -1.43 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.51 |
| Pregabalin | -0.55 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 2.83 |
| Pregabalin | 4.66 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 9.50 |
| Pregabalin | 11.65 |
Change from baseline in mean NRS-Pain scores at endpoint-LOCF. Daily pain scores were assessed on an 11-point numerical rating scale <(NRS)-Pain> ranging from 0 (no pain) to 10 (worst possible pain). (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.03 |
| Pregabalin | -1.48 |
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse) , 6 (much worse) or 7 (very much worse) on the scale. (NCT00830167)
Timeframe: Week 15 or study discontinuation
| Intervention | Percentage of participants (Number) |
|---|---|
| Placebo | 62.1 |
| Pregabalin | 70.0 |
MOS-Sleep is a patient-rated questionnaire to assess sleep quality and quantity. Optimal sleep component is derived from Sleep Quantity average hours of sleep each night during the past 4 weeks. Optimal sleep was defined as sleep quantity of 7 or 8 hours per night. (NCT00830167)
Timeframe: Week 15 or study discontinuation
| Intervention | Participants (Number) |
|---|---|
| Placebo | 53 |
| Pregabalin | 71 |
Change: Mean sleep quality score at endpoint minus mean at baseline. Sleep quality scores range from 0-10 with higher scores indicating decreased sleep quality. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.79 |
| Pregabalin | -1.52 |
The pain VAS is a horizontal line; 100 mm in length, self-administered by the patient to rate pain from 0 (no pain) to 100 (worst possible pain). The score indicates the pain intensity during the past 1 week before a visit. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -14.11 |
| Pregabalin | -20.30 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Somnolence subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of somnolence. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -4.66 |
| Pregabalin | 6.65 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Snoring subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of snoring. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.61 |
| Pregabalin | 3.37 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Disturbance subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep disturbance. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -8.13 |
| Pregabalin | -17.62 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Sleep Adequacy subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of sleep adequacy. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 8.02 |
| Pregabalin | 15.50 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Quantity of Sleep subscales rated 0 to 24 (number of hours slept). A higher score indicates greater quantity of sleep. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 0.17 |
| Pregabalin | 0.46 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Overall Sleep Problems Index subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of overall sleep problems. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -7.07 |
| Pregabalin | -10.06 |
MOS: participant-rated questionnaire to assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); The MOS Awaken Short of Breath or With a Headache subscales rated 1 (all the time) to 6 (none of the time). Scores are transformed (actual raw score minus lowest possible score) divided by possible raw score range multiplied by 100; total score range = 0 to 100. A higher score indicates greater intensity of the symptom. Change = mean scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -3.02 |
| Pregabalin | -8.01 |
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 0.00 |
| Pregabalin | -0.29 |
Change: Mean HADS score at observation minus Mean at baseline. HADS anxiety and depression subscale scores range from 0 to 21, with higher scores indicating greater severity of the subscale condition. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.09 |
| Pregabalin | -0.57 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.30 |
| Pregabalin | -0.31 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -7.26 |
| Pregabalin | -10.59 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.90 |
| Pregabalin | -1.05 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.19 |
| Pregabalin | -0.47 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.06 |
| Pregabalin | -1.46 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.97 |
| Pregabalin | -1.56 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.00 |
| Pregabalin | -1.32 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.82 |
| Pregabalin | -1.45 |
FIQ is a 20-item patient-reported outcome instrument designed to assess health status, progress, and outcomes in patients with fibromyalgia (10 subscales; 11 questions). Scores range from 0 to 100 with higher scores indicating more impairment. Change = mean FIQ scores at observation minus mean scores at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | -0.64 |
| Pregabalin | -0.92 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 5.12 |
| Pregabalin | 9.53 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 6.84 |
| Pregabalin | 8.43 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 8.36 |
| Pregabalin | 10.04 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 3.50 |
| Pregabalin | 3.27 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 4.72 |
| Pregabalin | 9.01 |
Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations-physical, bodily pain, general health perceptions, vitality, social functioning, role limitations-emotional, and mental health. Subscale scores range: 0-100. Higher subscale scores = better health status. Change from baseline = score at observation minus score at baseline. (NCT00830167)
Timeframe: Baseline, Week 15 or study discontinuation
| Intervention | Scores on a scale (Least Squares Mean) |
|---|---|
| Placebo | 3.33 |
| Pregabalin | 5.97 |
The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week. Q1:Have you felt calm and relaxed? Q2: Have you felt full of energy? Q3: Have you felt discouraged and sad? Final Visit = Week 8 or time of discontinuation. (NCT00843284)
Timeframe: Baseline, Final Visit (Week 8 or discontinuation)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Q1 at baseline: Always | Q1 at baseline: Most of the time | Q1 at baseline: Fairly often | Q1 at baseline: Sometimes | Q1 at baseline: Rarely | Q1 at baseline: Never | Q1 at baseline: Missing | Q1 at baseline: Not done | Q1 at final visit: Always | Q1 at final visit: Most of the time | Q1 at final visit: Fairly often | Q1 at final visit: Sometimes | Q1 at final visit: Rarely | Q1 at final visit: Never | Q1 at final visit: Missing | Q1 at final visit: Not done | Q2 at baseline: Always | Q2 at baseline: Most of the time | Q2 at baseline: Fairly often | Q2 at baseline: Sometimes | Q2 at baseline: Rarely | Q2 at baseline: Never | Q2 at baseline: Missing | Q2 at baseline: Not done | Q2 at final visit: Always | Q2 at final visit: Most of the time | Q2 at final visit: Fairly often | Q2 at final visit: Sometimes | Q2 at final visit: Rarely | Q2 at final visit: Never | Q2 at final visit: Missing | Q2 at final visit: Not done | Q3 at baseline: Always | Q3 at baseline: Most of the time | Q3 at baseline: Fairly often | Q3 at baseline: Sometimes | Q3 at baseline: Rarely | Q3 at baseline: Never | Q3 at baseline: Missing | Q3 at baseline: Not done | Q3 at final visit: Always | Q3 final visit: Most of the time | Q3 at final visit: Fairly often | Q3 at final visit: Sometimes | Q3 at final visit: Rarely | Q3 at final visit: Never | Q3 at final visit: Missing | Q3 at final visit: Not done | |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 8 | 14 | 57 | 199 | 186 | 183 | 0 | 21 | 27 | 152 | 168 | 176 | 72 | 37 | 1 | 35 | 5 | 15 | 62 | 150 | 196 | 219 | 0 | 21 | 21 | 108 | 168 | 174 | 102 | 59 | 1 | 35 | 48 | 167 | 190 | 143 | 59 | 40 | 0 | 21 | 7 | 37 | 73 | 179 | 161 | 175 | 1 | 35 |
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine. (NCT00843284)
Timeframe: Baseline, Final Visit (Week 8 or discontinuation)
| Intervention | scores on scale (Mean) | ||
|---|---|---|---|
| Baseline | Final visit (Week 8 or discontinuation) | Change from baseline | |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 7.61 | 3.46 | -4.16 |
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep (NCT00843284)
Timeframe: Baseline, Final Visit (Week 8 or discontinuation)
| Intervention | scores on a scale (Mean) | ||
|---|---|---|---|
| Baseline | Final visit (Week 8 or discontinuation) | Change from baseline | |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 6.28 | 2.27 | -4.02 |
"Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from very much improved to very much worse." (NCT00843284)
Timeframe: Final Visit (Week 8 or discontinuation)
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Not assessed | Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | Not done | |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 0 | 175 | 245 | 193 | 44 | 7 | 2 | 0 | 0 |
"Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from very much improved to very much worse." (NCT00843284)
Timeframe: Final Visit (Week 8 or discontinuation)
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Not assessed | Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | Not done | |
| Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses) | 0 | 160 | 292 | 171 | 39 | 1 | 2 | 0 | 0 |
Numerical assessment of change in total number of days hospitalized because of epilepsy during the study. (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | Days (Mean) |
|---|---|
| All Antiepileptic Drugs | -8.0 |
Percent of participants with cessation of usual occupation, requirement of an informal caregiver, and who required admission to the intensive care unit (ICU). (NCT00855738)
Timeframe: Month 6
| Intervention | percent of participants (Number) | ||
|---|---|---|---|
| Stopped Usual Occupation | Required Informal Caregiver | Required Admission to ICU | |
| All Antiepileptic Drugs | 16.2 | 6.6 | 0.0 |
MOS-SS: subject rated instrument used to assess the key constructs of sleep; assesses sleep quantity and quality and is comprised of 12 items yielding 7 subscale scores and 2 composite index scores. Optimal sleep subscale is derived from sleep quantity average hours of sleep over the past 4 weeks; percent of participants with response YES (optimal) if sleep quantilty was 7-8 hours of sleep per night. (NCT00855738)
Timeframe: Baseline, Month 6
| Intervention | percent of participants (Number) | |
|---|---|---|
| Baseline | Month 6 | |
| All Antiepileptic Drugs | 56.5 | 65.7 |
Responder = decrease in number of seizures by >=50 percent (%) during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the number of seizures that occurred during the 3 months before the baseline visit (baseline). (NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)
| Intervention | percent of participants (Number) | |
|---|---|---|
| Month 3 | Month 6 | |
| All Antiepileptic Drugs | 76.7 | 80.0 |
(NCT00855738)
Timeframe: Baseline through Month 6 (or end of treatment)
| Intervention | percent of participants (Number) | ||
|---|---|---|---|
| Reduced | Maintained | Increased | |
| All Antiepileptic Drugs | 0.0 | 100.0 | 0.0 |
(NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)
| Intervention | percent of participants (Number) | ||
|---|---|---|---|
| Reduced | Maintained | Increased | |
| All Antiepileptic Drugs | 0.9 | 68.5 | 30.6 |
Subject rated instrument to assess key constructs of sleep; assesses sleep quality and quantity. Consists of a 6-item and 9-item overall sleep problems index measuring time to fall asleep and sleep duration in past 4 weeks; 5 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath, somnolence, and adequacy. Transformed scores range = 0 to 100; higher score indicates greater intensity of attribute. Two additional subscales = sleep quantity (range 0-24 hours) and optimal sleep (number of participants with optimal sleep 7-8 hours per night). (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | scores on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sleep disturbance | Snoring | Awake short of breath | Quantity | Adequacy | Somnolence | Sleep problems (summary 6) | Sleep problems (summary 9) | |
| All Antiepileptic Drugs | -1.7 | 0.0 | 1.1 | 0.2 | 2.8 | 0.6 | -0.9 | -0.9 |
Percent of participants with reduction in number of seizures >=25% and >=75% during the last 3 months of treatment before discontinuation (assessed at Month 3 and Month 6) versus the 3 month period before the baseline visit. (NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)
| Intervention | percent of participants (Number) | |||
|---|---|---|---|---|
| Month 3: >=25% | Month 3: >=75% | Month 6: >= 25% | Month 6: >=75% | |
| All Antiepileptic Drugs | 86.7 | 27.8 | 86.7 | 54.4 |
(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)
| Intervention | percent of participants (Number) | |
|---|---|---|
| Month 3 | Month 6 | |
| All Antiepileptic Drugs | 10.0 | 20.0 |
Assessment of the health condition of the subjects using the EQ-5D VAS: subject rated questionnaire to assess health-related quality of life in terms of a single index value. Using the VAS subjects rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. (NCT00855738)
Timeframe: Baseline, Month 3, Month 6
| Intervention | scores on scale (Mean) | |
|---|---|---|
| Month 3 | Month 6 | |
| All Antiepileptic Drugs | -0.4 | 1.2 |
Numerical assessment of change in the number of visits to a specialist or the emergency room because of epilepsy needed during the study. (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | visits (Mean) | |
|---|---|---|
| Number of visits to a specialist (n=94) | Number of visits to the emergency room (n=79) | |
| All Antiepileptic Drugs | -0.6 | -0.3 |
HADS: subject rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | scores on scale (Mean) | |
|---|---|---|
| Depression | Anxiety | |
| All Antiepileptic Drugs | -0.5 | -0.6 |
QOLIE-10: 10-item questionnaire evaluates health-related quality of life in individuals with epliepsy. Comprised of 7 components: seizure worry, overall quality of life, emotional well-being, energy, cognitive functioning, medication effects (physical and mental effects), and social function (work, driving, social function). Total score rated 0 to 100; higher score = higher quality of life. (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | scores on scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Energy | Emotions (mood) | Daily activities | Mental function | Medication effects (physical/ mental) | Worry about seizures (impact of seizures) | Overall quality of life | |
| All Antiepileptic Drugs | 0.4 | 0.7 | 0.6 | 1.2 | -1.1 | 9.0 | 3.8 |
Number of days to first seizure after baseline. (NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)
| Intervention | days (Mean) |
|---|---|
| All Antiepileptic Drugs | 35.9 |
Retention rate: percent of participants who continued on study medication throughout the 6 Month period after inclusion in the study. (NCT00855738)
Timeframe: Baseline to Month 6
| Intervention | percent of participants (Number) |
|---|---|
| All Antiepileptic Drugs | 97.1 |
Percent of participants who started on more than one treatment (bitherapy) and reached monotherapy by end of study. (NCT00855738)
Timeframe: Baseline through Month 6 (or end of study)
| Intervention | percent of partipants (Number) |
|---|---|
| All Antiepileptic Drugs | 2.9 |
(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)
| Intervention | percent change (Median) |
|---|---|
| All Antiepileptic Drugs | -75.0 |
LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 51.23 | 49.94 | 48.92 | 46.70 |
| Pregabalin | 43.56 | 42.27 | 43.24 | 40.51 |
TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 370.6 |
| Pregabalin | 396.2 |
WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 9.19 |
| Pregabalin | 7.38 |
sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 80.86 | 75.48 | 74.97 | 69.65 |
| Pregabalin | 62.59 | 59.43 | 61.73 | 59.40 |
NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Awakenings (Least Squares Mean) |
|---|---|
| Placebo | 26.92 |
| Pregabalin | 24.51 |
NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Awakenings (Least Squares Mean) |
|---|---|
| Placebo | 10.16 |
| Pregabalin | 8.63 |
SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Percentage of time asleep (Least Squares Mean) |
|---|---|
| Placebo | 77.21 |
| Pregabalin | 82.64 |
SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Percentage of total sleep time (Least Squares Mean) |
|---|---|
| Placebo | 15.04 |
| Pregabalin | 17.18 |
sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 336.8 | 341.9 | 344.1 | 352.5 |
| Pregabalin | 361.7 | 371.3 | 370.9 | 377.9 |
Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Unit on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 4.79 | 4.95 | 5.09 | 5.17 |
| Pregabalin | 5.70 | 6.09 | 5.96 | 6.06 |
Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores. (NCT00883740)
Timeframe: Daily up to Day 73 or ET
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 6.12 | 5.81 | 5.73 | 5.44 |
| Pregabalin | 5.42 | 5.10 | 5.14 | 4.92 |
WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 63.38 |
| Pregabalin | 45.83 |
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Change Week 1 to Week 5 (n=59, 56) | Change Week 7 to Week 11 (50, 52) | |
| Placebo | -16.4 | -0.98 |
| Pregabalin | -21.9 | -14.4 |
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Change Week 1 to Week 5 (n=59, 56) | Change Week 7 to Week 11 (n=50, 52) | |
| Placebo | -19.0 | -2.23 |
| Pregabalin | -27.1 | -21.0 |
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 70.69 |
| Pregabalin | 51.54 |
LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 41.63 |
| Pregabalin | 34.45 |
WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Quarter 1 | Quarter 2 | Quarter 3 | Quarter 4 | |
| Placebo | 7.23 | 16.04 | 21.73 | 28.04 |
| Pregabalin | 5.98 | 10.04 | 14.90 | 22.60 |
WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hour 1 | Hour 2 | Hour 3 | Hour 4 | Hour 5 | Hour 6 | Hour 7 | Hour 8 | |
| Placebo | 1.96 | 5.66 | 7.09 | 8.95 | 10.55 | 11.26 | 10.96 | 17.08 |
| Pregabalin | 1.62 | 4.56 | 4.65 | 5.43 | 7.54 | 7.38 | 8.38 | 14.23 |
Physician's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of the CGI has a scale of five discrete score points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=272); Final Vst: Excellent | 2nd Visit: Excellent (n=272); Final Vst: Very Good | 2nd Visit: Excellent (n=272); Final Visit: Good | 2nd Visit: Excellent (n=272); Final Visit: Fair | 2nd Visit: Excellent (n=272); Final Visit: Poor | 2nd Visit: Excellent (n=272); Final Visit: Missing | 2nd Visit: Very Good (n=803); Final Vst: Excellent | 2nd Visit: Very Good (n=803); Final Vst: Very Good | 2nd Visit: Very Good (n=803); Final Visit: Good | 2nd Visit: Very Good (n=803); Final Visit: Fair | 2nd Visit: Very Good (n=803); Final Visit: Poor | 2nd Visit: Very Good (n=803); Final Visit: Missing | 2nd Visit: Good (n=438); Final Visit: Excellent | 2nd Visit: Good (n=438); Final Visit: Very Good | 2nd Visit: Good (n=438); Final Visit: Good | 2nd Visit: Good (n=438); Final Visit: Fair | 2nd Visit: Good (n=438); Final Visit: Poor | 2nd Visit: Good (n=438); Final Visit: Missing | 2nd Visit: Fair (n=71); Final Visit: Excellent | 2nd Visit: Fair (n=71); Final Visit: Very Good | 2nd Visit: Fair (n=71); Final Visit: Good | 2nd Visit: Fair (n=71); Final Visit: Fair | 2nd Visit: Fair (n=71); Final Visit: Poor | 2nd Visit: Fair (n=71); Final Visit: Missing | 2nd Visit: Poor (n=7); Final Visit: Excellent | 2nd Visit: Poor (n=7); Final Visit: Very Good | 2nd Visit: Poor (n=7); Final Visit: Good | 2nd Visit: Poor (n=7); Final Visit: Fair | 2nd Visit: Poor (n=7); Final Visit: Poor | 2nd Visit: Poor (n=7); Final Visit: Missing | 2nd Visit: Missing (n=12); Final Visit: Excellent | 2nd Visit: Missing (n=12); Final Visit: Very Good | 2nd Visit: Missing (n=12); Final Visit: Good | 2nd Visit: Missing (n=12); Final Visit: Fair | 2nd Visit: Missing (n=12); Final Visit: Poor | 2nd Visit: Missing (n=12); Final Visit: Missing | |
| Pregabalin | 209 | 6 | 2 | 0 | 0 | 55 | 307 | 421 | 10 | 0 | 0 | 65 | 27 | 267 | 119 | 4 | 0 | 21 | 7 | 22 | 30 | 3 | 1 | 8 | 0 | 1 | 2 | 1 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 12 |
Patient's Clinical Global Impression of efficacy. Efficacy item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=264); Final Visit: Excell | 2nd Visit: Excellent (n=264); Final Vst: Very Good | 2nd Visit: Excellent (n=264); Final Visit: Good | 2nd Visit: Excellent (n=264); Final Visit: Fair | 2nd Visit: Excellent (n=264); Final Visit: Poor | 2nd Visit: Excellent (n=264); Final Visit: Missing | 2nd Visit: Very Good (n=775); Final Visit: Excell | 2nd Visit: Very Good (n=775); Final Vst: Very Good | 2nd Visit: Very Good (n=775); Final Visit: Good | 2nd Visit: Very Good (n=775); Final Visit: Fair | 2nd Visit: Very Good (n=775); Final Visit: Poor | 2nd Visit: Very Good (n=775); Final Visit: Missing | 2nd Visit: Good (n=450); Final Visit: Excellent | 2nd Visit: Good (n=450): Final Visit: Very Good | 2nd Visit: Good (n=450); Final Visit: Good | 2nd Visit: Good (n=450); Final Visit: Fair | 2nd Visit: Good (n=450); Final Visit: Poor | 2nd Visit: Good (n=450); Final Visit: Missing | 2nd Visit: Fair (n=75); Final Visit: Excellent | 2nd Visit: Fair (n=75); Final Visit: Very Good | 2nd Visit: Fair (n=75); Final Visit: Good | 2nd Visit: Fair (n=75); Final Visit: Fair | 2nd Visit: Fair (n=75); Final Visit: Poor | 2nd Visit: Fair (n=75); Final Visit: Missing | 2nd Visit: Poor (n=12); Final Visit: Excellent | 2nd Visit :Poor (n=12); Final Visit: Very Good | 2nd Visit: Poor (n=12); Final Visit: Good | 2nd Visit: Poor (n=12); Final Visit: Fair | 2nd Visit: Poor (n=12); Final Visit: Poor | 2nd Visit: Poor (n=12); Final Visit: Missing | 2nd Visit: Missing (n=27); Final Visit: Excellent | 2nd Visit: Missing (n=27); Final Visit: Very Good | 2nd Visit: Missing (n=27); Final Visit: Good | 2nd Visit: Missing (n=27); Final Visit: Fair | 2nd Visit: Missing (n=27); Final Visit: Poor | 2nd Visit: Missing (n=27); Final Visit: Missing | |
| Pregabalin | 206 | 8 | 0 | 0 | 0 | 50 | 286 | 405 | 12 | 1 | 0 | 71 | 34 | 266 | 127 | 1 | 0 | 22 | 6 | 21 | 32 | 10 | 0 | 6 | 1 | 2 | 2 | 0 | 3 | 4 | 0 | 3 | 0 | 1 | 0 | 23 |
Discontinuations due to adverse events by MedDRA system organ class and preferred term. (NCT00892008)
Timeframe: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cardiac Disorders: palpitations | Ear and Labyrinth Disorders: vertigo | Gastrointestinal Disorders: nausea | Gastrointestinal Disorders: vomiting | General/ Administrative Site Conditions: asthenia | Nervous System Disorders: somnolence | Resp., Thoracic & Mediastinal Disorders: snoring | Vascular Disorders: hypertension | |
| Pregabalin | 1 | 1 | 5 | 3 | 2 | 26 | 1 | 1 |
Number and severity of adverse events, including serious adverse events. If the same subject had more than one occurance in the same preferred term event category, only the most severe occurrence was taken. (NCT00892008)
Timeframe: Baseline through Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cardiac Disorders | palpitations (mild) | Ear and Labyrinth Disorders | ear disorder (moderate) | vertigo (moderate) | vertigo (severe) | Gastrointestinal Disorders | abdominal discomfort (moderate) | abdominal distension (unspecified) | abdominal pain (upper) | constipation (unspecified) | constipation (mild) | diarrhoea (mild) | diarrhoea (moderate) | dry mouth (mild) | dry mouth (moderate) | dyspepsia (mild) | epigastric discomfort (mild) | nausea (mild) | nausea (moderate) | nausea (severe) | vomiting (mild) | vomiting (moderate) | vomiting (severe) | General Disorders & Administration Site Conditions | asthenia (mild) | asthenia (moderate) | asthenia (severe) | fatigue (moderate) | ill-defined disorder (mild) | ill-defined disorder (moderate) | ill-defined disorder (severe) | irritability (mild) | irritability (moderate) | multi-organ failure (unspecified) | oedema peripheral (unspecified) | oedema peripheral (moderate) | pyrexia (mild) | Hepatobiliary Disorders | jaundice (moderate) | Infections and Infestations | bronchopneumonia (unspecified) | pneumonia (unspecified) | Investigations | weight increased (moderate) | Metabolism and Nutrition Disorders | anorexia (moderate) | hypoglycemia (moderate) | increased appetite (mild) | Musculoskeletal and Connective Tissue Disorders | muscular weakness (mild) | myalgia (mild) | Neoplasms Benign, Malignant and Unspecified | breast cancer stage III (unspecified) | metastases to central nervous system (unspecified) | metastatic neoplasm (unspecified) | Nervous System Disorders | balance disorder (mild) | dizziness (unspecified) | dizziness (mild) | dizziness (moderate) | dizziness (severe) | headache (mild) | headache (moderate) | hypersomnia (mild) | hypersomnia (moderate) | incoherent (moderate) | neuralgia (unspecified) | paraesthesia (mild) | sedation (moderate) | sedation (severe) | somnolence (unspecified) | somnolence (mild) | somnolence (moderate) | somnolence (severe) | syncope (moderate) | syncope (severe) | tremor (moderate) | Psychiatric Disorders | abnormal dreams (moderate) | confusional state (mild) | insomnia (severe) | Reproductive and Breast Disorders | ejaculation disorder (unspecified) | Respiratory, Thoracic and Mediastinal Disorders | dyspnoea (severe) | dyspnoea exertional (mild) | snoring (severe) | Skin and Subcutaneous Tissue Disorders | rash generalized (severe) | Vascular Disorders | hypertension (unspecified) | hypotension (moderate) | pallor (mild) | |
| Pregabalin | 1 | 1 | 3 | 1 | 1 | 1 | 44 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 3 | 1 | 1 | 10 | 13 | 4 | 8 | 4 | 1 | 20 | 2 | 2 | 1 | 2 | 5 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 2 | 1 | 1 | 3 | 1 | 1 | 1 | 233 | 1 | 2 | 79 | 47 | 8 | 3 | 1 | 5 | 2 | 1 | 1 | 1 | 3 | 2 | 3 | 62 | 24 | 4 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 |
Patient's Clinical Global Impression of tolerability. The tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. Abbreviation: vst = visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=278); Final Visit: Excell | 2nd Visit: Excellent (n=278); Final Vst: Very Good | 2nd Visit: Excellent (n=278); Final Visit: Good | 2nd Visit: Excellent (n=278); Final Visit: Fair | 2nd Visit: Excellent (n=278); Final Visit: Poor | 2nd Visit: Excellent (n=278); Final Visit: Missing | 2nd Visit: Very Good (n=750); Final Visit: Excell | 2nd Visit: Very Good (n=750); Final Vst: Very Good | 2nd Visit: Very Good (n=750); Final Visit: Good | 2nd Visit: Very Good (n=750); Final Visit: Fair | 2nd Visit: Very Good (n=750); Final Visit: Poor | 2nd Visit: Very Good (n=750); Final Visit: Missing | 2nd Visit: Good (n=465); Final Visit: Excellent | 2nd Visit: Good (n=465); Final Visit: Very Good | 2nd Visit: Good (n=465); Final Visit: Good | 2nd Visit: Good (n=465); Final Visit: Fair | 2nd Visit: Good (n=465); Final Visit: Poor | 2nd Visit: Good (n=465); Final Visit: Missing | 2nd Visit: Fair (n=71); Final Visit: Excellent | 2nd Visit: Fair (n=71); Final Visit: Very Good | 2nd Visit: Fair (n=71); Final Visit: Good | 2nd Visit: Fair (n=71); Final Visit: Fair | 2nd Visit: Fair (n=71); Final Visit: Poor | 2nd Visit: Fair (n=71); Final Visit: Missing | 2nd Visit: Poor (n=11); Final Visit: Excellent | 2nd Visit: Poor (n=11); Final Visit: Very Good | 2nd Visit: Poor (n=11); Final Visit: Good | 2nd Visit: Poor (n=11); Final Visit: Fair | 2nd Visit: Poor (n=11); Final Visit: Poor | 2nd Visit: Poor (n=11); Final Visit: Missing | 2nd Visit: Missing (n=28); Final Visit: Excellent | 2nd Visit: Missing (n=28); Final Visit: Very Good | 2nd Visit: Missing (n=28); Final Visit: Good | 2nd Visit: Missing (n=28); Final Visit: Fair | 2nd Visit: Missing (n=28); Final Visit: Poor | 2nd Visit: Missing (n=28); Final Visit: Missing | |
| Pregabalin | 213 | 14 | 0 | 0 | 0 | 51 | 257 | 415 | 13 | 1 | 0 | 64 | 27 | 255 | 151 | 4 | 2 | 26 | 8 | 18 | 31 | 7 | 1 | 6 | 1 | 2 | 1 | 0 | 3 | 4 | 1 | 2 | 0 | 1 | 0 | 24 |
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at second visit and final visit minus score at Baseline. (NCT00892008)
Timeframe: Baseline, Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | scores on scale (Mean) | |
|---|---|---|
| Second Visit (n=1472) | Final Visit (n=1126) | |
| Pregabalin | 3.5 | 5.1 |
VAS Pain Score 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Final Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit. (NCT00892008)
Timeframe: Baseline, Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BL: Mild Pain (n=25); Final Visit: Mild Pain | BL: Mild Pain (n=25); Final Visit: Moderate Pain | BL: Mild Pain (n=25); Final Visit: Severe Pain | BL: Mild Pain (n=25); Final Visit: Missing | BL: Moderate Pain (n=450); Final Visit: Mild Pain | BL: Moderate Pain (n=450); Final Visit: Mod. Pain | BL: Moderate Pain (n=450); Final Visit: Sev. Pain | BL: Moderate Pain (n=450); Final Visit: Missing | BL: Severe Pain (n=985); Final Visit: Mild Pain | BL: Severe Pain (n=985); Final Visit: Mod. Pain | BL: Severe Pain (n=985); Final Visit: Severe Pain | BL: Severe Pain (n=985); Final Visit: Missing | BL: Worst Poss. Pain (n=98); Final Vst: Mild Pain | BL: Worst Poss. Pain (n=98); Final Vst: Mod Pain | BL: Worst Poss. Pain (n=98); Final Visit: Sev Pain | BL: Worst Poss. Pain (n=98); Final Visit: Missing | BL: Missing (n=45); Final Visit: Mild Pain | BL: Missing (n=45); Final Visit: Moderate Pain | BL: Missing (n=45); Final Visit: Severe Pain | BL: Missing (n=45); Final Visit: Missing | |
| Pregabalin | 12 | 0 | 0 | 13 | 272 | 19 | 1 | 158 | 602 | 134 | 6 | 243 | 54 | 25 | 1 | 18 | 4 | 1 | 1 | 39 |
Physician's Clinical Global Impression of tolerability. Tolerability item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=309); Final Visit: Excell | 2nd Visit: Excellent (n=309); Final Vst: Very Good | 2nd Visit: Excellent (n=309); Final Visit: Good | 2nd Visit: Excellent (n=309); Final Visit: Fair | 2nd Visit: Excellent (n=309); Final Visit: Poor | 2nd Visit: Excellent (n=309); Final Visit: Missing | 2nd Visit: Very Good (n=764); Final Visit: Excell | 2nd Visit: Very Good (n=764); Final Vst:Very Good | 2nd Visit: Very Good (n=764); Final Visit: Good | 2nd Visit: Very Good (n=764); Final Visit: Fair | 2nd Visit: Very Good (n=764); Final Visit: Poor | 2nd Visit: Very Good (n=764); Final Visit: Missing | 2nd Visit: Good (n=436); Final Visit: Excellent | 2nd Visit: Good (n=436); Final Visit: Very Good | 2nd Visit: Good (n=436); Final Visit: Good | 2nd Visit: Good (n=436); Final Visit: Fair | 2nd Visit: Good (n=436); Final Visit: Poor | 2nd Visit: Good (n=436); Final Visit: Missing | 2nd Visit: Fair (n=67); Final Visit: Excellent | 2nd Visit: Fair (n=67); Final Visit: Very Good | 2nd Visit: Fair (n=67); Final Visit: Good | 2nd Visit: Fair (n=67); Final Visit: Fair | 2nd Visit: Fair (n=67); Final Visit: Poor | 2nd Visit: Fair (n=67); Final Visit: Missing | 2nd Visit: Poor (n=6); Final Visit: Excellent | 2nd Visit: Poor (n=6); Final Visit: Very Good | 2nd Visit: Poor (n=6); Final Visit: Good | 2nd Visit: Poor (n=6); Final Visit: Fair | 2nd Visit: Poor (n=6); Final Visit: Poor | 2nd Visit: Poor (n=6); Final Visit: Missing | 2nd Visit: Missing (n=21); Final Visit: Excellent | 2nd Visit: Missing (n=21); Final Visit: Very Good | 2nd Visit: Missing (n=21); Final Visit: Good | 2nd Visit: Missing (n=21); Final Visit: Fair | 2nd Visit: Missing (n=21); Final Visit: Poor | 2nd Visit: Missing (n=21); Final Visit: Missing | |
| Pregabalin | 237 | 12 | 0 | 0 | 0 | 60 | 255 | 431 | 9 | 1 | 1 | 67 | 24 | 254 | 135 | 1 | 1 | 21 | 6 | 19 | 30 | 5 | 1 | 6 | 1 | 0 | 1 | 0 | 3 | 1 | 1 | 2 | 0 | 0 | 0 | 18 |
VAS Pain Score: 10 cm (10-point) pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Shift table shows the number of subjects with each pain intensity rating at the Second Visit by the number of subjects with each pain intensity rating at Baseline. Abbreviations: mod = moderate, sev = severe, wrst = worst, poss = possible, pn = pain, vst = visit . (NCT00892008)
Timeframe: Baseline, Second Visit (Week ≥ 2)
| Intervention | participants (Number) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BL: Mild Pain (n=25); 2nd Visit: Mild Pain | BL: Mild Pain (n= 25); 2nd Visit: Moderate Pain | BL: Mild Pain (n= 25); 2nd Visit: Severe Pain | BL:Mild Pain (n= 25); 2nd Visit: Worst Poss. Pain | BL: Mild Pain (n= 25); 2nd Visit: Missing | BL: Moderate Pain (n=450); 2nd Visit: Mild Pain | BL: Moderate Pain (n=450): 2nd Visit: Mod Pain | BL: Moderate Pain (n=450); 2nd Visit: Severe Pain | BL: Mod Pain (n=450); 2nd Visit: Worst Poss. Pain | BL: Moderate Pain (n=450); 2nd Visit: Missing | BL: Severe Pain (n=985); 2nd Visit: Mild Pain | BL: Severe Pain (n=985); 2nd Visit: Moderate Pain | BL: Severe Pain (n=985) ; 2nd Visit: Severe Pain | BL: Sev Pain (n=985); 2nd Visit: Worst Poss. pain | BL: Severe Pain (n=985); 2nd Visit: Missing | BL: Worst Poss. Pain (n=98) ; 2nd Visit: Mild Pain | BL: Worst Poss. Pain (n=98); 2nd Visit: Mod Pain | BL: Worst Poss. Pain (n=98); 2nd Visit: Sev Pain | BL:Wrst Poss Pain (n=98); 2nd Visit: Wrst Poss. Pn | BL: Worst Poss. Pain (n=98) ; 2nd Visit: Missing | BL: Missing (n=45); 2nd Visit: Mild Pain | BL: Missing (n=45) ; 2nd Visit: Moderate Pain | BL: Missing (n=45) ; 2nd Visit: Severe Pain | BL: Missing (n=45) ; 2nd Visit: Worst Poss. Pain | BL: Missing (n=45); 2nd Visit: Missing | |
| Pregabalin | 22 | 0 | 0 | 0 | 3 | 300 | 115 | 2 | 0 | 33 | 348 | 533 | 59 | 0 | 45 | 18 | 49 | 25 | 1 | 5 | 3 | 1 | 3 | 0 | 38 |
Patient's Clinical Global Impression of treatment satisfaction. Treatment satisfaction item of CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=260); Final Vst: Excell | 2nd Visit: Excell (n=260) ; Final Vst:Very Good | 2nd Visit: Excellent (n=260); Final Visit: Good | 2nd Visit: Excellent (n=260) ; Final Visit: Fair | 2nd Visit: Excellent (n=260) ; Final Visit: Poor | 2nd Visit: Excellent (n=260); Final Visit: Missing | 2nd Visit: Very Good (n=778); Final Visit: Excell | 2nd Visit: Very Good (n=778); Final Vst: Very Good | 2nd Visit: Very Good (n=778); Final Visit: Good | 2nd Visit: Very Good (n=778); Final Visit: Fair | 2nd Visit: Very Good (n=778); Final Visit: Poor | 2nd Visit: Very Good (n=778); Final Visit: Missing | 2nd Visit: Good (n=454); Final Visit: Excellent | 2nd Visit: Good (n=454); Final Visit: Very Good | 2nd Visit: Good (n=454); Final Visit: Good | 2nd Visit: Good (n=454); Final Visit: Fair | 2nd Visit: Good (n=454); Final Visit: Poor | 2nd Visit: Good (n=454); Final Visit: Missing | 2nd Visit: Fair (n=81); Final Visit: Excellent | 2nd Visit: Fair (n=81); Final Visit: Very Good | 2nd Visit: Fair (n=81); Final Visit:: Good | 2nd Visit: Fair (n=81); Final Visit: Fair | 2nd Visit: Fair (n=81); Final Visit: Poor | 2nd Visit: Fair (n=81); Final Visit: Missing | 2nd Visit: Poor (n=12); Final Visit: Excellent | 2nd Visit: Poor (n=12); Final Visit: Very Good | 2nd Visit: Poor (n=12); Final Visit: Good | 2nd Visit: Poor (n=12); Final Visit: Fair | 2nd Visit::Poor (n=12); Final Visit: Poor | 2nd Visit: Poor (n=12); Final Visit: Missing | 2nd Visit: Missing (n=18); Final Visit: Excellent | 2nd Visit: Missing (n=18); Final Visit: Very Good | 2nd Visit: Missing (n=18); Final Visit: Good | 2nd Visit: Missing (n=18); Final Visit: Fair | 2nd Visit: Missing (n=18); Final Visit: Poor | 2nd Visit: Missing (n=18); Final Visit: Missing | |
| Pregabalin | 201 | 11 | 1 | 0 | 0 | 47 | 297 | 394 | 13 | 1 | 0 | 73 | 35 | 263 | 130 | 4 | 0 | 22 | 9 | 23 | 31 | 9 | 1 | 8 | 1 | 2 | 2 | 2 | 2 | 3 | 0 | 2 | 0 | 1 | 0 | 15 |
Physician's Clinical Global Impression of efficacy. Efficacy item of the CGI has a scale of five discrete points: excellent, very good, good, fair and poor. Shift table shows the number of subjects with each score point rating at the Final Visit by the number of subjects with each score point rating at the Second Visit. (NCT00892008)
Timeframe: Second Visit (Week ≥ 2), Final Visit (Week 4)
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2nd Visit: Excellent (n=279); Final Visit: Excell | 2nd Visit: Excellent (n=279); Final Vst: Very Good | 2nd Visit: Excellent (n=279); Final Visit: Good | 2nd Visit: Excellent (n=279); Final Visit: Fair | 2nd Visit: Excellent (n=279); Final Visit: Poor | 2nd Visit: Excellent (n=279); Final Visit: Missing | 2nd Visit: Very Good (n=813); Final Visit: Excell | 2nd Visit: Very Good (n=813); Final Vst: Very Good | 2nd Visit: Very Good (n=813); Final Visit: Good | 2nd Visit: Very Good (n=813); Final Visit: Fair | 2nd Visit: Very Good (n=813); Final Visit: Poor | 2nd Visit: Very Good (n=813); Final Visit: Missing | 2nd Visit: Good (n=418); Final Visit: Excellent | 2nd Visit: Good (n=418); Final Visit: Very Good | 2nd Visit: Good (n=418); Final Visit: Good | 2nd Visit: Good (n=418); Final Visit: Fair | 2nd Visit: Good (n=418); Final Visit: Poor | 2nd Visit: Good (n=418); Final Visit: Missing | 2nd Visit: Fair (n=66); Final Visit: Excellent | 2nd Visit: Fair (n=66); Final Visit: Very Good | 2nd Visit: Fair (n=66); Final Visit: Good | 2nd Visit: Fair (n=66); Final Visit: Fair | 2nd Visit: Fair (n=66); Final Visit: Poor | 2nd Visit: Fair (n=66); Final Visit: Missing | 2nd Visit: Poor (n=7); Final Visit: Excellent | 2nd Visit: Poor (n=7); Final Visit: Very Good | 2nd Visit: Poor (n=7); Final Visit: Good | 2nd Visit: Poor (n=7); Final Visit: Fair | 2nd Visit: Poor (n=7); Final Visit: Poor | 2nd Visit: Poor (n=7); Final Visit: Missing | 2nd Visit: Missing (n=20); Final Visit: Excellent | 2nd Visit: Missing (n=20); Final Visit: Very Good | 2nd Visit: Missing (n=20); Final Visit: Good | 2nd Visit: Missing (n=20); Final Visit: Fair | 2nd Visit: Missing (n=20); Final Visit: Poor | 2nd Visit: Missing (n=20); Final Visit: Missing | |
| Pregabalin | 217 | 8 | 1 | 0 | 0 | 53 | 298 | 437 | 10 | 0 | 0 | 68 | 19 | 258 | 115 | 5 | 0 | 21 | 4 | 20 | 28 | 5 | 2 | 7 | 0 | 2 | 2 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 19 |
Rescue medications were used for participants with moderate or severe resting pain. Fentanyl injection (25 microgram [mcg] intravenous bolus to a maximum dose of 3 milliliter/day), paracetamol tablet (15 milligram/kilogram orally to a maximum dose of 45 milligram/kilogram/day) were used as rescue medications. (NCT00905437)
Timeframe: Day 0 to Day 6 post-surgery
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 17 |
| Placebo | 25 |
Mean anxiety visual analogue scale (VAS) was defined as the mean of VAS score on the day of surgery and over Days 1 to 5 post-surgery. Participants measured their degree of anxiety over past 24 hours on a VAS of 0 to 100, where 0 = not at all anxious to 100 = extremely anxious. (NCT00905437)
Timeframe: Day 0 to Day 5 post-surgery
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 23.3 |
| Placebo | 24.7 |
Participant was encouraged each day (from Day 3) to attempt walking depending upon the degree of pain on standing. The first day on which the participant was able to walk for 5 steps was the day of mobilization. Median time to mobilization (in hours) was calculated till the day of mobilization. (NCT00905437)
Timeframe: Day 1 to Day 5 post-surgery
| Intervention | hours (Median) |
|---|---|
| Pregabalin | 72.500 |
| Placebo | 52.417 |
Mean daily pain score was defined as the mean of daily pain score over Days 1 to 7 and Days 8 to 14 post-surgery. Daily Pain Rating Scale (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. (NCT00905437)
Timeframe: Day 1 to Day 7, Day 8 to Day 14 post-surgery
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Days 1 to 7 (n=27,30) | Days 8 to 14 (n=26,27) | |
| Placebo | 2.6 | 1.4 |
| Pregabalin | 2.6 | 1.8 |
Mean daily sleep interference score was defined as the mean of daily sleep interference numeric rating scale (NRS) score over Days 1 to 5 post-surgery. Daily Sleep Interference Scale (DSIS): participant rated pain during past 24-hour period on NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep). Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. (NCT00905437)
Timeframe: Day 1 to Day 5 post-surgery
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 2.6 |
| Placebo | 3.1 |
Mean pain on movement score was defined as the mean of the pain on movement score over Days 1 to 5 post-surgery. Pain experienced by participant during passive flexion through 90 degree and passive abduction through 30 degree at operated hip joint was evaluated on a scale of 0 to 10 where, 0= no pain and 10= worst possible pain. (NCT00905437)
Timeframe: Every 12 hours from Day 1 to Day 5 post-surgery
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin | 4.0 |
| Placebo | 3.9 |
Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. We asked patients about sedation, headache, dizziness, blurred vision. (NCT00905580)
Timeframe: 1, 6, 24 & 48 hours
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| PONV | headache | dizziness | sedation | blurred vision | |
| Placebo | 10 | 11 | 6 | 1 | 0 |
| Pregabalin | 7 | 8 | 14 | 6 | 3 |
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 means no pain at all, and 10 represents the worst pain imaginable (NCT00905580)
Timeframe: 1, 6, 24 & 48 hours
| Intervention | VNRS (Median) | |||
|---|---|---|---|---|
| 1 Hour | 6 Hour | 24 Hour | 48 Hour | |
| Placebo | 6 | 3 | 2 | 2 |
| Pregabalin | 6 | 2 | 1 | 1 |
we checked Hypoesthesia in the anterior chest at 3 months after operation by phone. (NCT00905580)
Timeframe: 3 months
| Intervention | participants (Number) |
|---|---|
| Placebo | 13 |
| Pregabalin | 10 |
(NCT00905580)
Timeframe: 1, 6, 24 & 48 hours
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| 0-1 hour | 1-6 hour | 6 - 24 hour | 24 - 48 hour | |
| Placebo | 31 | 17 | 15 | 7 |
| Pregabalin | 26 | 7 | 2 | 1 |
"Global impression of change in patient status reported at 3 weeks. The global impression of change consists of a Likert scale as below:~Very Much Improved~Much Improved~Minimally Improved~No Change~Minimally Worse~Much Worse~Very Much Worse" (NCT00908375)
Timeframe: 3 weeks
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 3.5 |
| Sugar Pill | 3 |
"Standard numeric rating pain scale ranging from 0 (no pain) to 10 (worst pain imaginable) after 3 weeks of treatment.~." (NCT00908375)
Timeframe: 3 weeks
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 6 |
| Sugar Pill | 3 |
"Oswestry disability index (ODI) is a tool to measure a subject's functional disability. The Oswestry disability index consists of 10 questions with a Likert 0-5 scale. Each individual score is converted into a percent which represents the percent disability. There are five tiers, 0-20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), 81%-100% (i.e. bed bound). We report the Oswestry disability scores at 3 weeks." (NCT00908375)
Timeframe: 3 weeks
| Intervention | percent disability (Median) |
|---|---|
| Pregabalin | 41 |
| Sugar Pill | 20 |
"The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C).~At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse." (NCT00922987)
Timeframe: Week 16 or ET
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Not Assessed | Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Pregabalin | 0 | 48 | 145 | 50 | 29 | 0 | 1 | 0 |
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the last 4 weeks in the study. (NCT00922987)
Timeframe: Week 4 through week 16 or ET
| Intervention | Participants (Number) |
|---|---|
| Pregabalin | 172 |
The partial seizure frequency for the baseline period was the total number of partial seizures recorded for that period at Visit 0 (week 0). For each participant's final visit, the 28 day partial seizure frequency equals total number of partial seizures since the last visit * 28 divided by total number of days since the last visit. For percent change from baseline: change from baseline in partial seizure frequency*100 divided by partial seizure frequency at baseline visit. (NCT00922987)
Timeframe: Baseline and week 16 or ET
| Intervention | percent change (Median) |
|---|---|
| Pregabalin | -100.00 |
Responder rate was defined as the percentage of participants with at least a 50% reduction in 28-day partial seizure frequency from baseline during the maintenance phase (Week 4 - Week 16). The percent change in partial seizure frequency in the maintenance phase was the change from baseline in partial seizure frequency * 100, divided by the partial seizure frequency at the baseline visit. (NCT00922987)
Timeframe: Baseline through week 16 or early termination (ET)
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 85.00 |
MOS: participant rated questionnaire, assess sleep quality and quantity. Consists of 9-item overall sleep problems index (length of time to fall asleep, how many hours of sleep each night during past 4 weeks); 7 subscales rated 1 (all the time) to 6 (none of the time): sleep disturbance, snoring, awaken short of breath (SOB) or with a headache, somnolence adequacy, and sleep quantity. Transformed scores (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); sub-scales total score range= 0-100; higher score indicates greater intensity of attribute. (NCT00922987)
Timeframe: Baseline and week 16 or ET
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Sleep Problems Index I | Baseline: Sleep Problems Index II | Baseline: Sleep Disturbance | Baseline: Snoring | Baseline: Awaken Short of Breath | Baseline: Quantity of Sleep (hours) | Baseline: Sleep Adequacy | Baseline: Somnolence | Change at Week 16: Sleep Problems Index I | Change at Week 16: Sleep Problems Index II | Change at Week 16: Sleep Disturbance | Change at Week 16: Snoring | Change at Week 16: Awaken Short of Breath | Change at Week 16: Quantity of Sleep (hours) | Change at Week 16: Sleep Adequacy | Change at Week 16: Somnolence | |
| Pregabalin | 44.72 | 44.55 | 44.31 | 33.71 | 34.41 | 6.77 | 45.50 | 37.19 | -16.93 | -19.44 | -25.04 | -10.14 | -16.55 | 0.92 | 9.27 | -17.72 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. (NCT00922987)
Timeframe: Baseline
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Not Assessed | Normal, not at all ill | Borderline ill | Mildly ill | Moderately ill | Markedly ill | Severely ill | Among the most extremely ill participants | |
| Pregabalin | 0 | 17 | 25 | 64 | 118 | 32 | 8 | 5 |
Participants who had a concomitant co-morbidity during the study for any period of time from baseline through to Week 16 (Final Visit); participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable. (NCT00922987)
Timeframe: Baseline through week 16 or ET
| Intervention | participants (Number) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anaemia | Thrombocytopenia | Cardiomyopathy | Coronary artery disease | Myocardial ischaemia | Sturge-Weber syndrome | Deafness | Hypoacusis | Vertigo | Autoimmune thyroiditis | Endocrine disorder | Goitre | Hypothyroidism | Reflux oesophagitis | Hepatic fibrosis | Liver disorder | Multiple allergies | Seasonal allergy | Neuroborreliosis | Injury | Diabetes mellitus | Hyperlipidemia | Obesity | Type 1 diabetes mellitus | Type 2 diabetes mellitus | Mucoskeletal pain | Osteoarthritis | Osteoporosis | Spinal disorder | Brain neoplasm malignant | Oligodendroglioma | Cerebral ischaemia | Cerebrovascular accident | Dementia Alzheimer's type | Dizziness | Encephalopathy | Grand mal convulsion | Headache | Hemiparesis | Mental retardation | Migraine | Migraine without aura | Neuropathy peripheral | Polyneuropathy | Anxiety | Anxiety disorder | Depression | Generalised anxiety disorder | Post-traumatic stress disorder | Psychotic disorder due to medical condition | Schizophrenia | Diabetic neuropathy | Nephropathy | Asthma | Chronic obstructive pulmonary disease | Hypertension | Post thrombotic syndrome | |
| Pregabalin | 1 | 1 | 1 | 3 | 4 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 4 | 1 | 1 | 1 | 1 | 6 | 2 | 1 | 1 | 1 | 1 | 3 | 2 | 2 | 1 | 1 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 1 | 1 | 1 | 6 | 1 | 11 | 1 | 1 | 4 | 2 | 1 | 1 | 1 | 2 | 28 | 1 |
Concomitant drug (any drug other than, and in addition to, the study drug) taken for any period of time during the study. (NCT00922987)
Timeframe: Baseline through Week 16 or ET
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acetylsalicylic acid | All other therapeutic products | Allopurinol | Alprazolam | Aminophylline | Amlodipine | Amlodipine Besilate | Asasantin | Atenolol | Atorvastatin | Baclofen | Betahistine | Betahistine hydrochloride | Betaxolol hydrochloride | Biselect | Bisoprolol | Carbamazepine | Citalopram | Clonazepam | Clopidogrel | Clopidogrel sulfate | Coversum combi | Desloratadine | Diazepam | Diclofenac | Digoxin | Drug unspecified | Ergenyl chrono | Escitalopram | Fenofibrate | Fentanyl | Fluphenazine decanoate | Folic acid | Furosemide | Gabapentin | Gingko biloba | Gingko biloba extract | Gliclazide | Hyzaar | Ibuprofen | Imidapril hydrochloride | Insulin | Ipratropium bromide | Lacosamide | Lamotrigine | Levetiracetam | Levothyroxine sodium | Magnesium | Metamizole sodium | Metformin hydrochloride | Molsidomine | Oxazepam | Oxcarbazepine | Paracetamol | Pentoxifylline | Perindopril | Perindopril arginine | Phenobarbital | Phenytoin | Piracetam | Pregabalin | Primidone | Ramipril | Seretide mite | Sertraline | Silymarin | Sultiame | Telmisartan | Theophylline | Thioctic acid | Tianeptine | Tiapride | Ticlopidine | Ticlopidine hydrochloride | Tocopherol | Topiramate | Tramadol | Trandolapril | Trazodone hydrochloride | Valproate sodium | Valproic acid | Venlafaxine | Venlafaxine hydrochloride | Verapamil hydrochloride | Vinpocetine | Warfarin sodium | |
| Pregabalin | 8 | 1 | 1 | 4 | 1 | 3 | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 2 | 114 | 1 | 8 | 2 | 1 | 1 | 1 | 2 | 2 | 1 | 4 | 27 | 3 | 1 | 1 | 1 | 1 | 1 | 2 | 1 | 5 | 1 | 1 | 1 | 1 | 3 | 1 | 3 | 54 | 30 | 1 | 1 | 1 | 2 | 1 | 1 | 11 | 1 | 1 | 1 | 1 | 1 | 11 | 6 | 66 | 1 | 2 | 1 | 3 | 1 | 1 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 2 | 34 | 1 | 3 | 1 | 23 | 55 | 1 | 1 | 1 | 2 | 1 |
VAS-A consists of a visual analog scale ranging from, 0 mm (no anxiety) to 100 mm (extreme anxiety). (NCT00922987)
Timeframe: Baseline, week 4 and week 16 or ET
| Intervention | millimeter (mm) (Mean) | ||
|---|---|---|---|
| Baseline | Change at Week 4 | Change at Week 16 or ET | |
| Pregabalin | 54.12 | -13.60 | -26.16 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
| Intervention | drinks/drinking day (Mean) | ||
|---|---|---|---|
| Drinks/Drinking Day Baseline | Drinks/Drinking Day Week 12 | Drinks/Drinking Day Change | |
| Duloxetine | 8.16 | 2.21 | -5.94 |
| Placebo | 8.91 | 2.90 | -6.01 |
| Pregabalin | 12.98 | 2.31 | -10.67 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
| Intervention | drinks/week (Mean) | ||
|---|---|---|---|
| Drinks/week Baseline | Drinks/week Week 12 | Drinks/week Change | |
| Duloxetine | 42.07 | 9.16 | -32.91 |
| Placebo | 41.20 | 8.06 | -33.15 |
| Pregabalin | 56.67 | 7.59 | -49.08 |
Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. A drinking day is a day where any alcohol is consumed. Change = (Week 12 - Baseline). More negative values indicate less use of alcohol. (NCT00929344)
Timeframe: Baseline and Week 12
| Intervention | drinking days/week (Mean) | ||
|---|---|---|---|
| Drinking Days/Week Baseline | Drinking Days/Week Week 12 | Drinking Days/Week Change | |
| Duloxetine | 5.11 | 2.17 | -2.94 |
| Placebo | 4.87 | 1.85 | -3.01 |
| Pregabalin | 4.54 | 1.14 | -3.40 |
Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. (NCT00938548)
Timeframe: 1, 6, 24, 48 hour
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| PONV | sedation | headache | dizziness | |
| Placebo | 4 | 8 | 9 | 12 |
| Pregabalin | 3 | 13 | 5 | 17 |
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable. (NCT00938548)
Timeframe: 1, 6, 24, 48 hour
| Intervention | Units on a scale (Median) | |||
|---|---|---|---|---|
| 1 hr | 6 hr | 24 hr | 48 hr | |
| Placebo | 7 | 6 | 5 | 3 |
| Pregabalin | 5 | 5 | 3 | 2 |
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable. (NCT00938548)
Timeframe: 1 week, 1 month
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| 1 week | 1 month | |
| Placebo | 2.9 | 1.7 |
| Pregabalin | 1.4 | 0.6 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Weeks 9-12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 16.9 |
| Placebo | 31.8 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 28.5 |
| Placebo | 44.2 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: weeks 9-12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 26.5 |
| Placebo | 42.2 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 26.1 |
| Placebo | 43.3 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: weeks 9-12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 25.3 |
| Placebo | 42.0 |
"One of the weekly questions asked of subjects was, Did you have adequate relief of your IBS symptoms over the last week? Possible answers were Yes or No." (NCT00977197)
Timeframe: Weeks 9-12
| Intervention | participants (Number) | |
|---|---|---|
| Adequate Relief (Yes) | Inadequate Relief (No) | |
| Placebo | 16 | 28 |
| Pregabalin | 19 | 22 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: baseline, week 12
| Intervention | participants (Number) | |
|---|---|---|
| Yes, >= 30 point change | No, >= 30 point change | |
| Placebo | 20 | 24 |
| Pregabalin | 26 | 15 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 26.3 |
| Placebo | 45.0 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Weeks 9-12)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 29.3 |
| Placebo | 43.6 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 26.1 |
| Placebo | 23.6 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Weeks 9-12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 25.8 |
| Placebo | 22.4 |
The Bowel Symptom Scale (BSS) consists of 5 questions, each with a 100 mm long Visual Analog Scale (VAS). The questions are regarding pain, bloating, constipation, diarrhea, and overall severity of Irritable Bowel Syndrome (IBS) symptoms. The VAS does not have any pre-set marks between the extremes of 0 for not present and 100 mm for very severe symptoms. The investigator measures the mark made by the participant in mm and records this for the value. (NCT00977197)
Timeframe: Week 12
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 15.6 |
| Placebo | 34.4 |
Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia. (NCT00978341)
Timeframe: Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose
| Intervention | scores on scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: pre-dose (n=14, 13) | Day 1: 0.5 hours post-dose (n=10, 8) | Day 1: 1 hour post-dose (n=10, 8) | Day 1: 2 hours post-dose (n=10, 8) | Day 1: 3 hours post-dose (n=10, 8) | Day 1: 4 hours post-dose (n=15, 13) | Day 1: 5 hours post-dose (n=10, 8) | Day 1: 6 hours post-dose (n=10, 8) | Day 8: pre-dose (n=11, 12) | Day 8: 0.5 hours post-dose (n=7, 8) | Day 8: 1 hour post-dose (n=7, 8) | Day 8: 2 hours post-dose (n=7, 8) | Day 8: 3 hours post-dose (n=9, 8) | Day 8: 4 hours post-dose (n=14, 13) | Day 8: 5 hours post-dose (n=9, 8) | Day 8: 6 hours post-dose (n=9, 8) | |
| Placebo | 2.1 | 1.9 | 1.8 | 1.7 | 2.3 | 1.2 | 1.9 | 1.9 | 2.0 | 1.7 | 1.4 | 1.5 | 1.6 | 0.9 | 1.5 | 1.5 |
| Pregabalin | 2.2 | 2.8 | 2.3 | 2.5 | 2.3 | 1.5 | 2.2 | 2.1 | 1.9 | 1.7 | 1.6 | 1.9 | 1.7 | 1.0 | 1.9 | 1.9 |
Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). (NCT00978341)
Timeframe: Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose
| Intervention | scores on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Day 1: pre-dose (n=14, 14) | Day 1: 2 hours post-dose (n=14, 14) | Day 1: 4 hours post-dose (n=14, 14) | Day 1: 6 hours post-dose (n=14, 14) | Day 8: pre-dose (n=13, 14) | Day 8: 2 hours post-dose (=13, 14) | Day 8: 4 hours post-dose (n=15, 13) | Day 8: 6 hours post-dose (n=15, 13) | |
| Placebo | 0.9 | 0.8 | 0.8 | 0.9 | 0.8 | 0.8 | 0.7 | 0.7 |
| Pregabalin | 0.8 | 0.7 | 0.7 | 0.8 | 0.7 | 0.7 | 0.7 | 0.8 |
NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain. (NCT00978341)
Timeframe: Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.
| Intervention | scores on scale (Median) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Category 1 Day 1 (n=15, 14) | Category 1: Day 8 (n=12, 11) | Category 2: Day 1 (n=15, 14) | Category 2: Day 8 (n=12, 11) | Category 3: Day 1 (n=15, 14) | Category 3: Day 8 (n=12, 11) | Category 4: Day 1 (n=15, 14) | Category 4: Day 8 (n=12, 11) | Category 5: Day 1 (n=15, 14) | Category 5: Day 8 (n=12, 11) | Total: Day 1 (n=15, 14) | Total: Day 8 (n=12, 11) | |
| Placebo | 6.0 | 6.0 | 2.5 | 3.0 | 3.3 | 2.0 | 0.3 | 0.0 | 5.0 | 5.0 | 27 | 24 |
| Pregabalin | 6.0 | 5.5 | 3.0 | 2.5 | 1.5 | 1.8 | 1.7 | 2.7 | 5.0 | 3.5 | 32 | 22 |
Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain). (NCT00978341)
Timeframe: Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)
| Intervention | scores on scale (Mean) | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: pre-dose (n=15, 14) | Day 1: 0.5 hours post-dose (n=15, 14) | Day 1: 1 hours post-dose (n=15, 14) | Day 1: 2 hours post-dose (n=15, 14) | Day 1: 3 hours post-dose (n=15, 14) | Day 1: 4 hours post-dose (n=15, 14) | Day 1: 5 hours post-dose (n=15, 14) | Day 1: 6 hours post-dose (n=15, 14) | Day 1: 8 hours post-dose (n=15, 14) | Day 1: 10 hours post-dose (n=14, 14) | Day 1: 12 hours post-dose (n=14, 14) | Day 8: pre-dose (n=13, 14) | Day 8: 0.5 hours post-dose (n=13, 14) | Day 8: 1 hour post-dose (n=13, 14) | Day 8: 2 hours post-dose (n=13, 14) | Day 8: 3 hours post-dose (n=15, 14) | Day 8: 4 hours post-dose (n=15, 14) | Day 8: 5 hours post-dose (n=15, 14) | Day 8: 6 hours post-dose (n=15, 14) | Day 8: 8 hours post-dose (n=15, 13) | Day 8: 10 hours post-dose (n=15, 13) | Day 8: 12 hours post-dose (n=15, 13) | Day 8: 24 hours post-dose (n=15, 14) | Day 8: 36 hours post-dose (n=15, 13) | Day 8: 48 hours post-dose (n=15, 14) | |
| Placebo | 4.9 | 4.6 | 4.7 | 4.7 | 4.7 | 4.6 | 4.9 | 5.1 | 5.1 | 5.3 | 5.4 | 5.4 | 5.0 | 4.9 | 4.6 | 4.7 | 4.9 | 4.9 | 5.2 | 5.3 | 5.2 | 5.2 | 5.4 | 5.7 | 5.8 |
| Pregabalin | 5.3 | 5.1 | 4.6 | 4.3 | 4.3 | 4.1 | 3.9 | 3.9 | 4.3 | 4.1 | 4.1 | 4.7 | 4.5 | 4.0 | 4.6 | 4.9 | 4.9 | 4.8 | 4.4 | 4.7 | 4.9 | 4.7 | 5.0 | 6.1 | 6.1 |
Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]). (NCT00978341)
Timeframe: Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose
| Intervention | cm2 (Mean) | |||
|---|---|---|---|---|
| Day 1: pre-dose (n=15, 14) | Day 1: 4 hours post-dose (n=15, 13) | Day 8: pre-dose (n=13, 14) | Day 8: 4 hours post-dose (n=15, 13) | |
| Placebo | 65.1 | 54.1 | 45.9 | 46.7 |
| Pregabalin | 75.6 | 68.7 | 53.1 | 70.8 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT00978341)
Timeframe: Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)
| Intervention | scores on scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Day 1 (n=15, 13) | Day 2 (n=15, 14) | Day 3 (n=15, 14) | Day 4 (n=15, 14) | Day 5 (n= 15, 14) | Day 6 (n=15, 14) | Day 7 (n=15, 14) | Day 8 (n=14, 14) | |
| Placebo | 6.3 | 5.4 | 5.1 | 5.0 | 5.1 | 4.9 | 4.9 | 5.6 |
| Pregabalin | 6.2 | 4.4 | 4.1 | 4.2 | 4.5 | 3.7 | 4.0 | 4.0 |
Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]). (NCT00978341)
Timeframe: Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,
| Intervention | cm2 (Mean) | |||
|---|---|---|---|---|
| Day 1: pre-dose (n=14, 14) | Day 1: 4 hours post-dose (n=15, 13) | Day 8: pre-dose (n=12, 14) | Day 8: 4 hours post-dose (n=15, 13) | |
| Placebo | 81.6 | 50.9 | 68.4 | 68.0 |
| Pregabalin | 95.8 | 63.0 | 48.4 | 50.5 |
LREM, as determined by PSG, was number of non-wake epochs from the beginning of the recording to the first occurrence of Stage R sleep divided by 2. Arithmetic mean of LREM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 95.22 |
| Pramipexole 0.5 mg | 130.99 |
| Placebo | 84.52 |
NASO, as determined by PSG, was calculated as number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | arousals (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 17.84 |
| Pramipexole 0.5 mg | 24.19 |
| Placebo | 20.29 |
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage 2 Non-REM [Stage N2] 30-second (30-sec) epoch, Stage 3 Non-REM [Stage N3] 30-sec epoch, or stage rapid eye movement [stage R] 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | awakenings (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 18.43 |
| Pramipexole 0.5 mg | 26.30 |
| Placebo | 21.10 |
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period. Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | awakenings (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 7.68 |
| Pramipexole 0.5 mg | 12.39 |
| Placebo | 10.55 |
CGI-I: 7-point clinician rated scale to assess improvement in disease condition as compared to the start of the study medication (baseline), ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved). Higher score = more affected. (NCT00991276)
Timeframe: Baseline, Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 300 mg | 61.2 |
| Pramipexole 0.5 mg | 50.0 |
| Placebo | 33.3 |
PLMAI, as determined by PSG was number of periodic limb movements leading to arousal per hour (per hour of Total Sleep Time [TST]). Arithmetic mean of PLMAI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | movement/hour (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 3.93 |
| Pramipexole 0.5 mg | 2.66 |
| Placebo | 7.61 |
PLMI, as determined by PSG was number of periodic limb movements per hour based on time in bed (TIB). Arithmetic mean of PLMI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | movement/hour (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 25.45 |
| Pramipexole 0.5 mg | 14.11 |
| Placebo | 39.95 |
PLMSI, as determined by PSG was number of periodic limb movements in sleep per hour based on TST. Arithmetic mean of PLMSI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | movement/hour (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 22.42 |
| Pramipexole 0.5 mg | 8.00 |
| Placebo | 36.95 |
RLS-QoL: psychometrically and clinically valid and reliable participant-rated instrument, assesses impact of RLS on participant quality of life. Specifically, it assessed effects of RLS on health status function (symptom severity, daily activity, social functioning, sleep, concentrating and decision making, travelling, sexual activity, and work) giving a summary score ranging from 0-100. Higher scores reflect better quality of life. Recall period: 1 week prior to assessment. Arithmetic mean of RLS-QoL score of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 73.30 |
| Pramipexole 0.5 mg | 70.05 |
| Placebo | 68.03 |
RLS-NDI:participant-rated instrument to assess daytime performance and participant's previous night's sleep, consists of 14 items encompassing 5 domains:tiredness;emotional functioning;social functioning;cognitive functioning;activities of daily living and 1 global item for overall well-being. Each item: 0-10 scale; 0=Not at all; 10=Extremely. Total score: sum of scores from question 1-14 (question 10, 11: scores reversed). Total score range: 0-140; higher scores: more severe impact. Arithmetic mean of RLS-NDI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 41.43 |
| Pramipexole 0.5 mg | 46.33 |
| Placebo | 46.78 |
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | Percentage of time asleep (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 83.81 |
| Pramipexole 0.5 mg | 78.58 |
| Placebo | 77.02 |
SSQ: participant-rated instrument assesses sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. Latency (time to fall asleep [in minutes]): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 - 840 minutes, lower value: better sleep. Arithmetic mean of subscale score of each participant for all periods was taken prior to employing linear mixed model. Hours of sleep subscale results reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 42.49 |
| Pramipexole 0.5 mg | 40.59 |
| Placebo | 50.07 |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items giving 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This (1 item) subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0 awakenings to 30 awakenings. Lower value indicates better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET
| Intervention | awakenings (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 1.69 |
| Pramipexole 0.5 mg | 2.64 |
| Placebo | 2.51 |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale: numerical rating completed by participant 30 minutes after waking; recall period: night before, Range: 0 to 100, higher score: better quality of sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 6.74 |
| Pramipexole 0.5 mg | 5.69 |
| Placebo | 5.70 |
SSQ: participant-rated instrument to assess sleep behavior; measures sleep quantity, quality. Comprised of 5 items yielding 5 subscale scores: latency, hours of sleep, number of awakenings, total wake time after sleep onset, quality of sleep. This 1 item subscale (in minutes): numerical rating completed by participant 30 minutes after waking; recall period: night before. Range: 0-1440 minutes. Lower value: better sleep. Arithmetic mean of this subscale score of each participant for all periods was taken prior to employing linear mixed model. Results of hours of sleep subscale reported as sTST. (NCT00991276)
Timeframe: Week 3 and Week 5 of each intervention period or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 53.78 |
| Pramipexole 0.5 mg | 82.23 |
| Placebo | 79.09 |
sTST as derived from Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Completed by the participant 30 minutes after waking; recall period is the night before. Arithmetic mean of sTST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 3 and Week 5 of Each Intervention Period or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 400.97 |
| Pramipexole 0.5 mg | 374.19 |
| Placebo | 370.16 |
TST, as determined by PSG, was the number of non-wake (30-sec) epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive days of recording divided by 2 at the end of each intervention period. Arithmetic mean of TST of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 402.38 |
| Pramipexole 0.5 mg | 376.52 |
| Placebo | 369.66 |
WTAS, as determined by PSG, was the number of wake (30-sec) epochs after the final awakening until the end of the 8-hour recording. WTAS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTAS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 5.58 |
| Pramipexole 0.5 mg | 7.86 |
| Placebo | 8.88 |
WTDS, as determined by PSG, was the number of wake (30-sec) epochs after the onset of persistent sleep and prior to the final awakening or at the end of 8-hour recording. WTDS was the sum of 2 consecutive days of recordings divided by 2 at the end of each intervention period. Arithmetic mean of WTDS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 45.77 |
| Pramipexole 0.5 mg | 70.51 |
| Placebo | 69.75 |
NASO, as determined by PSG was the number of times there is a shift from a stage N2 to N3 or R 30-sec epoch to a stage N1 30-sec epoch from the onset of persistent sleep to light on. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NASO for each participant at each period was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | arousals (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | Hour 2 (n= 67, 70, 66) | Hour 3 (n= 67, 70, 67) | Hour 4 (n= 67, 70, 68) | Hour 5 (n= 67, 70, 68) | Hour 6 (n= 67, 71, 68) | Hour 7 (n= 67, 71, 68) | Hour 8 (n= 67, 71, 68) | Quarter 1 (n= 67, 70, 66) | Quarter 2 (n= 67, 70, 68) | Quarter 3 (n= 67, 71, 68) | Quarter 4 (n= 67, 71, 68) | |
| Placebo | 1.79 | 2.68 | 2.80 | 2.76 | 2.89 | 2.70 | 2.66 | 2.46 | 4.26 | 5.55 | 5.61 | 5.13 |
| Pramipexole 0.5 mg | 2.06 | 3.23 | 3.23 | 3.41 | 3.20 | 3.30 | 3.28 | 2.98 | 5.09 | 6.67 | 6.44 | 6.24 |
| Pregabalin 300 mg | 1.48 | 2.36 | 2.31 | 2.94 | 2.33 | 2.39 | 2.15 | 2.07 | 3.75 | 5.25 | 4.75 | 4.23 |
NAASO1, as determined by PSG, was the number of times there was a wake period of at least 1 30-sec epoch from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO1 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | awakenings (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | Hour 2 (n= 67, 70, 66) | Hour 3 (n= 67, 70, 67) | Hour 4 (n= 67, 70, 68) | Hour 5 (n= 67, 70, 68) | Hour 6 (n= 67, 71, 68) | Hour 7 (n= 67, 71, 68) | Hour 8 (n= 67, 71, 68) | Quarter 1 (n= 67, 70, 66) | Quarter 2 (n= 67, 70, 68) | Quarter 3 (n= 67, 71, 68) | Quarter 4 (n= 67, 71, 68) | |
| Placebo | 1.10 | 2.47 | 2.66 | 2.71 | 2.87 | 3.16 | 3.32 | 3.11 | 3.49 | 5.32 | 6.04 | 6.44 |
| Pramipexole 0.5 mg | 1.39 | 3.32 | 3.42 | 3.83 | 3.76 | 3.68 | 4.04 | 3.46 | 4.61 | 7.27 | 7.37 | 7.36 |
| Pregabalin 300 mg | 0.70 | 2.06 | 2.09 | 2.44 | 2.47 | 2.91 | 3.07 | 2.76 | 2.71 | 4.53 | 5.39 | 5.87 |
NAASO2, as determined by PSG, was the number of times there was a wake period of at least 2 30-sec epochs from the onset of persistent sleep to light on. Each entry to be counted must be separated by a Stage N2 30-sec epoch, Stage N3 30-sec epoch, or Stage R 30-sec epoch. The sum of 2 consecutive days of recording was divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of NAASO2 of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | awakenings (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | Hour 2 (n= 67, 70, 66) | Hour 3 (n= 67, 70, 67) | Hour 4 (n= 67, 70, 68) | Hour 5 (n= 67, 70, 68) | Hour 6 (n= 67, 71, 68) | Hour 7 (n= 67, 71, 68) | Hour 8 (n= 67, 71, 68) | Quarter 1 (n= 67, 70, 66) | Quarter 2 (n= 67, 70, 68) | Quarter 3 (n= 67, 71, 68) | Quarter 4 (n= 67, 71, 68) | |
| Placebo | 0.73 | 1.37 | 1.41 | 1.48 | 1.48 | 1.44 | 1.57 | 1.28 | 2.06 | 2.85 | 2.92 | 2.86 |
| Pramipexole 0.5 mg | 0.61 | 1.72 | 1.71 | 1.84 | 1.76 | 1.57 | 1.94 | 1.56 | 2.27 | 3.56 | 3.30 | 3.44 |
| Pregabalin 300 mg | 0.42 | 1.04 | 0.99 | 1.01 | 1.06 | 1.02 | 1.24 | 1.00 | 1.43 | 1.99 | 2.10 | 2.25 |
PLM, as determined by PSG was number of periodic limb movements based on time in bed (TIB). Calculated at each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean of PLM of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | movement/hour (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 | Hour 2 | Hour 3 | Hour 4 | Hour 5 | Hour 6 | Hour 7 | Hour 8 | Quarter 1 | Quarter 2 | Quarter 3 | Quarter 4 | |
| Placebo | 54.67 | 52.93 | 48.76 | 46.58 | 36.17 | 32.47 | 27.04 | 20.97 | 107.56 | 95.31 | 68.66 | 48.01 |
| Pramipexole 0.5 mg | 21.57 | 12.49 | 14.05 | 14.50 | 11.93 | 10.57 | 11.11 | 16.55 | 34.02 | 28.55 | 22.49 | 27.64 |
| Pregabalin 300 mg | 31.45 | 26.38 | 40.93 | 30.35 | 25.70 | 21.02 | 14.22 | 13.37 | 57.82 | 71.29 | 46.77 | 27.60 |
SE, as determined by PSG, was the TST divided by the time in bed (TIB)(both in minutes), multiplied by 100. Sum of 2 consecutive days of recording divided by 2 at the end of each intervention period by each individual hour (8 hours total) and each individual quarter of the night (eight hours in 2 hour increments). Arithmetic mean for SE of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | percentage of time asleep (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 | Hour 2 | Hour 3 | Hour 4 | Hour 5 | Hour 6 | Hour 7 | Hour 8 | Quarter 1 | Quarter 2 | Quarter 3 | Quarter 4 | |
| Placebo | 57.80 | 77.31 | 81.86 | 82.61 | 82.92 | 82.49 | 79.86 | 69.75 | 67.62 | 82.30 | 82.75 | 74.84 |
| Pramipexole 0.5 mg | 66.88 | 83.43 | 84.86 | 79.84 | 81.85 | 81.64 | 80.90 | 69.51 | 75.15 | 82.37 | 81.74 | 75.16 |
| Pregabalin 300 mg | 62.31 | 86.13 | 90.22 | 89.41 | 90.00 | 90.33 | 84.70 | 78.07 | 74.21 | 89.84 | 90.09 | 81.37 |
WASO, as determined by PSG was time spent awake from sleep onset to final awakening. WASO = (sum of WTDS 30-sec epochs and WTAS 30-sec epochs)/2, measured on 2 consecutive days at end of each intervention period by each individual hour (8 hours total) and each individual quarter of night (eight hours in 2 hour increments). Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hour 1 (n= 66, 67, 66) | Hour 2 (n= 67, 70, 66) | Hour 3 (n= 67, 70, 67) | Hour 4 (n= 67, 70, 68) | Hour 5 (n= 67, 70, 68) | Hour 6 (n= 67, 71, 68) | Hour 7 (n= 67, 71, 68) | Hour 8 (n= 67, 71, 68) | Quarter 1 (n= 67, 70, 66) | Quarter 2 (n= 67, 70, 68) | Quarter 3 (n= 67, 71, 68) | Quarter 4 (n= 67, 71, 68) | |
| Placebo | 3.35 | 7.39 | 8.90 | 9.52 | 10.04 | 10.52 | 12.09 | 18.15 | 10.35 | 18.18 | 20.55 | 30.21 |
| Pramipexole 0.5 mg | 2.26 | 7.07 | 8.23 | 11.54 | 10.39 | 10.54 | 11.44 | 18.27 | 8.99 | 19.77 | 20.77 | 29.55 |
| Pregabalin 300 mg | 1.62 | 5.04 | 4.89 | 6.21 | 5.93 | 5.78 | 9.18 | 13.16 | 6.42 | 11.08 | 11.81 | 22.37 |
MOS-SS:Participant rated instrument, assesses sleep quantity, quality;with 12 items(7 subscale scores:sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep;2 composite index scores:sleep problems Index I, II). Subscale scores total range:0-100(except sleep quantity[range 0-24 hours], optimal sleep[range 0-1: 0= <7 or >8 hours;1=7/8 hours]). Higher scores=poorer sleep outcomes(except sleep quantity, adequacy). Arithmetic mean of MOS-SS scores of each participant for all periods was taken before linear mixed model analysis. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | units on a scale (Least Squares Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Awaken Short of Breath/with Headache (n= 68,71,69) | Adequacy (n= 68,71,69) | Somnolence (n= 68,71,69) | Sleep Quantity (n= 68,71,69) | 6-Item Sleep Problems Index (n= 68,71,69) | 9-Item Sleep Problems Index (n= 68,71,69) | Optimal Sleep (n= 68,71,69) | Sleep Disturbance (n= 68,71,69) | Snoring (n= 67,71,68) | |
| Placebo | 10.88 | 40.79 | 23.71 | 5.97 | 40.59 | 42.89 | 0.29 | 48.65 | 17.96 |
| Pramipexole 0.5 mg | 13.10 | 43.90 | 21.32 | 6.50 | 37.24 | 37.88 | 0.35 | 40.19 | 15.97 |
| Pregabalin 300 mg | 11.59 | 54.96 | 21.28 | 6.43 | 30.69 | 32.75 | 0.43 | 34.08 | 15.27 |
Minutes of Stage 1 Non-Rapid Eye Movement (Non-REM) sleep (Stage N1), Stage 2 Non-REM sleep (Stage N2), Stage 3 Non-REM sleep (Stage N3) or Slow Wave Sleep (SWS) and Stage REM (Stage R) sleep, as determined by PSG were calculated as total number of Stage N1 30-second (30-sec) epochs divided by 2, total number of Stage N2 30-sec epochs divided by 2, total number of Stage N3 30-sec epochs divided by 2 and total number of Stage R 30-sec epochs divided by 2 respectively. Arithmetic mean of minutes of stage N1, N2, N3 and R sleep of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Stage N1 Sleep | Stage N2 Sleep | Stage N3 Sleep/SWS | Stage R Sleep | |
| Placebo | 43.72 | 204.35 | 45.95 | 75.37 |
| Pramipexole 0.5 mg | 48.38 | 241.52 | 34.78 | 51.80 |
| Pregabalin 300 mg | 38.06 | 227.05 | 66.88 | 70.40 |
Arousal index, as determined by PSG, was NASO per hours of sleep from the onset of persistent sleep to light on. Arithmetic mean of NASOI of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | arousals/hour (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 2.75 |
| Pramipexole 0.5 mg | 4.18 |
| Placebo | 3.44 |
IRLS: psychometrically; clinically valid; clinician-administered instrument assesses severity of RLS. RLS symptom severity and impact on daily living comprise of 10 items giving 2 subscale scores and 1 global score. Subscale scores: symptom severity(6 items) and impact on daily living(3 items), item 3 loaded equally on both subscales. Global score calculated from 10 items. Score of all items range from 0-4, total score range:0-40. Lower scores: lower severity and better quality of life. Arithmetic mean of IRLS of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 12.28 |
| Pramipexole 0.5 mg | 15.35 |
| Placebo | 18.38 |
"LPS, as determined by PSG, was number of epochs from the beginning of the recording (lights-out) to the start of the first 20 consecutive non-wake epochs (10 minutes of persistent sleep) divided by 2. Arithmetic mean of LPS of each participant for all periods was taken prior to employing linear mixed model." (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or ET
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 31.13 |
| Pramipexole 0.5 mg | 31.52 |
| Placebo | 38.86 |
WASO as determined by Polysomnography (PSG) was time spent awake from sleep onset to final awakening. WASO= Wake Time During Sleep [WTDS] epochs + Wake Time After Sleep [WTAS] epochs)/2. WTDS: number of wake epochs (30 seconds of PSG recording) after onset of persistent sleep and prior to final awakening or end of 8-hour recording/2 and WTAS: number of wake epochs after final awakening until end of the 8-hour recording/2. WASO was measured on 2 consecutive days within a period. Arithmetic mean of WASO of each participant for all periods was taken prior to employing linear mixed model. (NCT00991276)
Timeframe: Week 5 (End of Intervention Period 1), Week 11 (End of Intervention Period 2) and Week 17 (End of Intervention Period 3) or Early Termination (ET)
| Intervention | minutes (Least Squares Mean) |
|---|---|
| Pregabalin 300 mg | 51.50 |
| Pramipexole 0.5 mg | 78.42 |
| Placebo | 78.60 |
Mean pain score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). For each week, only days up to the last day on study medication were considered. A minimum of 4 pain diaries were required to calculate the mean pain score. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). (NCT01020474)
Timeframe: Baseline to Week 15
| Intervention | Units on a scale (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (N= 52, 49) | Week 2 (N= 54, 47) | Week 3 (N= 52, 44) | Week 4 (N= 50, 46) | Week 5 (N= 49, 44) | Week 6 (N= 49, 44) | Week 7 (N= 48, 42) | Week 8 (N= 46, 44) | Week 9 (N= 46, 42) | Week 10 (N= 45, 40) | Week 11 (N= 44, 38) | Week 12 (N= 43, 34) | Week 13 (N= 42, 33) | Week 14 (N= 41, 34) | Week 15 (N= 35, 33) | |
| Placebo | -0.41 | -0.48 | -0.45 | -0.55 | -0.59 | -0.51 | -0.77 | -0.59 | -0.66 | -0.85 | -1.07 | -0.78 | -1.01 | -1.11 | -1.16 |
| Pregabalin | -0.48 | -1.11 | -1.27 | -1.45 | -1.27 | -1.47 | -1.67 | -1.65 | -1.61 | -1.82 | -1.93 | -1.75 | -1.75 | -2.01 | -1.90 |
"Mean sleep quality score was calculated for each week during the double-blind treatment phase (Week 1 to Week 15). A minimum of 4 sleep diaries are required to calculate the mean pain score. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep." (NCT01020474)
Timeframe: Baseline to Week 15
| Intervention | Units on a scale (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (N= 52, 49) | Week 2 (N= 54, 47) | Week 3 (N= 52, 44) | Week 4 (N= 50, 46) | Week 5 (N= 49, 44) | Week 6 (N= 49, 44) | Week 7 (N= 48, 42) | Week 8 (N= 46, 44) | Week 9 (N= 46, 42) | Week 10 (N= 45, 40) | Week 11 (N= 44, 38) | Week 12 (N= 43, 34) | Week 13 (N= 42, 33) | Week 14 (N= 41, 34) | Week 15 (N= 35, 33) | |
| Placebo | -0.30 | -0.65 | -0.44 | -0.54 | -0.61 | -0.54 | -0.81 | -0.42 | -0.81 | -0.66 | -0.95 | -0.77 | -1.00 | -0.94 | -1.08 |
| Pregabalin | -0.52 | -0.84 | -0.89 | -1.03 | -0.99 | -1.18 | -1.30 | -1.43 | -1.38 | -1.43 | -1.39 | -1.38 | -1.34 | -1.36 | -1.25 |
Responder rates based on PGIC was derived and tabulated by treatment group. A responder was defined as a participant who reports much improved or very much improved. The PGIC is a patient-rated single item that measures patient's perception of change in their overall status since starting study medication on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT01020474)
Timeframe: Week 15
| Intervention | percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 2.3 | 27.3 | 27.3 | 38.6 | 2.3 | 2.3 | 0 |
| Pregabalin | 16.3 | 36.7 | 22.4 | 18.4 | 6.1 | 0 | 0 |
"Change from Baseline to endpoint in mean sleep quality score from the daily sleep diary, defined as the mean of the last 7 diary entries prior to Visit 10 in the study while the participant is on study medication. The daily quality of sleep diary consists of an 11-point numeric rating scale with which the patient rates the quality of their sleep during the past 24 hours. Zero indicates best possible sleep and 10 indicates worst possible sleep." (NCT01020474)
Timeframe: Week 15
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.13 |
| Placebo | -0.94 |
"The Primary Endpoint is based on the daily pain diary, and is defined as change from baseline to Week 15 in mean pain diary score. The daily pain diary consists of an 11-point numeric rating scale ranging from zero (no pain) to 10 (worst possible pain). The patients rate their pain during the past 24 hours by choosing the appropriate number between 0 (no pain) and 10 (worst possible pain)." (NCT01020474)
Timeframe: Week 15
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.60 |
| Placebo | -0.94 |
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate greater degree of impairment. Participants choose the number that best describes the pain during the last week. (NCT01020474)
Timeframe: Week 15
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.64 |
| Placebo | -0.77 |
At each visit, participants with at least 30% reduction from Baseline in mean pain score were defined as a 30% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). (NCT01020474)
Timeframe: Week 15
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 42.6 |
| Placebo | 38.8 |
At each visit, participants with at least 50% reduction from Baseline in mean pain score were defined as a 50% responder at the visit. The pain NRS consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). (NCT01020474)
Timeframe: Week 15
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 20.4 |
| Placebo | 10.2 |
The weekly pain numeric rating scale (Weekly Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. Negative change indicates improvement. (NCT01020526)
Timeframe: Baseline, Weeks 3, 8, 16, 24 and Last Visit.
| Intervention | Number (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline (N=63) | Week 3 (N=61) | Week 8 (N=55) | Week 16 (N=51) | Week 24 (N=55) | Last Visit (N=63) | |
| Pregabalin | 6.7 | -2.1 | -1.8 | -2.1 | -2.1 | -2.1 |
NPSI: participant rated questionnaire to evaluate different symptoms of neuropathic pain (subscales: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]). Includes 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. The relevant subscales and total score were transformed to 0-1, higher score indicates a greater intensity of pain. Endpoint=last observation for participant as per imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Burning Pain (n=183, 192) | Change at Endpoint: Burning Pain (n=173, 176) | Baseline: Pressing Pain (n=182, 192) | Change at Endpoint: Pressing Pain (n=173, 176) | Baseline: Paroxysmal Pain (n=183, 192) | Change at Endpoint: Paroxysmal Pain (n=173, 176) | Baseline: Evoked Pain (n=183, 192) | Change at Endpoint: Evoked Pain (n=173, 176) | Baseline: P/D (n=183, 192) | Change at Endpoint: P/D (n=173, 176) | Baseline: Total Score (n=182, 192) | Change at Endpoint: Total Score (n=173,176) | |
| Placebo | 0.62 | -0.26 | 0.54 | -0.21 | 0.56 | -0.23 | 0.55 | -0.21 | 0.63 | -0.25 | 0.57 | -0.23 |
| Pregabalin | 0.61 | -0.24 | 0.55 | -0.22 | 0.56 | -0.22 | 0.57 | -0.22 | 0.62 | -0.23 | 0.58 | -0.22 |
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning). (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Ph Fn (n=183, 192) | Change at Endpoint: Ph Fn (n=173, 176) | Baseline: R-P (n=183, 192) | Change at Endpoint: R-P (n=173, 176) | Baseline: BP (n=183, 192) | Change at Endpoint: BP (n=172, 176) | Baseline: GH (n=183, 192) | Change at Endpoint: GH (n=173, 176) | Baseline: Ph C (n=183, 192) | Change at Endpoint: Ph C (n=171, 176) | Baseline: Vit (n=183, 192) | Change at Endpoint: Vit (n=172, 176) | Baseline: So Fn (n=183, 192) | Change at Endpoint: So Fn (n=173, 176) | Baseline: R-E (n=183, 192) | Change at Endpoint: R-E (n=173, 176) | Baseline: MnH (n=183, 192) | Change at Endpoint: MnH (n=172, 176) | Baseline: Mn C (n=183, 192) | Change at Endpoint: Mn C (n=171, 176) | |
| Placebo | 56.30 | 6.85 | 58.37 | 7.05 | 48.47 | 12.86 | 59.47 | 7.37 | 40.06 | 4.17 | 59.80 | 4.87 | 66.34 | 6.18 | 67.93 | 1.85 | 68.59 | 4.12 | 47.18 | 1.21 |
| Pregabalin | 55.25 | 8.29 | 55.43 | 9.03 | 48.11 | 13.13 | 58.83 | 8.25 | 39.66 | 4.44 | 61.01 | 2.86 | 68.37 | 2.60 | 63.80 | 6.74 | 69.07 | 3.11 | 47.12 | 1.18 |
BPI-sf:5-item self-administered questionnaire to assess severity,impact of pain on daily functions. Pain Severity Index (PSI):average of Question 1-4 each measured severity of pain over past 24-hours on 11-point scale (0=no pain to 10=worst possible pain). Pain Interference Index (PII):average of 7 pain interference items of Question 5 that measured level of interference of pain on daily function on 11-point scale (0=does not interfere to 10=completely interferes). For PSI, PII range:0-10 higher score=higher pain/interference. Endpoint=last observation for participant as per imputation method. (NCT01049217)
Timeframe: Baseline, Week 4, 8, 12, 16, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: PSI (n=182, 192) | Change at Week 4: PSI (n=158, 169) | Change at Week 8: PSI (n=146, 154) | Change at Week 12: PSI (n=126, 137) | Change at Week 16: PSI (n=166, 166) | Change at Endpoint: PSI (n=175,182) | Baseline: PII (n=182, 192) | Change at Week 4: PII (n=158, 169) | Change at Week 8: PII (n=146, 154) | Change at Week 12: PII (n=126, 137) | Change at Week 16: PII (n=166, 165) | Change at Endpoint: PII (n=175,182) | |
| Placebo | 6.47 | -1.28 | -2.02 | -2.60 | -2.55 | -2.44 | 5.44 | -1.40 | -1.97 | -2.32 | -2.38 | -2.31 |
| Pregabalin | 6.49 | -1.55 | -2.15 | -2.49 | -2.38 | -2.36 | 5.51 | -1.43 | -2.00 | -2.32 | -2.14 | -2.12 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. Endpoint was the last observation for a participant assessed using imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline: HADS-A (n=183, 192) | Change at Endpoint: HADS-A (n=173, 176) | Baseline: HADS-D (n=183, 192) | Change at Endpoint: HADS-D (n=173, 176) | |
| Placebo | 6.32 | -1.50 | 5.42 | -1.02 |
| Pregabalin | 5.99 | -1.03 | 4.92 | 0.07 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their Human Immunodeficiency Virus (HIV) neuropathy pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method, modified Baseline Observation Carried Forward (mBOCF). (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Endpoint | |
| Placebo | 6.85 | -2.36 |
| Pregabalin | 6.76 | -2.26 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. Endpoint was the last observation for a participant assessed using imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Sleep Disturbance (n=183, 192) | Change at Endpoint: Sleep Disturbance (n=173, 175) | Baseline: Snoring (n=181, 192) | Change at Endpoint: Snoring (n=171, 175) | Baseline: SOB (n= 183, 192) | Change at Endpoint: SOB (n=173, 175) | Baseline: Quantity (n= 183, 192) | Change at Endpoint: Quantity (n=173, 175) | Baseline: Adequacy (n= 183, 192) | Change at Endpoint: Adequacy (n=173, 175) | Baseline: Somnolence (n= 183, 192) | Change at Endpoint: Somnolence (n=173, 175) | Baseline: Sleep Problems Index (n= 183, 192) | Change at Endpoint:Sleep Problems Index(n=173,175) | |
| Placebo | 39.32 | -8.64 | 26.04 | -3.77 | 25.83 | -7.09 | 7.96 | 0.36 | 54.22 | 4.63 | 29.10 | -4.23 | 36.91 | -6.70 |
| Pregabalin | 35.27 | -6.58 | 25.30 | 0.94 | 22.08 | -3.01 | 7.50 | 0.27 | 57.81 | 5.26 | 26.05 | -0.77 | 32.97 | -4.25 |
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors and 2 temporal items. Results reported for the 10 descriptors (burning, squeezing, pressure, electric shocks, stabbing, light touching of area, pressure of area, cold of area, pins and needles, tingling) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) scale. Endpoint was the last observation for a participant assessed using specified imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Burning (n=183, 192) | Change at Endpoint: Burning (n=173, 176) | Baseline: Squeezing (n=183, 192) | Change at Endpoint: Squeezing (n=173, 176) | Baseline: Pressure (n=183, 192) | Change at Endpoint: Pressure (n=172, 176) | Baseline: Electric Shocks (n=183, 192) | Change at Endpoint: Electric Shocks (n=173, 176) | Baseline: Stabbing (n=183, 192) | Change at Endpoint: Stabbing (n=173, 176) | Baseline: Light Touching (n=183, 192) | Change at Endpoint: Light Touching (n=173, 176) | Baseline: Pressure of Area (n=183, 192) | Change at Endpoint: Pressure of Area (n=173, 176) | Baseline: Cold of Area (n=183, 192) | Change at Endpoint: Cold of Area (n=173, 176) | Baseline: Pins and Needles (n=183, 192) | Change at Endpoint: Pins and Needles (n=173, 176) | Baseline: Tingling (n=183, 192) | Change at Endpoint: Tingling (n=173, 176) | |
| Placebo | 6.2 | -2.6 | 5.2 | -2.1 | 5.5 | -2.2 | 5.1 | -2.0 | 6.1 | -2.5 | 5.0 | -1.9 | 6.0 | -2.3 | 5.5 | -2.0 | 6.6 | -2.6 | 6.1 | -2.4 |
| Pregabalin | 6.1 | -2.4 | 5.3 | -2.1 | 5.8 | -2.3 | 5.4 | -2.2 | 5.8 | -2.2 | 5.0 | -1.9 | 6.0 | -2.5 | 5.9 | -2.2 | 6.7 | -2.6 | 5.8 | -2.1 |
The CGIC scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGIC). At final visit, the participants CGIC will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse. Number of participants in each category is reported. (NCT01049217)
Timeframe: Week 16
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Placebo | 47 | 53 | 49 | 25 | 2 | 0 | 0 |
| Pregabalin | 45 | 59 | 48 | 17 | 3 | 0 | 0 |
"Weekly current pain score was defined as the mean of the daily current pain diary ratings split into 7 day intervals. Participants rated current (right now) HIV neuropathy pain an 11-point NRS ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Endpoint was the last observation for a participant assessed using specified imputation method." (NCT01049217)
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=183, 192) | Change at Week 1 (n=181, 190) | Change at Week 2 (n=174, 179) | Change at Week 3 (n=170, 172) | Change at Week 4 (n=158, 169) | Change at Week 5 (n=157, 166) | Change at Week 6 (n=152, 157) | Change at Week 7 (n=153, 153) | Change at Week 8 (n=148, 153) | Change at Week 9 (n=143, 148) | Change at Week 10 (n=138, 142) | Change at Week 11 (n=132, 136) | Change at Week 12 (n=128, 135) | Change at Week 13 (n=126, 133) | Change at Week 14 (n=124, 131) | Change at Week 15 (n=120, 132) | Change at Week 16 (n=111, 128) | Change at Endpoint (n=183, 191) | |
| Placebo | 6.71 | -0.34 | -0.67 | -0.82 | -1.17 | -1.48 | -1.73 | -1.88 | -1.99 | -2.21 | -2.24 | -2.37 | -2.44 | -2.60 | -2.74 | -2.78 | -2.81 | -2.29 |
| Pregabalin | 6.66 | -0.43 | -0.79 | -1.10 | -1.41 | -1.74 | -1.87 | -1.92 | -2.01 | -2.30 | -2.38 | -2.42 | -2.55 | -2.53 | -2.66 | -2.77 | -2.94 | -2.24 |
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how HIV neuropathy pain has interfered with their sleep during the past 24 hours on an 11-point NRS ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). Endpoint was the last observation for a participant assessed using specified imputation method. (NCT01049217)
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, Endpoint (up to Week 16)
| Intervention | units on a scale (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=183, 191) | Change at Week 1 (n=177, 182) | Change at Week 2 (n=168, 170) | Change at Week 3 (n=163, 163) | Change at Week 4 (n=153, 160) | Change at Week 5 (n=150, 159) | Change at Week 6 (n=144, 152) | Change at Week 7 (n=145, 145) | Change at Week 8 (n=139, 145) | Change at Week 9 (n=135, 137) | Change at Week 10 (n=131, 135) | Change at Week 11 (n=125, 133) | Change at Week 12 (n=122, 131) | Change at Week 13 (n=118, 127) | Change at Week 14 (n=118, 129) | Change at Week 15 (n=117, 127) | Change at Week 16 (n=103, 121) | Change at Endpoint (n=183, 189) | |
| Placebo | 6.70 | -0.37 | -0.66 | -0.81 | -1.20 | -1.49 | -1.81 | -1.94 | -2.04 | -2.32 | -2.39 | -2.47 | -2.59 | -2.82 | -2.90 | -2.95 | -2.94 | -2.43 |
| Pregabalin | 6.55 | -0.48 | -0.85 | -1.09 | -1.42 | -1.81 | -1.95 | -2.06 | -2.01 | -2.45 | -2.48 | -2.56 | -2.69 | -2.73 | -2.81 | -2.90 | -3.14 | -2.40 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. Endpoint was the last observation for a participant assessed using imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | participants (Number) | |
|---|---|---|
| Baseline (n=183, 192) | Endpoint (n=173, 176) | |
| Placebo | 77 | 80 |
| Pregabalin | 80 | 80 |
NPSI: participant-rated questionnaire to evaluate different symptoms of neuropathic pain. It includes 10 descriptors, and 2 temporal items. Results reported for categorical change in temporal items assessed on 5-point scale for duration of spontaneous pain (1=continuously, 2=8-12 hours [hrs], 3=4-7 hrs, 4=1-3 hrs, 5=less than 1 hr), numbers of pain attacks (1=more than 20, 2=11-20 attacks, 3=6-10 attacks, 4=1-5 attacks, 5=no attack). Change data categorized as worsened (negative change), unchanged (no change), and improved (positive change). Endpoint=last observation as per imputation method. (NCT01049217)
Timeframe: Baseline, Endpoint (up to Week 16)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Duration of Spontaneous Pain, Worsened (n=173,172) | Duration of Spontaneous Pain, Unchanged(n=173,172) | Duration of Spontaneous Pain, Improved (n=173,172) | Number of Pain Attacks, Worsened (n=173, 176) | Number of Pain Attacks, Unchanged (n=173, 176) | Number of Pain Attacks, Improved (n=173, 176) | |
| Placebo | 33 | 50 | 89 | 25 | 54 | 97 |
| Pregabalin | 31 | 56 | 86 | 40 | 49 | 84 |
(NCT01049217)
Timeframe: Screening, Week 1, 4, 8, 12, 16, 17
| Intervention | beats per minute (bpm) (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Screening (n=183, 192) | Week 1 (n=183, 192) | Week 4 (n=159, 169) | Week 8 (n=147, 154) | Week 12 (n=127, 137) | Week 16 (n=171, 176) | Week 17 (n=167, 171) | |
| Placebo | 74.6 | 74.9 | 77.2 | 77.1 | 77.5 | 76.5 | 76.2 |
| Pregabalin | 75.2 | 76.0 | 77.5 | 77.4 | 78.0 | 76.2 | 76.0 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired). (NCT01049217)
Timeframe: Baseline, Week 16, 17
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline: Productivity Affected (n=55, 57) | Week 16: Productivity Affected (n=60, 54) | Week 17: Productivity Affected (n=58, 48) | Baseline: Daily Activity Affected (n=183, 192) | Week 16: Daily Activity Affected (n=169, 170) | Week 17: Daily Activity Affected (n=167, 171) | |
| Placebo | 5.93 | 3.15 | 3.00 | 6.12 | 3.66 | 3.64 |
| Pregabalin | 5.00 | 3.60 | 3.40 | 6.03 | 3.75 | 3.82 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01049217)
Timeframe: Baseline up to 28 days after last dose
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Placebo | 117 | 7 |
| Pregabalin | 126 | 7 |
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm. (NCT01049217)
Timeframe: Screening, Post-Baseline (Week 4 up to Week 17)
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Screening: Su Attempt (n=183, 192) | Screening: Preparatory Acts (n=183, 192) | Screening: Su ID (n=183, 192) | Screening: SI BHV, no Su intent (n=183, 192) | Post-Baseline: Completed Suicide (n=178, 185) | Post-Baseline: Su Attempt (n=178, 185) | Post-Baseline: Preparatory Acts (n=178, 185) | Post-Baseline: Su ID (n=178, 185) | Post-Baseline: SI BHV, no Su intent (n=178, 185) | |
| Placebo | 8 | 8 | 37 | 4 | 0 | 1 | 2 | 11 | 0 |
| Pregabalin | 5 | 5 | 28 | 4 | 0 | 0 | 0 | 5 | 0 |
"PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated Over past 2 weeks, how often bothered by any of following problems?: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual (8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity." (NCT01049217)
Timeframe: Screening
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Little Interest: Not at All (n=183, 192) | Little Interest: Several Days (n=183, 192) | Little Interest: > 1/2 Days (n=183,192) | Little Interest: Nearly Every Day (n=183, 192) | Feeling Down: Not at All (n=183, 192) | Feeling Down: Several Days (n=183, 192) | Feeling Down: > 1/2 Days the Days (n=183, 192) | Feeling Down: Nearly Every Day (n=183, 192) | Trouble With Sleep: Not at All (n=182, 192) | Trouble With Sleep: Several Days (n=182, 192) | Trouble With Sleep: > 1/2 Days (n=182, 192) | Trouble With Sleep: Nearly Every Day (n=182, 192) | Feeling Tired: Not at All (n=183, 192) | Feeling Tired: Several Days (n=183, 192) | Feeling Tired: > 1/2 Days (n=183, 192) | Feeling Tired: Nearly Every Day (n=183, 192) | Poor Appetite/Overeat: Not at All (n=183, 192) | Poor Appetite/Overeat: Several Days (n=183, 192) | Poor Appetite/Overeat: > 1/2 Days (n=183, 192) | Poor Appetite/Overeat: Nearly Everyday (n=183,192) | Feeling Bad About Self: Not at All (n=183, 192) | Feeling Bad About Self: Several Days (n=183, 192) | Feeling Bad About Self: > 1/2 Days (n=183, 192) | Feeling Bad About Self: Nearly Everyday(n=183,192) | Trouble Concentrating: Not at All (n=183, 192) | Trouble Concentrating: Several Days (n=183, 192) | Trouble Concentrating: > 1/2 Days (n=183, 192) | Trouble Concentrating: Nearly Everyday (n=183,192) | Move-Speak Slow/Fidgety: Not at All (n=183,192) | Move-Speak Slow/Fidgety:Several Days(n=183,192) | Move-Speak Slow/Fidgety: >1/2 Days (n=183, 192) | Move-Speak Slow/Fidgety:Nearly Everyday(n=183,192) | |
| Placebo | 89 | 72 | 20 | 11 | 109 | 59 | 12 | 12 | 68 | 86 | 22 | 16 | 56 | 100 | 29 | 7 | 116 | 56 | 15 | 5 | 138 | 43 | 6 | 5 | 140 | 33 | 13 | 6 | 143 | 33 | 10 | 6 |
| Pregabalin | 77 | 63 | 23 | 20 | 105 | 61 | 13 | 4 | 63 | 69 | 26 | 24 | 57 | 87 | 27 | 12 | 99 | 53 | 21 | 10 | 124 | 41 | 12 | 6 | 131 | 35 | 11 | 6 | 144 | 23 | 10 | 6 |
A neurological examination consisted of examination of the mental state, cranial nerve function, motor function (reflexes of patellar, achilles, biceps, babinski and coordination) and sensory function (sharp sensation of dorsal surface of right and left great toe, light touch of lower extremities [LE], right and left first metatarsal joint position sense, and vibration sensation [vibration is felt for < 6 seconds = markedly diminished, 6 to 10 seconds = mild loss, > 10 seconds = normal]). (NCT01049217)
Timeframe: Screening
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cranial Nerve Function: Missing | Cranial Nerve Function: Normal | Cranial Nerve Function: Abnormal | Cranial Nerve Function: Not Done | Coordination, Gait: Missing | Coordination, Gait: Normal | Coordination, Gait: Not Evaluable | Coordination, Gait: Mild Ataxia | Coordination, Gait: Moderate Ataxia | Coordination, Gait: Severe Ataxia | Coordination, Romberg Test: Missing | Coordination, Romberg Test: Normal | Coordination, Romberg Test: Abnormal | Coordination, Romberg Test: Not Done | Reflexes, Left Patellar: Missing | Reflexes, Left Patellar: None/Absent | Reflexes, Left Patellar: Normal | Reflexes, Left Patellar: Not Done | Reflexes, Left Patellar: Hypoactive (Diminished) | Reflexes, Left Patellar: Hyperactive (More Brisk) | Reflexes, Left Patellar: Clonus (Very Intense) | Reflexes, Right Patellar: Missing | Reflexes, Right Patellar: None/Absent | Reflexes, Right Patellar: Normal | Reflexes, Right Patellar: Not Done | Reflexes, Right Patellar: Hypoactive (Diminished) | Reflexes, Right Patellar: Hyperactive (More Brisk) | Reflexes, Right Patellar: Clonus (Very Intense) | Reflexes, Left Achilles: Missing | Reflexes, Left Achilles: None/Absent | Reflexes, Left Achilles: Normal | Reflexes, Left Achilles: Not Done | Reflexes, Left Achilles: Hypoactive (Diminished) | Reflexes, Left Achilles: Hyperactive (More Brisk) | Reflexes, Left Achilles: Clonus (Very Intense) | Reflexes, Right Achilles: Missing | Reflexes, Right Achilles: None/Absent | Reflexes, Right Achilles: Normal | Reflexes, Right Achilles: Not Done | Reflexes, Right Achilles: Hypoactive (Diminished) | Reflexes, Right Achilles: Hyperactive (More Brisk) | Reflexes, Right Achilles: Clonus (Very Intense) | Reflexes, Right Biceps: Missing | Reflexes, Right Biceps: None/Absent | Reflexes, Right Biceps: Normal | Reflexes, Right Biceps: Not Done | Reflexes, Right Biceps: Hypoactive (Diminished) | Reflexes, Right Biceps: Hyperactive (More Brisk) | Reflexes, Right Biceps: Clonus (Very Intense) | Reflexes, Left Biceps: Missing | Reflexes, Left Biceps: None/Absent | Reflexes, Left Biceps: Normal | Reflexes, Left Biceps: Not Done | Reflexes, Left Biceps: Hypoactive (Diminished) | Reflexes, Left Biceps: Hyperactive (More Brisk) | Reflexes, Left Biceps: Clonus (Very Intense) | Mental State: Missing | Mental State: Normal | Mental State: Abnormal | Mental State: Not Done | Sensory Function, Right Great Toe: Missing | Sensory Function, Right Great Toe: Absent | Sensory Function, Right Great Toe: Diminished | Sensory Function, Right Great Toe: Normal | Sensory Function, Right Great Toe: Increased | Sensory Function, Left Great Toe: Missing | Sensory Function, Left Great Toe: Absent | Sensory Function, Left Great Toe: Diminished | Sensory Function, Left Great Toe: Normal | Sensory Function, Left Great Toe: Increased | Sensory Function-Light Touch, LE: Missing | Sensory Function-Light Touch, LE: Not Done | Sensory Function-Light Touch, LE: Unable to Detect | Sensory Function-Light Touch, LE: Hyposensitivity | Sensory Function-Light Touch, LE: Normal Sensation | Sensory Function-Light Touch, LE: Hypersensitivity | Sensory Function, Right Metatarsal Sense: Missing | Sensory Function, Right Metatarsal Sense: Normal | Sensory Function, Right Metatarsal Sense: Abnormal | Sensory Function, Right Metatarsal Sense: Not Done | Sensory Function, Left Metatarsal Sense: Missing | Sensory Function, Left Metatarsal Sense: Normal | Sensory Function, Left Metatarsal Sense: Abnormal | Sensory Function, Left Metatarsal Sense: Not Done | Vibration Sensation: Missing | Vibration Sensation: Not Done | Vibration Sensation: Absent | Vibration Sensation: Markedly Diminished | Vibration Sensation: Mild Loss | Vibration Sensation: Normal | Reflexes, Right Babinski: Missing | Reflexes, Right Babinski: Not Evaluable | Reflexes, Right Babinski: Absent | Reflexes, Right Babinski: Present | Reflexes, Left Babinski: Missing | Reflexes, Left Babinski: Not Evaluable | Reflexes, Left Babinski: Absent | Reflexes, Left Babinski: Present | |
| Placebo | 0 | 192 | 0 | 0 | 1 | 181 | 2 | 7 | 1 | 0 | 0 | 188 | 2 | 2 | 0 | 13 | 130 | 0 | 41 | 8 | 0 | 0 | 13 | 129 | 0 | 41 | 9 | 0 | 0 | 100 | 13 | 0 | 78 | 1 | 0 | 0 | 100 | 9 | 0 | 82 | 1 | 0 | 0 | 2 | 178 | 2 | 7 | 3 | 0 | 0 | 2 | 180 | 1 | 6 | 3 | 0 | 0 | 192 | 0 | 0 | 0 | 57 | 114 | 7 | 14 | 0 | 58 | 112 | 8 | 14 | 3 | 6 | 48 | 102 | 25 | 8 | 0 | 143 | 47 | 2 | 0 | 143 | 46 | 3 | 2 | 1 | 24 | 52 | 79 | 34 | 0 | 6 | 180 | 6 | 0 | 6 | 180 | 6 |
| Pregabalin | 1 | 178 | 4 | 0 | 1 | 169 | 2 | 7 | 3 | 1 | 1 | 174 | 6 | 2 | 1 | 7 | 124 | 0 | 43 | 8 | 0 | 1 | 8 | 124 | 1 | 42 | 7 | 0 | 1 | 92 | 14 | 0 | 73 | 3 | 0 | 1 | 90 | 14 | 0 | 75 | 3 | 0 | 1 | 1 | 166 | 3 | 8 | 4 | 0 | 1 | 1 | 169 | 2 | 7 | 3 | 0 | 3 | 179 | 1 | 0 | 1 | 63 | 99 | 5 | 15 | 1 | 61 | 102 | 5 | 14 | 2 | 7 | 39 | 99 | 28 | 8 | 1 | 129 | 52 | 1 | 1 | 129 | 51 | 2 | 2 | 1 | 27 | 42 | 86 | 25 | 1 | 3 | 173 | 6 | 1 | 3 | 173 | 6 |
Total sleep time is the number of minutes asleep between time of sleep onset to morning awakening and MIS is the number of minutes spent awake after sleep onset to final awakening. TST and MIS were determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method. (NCT01049217)
Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
| Intervention | minutes (Least Squares Mean) | |
|---|---|---|
| Endpoint: TST | Endpoint: MIS | |
| Placebo | 400.29 | 45.14 |
| Pregabalin | 396.84 | 41.48 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category is reported. (NCT01049217)
Timeframe: Week 16
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Placebo | 51 | 66 | 36 | 17 | 2 | 4 | 0 |
| Pregabalin | 42 | 69 | 42 | 13 | 5 | 2 | 0 |
Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. (NCT01049217)
Timeframe: Screening, Week 1, 4, 8, 12, 16, 17
| Intervention | millimeter of mercury (mmHg) (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening: SBP (n=183, 192) | Week 1: SBP (n=183, 192) | Week 4: SBP (n=159, 169) | Week 8: SBP (n=147, 154) | Week 12: SBP (n=127, 137) | Week 16: SBP (n=171, 176) | Week 17: SBP (n=167, 171) | Screening: DBP (n=183, 192) | Week 1: DBP (n=183, 192) | Week 4: DBP (n=159, 169) | Week 8: DBP (n=147, 154) | Week 12: DBP (n=127, 137) | Week 16: DBP (n=171, 176) | Week 17: DBP (n=167, 171) | |
| Placebo | 122.1 | 120.4 | 119.8 | 120.7 | 121.7 | 122.9 | 121.6 | 78.4 | 77.5 | 76.5 | 77.6 | 78.0 | 78.1 | 78.5 |
| Pregabalin | 121.2 | 119.9 | 117.9 | 118.6 | 120.2 | 119.3 | 120.1 | 78.7 | 76.9 | 76.0 | 76.0 | 77.5 | 76.4 | 76.4 |
"WPAI: 6-question participant rated questionnaire to determine the degree to which specific health problem (SHP) affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Number of participants who responded Yes/No to Question 1: Are you currently employed (working for pay)? are reported." (NCT01049217)
Timeframe: Baseline, Week 16, 17
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline: Employed (n=183, 192) | Week 16: Employed (n=169, 170) | Week 17: Employed (n=167, 171) | Baseline: Unemployed (n=183, 192) | Week 16: Unemployed (n=169, 170) | Week 17: Unemployed (n=167, 171) | |
| Placebo | 57 | 51 | 47 | 135 | 119 | 124 |
| Pregabalin | 57 | 57 | 58 | 126 | 112 | 109 |
A physical examination included an examination of the general appearance, skin, chest, pulses, pulmonary, cardiovascular, head, eyes, ears, nose, throat, abdominal, and extremities. (NCT01049217)
Timeframe: Screening, Week 8, 17
| Intervention | participants (Number) | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening: General (n=183, 192) | Week 8: General (n=146, 154) | Week 17: General (n=170, 174) | Screening: Skin (n=183, 192) | Week 8: Skin (n=146, 154) | Week 17: Skin (n=170, 174) | Screening: Chest (n=183, 192) | Week 8: Chest (n=146, 154) | Week 17: Chest (n=170, 174) | Screening: Pulses (n=183, 191) | Week 8: Pulses (n=146, 153) | Week 17: Pulses (n=170, 174) | Screening: Lungs (n=183, 192) | Week 8: Lungs (n=146, 154) | Week 17: Lungs (n=170, 174) | Screening: Heart (n=183, 192) | Week 8: Heart (n=146, 154) | Week 17: Heart (n=170, 174) | Screening: Abdomen (n=183, 192) | Week 8: Abdomen (n=146, 154) | Week 17: Abdomen (n=170, 174) | Screening: Extremities (n=183, 192) | Week 8: Extremities (n=146, 154) | Week 17: Extremities (n=170, 174) | Screening: Head (n=183, 192) | Week 8: Head (n=146, 154) | Week 17: Head (n=170, 174) | Screening: Ears (n=181, 191) | Week 8: Ears (n=145, 154) | Week 17: Ears (n=170, 174) | Screening: Eyes (n=183, 192) | Week 8: Eyes (n=146, 154) | Week 17: Eyes (n=170, 174) | Screening: Nose (n=183, 192) | Week 8: Nose (n=146, 154) | Week 17: Nose (n=170, 174) | Screening: Throat (n=183, 192) | Week 8: Throat (n=146, 154) | Week 17: Throat (n=170, 174) | |
| Placebo | 13 | 7 | 6 | 37 | 20 | 32 | 4 | 3 | 2 | 1 | 1 | 2 | 6 | 3 | 5 | 4 | 3 | 3 | 6 | 2 | 6 | 46 | 26 | 23 | 5 | 2 | 2 | 3 | 0 | 3 | 7 | 5 | 6 | 3 | 4 | 1 | 3 | 6 | 2 |
| Pregabalin | 16 | 12 | 11 | 30 | 20 | 21 | 6 | 2 | 4 | 3 | 2 | 1 | 2 | 2 | 3 | 3 | 4 | 4 | 11 | 9 | 8 | 50 | 28 | 29 | 2 | 0 | 2 | 1 | 0 | 1 | 12 | 8 | 9 | 0 | 3 | 3 | 3 | 4 | 5 |
Laboratory tests included hematology, chemistry, cluster of differentiation 4 (CD4) count and cluster of differentiation 8 (CD8) count, HIV plasma viral load, B12, Venereal Disease Research Laboratory (VDRL), toxic screens for drugs and alcohol, reflex thyroid-stimulating hormone (TSH), urinalysis. Number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time was reported. (NCT01049217)
Timeframe: Screening up to Week 17
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 165 |
| Placebo | 170 |
(NCT01049217)
Timeframe: Screening, Week 1, 4, 8, 12, 16, 17
| Intervention | kilogram (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Screening (n=183, 192) | Week 1 (n=183, 192) | Week 4 (n=158, 169) | Week 8 (n=146, 154) | Week 12 (n=127, 137) | Week 16 (n=170, 176) | Week 17 (n=167, 171) | |
| Placebo | 72.0 | 72.5 | 71.8 | 72.1 | 72.7 | 72.5 | 72.6 |
| Pregabalin | 70.8 | 71.2 | 72.6 | 73.1 | 74.0 | 73.6 | 73.6 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. A participant who had responded 'no' to question 1 regarding employment status reported hours of work and as this was a self-reported questionnaire the source data were included. (NCT01049217)
Timeframe: Baseline, Week 16, 17
| Intervention | hours (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline, Hours Missed,Leg/Foot Pain (n=57, 58) | Week 16, Hours Missed,Leg/Foot Pain (n=57, 54) | Week 17, Hours Missed,Leg/Foot Pain (n=58, 48) | Baseline, Hours Missed,Other Reason (n=57, 58) | Week 16, Hours Missed,Other Reason (n=57, 54) | Week 17, Hours Missed,Other Reason (n=58, 48) | Baseline: Hours Worked (n=57, 58) | Week 16: Hours Worked (n=57, 54) | Week 17: Hours Worked (n=58, 48) | |
| Placebo | 4.86 | 2.41 | 1.27 | 7.31 | 6.74 | 2.94 | 28.76 | 32.72 | 38.15 |
| Pregabalin | 5.58 | 2.05 | 3.03 | 12.77 | 7.53 | 7.72 | 32.54 | 37.44 | 34.83 |
"Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non sleep period). A total activity count was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method." (NCT01049217)
Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
| Intervention | activity counts per day (Least Squares Mean) |
|---|---|
| Pregabalin | 297350 |
| Placebo | 305787 |
SFI is a measure to quantify sleep restlessness. SFI calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. SFI determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on wrist like a watch. It was programmed to record movements while device was being worn. Endpoint was the last observation for a participant assessed using imputation method. (NCT01049217)
Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
| Intervention | percentage of immobile bouts (Least Squares Mean) |
|---|---|
| Pregabalin | 18.57 |
| Placebo | 19.60 |
Sleep efficiency is the time spent asleep divided by total time between sleep onset and sleep end, multiplied by 100. Sleep efficiency was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method. (NCT01049217)
Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
| Intervention | Percent time between sleep onset and end (Least Squares Mean) |
|---|---|
| Pregabalin | 85.80 |
| Placebo | 84.84 |
"Percentage of time above sedentary level is number of epochs (60 seconds) with greater than (>) 200 activity counts per minute divided by total number of epochs during the day (non sleep period) multiplied by 100. This was determined by actigraphy. Actigraphy was performed with an accelerometer that was worn on the wrist like a watch. It was programmed to record movements while the device was being worn. Endpoint was the last observation for a participant assessed using specified imputation method." (NCT01049217)
Timeframe: Baseline (Day -14 to 1), Week 1 through Week 4, Week 12 through Week 16, Endpoint (up to Week 16)
| Intervention | percentage of day time (Least Squares Mean) |
|---|---|
| Pregabalin | 52.43 |
| Placebo | 52.28 |
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). (NCT01057693)
Timeframe: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DB Baseline (n= 147, 147) | Week 7 (n= 144, 145) | Week 8 (n= 143, 142) | Week 9 (n= 140, 134) | Week 10 (n= 138, 133) | Week 11 (n= 138, 128) | Week 12 (n= 136, 123) | Week 13 (n= 134, 122) | Week 14 (n= 133, 122) | Week 15 (n= 132, 120) | Week 16 (n= 132, 120) | Week 17 (n= 129, 116) | Week 18 (n= 128, 116) | Week 19 (n= 121, 111) | |
| Placebo | 2.3 | 2.7 | 3.0 | 2.7 | 2.7 | 2.5 | 2.4 | 2.3 | 2.3 | 2.3 | 2.3 | 2.2 | 2.3 | 2.2 |
| Pregabalin DB | 2.5 | 2.6 | 2.6 | 2.3 | 2.3 | 2.2 | 2.3 | 2.3 | 2.3 | 2.4 | 2.3 | 2.2 | 2.3 | 2.3 |
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. (NCT01057693)
Timeframe: Week 1, 2, 3, 4, 5, 6
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 (n= 657) | Week 2 (n= 636) | Week 3 (n= 613) | Week 4 (n= 585) | Week 5 (n= 565) | Week 6 (n= 548) | |
| Pregabalin SB | 6.0 | 5.4 | 4.9 | 4.6 | 4.5 | 4.3 |
Weekly mean pain score was defined as the mean of the daily diary pain ratings split into 7 day intervals. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. DB baseline refers to the last 7 pain diary entries up to and including DB Day 1. (NCT01057693)
Timeframe: DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DB Baseline (n= 147, 147) | Week 7 (n= 144, 145) | Week 8 (n= 143, 142) | Week 9 (n= 140, 133) | Week 10 (n= 138, 133) | Week 11 (n= 138, 128) | Week 12 (n= 135, 123) | Week 13 (n= 134, 122) | Week 14 (n= 133, 122) | Week 15 (n= 131, 118) | Week 16 (n= 132, 118) | Week 17 (n= 128, 115) | Week 18 (n= 128, 115) | Week 19 (n= 115, 104) | |
| Placebo | 3.0 | 3.3 | 3.6 | 3.4 | 3.4 | 3.3 | 3.2 | 3.1 | 3.1 | 3.0 | 3.0 | 2.9 | 2.9 | 2.8 |
| Pregabalin DB | 3.1 | 3.2 | 3.2 | 3.0 | 3.0 | 2.9 | 2.9 | 2.9 | 2.9 | 2.9 | 2.8 | 2.7 | 2.8 | 2.7 |
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SB Baseline: Total QOL Scores (n= 665) | SB Baseline: Ph Fn/Large Fiber (n= 665) | SB Baseline: Activities of Daily Living (n= 665) | SB Baseline: Symptoms (n= 665) | SB Baseline: Small Fiber (n= 665) | SB Baseline: Autonomic (n= 665) | Week 6: Total QOL Scores (n= 618) | Week 6: Ph Fn/Large Fiber (n= 618) | Week 6: Activities of Daily Living (n= 618) | Week 6: Symptoms (n= 618) | Week 6: Small Fiber (n= 618) | Week 6: Autonomic (n= 618) | |
| Pregabalin SB | 42.6 | 23.9 | 3.2 | 10.8 | 3.4 | 1.3 | 29.3 | 15.8 | 2.2 | 7.8 | 2.3 | 1.1 |
QOL-DN: 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. Consists of 5 domains: Physical functioning(Ph Fn)/large fiber (sum of item 8, 11, 13-15, 24, 27-35; range -4 to 56); Activities of daily living (sum of item 12, 22, 23, 25, 26; range 0 to 20); Symptoms (sum of item 1-7, 9; range 0 to 32); Small fiber (sum of item 10, 16, 17, 18; range 0 to 16); Autonomic (sum of item 19, 20, 21; range 0 to 12) and total QOL score (sum of items 1-35) range: -4 to 136. Higher score implied worse QOL. (NCT01057693)
Timeframe: Week 19
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Total QOL Scores | Ph Fn/Large Fiber | Activities of Daily Living | Symptoms | Small Fiber | Autonomic | |
| Placebo | 24.1 | 12.9 | 1.8 | 6.6 | 1.7 | 1.1 |
| Pregabalin DB | 21.9 | 11.4 | 1.8 | 6.1 | 1.8 | 0.9 |
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| SB Baseline: HADS-A (n= 663) | SB Baseline: HADS-D (n= 663) | Week 6: HADS-A (n= 616) | Week 6: HADS-D (n= 616) | |
| Pregabalin SB | 5.8 | 5.3 | 4.6 | 4.0 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. (NCT01057693)
Timeframe: Week 19
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance | Snoring | Awaken SOB or With Headache | Quantity of sleep | Sleep Adequacy | Somnolence | Sleep Problems Index | |
| Placebo | 30.9 | 35.4 | 12.2 | 6.5 | 59.0 | 30.6 | 30.9 |
| Pregabalin DB | 26.6 | 41.9 | 12.3 | 6.7 | 59.2 | 29.7 | 28.5 |
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving DB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). (NCT01057693)
Timeframe: Week 19
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin DB | 2.4 |
| Placebo | 2.4 |
Endpoint mean sleep interference score was defined as the mean of the last 7 sleep interference diaries while receiving SB treatment. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere to 10 = completely interferes (unable to sleep due to pain). (NCT01057693)
Timeframe: Week 6
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin SB | 3.8 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. (NCT01057693)
Timeframe: Week 19
| Intervention | participants (Number) |
|---|---|
| Pregabalin DB | 67 |
| Placebo | 60 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 6 is reported. SB baseline refers to the last 7 pain diary entries up to and including Day 1. (NCT01057693)
Timeframe: Week 6
| Intervention | percentage of participants (Number) | |
|---|---|---|
| >=30 % Reduction | >=50 % Reduction | |
| Pregabalin SB | 49.92 | 27.22 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. Percentage of participants who had at least 30% and 50% pain reduction from SB baseline to Week 19 is reported. (NCT01057693)
Timeframe: Week 19
| Intervention | percentage of participants (Number) | |
|---|---|---|
| >=30% Reduction | >=50% Reduction | |
| Placebo | 79.19 | 55.03 |
| Pregabalin DB | 82.99 | 62.59 |
Participant-rated 12-item questionnaire to assess constructs of sleep over past week; 7 subscales: sleep disturbance (range 0-100), snoring (range 0-100), awaken short of breath (SOB) or with headache (range 0-100), sleep adequacy (range 0-100), somnolence (range: 0-100); sleep quantity (range: 0-24), optimal sleep (yes/no), and 9 item index measures of sleep disturbance provide composite scores: sleep problems index (range 0-100). Except adequacy, optimal sleep and quantity, higher scores=more impairment. (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SB Baseline: Sleep disturbance (n= 665) | SB Baseline: Snoring (n= 664) | SB Baseline: Awaken SOB or With Headache (n=665) | SB Baseline: Quantity of sleep (n=663) | SB Baseline: Sleep Adequacy (n=665) | SB Baseline: Somnolence (n=665) | SB Baseline: Sleep Problems Index (n=665) | Week 6: Sleep disturbance (n= 621) | Week 6: Snoring (n= 621) | Week 6: Awaken SOB or With Headache (n= 621) | Week 6: Quantity of sleep (n= 615) | Week 6: Sleep Adequacy (n= 621) | Week 6: Somnolence (n= 621) | Week 6: Sleep Problems Index (n= 621) | |
| Pregabalin SB | 53.6 | 44.7 | 18.9 | 5.9 | 39.2 | 42.6 | 49.2 | 33.6 | 39.9 | 12.6 | 6.6 | 52.6 | 34.2 | 34.4 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. (NCT01057693)
Timeframe: Week 19
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Placebo | 23 | 46 | 28 | 20 | 6 | 8 | 3 |
| Pregabalin DB | 23 | 50 | 27 | 28 | 9 | 1 | 0 |
"GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported." (NCT01057693)
Timeframe: Week 6
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Satisfied | Somewhat Satisfied | Slightly Satisfied | Neither Satisfied Nor Dissatisfied | Slightly Dissatisfied | Somewhat Dissatisfied | Very Dissatisfied | |
| Pregabalin SB | 241 | 181 | 66 | 71 | 22 | 21 | 19 |
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. (NCT01057693)
Timeframe: Week 19
| Intervention | mm (Mean) |
|---|---|
| Pregabalin DB | 25.3 |
| Placebo | 30.1 |
Time to loss of pain response (based on the daily pain diary data) during the DB treatment phase was analyzed using survival analysis technique. Loss of pain response was defined as less than (<) 15% pain response relative to the SB baseline. SB baseline refers to the last 7 pain diary entries up to and including Day 1. (NCT01057693)
Timeframe: SB Baseline up to Week 19
| Intervention | days (Median) |
|---|---|
| Pregabalin DB | NA |
| Placebo | NA |
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). (NCT01057693)
Timeframe: Week 19
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Pain Severity | Pain Interference | |
| Placebo | 3.0 | 2.4 |
| Pregabalin DB | 2.6 | 2.0 |
BPI-sf: self-administered questionnaire developed to assess severity, impact of pain on daily functions, consisted of 5 questions. Questions 1-4 measured the severity of pain based on pain experienced over the past 24-hours on an 11-point scale ranged from 0 (no pain) to10 (worst possible pain). Question 5: 7 item subsets that measured level of interference of pain on daily functions on an 11-point scale ranged from 0 (does not interfere) to 10 (completely interferes). (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| SB Baseline: Pain Severity (n= 665) | SB Baseline: Pain Interference (n= 665) | Week 6: Pain Severity (n= 637) | Week 6: Pain Interference (n= 637) | |
| Pregabalin SB | 6.1 | 5.2 | 3.9 | 3.1 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. (NCT01057693)
Timeframe: Week 6
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Pregabalin SB | 93 | 221 | 194 | 65 | 29 | 15 | 3 |
MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week. It included 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep, and 9 item index measures of sleep disturbance provide composite scores: sleep problems index. Participants responded whether their sleep was optimal or not optimal by choosing yes or no. (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | participants (Number) | |
|---|---|---|
| SB Baseline | Week 6 | |
| Pregabalin SB | 180 | 266 |
Participants rated their pain on a 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 mm = no pain to 100 mm = worst possible pain. (NCT01057693)
Timeframe: SB Baseline, Week 6
| Intervention | mm (Mean) | |
|---|---|---|
| SB Baseline (n= 665) | Week 6 (n= 621) | |
| Pregabalin SB | 68.1 | 39.8 |
HADS: self-administered questionnaire, consists of 2 sub-scales; measuring anxiety (HADS-A), and depression (HADS-D). Each sub-scale consists of 7 items on which participants responded as to how each item applies to them on a 4-point scale ranging from 0 (no anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score range for each sub-scale = 0 to 21, where higher score indicates more severe anxiety or depression. (NCT01057693)
Timeframe: Week 19
| Intervention | units on a scale (Mean) | |
|---|---|---|
| HADS-A | HADS-D | |
| Placebo | 4.3 | 3.5 |
| Pregabalin DB | 3.8 | 3.3 |
"GESM: single-item, self-administered treatment satisfaction questionnaire. Participants answered how would you rate the study medication you received for pain? on a 7-point scale ranging from 1 (very satisfied) to 7 (very dissatisfied). Number of participants in each category are reported." (NCT01057693)
Timeframe: Week 19
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Satisfied | Somewhat Satisfied | Slightly Satisfied | Neither Satisfied Nor Dissatisfied | Slightly Dissatisfied | Somewhat Dissatisfied | Very Dissatisfied | |
| Placebo | 64 | 36 | 14 | 10 | 2 | 6 | 2 |
| Pregabalin DB | 80 | 35 | 9 | 6 | 5 | 1 | 2 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. (NCT01057693)
Timeframe: SB Baseline, Week 6 (SB Phase)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| SB Baseline (n= 663) | Change at Week 6 (SB Phase) (n= 658) | |
| Pregabalin SB | 6.7 | -2.2 |
Weekly mean sleep interference score was defined as the mean of the daily sleep interference diary ratings split into 7 day intervals. Participants rated how painful DPN has interfered with their sleep during the past 24 hours on an 11-point numeric rating scale ranging from 0 = does not interfere with sleep to 10 = completely interferes (unable to sleep due to pain). SB baseline refers to the last 7 pain diary entries up to and including Day 1. (NCT01057693)
Timeframe: SB Baseline, Week 1, 2, 3, 4, 5, 6
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| SB Baseline (n= 663) | Week 1 (n= 657) | Week 2 (n= 636) | Week 3 (n= 614) | Week 4 (n= 589) | Week 5 (n= 566) | Week 6 (n= 548) | |
| Pregabalin SB | 5.9 | 5.1 | 4.5 | 4.1 | 3.8 | 3.7 | 3.6 |
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1. (NCT01057693)
Timeframe: SB Baseline, Week 19 (DB Phase)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Single-Blind Baseline | Change at Week 19 (DB Phase) | |
| Placebo | 6.7 | -3.5 |
| Pregabalin DB | 6.8 | -3.9 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | percentage of participants (Number) |
|---|---|
| Combination | 52.1 |
| Monotherapy | 39.3 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Duloxetine | 52.0 |
| Pregabalin | 36.9 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Duloxetine | 57.1 |
| Pregabalin | 45.7 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | percentage of participants (Number) |
|---|---|
| Combination | 66.7 |
| Monotherapy | 64.4 |
Measures participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit. (NCT01089556)
Timeframe: Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | 2.601 |
| Pregabalin | 2.944 |
Measures participant's perception of improvement at the time of assessment compared with the start of treatment for Study Period III. The score ranges from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | 2.256 |
| Monotherapy | 2.350 |
TEAEs in Study Period III are events that began or worsened after Week 8 compared with the period before Week 8. (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | participants (Number) |
|---|---|
| Combination | 62 |
| Monotherapy | 57 |
TEAEs in Study Period II are events that began or worsened after Week 0 compared with the period before Week 0. (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | participants (Number) |
|---|---|
| Duloxetine | 223 |
| Pregabalin | 232 |
(NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | participants (Number) |
|---|---|
| Combination | 21 |
| Monotherapy | 21 |
(NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | participants (Number) |
|---|---|
| Duloxetine | 68 |
| Pregabalin | 70 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | beats per minute (bpm) (Least Squares Mean) |
|---|---|
| Combination | 1.025 |
| Monotherapy | 1.968 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | beats per minute (bpm) (Least Squares Mean) |
|---|---|
| Duloxetine | 0.839 |
| Pregabalin | -2.478 |
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | -13.734 |
| Monotherapy | -11.801 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | -2.625 |
| Monotherapy | -2.431 |
BPI Modified Short Form worst pain score is a self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | -2.374 |
| Monotherapy | -2.371 |
The NPSI is a 12-item self-administered questionnaire to assess 5 different dimensions of neuropathic pain: superficial spontaneous burning pain, deep spontaneous pressing pain, paroxysmal pain, evoked pains, and paresthesias/dysesthesias. A total score ranges from 0 to 100. Higher score indicates a greater intensity of pain. Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | -19.442 |
| Pregabalin | -14.684 |
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work (Item 1), social (Item 2), and family life (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) mean values are controlled for treatment, site, baseline value and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | -4.387 |
| Pregabalin | -3.367 |
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, visit, and treatment*visit. (NCT01089556)
Timeframe: Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | 2.508 |
| Pregabalin | 2.848 |
Measures clinician's perception of participant improvement at the time of assessment compared with the start of treatment for Study Period III. Scores range from 1 (very much better) to 7 (very much worse). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | 2.286 |
| Monotherapy | 2.359 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Combination | -2.353 |
| Monotherapy | -2.161 |
Data presented are the average number of hours worked for pay per week during the last 8 weeks. (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | hours (Mean) |
|---|---|
| Combination | 39.8 |
| Monotherapy | 34.7 |
Data presented are the average number of hours worked for pay per week during the last 8 weeks. (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | hours (Mean) |
|---|---|
| Duloxetine | 37.6 |
| Pregabalin | 42.4 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Duloxetine | -2.295 |
| Pregabalin | -1.682 |
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks. (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | days (Mean) | |
|---|---|---|
| Days hospitalized (n=140, 146) | Days of sick leave (n=41, 36) | |
| Combination | 0 | 0.1 |
| Monotherapy | 0 | 0.4 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Week 8 through Week 16
| Intervention | percentage of participants (Number) |
|---|---|
| Combination | 61.8 |
| Monotherapy | 55.8 |
Data presented are the number of days hospitalized and work/school missed (sick leave) due to diabetic peripheral neuropathic pain (DPNP) during the last 8 weeks. (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | days (Mean) | |
|---|---|---|
| Days hospitalized | Days of sick leave (n=108, 101) | |
| Duloxetine | 0 | 1.9 |
| Pregabalin | 0 | 0.3 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, treatment*site and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | millimeter of mercury (mm Hg) (Least Squares Mean) | |
|---|---|---|
| Systolic BP | Diastolic BP | |
| Combination | -1.206 | -0.555 |
| Monotherapy | 0.124 | -0.551 |
Least Squares (LS) mean values are controlled for treatment, site, baseline value, and treatment*site. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | millimeter of mercury (mm Hg) (Least Squares Mean) | |
|---|---|---|
| Systolic BP | Diastolic BP | |
| Duloxetine | -3.702 | -0.816 |
| Pregabalin | -1.682 | -0.951 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit, baseline*visit and treatment in Study Period II. (NCT01089556)
Timeframe: Week 8, Week 16
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Anxiety Subscale Score (n=169, 169) | Depression Subscale Score (n=168, 170) | |
| Combination | -0.860 | -0.461 |
| Monotherapy | -0.245 | -0.083 |
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale (0-3), giving maximum scores of 21 for anxiety and for depression. Scores of 11 or more on either subscale are considered to be a significant case of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7 represent 'normal.' Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and 95% Confidence Interval (CI). LS Mean values are controlled for treatment, site, baseline value, visit, treatment*visit and baseline*visit. (NCT01089556)
Timeframe: Baseline, Week 8
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Anxiety Subscale Score (n= 398, 400) | Depression Subscale Score | |
| Duloxetine | -1.991 | -1.064 |
| Pregabalin | -1.433 | -0.642 |
BPI Modified Short Form 24-Hour average pain item score is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). (NCT01089556)
Timeframe: Baseline through Week 8
| Intervention | percentage of participants (Number) |
|---|---|
| Duloxetine | 40.3 |
| Pregabalin | 27.8 |
"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum value of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance." (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm Hg (Mean) |
|---|---|
| Pregabalin 75 mg | 17.6 |
| Pregabalin 200 mg | 19.1 |
| Placebo | 17.4 |
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. The values across the 4 distension pressures were averaged for this outcome measure. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) |
|---|---|
| Pregabalin 75 mg | 44.364 |
| Pregabalin 200 mg | 35.301 |
| Placebo | 43.286 |
The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) (NCT01094808)
Timeframe: The first 30 minutes postprandially, and preprandial (30 minutes)
| Intervention | Symmetric percentage change (Mean) |
|---|---|
| Pregabalin 75 mg | 21.9 |
| Pregabalin 200 mg | 35.3 |
| Placebo | 27.8 |
The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm Hg (Mean) |
|---|---|
| Pregabalin 75 mg | 27.6 |
| Pregabalin 200 mg | 34.3 |
| Placebo | 34.5 |
The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT01094808)
Timeframe: approximately 60 minutes after drug administration
| Intervention | mm Hg (Mean) |
|---|---|
| Pregabalin 75 mg | 45.8 |
| Pregabalin 200 mg | 46.7 |
| Placebo | 45.0 |
The first 30 minute postprandial motility index (MI), MI = log_e [(number of contractions * sum of amplitudes)+1] (NCT01094808)
Timeframe: 30 minutes after the meal
| Intervention | log mm Hg (Mean) | |
|---|---|---|
| Motility index proximal colon at 30 minutes | Motility index distal colon at 30 minutes | |
| Placebo | 11.465 | 9.879 |
| Pregabalin 200 mg | 11.764 | 9.783 |
| Pregabalin 75 mg | 11.264 | 8.806 |
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) | ||
|---|---|---|---|
| Sensation Ratings for Gas at 16 mm Hg distention | Sensation Ratings for Gas at 24 mm Hg distention | Sensation Ratings for Gas at 36 mm Hg distention | |
| Placebo | 37.14 | 42.76 | 46.24 |
| Pregabalin 200 mg | 30.00 | 32.00 | 36.58 |
| Pregabalin 75 mg | 37.40 | 44.05 | 49.65 |
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) | ||
|---|---|---|---|
| Sensation ratings of pain at 16 mm distension | Sensation ratings of pain at 24 mm distension | Sensation ratings of pain at 36 mm distension | |
| Placebo | 34.29 | 39.48 | 47.62 |
| Pregabalin 200 mg | 29.00 | 36.84 | 43.37 |
| Pregabalin 75 mg | 28.70 | 43.00 | 44.30 |
The 30 mm Hg distension refers to inflation of the balloon placed in placed in the mid-descending or junction of the sigmoid and descending colon. Pain and gas were individually measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of either pain or gas. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) | |
|---|---|---|
| Sensation ratings for pain at 30 mm Hg | Sensation ratings for gas at 30 mm Hg | |
| Placebo | 46.0 | 46.6 |
| Pregabalin 200 mg | 36.1 | 33.2 |
| Pregabalin 75 mg | 47.4 | 53.4 |
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Gas sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the gas VAS, 0 means no gas sensation and 100 mm means extreme gas sensation. The investigator measures the mark made by the participant in mm and records this for the value of gas. The values across the 4 distension pressures were averaged for this outcome measure. (NCT01094808)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) |
|---|---|
| Pregabalin 75 mg | 43.379 |
| Pregabalin 200 mg | 33.391 |
| Placebo | 41.789 |
Determine if there was a reduction in healing time associated with pregabalin as seen with daily slit-lamp observation. Epithelial defect was measured at post-operative day 3, 5, 7, and 9 in each eye. A higher number of days required for healing indicates a worse outcome. (NCT01097577)
Timeframe: 5 days or more
| Intervention | Days (Mean) | |
|---|---|---|
| Days to Heal OD (Right Eye) | Days to Heal OS (Left Eye) | |
| Lactose Capsule | 2.9 | 2.9 |
| Pregabalin | 3 | 3.09 |
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain. (NCT01097577)
Timeframe: 5 days
| Intervention | units on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Surgery Day | Postop day 1 morning | Postop day 1 evening | Postop day 2 morning | Postop day 2 evening | Postop day 3 morning | Postop day 3 evening | Postop day 4 morning | |
| Lactose Capsule | 1.33 | 10.34 | 10.22 | 27.09 | 29.27 | 25.78 | 8.76 | 6.02 | 2.65 |
| Pregabalin | 0.89 | 7.56 | 6.32 | 21.32 | 23.49 | 26.14 | 8.48 | 3.48 | 1.9 |
Determine if there was a reduction in the need for use of rescue pain medications, Percocet and tetracaine, in those subjects who received pregabalin. Total number of doses was collected. A higher number of doses required indicates a worse outcome. (NCT01097577)
Timeframe: 5 days
| Intervention | Rescue medication doses (Mean) | |||
|---|---|---|---|---|
| Surgery Day | Postop Day 1 | Postop Day 3 | Postop Day 4 | |
| Lactose Capsule | 0.94 | 2.44 | 2.56 | 0.62 |
| Pregabalin | 0.81 | 1.7 | 1.7 | 0.43 |
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed with present pain intensity (PPI) score. Scale is 0 (no pain) to 5 (excruciating pain) (NCT01097577)
Timeframe: 5 days
| Intervention | score on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Surgery Day | Postop day 1 morning | Postop day 1 evening | Postop day 2 morning | Postop day 2 evening | Postop day 3 morning | Postop day 3 evening | Postop day 4 morning | |
| Lactose Capsule | 0.03 | 0.84 | 0.89 | 1.62 | 1.62 | 1.48 | 0.68 | 0.48 | 0.22 |
| Pregabalin | 0.03 | 0.69 | 0.67 | 1.37 | 1.43 | 1.46 | 0.67 | 0.3 | 0.18 |
Determine if there was an improvement in the patient's functional health and well-being associated with pregabalin compared to standard of care as assessed by Brief Pain Inventory-short form (BPI-SF). Data was assessed on the day of surgery (Day 0) and at the expected peak of pain, postop Day 2 in the morning. Scale is minimum 0 (no pain) to maximum of 10 (pain as bad as you can imagine). A higher score indicates a worse outcome. (NCT01097577)
Timeframe: 5 days
| Intervention | score on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Pain at its Worst, Day0 | Pain at its Worst, Day2 | Pain at its Least, Day 0 | Pain at its least, Day2 | Avg Pain, Day0 | Avg Pain, Day2 | Pain Interference, Day0 | Pain Interference, Day2 | |
| Lactose Capsule | 0.24 | 4.67 | 0.08 | 1.48 | 0.33 | 3.03 | 0.13 | 3.5 |
| Pregabalin | 0.51 | 3.76 | 0.13 | 1.31 | 0.37 | 2.28 | 0.13 | 2.56 |
Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Secondary efficacy is assessed using the Total MPQ Score. Scale minimum is 0 (no pain) to maximum of 45 (severe pain). A higher score indicates a worse outcome. (NCT01097577)
Timeframe: 5 days
| Intervention | score on a scale (Mean) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | Surgery Day | Postop day 1 morning | Postop day 1 evening | Postop day 2 morning | Postop day 2 evening | Postop day 3 morning | Postop day 3 evening | Postop day 4 morning | |
| Lactose Capsule | 0.16 | 2.18 | 2.16 | 5.37 | 5.61 | 5.68 | 2.9 | 1.16 | 0.39 |
| Pregabalin | 0.15 | 1.85 | 1.79 | 4.6 | 4.67 | 4.87 | 1.7 | 0.97 | 0.6 |
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 3 (Visits 3 and 6) (40 degrees, n=15,16) | Week 3 (Visits 3 and 6) (44 degrees, n=15,16) | Week 3 (Visits 3 and 6) (47 degrees, n=15,16) | Week 3 (Visits 3 and 6) (50 degrees, n=15,16) | Week 4 (Visits 4 and 7) (40 degrees, n=18,21) | Week 4 (Visits 4 and 7) (44 degrees, n=18,21) | Week 4 (Visits 4 and 7) (47 degrees, n=18,21) | Week 4 (Visits 4 and 7) (50 degrees, n=18,21) | |
| Placebo | -0.625 | -0.938 | -0.578 | -0.865 | -0.143 | -0.495 | -0.083 | -0.387 |
| Pregabalin | -1.100 | 0.400 | -0.908 | -1.385 | -0.639 | -0.444 | -0.337 | -0.566 |
Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline). (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=19,18) | Week 4 (Visits 4 and 7) (n=18,18) | |
| Placebo | -0.484 | -0.769 |
| Pregabalin | -1.456 | -1.397 |
Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score. (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 3 (Visits 3 and 6) (Size 8, n=15,16) | Week 3 (Visits 3 and 6) (Size 16, n=15,16) | Week 3 (Visits 3 and 6) (Size 32, n=15,16) | Week 3 (Visits 3 and 6) (Size 64, n=15,16) | Week 3 (Visits 3 and 6) (Size 128, n=15,16) | Week 3 (Visits 3 and 6) (Size 256, n=15,16) | Week 3 (Visits 3 and 6) (Size 512, n=15,16) | Week 4 (Visits 4 and 7) (Size 8, n=18,21) | Week 4 (Visits 4 and 7) (Size 16, n=18,21) | Week 4 (Visits 4 and 7) (Size 32, n=18,21) | Week 4 (Visits 4 and 7) (Size 64, n=18,21) | Week 4 (Visits 4 and 7) (Size 128, n=18,21) | Week 4 (Visits 4 and 7) (Size 256, n=18,21) | Week 4 (Visits 4 and 7) (Size 512, n=18,21) | |
| Placebo | 0.417 | 0.208 | -0.188 | 0.561 | -0.097 | -0.171 | -0.480 | -0.429 | -0.889 | -0.825 | -0.462 | -0.841 | -0.751 | -0.420 |
| Pregabalin | -0.133 | -1.356 | -0.200 | -1.128 | -1.267 | -0.773 | -1.533 | -0.370 | -0.611 | -0.333 | -1.116 | -1.315 | -1.322 | -1.836 |
PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse. (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=15,16) | Week 4 (Visits 4 and 7) (n=18,21) | |
| Placebo | 3.4 | 3.8 |
| Pregabalin | 3.3 | 2.4 |
Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | cm2 (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=16,17) | Week 4 (Visits 4 and 7) (n=17,20) | |
| Placebo | -3.232 | -4.130 |
| Pregabalin | -75.571 | -75.834 |
"Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to How intense is your pain today?" (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=7,10) | Week 4 (Visits 4 and 7) (n=11,11) | |
| Placebo | -0.4 | 0.0 |
| Pregabalin | -1.5 | -1.6 |
"Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a strange or tickly sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score." (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=15,16) | Week 4 (Visits 4 and 7) (n=18,21) | |
| Placebo | -1.16 | -0.67 |
| Pregabalin | -1.09 | -1.31 |
Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths) (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | cm2 (Mean) | |
|---|---|---|
| Week 3 (Visits 3 and 6) (n=16,17) | Week 4 (Visits 4 and 7) (n=17,20) | |
| Placebo | -49.180 | -18.921 |
| Pregabalin | -53.441 | -49.808 |
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score. (NCT01117766)
Timeframe: Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 3 (Visits 3 and 6) (5 degrees, n=15,16) | Week 3 (Visits 3 and 6) (10 degrees, n=15,16) | Week 3 (Visits 3 and 6) (15 degrees, n=15,16) | Week 3 (Visits 3 and 6) (20 degrees, n=15,16) | Week 4 (Visits 4 and 7) (5 degrees, n=18,21) | Week 4 (Visits 4 and 7) (10 degrees, n=18,21) | Week 4 (Visits 4 and 7) (15 degrees, n=18,21) | Week 4 (Visits 4 and 7) (20 degrees, n=18,21) | |
| Placebo | -1.402 | -1.313 | 0.125 | 0.031 | -0.703 | -0.810 | 0.095 | -0.333 |
| Pregabalin | -0.821 | -0.333 | -0.567 | -0.500 | -0.726 | -0.278 | -0.583 | -0.111 |
NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100. (NCT01117766)
Timeframe: Week 4 (Visits 4 and 7) of each period
| Intervention | scores on a scale (Mean) |
|---|---|
| Pregabalin | -10.67 |
| Placebo | -7.72 |
"WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a Human Immunodeficiency Virus (HIV) neuropathy pain. Number of participants who responded Yes/No to Question 1: Are you currently employed (working for pay)? are reported." (NCT01145417)
Timeframe: Baseline, Week 24
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Baseline, employed (n=52,51) | Baseline, unemployed (n=52,51) | Week 24, employed (n=103,104) | Week 24, unemployed (n=103,104) | |
| Placebo-Pregabalin | 11 | 40 | 27 | 77 |
| Pregabalin-Pregabalin | 12 | 40 | 35 | 68 |
PGI-C: participant rated instrument to measure participant's change in overall status since the start of the study, on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. (NCT01145417)
Timeframe: Week 24
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Placebo-Pregabalin | 37 | 47 | 16 | 3 | 0 | 1 | 0 |
| Pregabalin-Pregabalin | 41 | 43 | 16 | 2 | 1 | 0 | 0 |
"PHQ-8: 8-item self-administered validated subset of PHQ-9, which comprises first 8 items of measure. Participant rated Over past 2 weeks, how often bothered by any of following problems?: little interest in doing things(1); feeling down(2); trouble falling or staying asleep/sleeping too much(3); feeling tired(4); poor appetite/overeating(5); feeling bad about self(6); trouble concentrating(7); moving or speaking slowly or being so fidgety/moving around more than usual(8). Each item scored on scale of 0(not at all)-3(nearly every day). Total score range: 0-24, higher score=greater severity." (NCT01145417)
Timeframe: Baseline
| Intervention | participants (Number) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Little interest in things: Not at All | Little interest in things: Several Days | Little interest in things: More Than Half the Days | Little interest in things: Nearly Every Day | Feeling down: Not at All | Feeling down: Several Days | Feeling down: More Than Half the Days | Feeling down: Nearly Every Day | Trouble with sleep: Not at All | Trouble with sleep: Several Days | Trouble with sleep: More Than Half the Days | Trouble with sleep: Nearly Every Day | Feeling tired: Not at All | Feeling tired: Several Days | Feeling tired: More Than Half the Days | Feeling tired: Nearly Every Day | Poor appetite/overeating: Not at All | Poor appetite/overeating: Several Days | Poor appetite/overeating: More Than Half the Days | Poor appetite/overeating: Nearly Every Day | Feeling bad about self: Not at All | Feeling bad about self: Several Days | Feeling bad about self: More Than Half the Days | Feeling bad about self: Nearly Every Day | Trouble concentrating: Not at All | Trouble concentrating: Several Days | Trouble concentrating: More Than Half the Days | Trouble concentrating: Nearly Every Day | Move or speak slow/fidgety: Not at All | Move or speak slow/fidgety: Several Days | Move or speak slow/fidget: More Than Half the Days | Move or speak slow/fidgety: Nearly Every Day | |
| Placebo-Pregabalin | 67 | 25 | 9 | 7 | 79 | 21 | 6 | 2 | 59 | 40 | 4 | 5 | 53 | 40 | 14 | 1 | 71 | 26 | 5 | 6 | 88 | 13 | 3 | 4 | 84 | 20 | 3 | 1 | 86 | 16 | 3 | 3 |
| Pregabalin-Pregabalin | 59 | 31 | 14 | 3 | 84 | 18 | 5 | 0 | 57 | 33 | 14 | 3 | 52 | 43 | 12 | 0 | 75 | 24 | 5 | 3 | 92 | 12 | 2 | 1 | 79 | 23 | 2 | 3 | 87 | 18 | 0 | 2 |
S-STS:8-item clinician/participant administered prospective rating scale to assess TE suicidal(Su) ideation(ID),behavior(BHV).Items 1a,2-6,7a,8 scored on 5-point Likert scale 0(not at all) to 4(extremely). Items 1,1b,7 require yes/no response. S-STS total score range 0-30. Lower score=reduced Su tendency. Responses on S-STS were mapped to Columbia Classification Algorithm of Suicide Assessment(C-CASA) as 1:Completed Su; 2: Su attempt; 3: Preparatory acts; 4: Su ID; 5: Self-injurious (SI) BHV, intent unknown; 6: Not enough information; 7: SI BHV, no Su intent; 8: Other, no deliberate self harm. (NCT01145417)
Timeframe: Baseline up to Week 25
| Intervention | participants (Number) | ||
|---|---|---|---|
| Suicide attempt: 2 | Preparatory acts toward suicidal behavior: 3 | Suicidal ideation: 4 | |
| Placebo-Pregabalin | 1 | 1 | 9 |
| Pregabalin-Pregabalin | 0 | 0 | 4 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT01145417)
Timeframe: Baseline up to 30 days after last dose of study treatment
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Placebo-Pregabalin | 70 | 3 |
| Pregabalin-Pregabalin | 67 | 4 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 5 and 6 assesses: How much leg/foot pain affect productivity and daily activity, respectively in past 7 days? on 11-point scale, where 0 (not affected/no impairment) to 10 (completely affected/impaired). (NCT01145417)
Timeframe: Baseline, Week 24
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline, productivity affected (n=12,10) | Baseline, daily activity affected (n=52,51) | Week 24, productivity affected (n=35,29) | Week 24, daily activity affected (n=103,104) | |
| Placebo-Pregabalin | 2.40 | 3.47 | 2.24 | 2.72 |
| Pregabalin-Pregabalin | 4.42 | 3.48 | 2.17 | 2.51 |
Participants rated the severity of HIV neuropathy pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. (NCT01145417)
Timeframe: Baseline, Week 4, 8, 12, 16, 20, 24
| Intervention | millimeter (mm) (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline (n=107,108) | Week 4 (n=106,106) | Week 8 (n=100,101) | Week 12 (n=89,88) | Week 16 (n=85,81) | Week 20 (n=72,67) | Week 24 (n=103,104) | |
| Placebo-Pregabalin | 40.7 | 33.1 | 27.8 | 23.8 | 22.6 | 17.7 | 23.7 |
| Pregabalin-Pregabalin | 40.6 | 33.1 | 27.4 | 24.1 | 22.6 | 17.2 | 22.2 |
WPAI: 6-question participant rated questionnaire to determine the degree to which SHP affected work productivity while at work and affected activities outside of work. It assesses amount of absenteeism, presenteeism and daily activity impairment attributable to a HIV neuropathy pain. Question 2 and 3 assesses absenteeism as: Hours of work missed in past 7 days due to leg/foot pain or other reason, respectively. Question 4 assesses presenteeism as: Hours of work performed in past 7 days. (NCT01145417)
Timeframe: Baseline, Week 24
| Intervention | hours (Mean) | |||||
|---|---|---|---|---|---|---|
| Baseline, hours missed,leg/foot pain (n=12,11) | Baseline, hours missed,other reason (n=12,11) | Baseline, hours worked (n=12,11) | Week 24, hours missed,leg/foot pain (n=35,28) | Week 24, hours missed,other reason (n=35,28) | Week 24, hours worked (n=35,28) | |
| Placebo-Pregabalin | 0.82 | 0.91 | 30.36 | 2.32 | 7.71 | 34.86 |
| Pregabalin-Pregabalin | 2.25 | 3.42 | 35.58 | 2.17 | 9.20 | 41.51 |
SF-36 is a standardized survey evaluating 8 domains of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). Two summary scores include Physical Component (Ph C) and Mental Component (Mn C). The score for a section is an average of the individual question scores. Score range for domain scores and summary scores: 0-100 (100=highest level of functioning). (NCT01145417)
Timeframe: Baseline, Week 24
| Intervention | Units on a scale (Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline: Ph Fn (n=51,53) | Baseline: R-P (n=51,53) | Baseline: BP (n=51,53) | Baseline: GH (n=51,53) | Baseline: Ph C (n=51,53) | Baseline: Vit (n=51,53) | Baseline: So Fn (n=51,53) | Baseline: R-E (n=51,53) | Baseline: MnH (n=51,53) | Baseline: Mn C (n=51,53) | Week 24: Ph Fn (n=103,104) | Week 24: R-P (n=103,104) | Week 24: BP (n=102,104) | Week 24: GH (n=103,104) | Week 24: Ph C (n=102,104) | Week 24: Vit (n=103,104) | Week 24: So Fn (n=103,104) | Week 24: R-E (n=103,104) | Week 24: MnH (n=103,104) | Week 24: Mn C (n=102,104) | |
| Placebo-Pregabalin | 75.47 | 71.93 | 68.87 | 68.79 | 46.85 | 73.11 | 82.08 | 79.87 | 80.00 | 52.71 | 75.24 | 72.96 | 72.19 | 71.31 | 48.48 | 66.29 | 81.85 | 75.80 | 75.77 | 49.72 |
| Pregabalin-Pregabalin | 73.14 | 75.49 | 68.86 | 72.25 | 47.68 | 71.57 | 78.92 | 81.05 | 76.27 | 51.41 | 70.34 | 71.18 | 69.57 | 73.14 | 47.28 | 68.51 | 79.98 | 74.19 | 76.21 | 50.15 |
Number of participants who had generalized or abdominal edema. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (n=103) | Week 4 (n=101) | Week 20 (n=93) | Week 36 (n=90) | Week 52/early termination (n=100) | Week 53/early termination (n=78) | |
| Pregabalin | 0 | 0 | 0 | 0 | 1 | 0 |
Number of participants who had facial or periorbital edema. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| Baseline (n=103) | Week 4 (n=101) | Week 20 (n=93) | Week 36 (n=90) | Week 52/early termination (n=100) | Week 53/early termination (n=78) | |
| Pregabalin | 0 | 0 | 0 | 0 | 1 | 0 |
Worsening of the condition relative to baseline was reported as deteriorated. Assessment categories are as follows: normal or abnormal for Cranial Nerve Function, Mental State, and Coordination; normal, mild, moderate, or severe ataxia for Gait; none/absent, normal, or hyper-reflexic for Deep Tendon Reflexes; absent or present for Abnormal Reflexes; normal, mild, moderate, or severe weakness for Muscle Strength; slight, more marked, or considerable increase, or affected parts rigid in flexion or extension for Muscle Tone; absent or present for Sensory Function. (NCT01202227)
Timeframe: 53 weeks
| Intervention | Participants (Number) | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cranial Nerve Function | Mental State | Coordination: Right (R)- Finger to Nose | Coordination: Left (L)- Finger to Nose | Coordination: R- Finger Tapping | Coordination: L- Finger Tapping | Coordination: R- Rapid Alternating Hand Movement | Coordination: L- Rapid Alternating Hand Movement | Coordination: Romberg Test | Gait | Deep Tendon Reflexes: R- Brachioradialis | Deep Tendon Reflexes: L- Brachioradialis | Deep Tendon Reflexes: R-Patellar | Deep Tendon Reflexes: L-Patellar | Deep Tendon Reflexes: R- Achilles | Deep Tendon Reflexes: L- Achilles | Abnormal Reflexes | Muscle Strength: R- Upper Limb | Muscle Strength: L- Upper Limb | Muscle Strength: R- Lower Limb | Muscle Strength: L- Lower Limb | Muscle Tone: R- Upper Limb | Muscle Tone: L- Upper Limb | Muscle Tone: R- Lower Limb | Muscle Tone: L- Lower Limb | Sensory Function: Anesthesia | Sensory Function: Hypesthesia | Sensory Function: Allodynia | Sensory Function: Hyperalgesia | |
| Pregabalin | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 2 | 1 | 1 | 1 | 1 | 3 | 3 | 2 | 3 | 1 | 1 | 2 | 1 | 2 | 1 | 1 | 5 | 5 | 0 | 1 | 1 | 2 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants who had normal visual field at baseline and showed abnormal result after the study treatment, assessed by confrontational visual field test (neurological examination). (NCT01202227)
Timeframe: 53 weeks
| Intervention | Participants (Number) | |
|---|---|---|
| Right eye | Left eye | |
| Pregabalin | 0 | 0 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 4 | 2 | 0 | 3 | 2 | 0 | 3 | 2 | 0 | 4 | 1 | 0 | 7 | 0 | 0 | 5 | 0 | 0 |
The Sheehan-STS is an 8-item prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Participants who reported a score of ≥1 (5-point scale ranging from 0: not at all to 4: extremely) for Item 2, 3, 4 or 5 of the Sheehan-STS prognostic scale is considered to have suicidal ideation as the scores are mapped to Category 4 (suicide ideation) of the Columbia Classification Algorithm of Suicide Assessment. (NCT01202227)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
| Intervention | Participants (Number) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (n=103) | Week 2 (n=102) | Week 4 (n=101) | Week 8 (n=99) | Week 12 (n=96) | Week 20 (n=93) | Week 28 (n=91) | Week 36 (n=90) | Week 44 (n=85) | Week 52 (n=101) | |
| Pregabalin | 3 | 2 | 1 | 0 | 0 | 2 | 2 | 2 | 2 | 0 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 45 for total score. Change = observation mean minus baseline mean. Negative change indicated improvement." (NCT01202227)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
| Intervention | Score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 (n=103) | Week 4 (n=102) | Week 8 (n=99) | Week 12 (n=98) | Week 20 (n=95) | Week 28 (n=92) | Week 36 (n=91) | Week 44 (n=87) | Week 52 (n=85) | Week 52 (LOCF, n=103) | |
| Pregabalin | -4.2 | -5.2 | -5.3 | -5.7 | -6.1 | -5.1 | -5.0 | -4.4 | -5.0 | -4.6 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 6 | 1 | 0 | 5 | 2 | 0 | 4 | 1 | 0 | 7 | 0 | 0 | 8 | 0 | 0 | 4 | 0 | 0 |
Number of participants who had peripheral edema in lower extremities. Edema was categorized as follows: trace, pitting 1 (lower leg), 2 (lower leg to knee), and 3 (above knee and /or presacral edema). (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Trace at Baseline (n=103) | Pitting +1 at Baseline (n=103) | Pitting +2 at Baseline (n=103) | Pitting +3 at Baseline (n=103) | Trace at Week 4 (n=101) | Pitting +1 at Week 4 (n=101) | Pitting +2 at Week 4 (n=101) | Pitting +3 at Week 4 (n=101) | Trace at Week 20 (n=93) | Pitting +1 at Week 20 (n=93) | Pitting +2 at Week 20 (n=93) | Pitting +3 at Week 20 (n=93) | Trace at Week 36 (n=90) | Pitting +1 at Week 36 (n=90) | Pitting +2 at Week 36 (n=90) | Pitting +3 at Week 36 (n=90) | Trace at Week 52/early termination (n=100) | Pitting +1 at Week 52/early termination (n=100) | Pitting +2 at Week 52/early termination (n=100) | Pitting +3 at Week 52/early termination (n=100) | Trace at Week 53/early termination (n=78) | Pitting +1 at Week 53/early termination (n=78) | Pitting +2 at Week 53/early termination (n=78) | Pitting +3 at Week 53/early termination (n=78) | |
| Pregabalin | 5 | 9 | 2 | 0 | 8 | 8 | 4 | 1 | 8 | 3 | 7 | 0 | 14 | 7 | 3 | 0 | 10 | 7 | 2 | 0 | 9 | 5 | 0 | 0 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling, pitting edema, collateral superficial veins (non-varicose), and skin redness. The symptom was assessed as mild, moderate or severe. (NCT01202227)
Timeframe: Baseline, Weeks 4, 20, 36, 52, and 53
| Intervention | Participants (Number) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mild at Baseline (n=103) | Moderate at Baseline (n=103) | Severe at Baseline (n=103) | Mild at Week 4 (n=101) | Moderate at Week 4 (n=101) | Severe at Week 4 (n=101) | Mild at Week 20 (n=93) | Moderate at Week 20 (n=93) | Severe at Week 20 (n=93) | Mild at Week 36 (n=90) | Moderate at Week 36 (n=90) | Severe at Week 36 (n=90) | Mild at Week 52/early termination (n=100) | Moderate at Week 52/early termination (n=100) | Severe at Week 52/early termination (n=100) | Mild at Week 53/early termination (n=78) | Moderate at Week 53/early termination (n=78) | Severe at Week 53/early termination (n=78) | |
| Pregabalin | 2 | 3 | 1 | 5 | 1 | 0 | 3 | 0 | 0 | 3 | 0 | 0 | 3 | 0 | 1 | 2 | 1 | 0 |
"The mBPI-10 is a self administered questionnaire that assesses pain interference with functional activities over the past week. These items are measured on an 11 point scale, ranging from does not interfere (0) to completely interferes (10). A composite score, the Pain Interference Index, will be calculated by averaging the 10 items that comprise the scale.~Change = observation mean at Week 52 minus baseline mean." (NCT01202227)
Timeframe: Baseline, Week 52
| Intervention | Score on a scale (Mean) |
|---|---|
| Pregabalin | -1.4 |
"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 12 for affective score. Change = observation mean minus baseline mean. Negative change indicated improvement." (NCT01202227)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
| Intervention | Score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 (n=103) | Week 4 (n=102) | Week 8 (n=99) | Week 12 (n=98) | Week 20 (n=95) | Week 28 (n=92) | Week 36 (n=91) | Week 44 (n=87) | Week 52 (n=85) | Week 52 (LOCF, n=103) | |
| Pregabalin | -1.1 | -1.3 | -1.3 | -1.5 | -1.6 | -1.3 | -1.3 | -1.3 | -1.4 | -1.0 |
"The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.~Range: 0 to 33 for sensory score. Change = observation mean minus baseline mean. Negative change indicated improvement." (NCT01202227)
Timeframe: Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52
| Intervention | Score on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 2 (n=103) | Week 4 (n=102) | Week 8 (n=99) | Week 12 (n=98) | Week 20 (n=95) | Week 28 (n=92) | Week 36 (n=91) | Week 44 (n=87) | Week 52 (n=85) | Week 52 (LOCF, n=103) | |
| Pregabalin | -3.1 | -3.9 | -3.9 | -4.2 | -4.5 | -3.8 | -3.7 | -3.1 | -3.6 | -3.6 |
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 5.58 | -3.02 |
Daily Pain Rating Score (DPRS): participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 5.61 | -3.02 |
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 6.69 | -3.37 |
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 30 | 62 | 21 | 5 | 0 | 0 | 0 |
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. (NCT01220180)
Timeframe: Baseline through Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 67.13 |
Participants were regarded as seizure-free if no seizures (partial or other) were reported for the participant during the period of 28 days in the study. (NCT01220180)
Timeframe: Baseline through Week 12
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 66.30 |
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. (NCT01220180)
Timeframe: Baseline through Week 12
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Greater than or equal to 75% | Greater than or equal to 50% to 74% | 0% to 49% | Worsening | |
| Pregabalin | 55.75 | 28.57 | 14.13 | 1.55 |
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much Improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 1018 | 1177 | 680 | 193 | 5 | 3 | 0 |
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much Improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 34 | 61 | 14 | 8 | 0 | 0 | 0 |
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 35 | 61 | 14 | 8 | 0 | 0 | 0 |
PGIC was defined as participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse) , 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 1027 | 1187 | 686 | 195 | 5 | 3 | 0 |
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 968 | 1313 | 671 | 141 | 7 | 5 | 0 |
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much Improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 956 | 1306 | 664 | 140 | 7 | 5 | 0 |
Percentage of participants with improvement in seizure frequency of greater than or equal to 75%; greater than or equal to 50% to 74%; 0% to 49% were considered. (NCT01220180)
Timeframe: Baseline through Week 12
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Greater than or equal to 75% | Greater than or equal to 50% to 74% | 0% to 49% | Worsening | |
| Pregabalin | 57.22 | 29.39 | 12.52 | 0.87 |
CGIC: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change was defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score is equal to more affected. (NCT01220180)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much Improved | A little improved | No change | A little worse | Much worse | Very much worse | |
| Pregabalin | 29 | 62 | 21 | 5 | 0 | 0 | 0 |
Daily Sleep Interference Score (DSIS): participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 4.25 | -2.38 |
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 6.41 | -3.24 |
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 6.43 | -3.19 |
DSIS: participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 4.23 | -2.37 |
DPRS: participant rated 11-point Likert scale ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicates greater level of pain. (NCT01220180)
Timeframe: Baseline and Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Week 6 | |
| Pregabalin | 6.69 | -3.37 |
The patient's impression (patient global impression of change [PGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. (NCT01256593)
Timeframe: At Week 13
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 583 | 1039 | 708 | 454 | 12 | 11 | 1 | 759 |
The physician's impression (clinical global impression of change [CGIC]) at Week 13, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. (NCT01256593)
Timeframe: At Week 13
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 626 | 1149 | 773 | 471 | 9 | 6 | 1 | 532 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 351 |
The pain experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. (NCT01256593)
Timeframe: Baseline and at Week 13
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -3.4 |
The sleep interference (inability to sleep because of pain) experienced at Week 13 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 13 was presented along with standard deviation. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. (NCT01256593)
Timeframe: Baseline and at Week 13
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -2.4 |
Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 13 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. For the participants who completed or discontinued the treatment before Week 13, the data at the time of the completion or discontinuation was used for the analysis. (NCT01256593)
Timeframe: At Week 13
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 84.1 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 53 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 16 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 15.03 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.61 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01256593)
Timeframe: 13 weeks at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.42 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -0.8 |
| Pregabalin 330 mg | -0.4 |
| Placebo | -0.5 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | 2.3 |
| Pregabalin 330 mg | -1.7 |
| Placebo | -1.5 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -2.2 |
| Pregabalin 330 mg | 0.4 |
| Placebo | 0.3 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -0.5 |
| Pregabalin 330 mg | 5.2 |
| Placebo | 5.0 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -3.5 |
| Pregabalin 330 mg | 5.4 |
| Placebo | -0.6 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 2 to Week 14
| Intervention | ln(28-day seizure rate) (Least Squares Mean) |
|---|---|
| Pregabalin 165 mg | 1.91 |
| Pregabalin 330 mg | 1.77 |
| Placebo | 1.88 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. (NCT01262677)
Timeframe: Week 0 to Week 14
| Intervention | seizures per 28 days (Mean) |
|---|---|
| Pregabalin 165 mg | 3.99 |
| Pregabalin 330 mg | 4.43 |
| Placebo | 7.51 |
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal (abdominal rigidity and tenderness), an extremities (e.g. edema). Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion. (NCT01262677)
Timeframe: Day 1 to Week 15
| Intervention | percentage of participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| General | Skin | Head | Ears | Eyes | Nose | Throat | Lungs | Heart | Abdomen | Extremities | Other | |
| Placebo | 0.0 | 4.5 | 0.0 | 0.9 | 3.6 | 1.8 | 1.8 | 0.0 | 0.0 | 0.0 | 1.8 | 10.9 |
| Pregabalin 165 mg | 1.0 | 2.0 | 1.0 | 3.0 | 1.0 | 0.0 | 0.0 | 0.0 | 1.0 | 0.0 | 2.0 | 14.0 |
| Pregabalin 330 mg | 2.7 | 6.2 | 1.8 | 1.8 | 2.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 2.7 | 7.1 |
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. 25/50% represents ≥25% or ≥50% increase over baseline respectively, based on cut points. Cut points are 100 ms for QRS and 200 ms for PR. (NCT01262677)
Timeframe: Week 15
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Max PR interval rise:%change≥25/50% | Max QRS complex rise:%change≥25/50% | Max. QTcB interval rise: 30≤x<60 | Max. QTcB interval rise: ≥60 | Max. QTcF interval rise: 30≤x<60 | Max. QTcF interval rise: ≥60 | |
| Placebo | 2.1 | 1.0 | 3.1 | 0.0 | 2.1 | 0.0 |
| Pregabalin 165 mg | 1.1 | 1.1 | 5.4 | 0.0 | 3.2 | 0.0 |
| Pregabalin 330 mg | 1.0 | 1.9 | 1.9 | 1.9 | 1.9 | 0.0 |
C-CASA is described as a standardized suicidal rating system. The C-CASA has eight categories (4 suicidal events: completed suicide, suicide attempt, preparatory act toward imminent suicidal behavior (PAISB), and suicidal ideation; 2 nonsuicidal events: self-injurious behavior, no suicidal intent (SIB-NSI) and other no deliberate self-harm, and 2 indeterminate or potentially suicidal events: self-injurious behavior, suicidal intent unknown and not enough information) that distinguish suicidal events from nonsuicidal events and indeterminate or potentially suicidal events. (NCT01262677)
Timeframe: Week -8 (Screening), Week 0 (Baseline), and Week 14 (double-blind treatment phase)
| Intervention | percentage of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Suicide attempt (Lifetime prior to Screening) | PAISB (Lifetime prior to Screening) | Suicidal ideation (Lifetime prior to Screening) | SIB-NSI (Lifetime prior to Screening) | Suicide attempts at Week 0 | PAISB at Week 0 | Suicidal ideation at Week 0 | SIB-NSI at Week 0 | Suicidal ideation at Week 14 | |
| Placebo | 5.5 | 4.5 | 14.5 | 0.9 | 0.0 | 0.0 | 2.7 | 0.0 | 1.8 |
| Pregabalin 165 mg | 2.0 | 1.0 | 11.0 | 1.0 | 1.0 | 0.0 | 8.0 | 1.0 | 4.0 |
| Pregabalin 330 mg | 1.8 | 1.8 | 10.6 | 0.9 | 0.9 | 0.9 | 7.1 | 0.0 | 2.7 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 2 to Week 14
| Intervention | ln (seizures per 28 days) (Least Squares Mean) |
|---|---|
| Pregabalin 165 mg | 0.46 |
| Pregabalin 330 mg | 0.48 |
| Placebo | 0.48 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -0.5 |
| Pregabalin 330 mg | -0.8 |
| Placebo | -0.1 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -3.9 |
| Pregabalin 330 mg | -1.5 |
| Placebo | -1.9 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | -2.4 |
| Pregabalin 330 mg | 0.7 |
| Placebo | 0.7 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin 165 mg | 0.2 |
| Pregabalin 330 mg | 1.0 |
| Placebo | -0.8 |
Participant-rated 12-item questionnaire to assess key constructs of sleep over the past week. 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes: 1, no: 0). 6 and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute. (NCT01262677)
Timeframe: Baseline, Week 14
| Intervention | hours (Mean) |
|---|---|
| Pregabalin 165 mg | 0.2 |
| Pregabalin 330 mg | -0.1 |
| Placebo | -0.1 |
Optimal sleep was considered between 7 to 8 hours of average sleep per night inclusive, while average sleep less than or greater than the 7 to 8 hour of average sleep per night was non-optimal. (NCT01262677)
Timeframe: Week 14
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 165 mg | 67.7 |
| Pregabalin 330 mg | 60.2 |
| Placebo | 60.2 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 0 to Week 14
| Intervention | ln (seizures per 28 days) (Least Squares Mean) |
|---|---|
| Pregabalin 165 mg | -15.00 |
| Pregabalin 330 mg | -31.54 |
| Placebo | -5.70 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. (NCT01262677)
Timeframe: Week 0 to Week 14
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 165 mg | 1.0 |
| Pregabalin 330 mg | 1.9 |
| Placebo | 1.9 |
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No | Little benefit | Much benefit | Not done | Missing | |
| Placebo | 22.0 | 33.0 | 42.2 | 1.8 | 0.9 |
| Pregabalin 165 mg | 12.0 | 31.0 | 54.0 | 2.0 | 1.0 |
| Pregabalin 330 mg | 17.9 | 23.2 | 56.3 | 1.8 | 0.9 |
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| No | Yes | Missing | |
| Placebo | 23.9 | 73.4 | 2.8 |
| Pregabalin 165 mg | 13.0 | 84.0 | 3.0 |
| Pregabalin 330 mg | 17.9 | 80.4 | 1.8 |
The BSW consisted of 3 single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was read aloud to the participant by the investigator or designated center personnel and then was given to the participant to complete independently. (NCT01262677)
Timeframe: Week 14
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| No | Yes | Missing | |
| Placebo | 26.6 | 70.6 | 2.8 |
| Pregabalin 165 mg | 18.0 | 79.0 | 3.0 |
| Pregabalin 330 mg | 22.3 | 75.9 | 1.8 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Natural logarithm of the 28-day seizure rate was reported in this outcome measure. (NCT01262677)
Timeframe: Week 0 to Week 14
| Intervention | ln (seizures per 28 days) (Mean) | |
|---|---|---|
| Baseline | Week 14 | |
| Placebo | 2.32 | 1.93 |
| Pregabalin 165 mg | 2.24 | 1.84 |
| Pregabalin 330 mg | 2.33 | 1.80 |
Seizures were recorded and documented in a daily Seizure Diary by the participants, family member, caregiver, or legal guardian. Simple partial seizures without a visible motor component (ie, lacking visible movements during the seizure) were not counted toward eligibility, or in the primary or secondary efficacy analyses. Participants who had a ≥50% reduction in the 28-day partial seizure rate from baseline were defined as a responder, otherwise they were default as a non-responder. (NCT01262677)
Timeframe: Week 0 to Week 14
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Responder | Non-responder | |
| Placebo | 35.8 | 64.2 |
| Pregabalin 165 mg | 37.8 | 62.2 |
| Pregabalin 330 mg | 45.9 | 54.1 |
Physical examinations included general appearance (including hight at baseline), vital sign (sitting heart rate and sitting blood pressure), weight, skin (examination for the presence of rash), HEENT (examinatin of head, eyes, ears, nose and throat), chest (ausculation of lung fields), cardiovascular (ausculatin of heart sounds (S1 and S2) and for the presence of murmurs, gallops, or rubs), gastrointestinal(abdominal rigidity and tenderness), an extremities (e.g. edema). (NCT01262677)
Timeframe: Day 1 to Week 15
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Maximum increase in systolic BP ≥30 mmHg | Maximum increase in diastolic BP ≥20 mmHg | |
| Placebo | 0.9 | 2.8 |
| Pregabalin 165 mg | 1.0 | 5.1 |
| Pregabalin 330 mg | 1.8 | 5.5 |
The original ECG was reviewed by the investigator and kept on site as part of source documentation. A central ECG reader was also used for this study. QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB) were calculated. (NCT01262677)
Timeframe: Week 15
| Intervention | percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Maximum QTcB 450 - <480 | Maximum QTcB 480 - <500 | Maximum QTcB ≥500 | Maximum QTcF 450 - <480 | Maximum QTcF 480 - <500 | Maximum QTcF ≥500 | |
| Placebo | 10.0 | 0.9 | 0.0 | 3.6 | 0.0 | 0.0 |
| Pregabalin 165 mg | 8.0 | 1.0 | 0.0 | 3.0 | 1.0 | 0.0 |
| Pregabalin 330 mg | 5.3 | 0.0 | 1.8 | 2.7 | 0.0 | 0.0 |
Laboratory samples in hematology, chemistry, and urinalysis were analyzed by a cental laboratory. Any laboratory value that was identified as clinically significant was reported as an AE. LLN: Lower limit of normal, ULN: Uper limit of normal, RBC: Red Blood Cell, WBC: White Blood Cell, AST: Aspartate Aminotransferase, ALT: Alanine Aminotransferase, BUN: Blood Urea Nitrogen (NCT01262677)
Timeframe: Day 1 to Week 15
| Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hemoglobin (HGB) <0.8xLLN , | Hematocrit (HCT) <0.8xLLN | RBC Count <0.8xLLN | Platelets <0.5xLLN | Platelets >1.75xULN | WBC Count <0.6xLLN | White Blood Cell Count >1.5xULN | Lymphocytes (absolute) <0.8xLLN | Lymphocytes (absolute) >1.2xULN | Lymphocytes (%) <0.8xLLN | Lymphocytes (%) >1.2xULN | Neutrophils (absolute) <0.8xLLN | Neutrophils (absolute) >1.2xULN | Neutrophils (%) <0.8xLLN | Neutrophils (%) >1.2xULN | Basophils (absolute) >1.2xULN | Basophils (%) >1.2xULN | Eosinophils (absolute) >1.2xULN | Eosinophils (%) >1.2xULN | Monocytes (absolute) >1.2xULN | Monocytes (%) >1.2xULN | Total Bilirubin >1.5xULN | AST >3.0xULN | ALT >3.0xULN | Alkaline Phosphatase >3.0xULN | Total Protein <0.8xLLN | Total Protein >1.2xULN | Albumin <0.8xLLN | Albumin >1.2xULN | BUN >1.3xULN | Creatinine >1.3xULN | Uric Acid >1.2xULN | Sodium <0.95xLLN | Sodium >1.05xULN | Potassium <0.9xLLN | Potassium >1.1xULN | Chloride <0.9xLLN | Chloride >1.1xULN | Calcium <0.9xLLN | Calcium >1.1xULN | Glucose <0.6xLLN | Glucose >1.5xULN | Urine Specific Gravity <1.003 | Urine Specific Gravity >1.030 | Urine pH <4.5 | Urine pH >8 | Urine Glucose (qualitative) ≥1 | Urine Ketones (qualitative) ≥1 | Urine Protein (qualitative) ≥1 | Urine Blood/Hgb (qualitative) ≥1 | Urine Nitrite ≥1 | Urine RBC ≥20 | Urine WBC ≥20 | |
| Placebo | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.9 | 3.8 | 1.9 | 0.9 | 1.9 | 1.9 | 0.0 | 0.0 | 0.0 | 0.0 | 1.9 | 3.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 4.8 | 0.0 | 1.9 | 0.0 | 1.9 | 1.0 | 9.5 | 13.3 | 9.5 | 29.6 |
| Pregabalin 165 mg | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 4.2 | 2.1 | 0.0 | 1.0 | 3.1 | 0.0 | 1.0 | 0.0 | 0.0 | 0.0 | 3.1 | 6.3 | 0.0 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 1.0 | 0.0 | 2.0 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.1 | 0.0 | 1.1 | 0.0 | 2.1 | 3.2 | 8.5 | 11.7 | 13.3 | 4.8 |
| Pregabalin 330 mg | 0.9 | 0.9 | 0.0 | 0.0 | 0.0 | 0.9 | 0.0 | 0.9 | 1.8 | 0.0 | 0.0 | 1.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 3.7 | 4.6 | 1.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 1.9 | 1.9 | 0.0 | 1.9 | 0.9 | 1.9 | 2.8 | 9.4 | 5.7 | 0.0 | 3.7 |
Neurological examinations included level of consciousness, mental status, cranial nerve assessment, muscle strength, reflexes, pin prick and vibratory sensation (the latter using a 128-Hz tuning fork), coordination and gait. (NCT01262677)
Timeframe: Day 1 to Week 15
| Intervention | percentage of participants (Number) | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| None | Any | Coordination | Cranial nerve function | Cranial nerve II | Cranial nerve III | Cranial nerve V | Cranial nerve VII | Cranial nerve VIII | Cranial nerve XI | Deep tendon reflexes | Gait and station | Level of consciousness | Mental state | Motor function | Muscle strength | Pain sensation | Reflexes | Vibration | |
| Placebo | 68.2 | 31.8 | 1.8 | 0.0 | 0.0 | 1.8 | 0.0 | 0.9 | 0.0 | 0.0 | 2.7 | 0.9 | 0.9 | 1.8 | 3.6 | 1.9 | 1.9 | 1.9 | 12.0 |
| Pregabalin 165 mg | 79.0 | 21.0 | 1.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 0.0 | 0.0 | 3.0 | 0.0 | 0.0 | 1.0 | 1.0 | 2.0 | 0.0 | 1.0 | 11.1 |
| Pregabalin 330 mg | 78.8 | 21.2 | 1.8 | 0.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.9 | 0.0 | 1.8 | 0.0 | 0.0 | 1.8 | 2.7 | 0.0 | 0.0 | 0.9 | 10.8 |
The 30% pain responders were defined as participants with at least a 30% reduction in the mean pain score from SB baseline to DB endpoint. (NCT01270828)
Timeframe: 13 Weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin CR DB | 95.6 |
| Placebo DB | 83.8 |
The BPI sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI sf consists of 5 questions. Questions 1, 2, 3, and 4 measure pain on an 11 point scale from 0 (no pain) to 10 (worst pain possible). Question 5 consists of 7 item subsets which measure the level of interference of pain on daily functions on an 11 point scale from 0 (Does not interfere) to 10 (Completely interferes). (NCT01270828)
Timeframe: Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Pain Severity Index-SB Baseline to Week 19 | Pain Severity Index-DB Baseline to Week 19 | Pain Interference Index-SB Baseline to Week 19 | Pain Interference Index-DB Baseline to Week 19 | |
| Placebo DB | -13.8 | 3.1 | -17.2 | 4.0 |
| Pregabalin CR DB | -18.0 | -0.7 | -21.9 | -0.2 |
The HADS is a self administered questionnaire that was designed to screen for the presence of a mood disorder in medically ill patients. To distinguish psychiatric presentations from physical illness, the items focus on subjective disturbance of mood rather than physical signs. The HADS contains 14 items rated on 4 point Likert type scales. Two subscales assess depression and anxiety. Each subscale consists of 7 statements, rated on a scale of 0 to 3 (0 = No anxiety or depression, to 3 = Severe feelings of anxiety or depression). Separate scores are calculated for each subscale ranging from 0 to 21. Higher scores denote greater severity of depression or anxiety (NCT01270828)
Timeframe: Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| HADS-Anxiety-SB Baseline to Week 19 | HADS-Anxiety-DB Baseline to Week 19 | HADS-Depression-SB Baseline to Week 19 | HADS-Depression-DB Baseline to Week 19 | |
| Placebo DB | -1.1 | 0.9 | -1.2 | 0.8 |
| Pregabalin CR DB | -1.8 | 0.1 | -1.8 | 0.2 |
The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain (NCT01270828)
Timeframe: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| SB Baseline to Week 19 | DB Baseline to Week 19 | |
| Placebo DB | -3.95 | 0.87 |
| Pregabalin CR DB | -4.89 | -0.04 |
Loss of Therapeutic Response (LTR) is defined as <30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of <30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician. (NCT01270828)
Timeframe: 13 Weeks
| Intervention | Participants (Number) |
|---|---|
| Pregabalin CR DB | 29 |
| Placebo DB | 63 |
The 50% pain responders were defined as participants with at least a 50% reduction in the mean pain score from SB baseline to DB endpoint. (NCT01270828)
Timeframe: 13 Weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin CR DB | 88.3 |
| Placebo DB | 68.6 |
"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The optimal sleep score is a dichotomous 'Yes' or 'No' rating, where 'Yes' indicates optimal sleep (average 7-8 hours per night) and 'No' indicates not optimal sleep. The percentage of participants with optimal sleep is presented here." (NCT01270828)
Timeframe: Week 6 and Week 19
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Week 6 (N=208,205) | Week 19 (N=204,197) | |
| Placebo DB | 62.4 | 54.8 |
| Pregabalin CR DB | 58.7 | 54.9 |
Percentage of participants with suicidal behavior/ideation were noted as Baseline, Weeks 6, 11, 15, 19 and 20. (NCT01270828)
Timeframe: Baseline, Weeks 6, 11, 15, 19 and 20
| Intervention | Percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| SB BL(N=208,205) | Week 6 (N=208,205) | Week 11 (N=194,178) | Week 15 (N=183,167) | Week 19 (N=204,197) | Week 20 (N=199,194) | |
| Placebo DB | 0.5 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin CR DB | 0 | 0 | 0 | 0 | 0 | 0 |
The PGIC is a participant-rated instrument that has been used in chronic pain and fibromyalgia studies to rate change in a patient's overall status. This single item instrument uses a 7 point Likert scale, anchored by (1) very much improved, to (7) very much worse. (NCT01270828)
Timeframe: Week 19
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo DB | 23.1 | 30.3 | 19.0 | 12.8 | 7.2 | 7.2 | 0.5 |
| Pregabalin CR DB | 31.5 | 36.9 | 16.7 | 10.3 | 2.5 | 1.5 | 0.5 |
The BSW is administered by the study physician or designated site personnel and consists of three single item measures designed to capture the patient's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01270828)
Timeframe: Week 19
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Benefit from treatment | Satisfaction with treatment | Willingness to continue treatment | |
| Placebo DB | 93.3 | 90.7 | 81.3 |
| Pregabalin CR DB | 98.5 | 96.0 | 87.6 |
"An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or Results in congenital anomaly/birth defect. The study physician used the adjective severe to those AEs that interfere significantly with participant's usual function." (NCT01270828)
Timeframe: Baseline to Week 20
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Participants with AEs | Participants with Serious AEs | Participants with Severe AEs | |
| Placebo DB | 63 | 3 | 3 |
| Pregabalin CR DB | 80 | 7 | 9 |
| Pregabalin CR SB | 441 | 17 | 35 |
The pain numeric rating scale (NRS Pain) consists of an 11 point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. Participants were asked to rate their pain over the past week. (NCT01270828)
Timeframe: SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| SB Baseline to Week 19 | DB Baseline to Week 19 | |
| Placebo DB | -3.9 | 0.9 |
| Pregabalin CR DB | -5.0 | -0.1 |
The SF 36 is a self administered, validated questionnaire that measures each of the following 8 health aspects: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception over the past week. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) where, higher scores indicate a better health related quality of life. (NCT01270828)
Timeframe: Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Physical Component-SB BL to wk 19(N=202,195) | Physical Component-DB BL to wk 19(N=202,195) | Mental Component-SB BL to wk 19(N=202,195) | Mental Component-DB BL to wk 19(N=202,195) | Physical functioning-SB BL to wk 19 | Physical functioning-DB BL to wk 19 | Role-Physical-SB BL to wk 19 | Role-Physical-DB BL to wk 19 | Bodily pain-SB BL to wk 19 | Bodily pain-DB BL to wk 19 | General Health Perception-SB BL to wk19(N=202,195) | General Health Perception-DB BL to wk19(N=202,195) | Vitality-SB BL to wk 19(N=202,195) | Vitality-DB BL to wk 19(N=202,195) | Social Functioning-SB BL to wk 19 | Social Functioning-DB BL to wk 19 | Role-Emotional-SB BL to wk 19 | Role-Emotional-DB BL to wk 19 | Mental Health-SB BL to wk 19(N=202,195) | Mental Health-DB BL to wk 19(N=202,195) | |
| Placebo DB | 5.6 | -2.3 | 5.5 | -2.2 | 8.9 | -4.9 | 13.9 | -7.7 | 23.6 | -6.2 | 8.2 | -4.0 | 10.7 | -6.5 | 15.7 | -4.3 | 11.6 | -5.4 | 9.5 | -3.7 |
| Pregabalin CR DB | 7.5 | 0.1 | 6.4 | -1.1 | 11.7 | -1.4 | 18.9 | -2.4 | 31.0 | 1.4 | 11.3 | 1.4 | 13.7 | -3.5 | 18.5 | -2.1 | 15.0 | -1.4 | 11.1 | -1.3 |
"The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week.~The item Quantity of sleep of MOS-SS is presented here." (NCT01270828)
Timeframe: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
| Intervention | Hours (Least Squares Mean) | |
|---|---|---|
| Quantity of sleep-SB BL to wk 19(N=203,192) | Quantity of sleep-DB BL to wk 19(N=202,192) | |
| Placebo DB | 0.7 | -0.4 |
| Pregabalin CR DB | 0.9 | -0.1 |
The MOS-SS is a validated self administered questionnaire consisting of 12 items that assess key constructs of sleep. The scale has been found reliable and valid with good overall measurement properties. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9 item overall sleep problems index assessing sleep over the past week. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range multiplied by 100); total score range = 0 to 100; higher score indicates greater intensity of attribute. (NCT01270828)
Timeframe: SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sleep Problems Index I-SB BL to wk 19(N=202,195) | Sleep Problems Index I-DB BL to wk 19(N=202,195) | SleepProblems Index II-SB BL to wk 19(N=202,195) | SleepProblems Index II-DB BL to wk 19(N=202,194) | Sleep Disturbance-SB BL to wk 19 | Sleep Disturbance-DB BL to wk 19 | Snoring-SB BL to wk 19(N=202,194) | Snoring-DB BL to wk 19(N=201,194) | Awaken short of breath/headache-SB BL to wk 19 | Awaken short of breath/headache-DB BL to wk 19 | Sleep adequacy-SB BL to wk 19 | Sleep adequacy-DB BL to wk 19(N=202,195) | Somnolence-SB BL to wk 19(N=202,195) | Somnolence-DB BL to wk 19(N=203,194) | |
| Placebo DB | -16.7 | 4.4 | -17.4 | 4.3 | -21.1 | 7.6 | -4.7 | 0.8 | -10.4 | -0.2 | 17.5 | -6.0 | -12.0 | -0.9 |
| Pregabalin CR DB | -19.9 | 1.2 | -21.2 | 0.2 | -28.3 | -1.1 | -3.3 | -0.6 | -11.9 | -1.2 | 19.9 | -3.3 | -12.0 | -0.7 |
"A secondary LTR endpoint (S-LTR) was defined as the 5 day rolling average pain score during DB, compared to the 5 day randomization baseline pain score. As a secondary endpoint, S-LTR was defined as:~At least a 30% increase in the 5 days rolling average pain score during DB relative to the 5 Day randomization baseline pain score~A 5 days rolling average pain score ≥4. Participants who discontinue due to lack of efficacy or adverse events in the DB phase of the study will also be counted as an LTR." (NCT01270828)
Timeframe: 13 Weeks
| Intervention | Participants (Number) |
|---|---|
| Pregabalin CR DB | 49 |
| Placebo DB | 87 |
The pain related sleep interference item rating scale is scored on an 11 point numeric rating scale (NRS Sleep). It is self administered by the subject in order to rate how pain has interfered with their sleep during the past 24 hours, ranging from 0 (pain does not interfere with sleep) to 10 (completely interferes (unable to sleep due to pain)). Participants are to describe how their pain has interfered with their sleep during the past 24 hours by choosing the appropriate number on the numeric rating scale. (NCT01270828)
Timeframe: Week 19
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| SB Baseline to Week 19 (N=205,203) | DB Baseline to Week 19 (N=206,204) | |
| Placebo DB | -3.5 | 0.7 |
| Pregabalin CR DB | -4.5 | -0.2 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Hours (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subjective Total Sleep Time (Week 7) | Subjective Total Sleep Time (Week 8) | Subjective Total Sleep Time (Week 9) | Subjective Total Sleep Time (Week 10) | Subjective Total Sleep Time (Week 11) | Subjective Total Sleep Time (Week 12) | Subjective Total Sleep Time (Week 13) | Subjective Total Sleep Time (Week 14) | Subjective Total Sleep Time (Week 15) | Subjective Total Sleep Time (Week 16) | Subjective Total Sleep Time (Week 17) | Subjective Total Sleep Time (Week 18) | Subjective Total Sleep Time (Week 19) | Subjective Total Sleep Time (Week 20) | |
| Placebo (Double Blind Phase) | 0.5 | 0.6 | 0.5 | 0.5 | 0.6 | 0.5 | 0.6 | 0.7 | 0.7 | 0.7 | 0.7 | 0.5 | 0.6 | 0.5 |
| Pregabalin (Double Blind Phase) | 0.7 | 0.9 | 0.8 | 0.9 | 0.9 | 0.8 | 0.7 | 0.9 | 0.7 | 0.7 | 0.7 | 0.6 | 0.5 | -0.1 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Minutes (Least Squares Mean) | |
|---|---|---|
| Subjective Wake after Sleep Onset | Subjective Latency to Sleep Onset | |
| Placebo (Double Blind Phase) | -20.6 | -11.9 |
| Pregabalin (Double Blind Phase) | -26.2 | -10.6 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Minutes (Mean) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subjective Wake after Sleep Onset (Week 7) | Subjective Wake after Sleep Onset (Week 8) | Subjective Wake after Sleep Onset (Week 9) | Subjective Wake after Sleep Onset (Week 10) | Subjective Wake after Sleep Onset (Week 11) | Subjective Wake after Sleep Onset (Week 12) | Subjective Wake after Sleep Onset (Week 13) | Subjective Wake after Sleep Onset (Week 14) | Subjective Wake after Sleep Onset (Week 15) | Subjective Wake after Sleep Onset (Week 16) | Subjective Wake after Sleep Onset (Week 17) | Subjective Wake after Sleep Onset (Week 18) | Subjective Wake after Sleep Onset (Week 19) | Subjective Wake after Sleep Onset (Week 20) | Subjective Latency to Sleep Onset (Week 7) | Subjective Latency to Sleep Onset (Week 8) | Subjective Latency to Sleep Onset (Week 9) | Subjective Latency to Sleep Onset (Week 10) | Latency to Sleep Onset (Week 11) | Subjective Latency to Sleep Onset (Week 12) | Subjective Latency to Sleep Onset (Week 13) | Subjective Latency to Sleep Onset (Week 14) | Subjective Latency to Sleep Onset (Week 15) | Subjective Latency to Sleep Onset (Week 16) | Subjective Latency to Sleep Onset (Week 17) | Subjective Latency to Sleep Onset (Week 18) | Subjective Latency to Sleep Onset (Week 19) | Subjective Latency to Sleep Onset (Week 20) | |
| Placebo (Double Blind Phase) | -32.0 | -28.0 | -33.2 | -26.2 | -37.4 | -31.0 | -31.4 | -43.3 | -35.1 | -35.0 | -36.2 | -37.3 | -23.1 | -7.1 | -19.1 | -12.3 | -16.0 | -18.0 | -18.0 | -18.8 | -16.8 | -21.8 | -19.1 | -20.9 | -20.9 | -18.7 | -19.5 | -28.7 |
| Pregabalin (Double Blind Phase) | -27.8 | -27.4 | -27.0 | -26.9 | -29.0 | -26.0 | -22.8 | -27.0 | -31.7 | -25.9 | -31.5 | -32.4 | -27.3 | -22.5 | -15.6 | -19.1 | -18.4 | -19.5 | -18.5 | -16.3 | -17.5 | -20.8 | -19.4 | -15.8 | -23.1 | -16.3 | -16.7 | 23.0 |
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Item 1: Physical activities | Item 2: feel good | Item 3: Work missed | Item 4: Do job | Item 5: Pain | Item 6: Fatigue | Item 7: Rested | Item 8: Stiffness | Item 9: Anxiety | Item 10: Depression | Total Score | |
| Placebo (Double Blind Phase) | -1.3 | -3.2 | -1.0 | -2.2 | -2.2 | -2.4 | -2.2 | -2.2 | -1.7 | -0.7 | -19.1 |
| Pregabalin (Double Blind Phase) | -1.0 | -3.0 | -1.2 | -2.1 | -2.7 | -2.3 | -2.6 | -2.4 | -1.8 | -0.7 | -19.6 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| HADS-A Anxiety scale | HADS-D Depression scale | |
| Placebo (Double Blind Phase) | -1.6 | -1.1 |
| Pregabalin (Double Blind Phase) | -0.7 | -1.4 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | |
| Placebo (Double Blind Phase) | -3.0 | -2.7 | -2.8 | -2.4 | -2.6 | -2.6 | -2.6 | -2.5 | -2.6 | -2.6 | -2.5 | -2.5 | -2.4 | -4.9 |
| Pregabalin (Double Blind Phase) | -3.9 | -3.7 | -3.6 | -3.7 | -3.7 | -3.7 | -3.6 | -3.5 | -3.6 | -3.4 | -3.6 | -3.4 | -3.4 | -3.0 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance | Snoring | Awakening Short of Breath/with a Headache | Sleep adequacy | Somnolence | Sleep Problems Index I | Sleep Problems Index II | |
| Placebo (Double Blind Phase) | -15.5 | -2.9 | -4.2 | 17.1 | -6.6 | -13.7 | -14.0 |
| Pregabalin (Double Blind Phase) | -25.4 | -2.4 | -8.1 | 23.9 | -11.9 | -19.5 | -19.7 |
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| General fatigue | Physical fatigue | Reduced activity | Reduced motivation | Mental fatigue | |
| Placebo (Double Blind Phase) | -0.1 | 0.2 | -0.3 | 0.3 | 0.1 |
| Pregabalin (Double Blind Phase) | 0.1 | -0.1 | 0.0 | 1.0 | -0.1 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SF-36 Physical Functioning | SF-36 Role-Physical | SF-36 Pain Index | SF-36 General Health Perceptions | SF-36 Vitality | SF-36 Social Functioning | SF-36 Role-Emotional | SF-36 Mental Health Index | Physical Component Score | Mental Component Score | |
| Placebo (Double Blind Phase) | 13.7 | 16.2 | 16.0 | 9.3 | 15.7 | 13.5 | 2.2 | 5.2 | 7.2 | 2.4 |
| Pregabalin (Double Blind Phase) | 12.4 | 18.9 | 19.2 | 3.3 | 12.2 | 13.3 | 3.8 | 6.6 | 6.8 | 2.6 |
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Percent Work Time Missed | Percent Impairment While Working | Percent Activity Impairment | Percent Overall Work Impairment | |
| Placebo (Double Blind Phase) | -26.7 | -15.0 | -19.6 | -17.5 |
| Pregabalin (Double Blind Phase) | -7.3 | -14.0 | -16.4 | -15.9 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 19
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Placebo (Double Blind Phase) | 7 | 11 | 12 | 11 | 6 | 8 | 2 |
| Pregabalin (Double Blind Phase) | 7 | 15 | 14 | 9 | 7 | 7 | 1 |
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 19
| Intervention | Participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Benefit from treatment-No | Benefit from treatment-Little benefit | Benefit from treatment-much benefit | Satisfaction from treatment-very dissatisfied | Satisfaction from treatment-a little dissatisfied | Satisfaction from treatment-a little satisfied | Satisfaction from treatment-very satisfied | Willing to continue treatment-very unwilling | Willing to continue treatment-little unwilling | Willing to continue treatment-little bit willing | Willing to continue treatment-very willing | |
| Placebo (Double Blind Phase) | 11 | 16 | 30 | 6 | 8 | 13 | 30 | 4 | 8 | 11 | 34 |
| Pregabalin (Double Blind Phase) | 3 | 15 | 41 | 4 | 10 | 10 | 36 | 8 | 6 | 9 | 37 |
C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Week 11 | Week 15 | Week 19 | Week 20 | |
| Placebo (Double Blind Phase) | 0 | 1 | 3 | 1 |
| Pregabalin (Double Blind Phase) | 3 | 1 | 1 | 1 |
C-CASA was used to categorize and summarize results from the Sheehan Suicidality Tracking Scale (S-STS) and the Columbia Suicidality Severity Rating Scale (C-SSRS). S-STS was an 8-item prospective rating scale that tracked treatment-emergent suicidal ideation and behaviors. Items 1a, 2 to 6, 7a, 8 were scored on a 5-point Likert scale (ranges 0 [not at all] to 4 [extremely]). Items 1, 1b, and 7 required yes or no responses. S-STS total score range 0-30. Lower score=reduced suicidal tendency. C-SSRS was a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Responses on S-STS or C-SSRS were mapped to C-CASA categories as: Completed suicide; suicide attempt; preparatory acts; suicide ideation; self-injurious behavior, intent unknown; not enough information; self-injurious behavior, no suicide intent; other, no deliberate self harm. (NCT01271933)
Timeframe: Week 1 to Week 7 and Week 11 to Week 20
| Intervention | Participants (Number) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 6 | Week 7 | |
| Pregabalin (Single Blind Phase) | 5 | 6 | 4 | 16 | 10 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
| Intervention | Percentage of immobile bouts (Mean) | ||||
|---|---|---|---|---|---|
| Sleep Fragmentation Index (Week 3) | Sleep Fragmentation Index (Week 4) | Sleep Fragmentation Index (Week 5) | Sleep Fragmentation Index (Week 6) | Sleep Fragmentation Index (Week 7) | |
| Pregabalin (Single Blind Phase) | -0.8 | -2.5 | -2.8 | -2.6 | 0.7 |
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100. Higher scores indicated a better health-related quality of life. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SF-36 Physical Functioning | SF-36 Role-Physical | SF-36 Pain Index | SF-36 General Health Perceptions | SF-36 Vitality | SF-36 Social Functioning | SF-36 Role-Emotional | SF-36 Mental Health Index | Physical Component Score | Mental Component Score | |
| Pregabalin (Single Blind Phase) | 14.0 | 17.8 | 20.7 | 8.5 | 18.2 | 12.9 | 8.6 | 7.9 | 7.2 | 4.5 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
| Intervention | Minutes (Mean) | ||||
|---|---|---|---|---|---|
| Minutes of Interrupted Sleep (Week 3) | Minutes of Interrupted Sleep (Week 4) | Minutes of Interrupted Sleep (Week 5) | Minutes of Interrupted Sleep (Week 6) | Minutes of Interrupted Sleep (Week 7) | |
| Pregabalin (Single Blind Phase) | -5.3 | -5.9 | -7.0 | -6.6 | 0.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
| Intervention | Percent of daytime (Mean) | ||||
|---|---|---|---|---|---|
| Percent Sedentary (Week 3) | Percent Sedentary (Week 4) | Percent Sedentary (Week 5) | Percent Sedentary (Week 6) | Percent Sedentary (Week 7) | |
| Pregabalin (Single Blind Phase) | 0.7 | 0.7 | 0.6 | 0.3 | 0.2 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
| Intervention | Counts of total daytime activity (Mean) | ||||
|---|---|---|---|---|---|
| Total daytime activity (Week 3) | Total daytime activity (Week 4) | Total daytime activity (Week 5) | Total daytime activity (Week 6) | Total daytime activity (Week 7) | |
| Pregabalin (Single Blind Phase) | 10264.3 | 10588.1 | 8635.8 | 7134.2 | 18420.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 3, 4, 5, 6 and 7
| Intervention | Hours (Mean) | ||||
|---|---|---|---|---|---|
| Total Sleep Time (Week 3) | Total Sleep Time (Week 4) | Total Sleep Time (Week 5) | Total Sleep Time (Week 6) | Total Sleep Time (Week 7) | |
| Pregabalin (Single Blind Phase) | -0.1 | 0.4 | 0.3 | 0.3 | 0.6 |
The tiredness assessment in the daily interactive voice response system (IVRS) diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Pregabalin (Single Blind Phase) | -0.7 | -1.2 | -1.6 | -2.0 | -2.2 | -2.3 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Number of times the participant awakened (Mean) | |||||
|---|---|---|---|---|---|---|
| Subjective No.of Awakenings after Sleep (Week 1) | Subjective No.of Awakenings after Sleep (Week 2) | Subjective No.of Awakenings after Sleep (Week 3) | Subjective No.of Awakenings after Sleep (Week 4) | Subjective No.of Awakenings after Sleep (Week 5) | Subjective No.of Awakenings after Sleep (Week 6) | |
| Pregabalin (Single Blind Phase) | -0.8 | -1.0 | -1.1 | -1.1 | -1.2 | -1.2 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Hours (Mean) | |||||
|---|---|---|---|---|---|---|
| Subjective Total Sleep Time (Week 1) | Subjective Total Sleep Time (Week 2) | Subjective Total Sleep Time (Week 3) | Subjective Total Sleep Time (Week 4) | Subjective Total Sleep Time (Week 5) | Subjective Total Sleep Time (Week 6) | |
| Pregabalin (Single Blind Phase) | 0.6 | 0.6 | 0.6 | 0.7 | 0.7 | 0.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Sleep quality (Week 1) | Sleep quality (Week 2) | Sleep quality (Week 3) | Sleep quality (Week 4) | Sleep quality (Week 5) | Sleep quality (Week 6) | |
| Pregabalin (Single Blind Phase) | 1.0 | 1.2 | 1.5 | 1.6 | 1.7 | 1.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Minutes (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subjective Wake after Sleep Onset (Week 1) | Subjective Wake after Sleep Onset (Week 2) | Subjective Wake after Sleep Onset (Week 3) | Subjective Wake after Sleep Onset (Week 4) | Subjective Wake after Sleep Onset (Week 5) | Subjective Wake after Sleep Onset (Week 6) | Subjective Latency to Sleep Onset (Week 1) | Subjective Latency to Sleep Onset (Week 2) | Subjective Latency to Sleep Onset (Week 3) | Subjective Latency to Sleep Onset (Week 4) | Subjective Latency to Sleep Onset (Week 5) | Subjective Latency to Sleep Onset (Week 6) | |
| Pregabalin (Single Blind Phase) | -19.1 | -22.4 | -25.0 | -27.5 | -31.4 | -32.8 | -10.3 | -13.0 | -15.5 | -19.6 | -20.0 | -16.9 |
The FIQ is a 20-item self-administered questionnaire. FIQ contains 10 subscales, which are combined to yield a total score. There are 11 questions that are related specifically to physical functioning (item 1). The remaining questions assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. The FIQ is scored from 0 to 100, with higher scores indicating more impairment. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Item 1: Physical activities | Item 2: Feel good | Item 3: Work missed | Item 4: Do job | Item 5: Pain | Item 6: Fatigue | Item 7: Rested | Item 8: Stiffness | Item 9: Anxiety | Item 10: Depression | Total Score | |
| Pregabalin (Single Blind Phase) | -0.9 | -2.2 | -0.5 | -1.5 | -1.6 | -1.4 | -1.7 | -1.8 | -1.2 | -0.6 | -13.4 |
HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| HADS-A Anxiety scale | HADS-D Depression scale | |
| Pregabalin (Single Blind Phase) | -1.8 | -1.5 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6
| Intervention | Units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 5 | Week 6 | |
| Pregabalin (Single Blind Phase) | -0.9 | -1.5 | -2.0 | -2.3 | -2.5 | -2.6 |
The MFI is a 20-item, self-administered questionnaire designed to measure the following dimensions of fatigue: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Items are summed to form subscale scores; there is no overall score. The score range is from 4 to 20, where higher scores indicate greater dysfunction. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| General fatigue | Physical fatigue | Reduced activity | Reduced motivation | Mental fatigue | |
| Pregabalin (Single Blind Phase) | -0.2 | 0.1 | -0.2 | 0.2 | -0.1 |
WPAI: 6 question participant rated questionnaire to determine the degree to which disease state affected work productivity while at work and affected activities outside of work. Subscale scores include percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Scores scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| Percent Work Time Missed | Percent Impairment While Working | Percent Activity Impairment | Percent Overall Work Impairment | |
| Pregabalin (Single Blind Phase) | -5.8 | -10.0 | -13.5 | -12.3 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01271933)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Pregabalin (Single Blind Phase) | 24 | 77 | 103 | 46 | 16 | 18 | 5 |
The questionnaire consists of 3 single-item measures designed to captures the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. (NCT01271933)
Timeframe: Week 6
| Intervention | Participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Benefit from treatment-No | Benefit from treatment-Little benefit | Benefit from treatment-much benefit | Satisfaction from treatment-very dissatisfied | Satisfaction from treatment-a little dissatisfied | Satisfaction from treatment-a little satisfied | Satisfaction from treatment-very satisfied | Willing to continue treatment-very unwilling | Willing to continue treatment-little unwilling | Willing to continue treatment-little bit willing | Willing to continue treatment-very willing | |
| Pregabalin (Single Blind Phase) | 69 | 137 | 211 | 52 | 59 | 103 | 203 | 68 | 33 | 49 | 266 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -3.5 |
| Placebo (Double Blind Phase) | -2.3 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | hours (Mean) |
|---|---|
| Pregabalin (Single Blind Phase) | 0.7 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
| Intervention | Percent of daytime (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -1.4 |
| Placebo (Double Blind Phase) | -2.0 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
| Intervention | Percentage of immobile bouts (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -2.5 |
| Placebo (Double Blind Phase) | -0.6 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
| Intervention | Counts of total daytime activity (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -182.7 |
| Placebo (Double Blind Phase) | -6672.2 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Double blind end point visit (Week 19)
| Intervention | Hours (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | 0.5 |
| Placebo (Double Blind Phase) | 0.1 |
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -2.6 |
| Placebo (Double Blind Phase) | -2.5 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | 1.9 |
| Placebo (Double Blind Phase) | 1.4 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Number of times the participant awakened (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -0.5 |
| Placebo (Double Blind Phase) | -0.8 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Hours (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | 0.6 |
| Placebo (Double Blind Phase) | 0.4 |
Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Double blind endpoint visit (Week 19)
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -2.9 |
| Placebo (Double Blind Phase) | -2.5 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | hours (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | 0.7 |
| Placebo (Double Blind Phase) | 0.5 |
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 19
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin (Double Blind Phase) | -3.1 |
| Placebo (Double Blind Phase) | -2.4 |
Participants who did not maintain at least 30% pain response during the DB phase relative to baseline or were discontinued during DB due to lack of efficacy or an adverse event were considered to have a loss of therapeutic response. (NCT01271933)
Timeframe: Randomization to Week 19
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin (Double Blind Phase) | 34 |
| Placebo (Double Blind Phase) | 41 |
The time to loss of therapeutic response (LTR) is the time to loss of pain response (<30% pain response relative to the single-blind (SB) baseline mean pain) or withdrawal due to lack of efficacy or adverse events (in the double blind phase). (NCT01271933)
Timeframe: Randomization to Week 19
| Intervention | Days (Median) |
|---|---|
| Pregabalin (Double Blind Phase) | 58 |
| Placebo (Double Blind Phase) | 23 |
Weekly pain scores were calculated from the daily pain diary. Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 NRS: 0 (no pain) to 10 (worst possible pain). (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin (Single Blind Phase) | -1.6 |
The MOS-SS is a validated self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) and two overall sleep problems indices assessing sleep over the past week. Score range for Sleep Disturbance (SD), sleep adequacy (SA), snoring, somnolence, awakening short of breath/headache was 0-100, where higher score=greater SD; greater SA; greater snoring; greater somnolence; greater shortness of breath/headache respectively. Quantity of Sleep (range-0 to 24 hours; higher scores/hours=greater quantity of sleep). Sleep Problem Index I and II: Score Range=0 to 100; higher scores =greater sleep problems. Optimal Sleep (assessed as yes or no), 'Yes' =optimal sleep (average 7-8 hours/night); 'No' =not optimal sleep. (NCT01271933)
Timeframe: Baseline, Week 6
| Intervention | Units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance | Snoring | Awakening Short of Breath/with a Headache | Sleep adequacy | Somnolence | Sleep Problems Index I | Sleep Problems Index II | |
| Pregabalin (Single Blind Phase) | -21.8 | -1.0 | -11.0 | 18.9 | -3.6 | -16.1 | -15.9 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Minutes of interrupted sleep = minutes awake after sleep onset (analogous to wake-time after sleep onset from polysomnography measurements). (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
| Intervention | Minutes (Mean) | ||||
|---|---|---|---|---|---|
| Minutes of Interrupted Sleep (Week 11) | Minutes of Interrupted Sleep (Week 12) | Minutes of Interrupted Sleep (Week 13) | Minutes of Interrupted Sleep (Week 14) | Minutes of Interrupted Sleep (Week 15) | |
| Placebo (Double Blind Phase) | 2.5 | -1.7 | 0.4 | -1.8 | -0.5 |
| Pregabalin (Double Blind Phase) | -9.0 | -3.0 | -3.0 | -3.2 | -0.4 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Percent sedentary = percent of daytime spent in sedentary activities as determined by the activity counts measured each minute. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
| Intervention | Percent of daytime (Mean) | ||||
|---|---|---|---|---|---|
| Percent Sedentary (Week 11) | Percent Sedentary (Week 12) | Percent Sedentary (Week 13) | Percent Sedentary (Week 14) | Percent Sedentary (Week 15) | |
| Placebo (Double Blind Phase) | 1.1 | -1.4 | -0.9 | -1.1 | -1.4 |
| Pregabalin (Double Blind Phase) | -0.7 | -0.8 | -1.3 | -2.1 | -1.5 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Sleep fragmentation index = a measure of sleep relatedness. Sleep fragmentation index calculated from analysis of the periods that participant was not moving (immobile bouts). It is number of immobile bouts that were exactly 1 minute long divided by total number of immobile bouts. Value ranges from 0-100 percent, with low number representing more restful sleep. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
| Intervention | Percentage of immobile bouts (Mean) | ||||
|---|---|---|---|---|---|
| Sleep Fragmentation Index (Week 11) | Sleep Fragmentation Index (Week 12) | Sleep Fragmentation Index (Week 13) | Sleep Fragmentation Index (Week 14) | Sleep Fragmentation Index (Week 15) | |
| Placebo (Double Blind Phase) | 0.1 | -0.4 | -0.3 | -0.6 | -0.9 |
| Pregabalin (Double Blind Phase) | -4.4 | -2.8 | -2.2 | -2.4 | -0.9 |
"Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total daytime activity = total activity counts during the day." (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
| Intervention | Counts of total daytime activity (Mean) | ||||
|---|---|---|---|---|---|
| Total daytime activity (Week 11) | Total daytime activity ((Week 12) | Total daytime activity ((Week 13) | Total daytime activity ((Week 14) | Total daytime activity ((Week 15) | |
| Placebo (Double Blind Phase) | -2083.9 | -6691.1 | 521.8 | -4523.8 | -4649.4 |
| Pregabalin (Double Blind Phase) | -1894.1 | -50.7 | -4362.4 | -179.7 | -4138.3 |
Actigraphy was assessed with an accelerometer that was worn on the wrist. The accelerometer was programmed to record movements. This information was used to calculate several endpoints reflecting daytime activity, and sleep quality and duration. Total sleep time = number of minutes asleep between time of sleep onset to morning awakening. (NCT01271933)
Timeframe: Baseline, Weeks 11, 12, 13, 14 and 15
| Intervention | Hours (Mean) | ||||
|---|---|---|---|---|---|
| Total Sleep Time (Week 11) | Total Sleep Time (Week 12) | Total Sleep Time (Week 13) | Total Sleep Time (Week 14) | Total Sleep Time (Week 15) | |
| Placebo (Double Blind Phase) | 0.0 | 0.1 | 0.1 | 0.1 | 0.3 |
| Pregabalin (Double Blind Phase) | 0.5 | 0.5 | 0.4 | 0.4 | 0.2 |
The tiredness assessment in the daily IVRS diary consists of an 11-point NRS ranging from zero (not tired) to 10 (extremely tired). Participants rate their tiredness due to fibromyalgia during the past 24 hours by choosing the appropriate number between 0 (not tired) and 10 (extremely tired). (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 7 | Week 8 | Week 9 | Week 10 | Week 11 | Week 12 | Week 13 | Week 14 | Week 15 | Week 16 | Week 17 | Week 18 | Week 19 | Week 20 | |
| Placebo (Double Blind Phase) | -3.0 | -2.8 | -2.9 | -2.6 | -2.5 | -2.5 | -2.6 | -2.5 | -2.6 | -2.7 | -2.5 | -2.4 | -2.4 | -4.9 |
| Pregabalin (Double Blind Phase) | -3.4 | -3.3 | -3.2 | -3.2 | -3.1 | -3.4 | -3.2 | -3.2 | -3.4 | -3.1 | -3.4 | -3.2 | -3.1 | -2.7 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Participants rated quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses at each week was therefore 0 (very poor) -10 (excellent), where higher scores indicated better quality of sleep. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sleep Quality (Week 7) | Sleep Quality (Week 8) | Sleep Quality (Week 9) | Sleep Quality (Week 10) | Sleep Quality (Week 11) | Sleep Quality (Week 12) | Sleep Quality (Week 13) | Sleep Quality (Week 14) N=48,43 | Sleep Quality (Week 15) | Sleep Quality (Week 16) | Sleep Quality (Week 17) | Sleep Quality (Week 18) | Sleep Quality (Week 19) | Sleep Quality (Week 20) | |
| Placebo (Double Blind Phase) | 1.9 | 1.7 | 1.8 | 1.7 | 1.7 | 1.7 | 1.9 | 2.1 | 2.0 | 1.9 | 1.9 | 1.8 | 1.5 | 3.3 |
| Pregabalin (Double Blind Phase) | 1.9 | 2.0 | 2.1 | 2.2 | 2.3 | 2.1 | 1.9 | 2.2 | 2.2 | 1.9 | 2.2 | 2.1 | 2.0 | 3.1 |
The SSQ is designed to capture subjective behavior in participants with disrupted sleep. Participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. (NCT01271933)
Timeframe: Baseline, Weeks 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
| Intervention | Number of times the participant awakened (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subjective No.of Awakenings after Sleep (Week 7) | Subjective No.of Awakenings after Sleep (Week 8) | Subjective No.of Awakenings after Sleep (Week 9) | Subjective No.of Awakenings after Sleep (Week 10) | Subjective No.of Awakenings after Sleep (Week 11) | Subjective No.of Awakenings after Sleep (Week 12) | Subjective No.of Awakenings after Sleep (Week 13) | Subjective No.of Awakenings after Sleep (Week 14) | Subjective No.of Awakenings after Sleep (Week 15) | Subjective No.of Awakenings after Sleep (Week 16) | Subjective No.of Awakenings after Sleep (Week 17) | Subjective No.of Awakenings after Sleep (Week 18) | Subjective No.of Awakenings after Sleep (Week 19) | Subjective No.of Awakenings after Sleep (Week 20) | |
| Placebo (Double Blind Phase) | -1.0 | -0.8 | -1.1 | -0.9 | -0.9 | -0.8 | -1.0 | -1.1 | -1.1 | -1.0 | -0.9 | -1.0 | -0.9 | -1.5 |
| Pregabalin (Double Blind Phase) | -1.1 | -1.2 | -1.2 | -1.2 | -1.1 | -1.1 | -1.0 | -1.0 | -0.8 | -1.0 | -1.2 | -1.1 | -0.7 | -1.5 |
The patient's impression (patient global impression of change [PGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. (NCT01279850)
Timeframe: At Week 104
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 95 | 223 | 183 | 71 | 3 | 2 | 0 | 214 |
The physician's impression (clinical global impression of change [CGIC]) at Week 104, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. (NCT01279850)
Timeframe: At Week 104
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 108 | 275 | 179 | 93 | 7 | 0 | 0 | 129 |
The pain experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in participant-rated pain score at Week 104 was presented along with standard deviation. (NCT01279850)
Timeframe: Baseline and at Week 104
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -4.4 |
The sleep interference (inability to sleep because of pain) experienced at Week 104 during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no disturbance) to 10 (totally unable to sleep because of pain). Mean change from baseline in participant-rated sleep interference score at Week 104 was presented along with standard deviation. (NCT01279850)
Timeframe: Baseline and at Week 104
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -3.9 |
Clinical effectiveness of LYRICA Capsules was determined by the physician based on the following categories: (1) effective, (2) ineffective, or (3) impossible to judge at Week 104 of the treatment. Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of the analysis population, was presented along with the corresponding 2-sided 95% CI. (NCT01279850)
Timeframe: At Week 104
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 91.0 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 4 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 12.75 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.25 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 65 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.50 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. (NCT01279850)
Timeframe: From Week 1 to Week 104 at maximum
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 14 |
"Colonic compliance is a measure of the stiffness of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance." (NCT01331213)
Timeframe: baseline (1 hour before drug administration), post-treatment (1 hour after drug administration)
| Intervention | mm Hg (Mean) | |
|---|---|---|
| Baseline | Post-Treatment | |
| Placebo | 16.86 | 15.75 |
| Pregabalin | 18.96 | 15.99 |
The postprandial motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1] A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostatically-controlled balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.) (NCT01331213)
Timeframe: Approximately 1 hour after meal
| Intervention | log mm Hg (Mean) | |
|---|---|---|
| Post-treatment, descending colon | Post-treatment, sigmoid colon | |
| Placebo | 12.27 | 10.21 |
| Pregabalin | 13.69 | 11.72 |
The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT01331213)
Timeframe: approximately 60 minutes after drug administration
| Intervention | mm Hg (Mean) |
|---|---|
| Pregabalin | 36.0 |
| Placebo | 38.0 |
The symmetric percent reduction in baseline colonic barostat balloon volume during the first 30 minutes postprandially (PP) corrected for the preprandial (30 min) tone, (symmetric percent change= 100*log_e[fasting/PP]). A positive symmetric percent change reflects a decrease in barostat balloon volume indicating a reduction in colonic tone. (The balloon was placed in the mid-descending or junction of the sigmoid and descending colon.) (NCT01331213)
Timeframe: The first 30 minutes postprandially, and preprandial (30 minutes)
| Intervention | Symmetric percentage change (Mean) |
|---|---|
| Pregabalin | -22.34 |
| Placebo | -24.45 |
The sensory threshold for first perception of gas was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of gas. The investigator recorded the threshold pressure at which the participants reported this sensation. (NCT01331213)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm Hg (Mean) |
|---|---|
| Pregabalin | 24.0 |
| Placebo | 19.2 |
Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.) (NCT01331213)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mL (Mean) |
|---|---|
| Pregabalin | 120.4 |
| Placebo | 116.8 |
The mm Hg distensions refer to the barostat balloon, which was placed in the mid-descending or junction of the sigmoid and descending colon. Pain sensation was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes. For the pain VAS, 0 means no pain and 100 mm means extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. (NCT01331213)
Timeframe: Approximately 60 minutes after drug administration
| Intervention | mm (Mean) | |||
|---|---|---|---|---|
| Sensation ratings of pain at 16 mm Hg distension | Sensation ratings of pain at 24 mm Hg distension | Sensation ratings of pain at 30 mm Hg distension | Sensation ratings of pain at 36 mm Hg distension | |
| Placebo | 52.3 | 59.60 | 60.3 | 53.7 |
| Pregabalin | 53.0 | 57.43 | 64.0 | 59.0 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.22 |
| Placebo | -0.88 |
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -25.07 |
| Placebo | -21.82 |
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.80 |
| Placebo | -0.73 |
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). (NCT01332149)
Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.58 |
| Placebo | 2.73 |
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). (NCT01332149)
Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.60 |
| Placebo | 2.74 |
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 63/Week 9) (Study Endpoint) compared to baseline. (NCT01332149)
Timeframe: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 50.3 |
| Placebo | 44.3 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night. (NCT01332149)
Timeframe: Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 43.8 |
| Placebo | 45.0 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01332149)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Anxiety total score | Depression total score | |
| Placebo | 3.67 | 4.35 |
| Pregabalin | 3.76 | 4.45 |
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). (NCT01332149)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | |
|---|---|---|
| VAS | PPI | |
| Placebo | 69.06 | 2.27 |
| Pregabalin | 69.08 | 2.28 |
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain. (NCT01332149)
Timeframe: Baseline; Weeks 1, 5, and 9
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sensory score, Baseline (N=313, 306) | Sensory score, Week 1 change (N=311, 304) | Sensory score, Week 5 change (N=297, 288) | Sensory score, Week 9 change (N=288, 274) | Affective score, Baseline (N=313, 307) | Affective score, Week 1 change (N=311, 304) | Affective score, Week 5 change (N=297, 289) | Affective score, Week 9 change (N=287, 274) | Total score, Baseline (N=313, 307) | Total score, Week 1 change (N=311, 305) | Total score, Week 5 change (N=297, 289) | Total score, Week 9 change (N=288, 274) | |
| Placebo | 8.11 | -1.34 | -2.47 | -3.37 | 1.20 | -0.37 | -0.62 | -0.62 | 9.28 | -1.70 | -3.07 | -4.00 |
| Pregabalin | 7.90 | -1.50 | -2.89 | -3.87 | 1.25 | -0.41 | -0.72 | -0.75 | 9.15 | -1.92 | -3.61 | -4.62 |
The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9. (NCT01332149)
Timeframe: Baseline and weekly from Weeks 1 to 9
| Intervention | units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 change from baseline (N=312, 307) | Week 2 change from baseline (N=304, 295) | Week 3 change from baseline (N=298, 291) | Week 4 change from baseline (N=297, 289) | Week 5 change from baseline (N=296, 287) | Week 6 change from baseline (N=293, 278) | Week 7 change from baseline (N=290, 275) | Week 8 change from baseline (N=290, 275) | Week 9 change from baseline (N=287, 273) | Overall change from baseline | |
| Placebo | -0.36 | -0.71 | -1.01 | -1.21 | -1.39 | -1.59 | -1.77 | -1.88 | -2.07 | -1.33 |
| Pregabalin | -0.60 | -0.97 | -1.25 | -1.47 | -1.61 | -1.84 | -2.04 | -2.18 | -2.32 | -1.59 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. The overall change is the average change from Weeks 1 to 9. (NCT01332149)
Timeframe: Baseline and weekly from Weeks 1 to 9
| Intervention | units on a scale (Least Squares Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 change from baseline (N=311, 307) | Week 2 change from baseline (N=303, 295) | Week 3 change from baseline (N=297, 291) | Week 4 change from baseline (N=296, 289) | Week 5 change from baseline (N=295, 287) | Week 6 change from baseline (N=292, 278) | Week 7 change from baseline (N=289, 275) | Week 8 change from baseline (N=289, 275) | Week 9 change from baseline (N=286, 273) | Overall change from baseline | |
| Placebo | -0.26 | -0.51 | -0.72 | -0.86 | -0.98 | -1.07 | -1.25 | -1.36 | -1.49 | -0.94 |
| Pregabalin | -0.38 | -0.66 | -0.88 | -1.06 | -1.14 | -1.32 | -1.43 | -1.59 | -1.67 | -1.13 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -6.71 |
| Placebo | -5.88 |
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. (NCT01332149)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 6.65 |
| Placebo | 6.67 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. (NCT01332149)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 5.25 |
| Placebo | 5.12 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.48 |
| Placebo | -0.31 |
The MOS-Sleep Scale was a participant-rated instrument which assesses sleep quantity and quality with 12 items (7 subscale scores: sleep disturbance, snoring, awakening short of breath/with headache, sleep adequacy, somnolence, sleep quantity, optimal sleep; and a 9-item overall sleep problems index). Subscale scores total range: 0-100 (except sleep quantity [range 0-24 hours], optimal sleep [yes:1, no:0]). Higher scores=poorer sleep outcomes (except sleep quantity, adequacy, and optimal sleep). (NCT01332149)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance score (N=313, 307) | Snoring score (N=312, 307) | Awaken short of breath score (N=313, 307) | Quantity of sleep score (N=311, 304) | Sleep adequacy score (N=313, 307) | Somnolence score (N=312, 307) | Sleep problems index score (N=312, 307) | |
| Placebo | 35.13 | 37.59 | 10.75 | 5.98 | 60.88 | 36.03 | 31.21 |
| Pregabalin | 36.29 | 35.13 | 11.50 | 6.07 | 57.32 | 33.87 | 32.19 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.57 |
| Placebo | -0.38 |
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose. (NCT01332149)
Timeframe: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.14 |
| Placebo | -1.86 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 9 (Day 63) dose. (NCT01332149)
Timeframe: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.52 |
| Placebo | -1.30 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.10 |
| Placebo | -2.31 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept). (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.33 |
| Placebo | 0.14 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 8.87 |
| Placebo | 7.82 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -9.11 |
| Placebo | -7.98 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring. (NCT01332149)
Timeframe: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.78 |
| Placebo | -0.53 |
Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes. (NCT01333956)
Timeframe: 3 months
| Intervention | units on a scale (Median) |
|---|---|
| Control | 0 |
| 50mg Arm | 0 |
| 100mg Arm | 0 |
| 150mg Arm | 0 |
Opioid Usage (POD1, POD 3, 2 weeks, 3 months) (NCT01333956)
Timeframe: 3 months
| Intervention | mg (Mean) | |||||
|---|---|---|---|---|---|---|
| Preop Total Opioid Use (mg) | POD 1 Total Opioid Use (mg) | POD 2 Total Opioid Use (mg) | POD 3 Total Opioid Use (mg) | POD 14 Total Opioid Use (mg) | 3 months Total Opioid Use (mg) | |
| 100mg Arm | 17 | 57 | 63 | 40 | 40 | 0 |
| 150mg Arm | 18 | 45 | 55 | 36 | 45 | 4 |
| 50mg Arm | 18 | 46 | 60 | 60 | 36 | 3 |
| Control | 19 | 50 | 70 | 55 | 40 | 0 |
Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied) (NCT01333956)
Timeframe: 2 weeks
| Intervention | units on a scale (Median) |
|---|---|
| Control | 9 |
| 50mg Arm | 8 |
| 100mg Arm | 8 |
| 150mg Arm | 8 |
NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months) (NCT01333956)
Timeframe: 3 months
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Preop NRS Pain Score with Flexion | POD1 NRS Pain Score with Flexion | POD3 NRS Pain Score with Flexion | POD14 NRS Pain Score with Flexion | 3 months NRS Pain Score with Flexion | |
| 100mg Arm | 3.9 | 2.7 | 3.6 | 4.5 | 1.7 |
| 150mg Arm | 5.7 | 2.5 | 4.3 | 4.2 | 1.8 |
| 50mg Arm | 5.4 | 2.9 | 4.2 | 4.9 | 1.9 |
| Control | 4.9 | 2.8 | 3.9 | 4 | 2 |
Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1) (NCT01333956)
Timeframe: 1 day postoperatively
| Intervention | percentage of patients (Number) | |
|---|---|---|
| Drowsiness POD1 [ORSDS] | Nausea POD1 [ORSDS] | |
| 100mg Arm | 55.2 | 44.8 |
| 150mg Arm | 58.6 | 31.0 |
| 50mg Arm | 37.9 | 41.4 |
| Control | 34.5 | 34.5 |
Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable). (NCT01333956)
Timeframe: 2 weeks postoperatively
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| POD14 Pain score with flexion | POD14 Pain score with ambulation | POD14 Pain score at rest | |
| 100mg Arm | 4.5 | 3.5 | 2.8 |
| 150mg Arm | 4.0 | 3.1 | 2.7 |
| 50mg Arm | 4.8 | 3.8 | 2.9 |
| Control | 4 | 3.6 | 2.9 |
Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high). (NCT01333956)
Timeframe: 2 weeks postoperatively
| Intervention | units on a scale (Median) | |
|---|---|---|
| ORSDS POD1 | ORSDS POD14 | |
| 100mg Arm | .5 | .3 |
| 150mg Arm | .4 | .3 |
| 50mg Arm | .4 | .3 |
| Control | .4 | .3 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit." (NCT01352741)
Timeframe: Randomization Visit (Day 22) to Final Evaluation (Day 77)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Improvement | No change | Worsening | Missing | |
| Tapentadol Prolonged Release | 39 | 63 | 21 | 16 |
| Tapentadol Prolonged Release and Pregabalin | 58 | 59 | 20 | 12 |
The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings. Participants were asked: How many times did you wake up during the night? The change in the Number of Awakenings was calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Final Evaluation Visit (Day 77). A negative change indicates that the number of awakenings in a treatment group have gone down since the Baseline or Randomization Visit. In general pain can interfere with sleep, one potential indicator is the number of awakenings. (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
| Intervention | Number of Awakenings (Mean) | |
|---|---|---|
| Change from Baseline Visit | Change from Randomization Visit | |
| Tapentadol Prolonged Release | -1.4 | -0.2 |
| Tapentadol Prolonged Release and Pregabalin | -2.5 | -0.8 |
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health. (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline Visit (N=131; N=143) | Change from Randomization Visit (N=131; N=143) | |
| Tapentadol Prolonged Release | 3.9 | 0.1 |
| Tapentadol Prolonged Release and Pregabalin | 6.5 | 2.5 |
"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear. The theoretical range of change in this trial ranged from -38 to 19. A negative change indicated a decrease in their neuropathic component of pain." (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline | Change from Randomization | |
| Tapentadol Prolonged Release | -10.2 | -6.0 |
| Tapentadol Prolonged Release and Pregabalin | -11.0 | -5.9 |
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. Spontaneous Pressing Pain Subscore). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 10 (100 for the overall score) . A negative change indicates that the intensity of the symptom has decreased since the start of treatment. (NCT01352741)
Timeframe: Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Overall Score | Subscore: Superficial Spontaneous Burning | Subscore: Deep Sponatenous Pressing Pain | Subscore: Paroxysmal Pain | Subscore: Evoked Pain | Subscore: Parasthesia/Dysesthesia | |
| Tapentadol Prolonged Release | -16.8 | -1.9 | -1.4 | -2.0 | -1.8 | -1.4 |
| Tapentadol Prolonged Release and Pregabalin | -16.6 | -2.3 | -1.4 | -1.6 | -1.7 | -1.5 |
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment. (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline Visit | Change from Randomization Visit | |
| Tapentadol Prolonged Release | -2.0 | -0.4 |
| Tapentadol Prolonged Release and Pregabalin | -3.1 | -1.3 |
"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A negative sign indicates that there has been a decrease in anxiety since the start of treatment." (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline Visit | Change from Randomization Visit | |
| Tapentadol Prolonged Release | -2.2 | -0.3 |
| Tapentadol Prolonged Release and Pregabalin | -3.1 | -1.2 |
"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline Visit | Change from Randomization Visit | |
| Tapentadol Prolonged Release | 0.34 | 0.09 |
| Tapentadol Prolonged Release and Pregabalin | 0.43 | 0.09 |
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group. (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
| Intervention | hours (Mean) | |
|---|---|---|
| Change from baseline visit | Change from randomization visit | |
| Tapentadol Prolonged Release | -0.3 | 0.2 |
| Tapentadol Prolonged Release and Pregabalin | -0.3 | -0.2 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?" (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | Number of Awakenings (Mean) |
|---|---|
| Enrollment Visit (Day -12) | 3.3 |
| Baseline Visit (Day 1) | 3.9 |
| Randomization Visit (Day 22) | 2.5 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the sleep latency.~To assess latency the participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]?" (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | hours (Mean) |
|---|---|
| Enrollment Visit (Day -12) | 1.2 |
| Baseline Visit (Day 1) | 1.5 |
| Randomization Visit (Day 22) | 1.3 |
"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine." (NCT01352741)
Timeframe: Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) |
|---|---|
| Tapentadol Prolonged Release After Tapentadol | 4.4 |
| Tapentadol Prolonged Release After Tapentadol and Pregabalin | 4.5 |
"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit.~A negative change indicates that the pain intensity decreased from the start of the trial." (NCT01352741)
Timeframe: Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) |
|---|---|
| Tapentadol Prolonged Release | -1.7 |
| Tapentadol Prolonged Release and Pregabalin | -1.8 |
"The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical summary scores were calculated from the individual responses to those questions covering physical health. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.~The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement." (NCT01352741)
Timeframe: Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from Baseline Visit | Change from Randomization Visit | |
| Tapentadol Prolonged Release | 12.3 | 6.2 |
| Tapentadol Prolonged Release and Pregabalin | 11.1 | 5.6 |
"The primary endpoint is defined as the comparison of tapentadol prolonged release (PR) 300 mg plus 200 mg per day and the combination of tapentadol PR 300 mg per day and pregabalin 300 mg per day regarding the change in NRS-3 pain intensity scores (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) from the randomization visit to the final evaluation visit.~Theoretically a maximum decrease of -10 and an increase of +4 in the pain intensity would have been possible. A negative sign indicates a decrease in pain intensity from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline visit)." (NCT01352741)
Timeframe: Randomization (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) |
|---|---|
| Tapentadol Prolonged Release | -1.6 |
| Tapentadol Prolonged Release and Pregabalin | -1.7 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Excellent | Good | Fair | Poor | Missing | |
| Baseline Visit (Day 1) | 5 | 76 | 149 | 210 | 5 |
| Enrollment Visit (Day -12) | 9 | 110 | 171 | 148 | 7 |
| Randomization Visit (Day 22) | 21 | 173 | 127 | 56 | 68 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor." (NCT01352741)
Timeframe: Baseline Visit (Day 1)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Tapentadol Prolonged Release | 2 | 23 | 42 | 72 |
| Tapentadol Prolonged Release and Pregabalin | 1 | 17 | 49 | 82 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor." (NCT01352741)
Timeframe: Enrollment Visit (Day-12)
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Excellent | Good | Fair | Poor | Missing | |
| Tapentadol Prolonged Release | 1 | 37 | 42 | 58 | 1 |
| Tapentadol Prolonged Release and Pregabalin | 5 | 30 | 61 | 53 | 0 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.~The participant rated this categorically as being one of the following: excellent, good, fair or poor." (NCT01352741)
Timeframe: Randomization Visit (Day 22)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Excellent | Good | Fair | Poor | |
| Tapentadol Prolonged Release | 7 | 62 | 48 | 22 |
| Tapentadol Prolonged Release and Pregabalin | 8 | 59 | 56 | 26 |
"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~How would you rate your overall satisfaction with your current pain treatment?: Excellent, Very Good, Good, Fair and Poor." (NCT01352741)
Timeframe: End of Open-label Titration Period at Randomization Visit (Day 22)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Poor | Fair | Good | Very Good | Excellent | Missing | |
| Tapentadol Prolonged Release | 12 | 119 | 178 | 58 | 11 | 67 |
"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked: Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit." (NCT01352741)
Timeframe: Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=438) | Baseline Visit (N=440) | Randomization Visit (N=377) | |
| Tapentadol Prolonged Release | 7.6 | 8.5 | 5.8 |
"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine." (NCT01352741)
Timeframe: Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Enrollment Visit (N=56) | Baseline Visit (N=57) | Randomization Visit (N=57) | Final Evaluation Visit (N=59) | |
| Tapentadol Prolonged Release | 7.3 | 7.9 | 2.6 | 2.6 |
"Participants rated their satisfaction with the study drug (IMPs) by answering the following question on a 5-point rating scale:~How would you rate your overall satisfaction with your current pain treatment?: Excellent, Very Good, Good, Fair and Poor." (NCT01352741)
Timeframe: End of Comparative Period at Final Evaluation Visit (Day 77)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Poor | Fair | Good | Very Good | Excellent | Missing | |
| Tapentadol and Pregabalin in the Comparative Period | 6 | 28 | 43 | 43 | 23 | 6 |
| Tapentadol in the Comparative Period | 3 | 32 | 43 | 32 | 21 | 8 |
"In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01352741)
Timeframe: Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | Missing | |
| Tapentadol Prolonged Release | 26 | 54 | 46 | 8 | 3 | 5 | 0 | 10 |
| Tapentadol Prolonged Release and Pregabalin | 30 | 82 | 19 | 10 | 2 | 5 | 2 | 7 |
"NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on 11-point NRS, where 0 is the no pain and 10 is pain as bad as you can imagine) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot).~The value reported represents the change from the randomization visit (i.e., the last 3 days in the titration period) to the end of the double-blind comparative period (i.e., the last 3 days in the comparative period). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit)." (NCT01352741)
Timeframe: Randomization Visit (Day 22); End of Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) |
|---|---|
| Tapentadol Prolonged Release | -1.5 |
| Tapentadol Prolonged Release and Pregabalin | -1.9 |
"The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS). This scale recalls the average pain intensity during the last 3 days. The participant was asked: Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit). Where 0 = no pain and 10 indicates pain as bad as you can imagine. This is the treatment period prior to the primary outcome period." (NCT01352741)
Timeframe: Enrollment (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=438) | Baseline Visit (N=440) | Randomization Visit (N=377) | |
| Tapentadol Prolonged Release | 7.2 | 8.3 | 5.4 |
"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=438) | Baseline Visit (N=440) | Randomization Visit (N=377) | |
| Tapentadol Prolonged Release | 21.4 | 22.7 | 16.9 |
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100. (NCT01352741)
Timeframe: Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22); Final Evaluation Visit (Day 77)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Overall Score Enrollment Visit (N=138, N=149) | Overall Score Baseline Visit (N=139, N=149) | Overall Score Randomization Visit (N=139, N=149) | Overall Score Final Evaluation Visit(N=131, N=143) | |
| Tapentadol Prolonged Release | 54.8 | 62.8 | 45.2 | 28.9 |
| Tapentadol Prolonged Release and Pregabalin | 57.6 | 65.4 | 46.5 | 30.5 |
The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group. (NCT01352741)
Timeframe: Baseline Visit (Day -12); Randomization Visit (Day 1); Final Evaluation Visit (Day 77)
| Intervention | hours (Mean) | |
|---|---|---|
| Change from baseline visit | Change from randomization visit | |
| Tapentadol Prolonged Release | 1.2 | 0.3 |
| Tapentadol Prolonged Release and Pregabalin | 1.6 | 0.3 |
"In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale where the patient's rates overall improvement. Patients rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse." (NCT01352741)
Timeframe: Randomization Visit (Day 22) to Final Evaluation Visit (Day 77)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | Missing | |
| Tapentadol Prolonged Release | 28 | 44 | 51 | 10 | 5 | 4 | 0 | 10 |
| Tapentadol Prolonged Release and Pregabalin | 32 | 66 | 31 | 10 | 5 | 5 | 1 | 7 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~The participant was asked: How long did you sleep last night? [Answered in hours and minutes]." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | hours (Mean) |
|---|---|
| Enrollment Visit (Day -12) | 5.8 |
| Baseline Visit (Day 1) | 5.3 |
| Randomization Visit (Day 22) | 6.4 |
In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 100. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 100. (NCT01352741)
Timeframe: Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Overall Score Enrollment Visit (N=438) | Overall Score Baseline Visit (N=440) | Overall Score Randomization Visit (N=377) | |
| Tapentadol Prolonged Release | 55.2 | 62.7 | 42.0 |
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 6.9 | 7.6 | 6.0 |
| Tapentadol Prolonged Release and Pregabalin | 7.8 | 8.6 | 6.8 |
"The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being negative (had no neuropathic pain component). A value between 19 and 38 was rated as being positive (neuropathic component present). Values from 13 to 18 were scored as being unclear." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=138; N=149) | |
| Tapentadol Prolonged Release | 21.6 | 22.4 | 17.6 |
| Tapentadol Prolonged Release and Pregabalin | 21.7 | 23.8 | 18.4 |
"The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.~A decrease in values over the trial period indicate that there has been an improvement." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 7.4 | 7.7 | 5.8 |
| Tapentadol Prolonged Release and Pregabalin | 8.6 | 9.0 | 7.1 |
"The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating full health and 0 representing dead). The higher the values (the closer the value is to 1) the better the health status in a treatment group." (NCT01352741)
Timeframe: Enrollment Visit (day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 0.32 | 0.29 | 0.55 |
| Tapentadol Prolonged Release and Pregabalin | 0.33 | 0.18 | 0.52 |
"The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric Rating Scale (NRS), where 0 = no pain and 10 = pain as bad as you can imagine.~The participant was asked : Please rate your pain intensity by assessing the one number that best describes your worst pain during the past 24 hours prior to the visit." (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 7.8 | 8.5 | 6.3 |
| Tapentadol Prolonged Release and Pregabalin | 7.5 | 8.7 | 6.4 |
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state. (NCT01352741)
Timeframe: Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 29.9 | 28.2 | 34.1 |
| Tapentadol Prolonged Release and Pregabalin | 29.8 | 28.5 | 34.1 |
The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The mental health summary scores were calculated from the individual responses to two of the 12 questions. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible mental health. (NCT01352741)
Timeframe: Enrollment Visit; Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 46.1 | 45.4 | 49.2 |
| Tapentadol Prolonged Release and Pregabalin | 44.8 | 43.2 | 47.3 |
The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep. Sleep evaluation questionnaire (SQ) items (NCT01352741)
Timeframe: Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | hours (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138, N=149) | Baseline Visit (N=139, N=149) | Randomization Visit (N=139, N=149) | |
| Tapentadol Prolonged Release | 1.3 | 1.5 | 1.1 |
| Tapentadol Prolonged Release and Pregabalin | 1.3 | 1.5 | 1.4 |
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine. (NCT01352741)
Timeframe: Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 7.1 | 8.1 | 5.6 |
| Tapentadol Prolonged Release and Pregabalin | 6.9 | 8.1 | 5.7 |
The NRS-3 pain intensity score at the visits in the open-label titration period for the two comparative double-blind period treatment groups analyzed is reported. NRS-3 pain intensity score (recalled average pain intensity score during the last 3 days on an 11-point NRS) for radiating pain (pain radiating into or towards the leg, typically of shooting, radiating character, usually radiating below the knee towards the foot) is reported. Where 0 = no pain and 10 indicates pain as bad as you can imagine. (NCT01352741)
Timeframe: Enrollment Visit (Day -14); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=438) | Baseline Visit (N=440) | Randomization Visit (N=377) | |
| Tapentadol Prolonged Release | 7.0 | 8.0 | 5.3 |
"The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the number of awakenings.~How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline), for the night prior to the Baseline Visit (Day 1) and the night prior to the Randomization Visit (Day 22).~The participant was asked at each visit: How many times did you wake up during the night?" (NCT01352741)
Timeframe: Enrollment Visit (Day-12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | Number of Awakenings (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138; N=149) | Baseline Visit (N=139; N=149) | Randomization Visit (N=139; N=149) | |
| Tapentadol Prolonged Release | 3.2 | 3.6 | 2.5 |
| Tapentadol Prolonged Release and Pregabalin | 3.4 | 4.6 | 2.7 |
"The participants were requested to answer the following question:~How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization)." (NCT01352741)
Timeframe: Enrollment Visit (Day -12); Baseline Visit (Day 1); Randomization Visit (Day 22)
| Intervention | hours (Mean) | ||
|---|---|---|---|
| Enrollment Visit (N=138, N=149) | Baseline Visit (N=139, N=149) | Randomization Visit (N=139, N=149) | |
| Tapentadol Prolonged Release | 5.8 | 5.3 | 6.2 |
| Tapentadol Prolonged Release and Pregabalin | 5.7 | 5.2 | 6.4 |
Sleep evaluation was performed by assessing number of participants who fell asleep in a particular pre-specified range of time duration, that is, 0-15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes and greater than 60 minutes at Day 84 (Week 12). (NCT01364298)
Timeframe: Day 84 (Week 12)
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 0 to 15 minutes | 16 to 30 minutes | 31 to 45 minutes | 46 to 60 minutes | Greater than 60 minutes | |
| Gabapentin/B-complex | 85 | 33 | 13 | 8 | 8 |
| Pregabalin | 72 | 33 | 12 | 4 | 2 |
NPIS is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| At least 30% improvement | At least 50% improvement | |
| Gabapentin/B-complex | 76.9 | 66.0 |
| Pregabalin | 85.4 | 72.4 |
GIPC is an assessment that the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Health: extremely improved | Health: much improved | Health: minimally improved | |
| Gabapentin/B-complex | 62 | 73 | 10 |
| Pregabalin | 47 | 65 | 10 |
CGIC is an assessment that the physician performs to assess the participant's global change in health condition from start of the study on a 7-point scale (1 = extremely improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse 6 = much worse, 7 = extremely worse). (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Health: extremely improved | Health: much improved | Health: minimally improved | |
| Gabapentin/B-complex | 55 | 79 | 11 |
| Pregabalin | 47 | 69 | 6 |
VAS is used to rate the pain as per 10 centimeter (cm) line. The pain intensity score ranges from '0=no pain' to '10=worst possible pain'. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | centimeter (Mean) | |
|---|---|---|
| Baseline (n=147, 123) | Change at Day 84 (n=146, 122) | |
| Gabapentin/B-complex | 7.0 | 4.182 |
| Pregabalin | 7.1 | 4.529 |
The LANSS scale score is 7-item pain scale that consists of grouped sensory description and sensory examination with simple scoring system. Evaluations in two main areas: pain and sensorial exploration. The first 5 questions asks for presence of unpleasant skin sensations (pricking, tingling, pins and needles), appearance of skin (mottled, red, or pink), increased sensitivity of skin to touch, sudden bursts of electric shock sensations, and hot or burning skin sensations. Last 2 questions involve sensory testing for the presence of allodynia and altered pinprick threshold. Different numbers of points, relative to their significance to neuropathic pain, are given to positive answers for maximum of 24 points. A score less than 12 makes unlikely that participant's symptoms are neuropathic in nature, whereas score more than 12 make neuropathic mechanisms likely to be contributing to participant's pain. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline (n=147, 123) | Change at Day 84 (n=146, 122) | |
| Gabapentin/B-complex | 16.2 | 8.082 |
| Pregabalin | 15.8 | 6.967 |
An adverse event (AE) is defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to Baseline during a clinical study with an investigational medicinal product (IMP), regardless of causal relationship and even if no IMP has been administered. (NCT01364298)
Timeframe: Day 7 up to Day 84 (+7 days)
| Intervention | participants (Number) |
|---|---|
| Gabapentin/B-complex | 80 |
| Pregabalin | 93 |
An average NPIS pain score (daily average records of the past seven days) was evaluated. Numeric pain intensity scale (NPIS) is a 11-point scale, with 0 representing no pain and 10 representing the worst possible pain. The participants were asked to mark the number that best represents the current level of pain they have experienced during the previous 24 hours. Change from baseline data has been calculated as value at baseline minus value at Day 84. (NCT01364298)
Timeframe: Baseline and Day 84 (Week 12)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline (n=147, 123) | Change at Day 84 (n=146, 122) | |
| Gabapentin/B-complex | 6.7 | 3.905 |
| Pregabalin | 6.8 | 4.260 |
"POMS is a rating scale, which comprises of 65 items that are evaluated in a 0-4 scale, where 0 means not at all and 4 extremely. The scores for the 65 items are added in various combinations to throw six validated factors which are used to calculate total POMS score: (tension-anxiety) + (depression-dejection) + (anger-hostility)+ (fatigue-Inertia) + (confusion-bewilderment) - (vigor-activity). Score range (-40 to 192). Score -40 denotes the best score and score 192 denotes the worst score." (NCT01364298)
Timeframe: Day 84 (Week 12)
| Intervention | units on a scale (Mean) |
|---|---|
| Gabapentin/B-complex | 1.3 |
| Pregabalin | 3.4 |
(NCT01366196)
Timeframe: Postoperative day 1
| Intervention | mL (Mean) |
|---|---|
| Control Group (C) | 44 |
| Pregabalin Group (P) | 39 |
Tabulate number of patients that used supplemental oral analgesics (NCT01366196)
Timeframe: Day of surgery
| Intervention | Participants (Count of Participants) |
|---|---|
| Control Group (C) | 25 |
| Pregabalin Group (P) | 21 |
Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. (NCT01366196)
Timeframe: Postoperative Day 1 with Physical Therapy
| Intervention | units on a scale (Mean) |
|---|---|
| Control Group (C) | 4.3 |
| Pregabalin Group (P) | 4.5 |
Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. (NCT01366196)
Timeframe: Postoperative Day 1 at rest
| Intervention | units on a scale (Mean) |
|---|---|
| Control Group (C) | 3.7 |
| Pregabalin Group (P) | 3.3 |
Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. (NCT01366196)
Timeframe: Day of Surgery
| Intervention | units on a scale (Mean) |
|---|---|
| Control Group (C) | 3.8 |
| Pregabalin Group (P) | 2.9 |
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for sleep disturbance was 0 to 100, with higher scores indicating more of the attribute. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -11.45 |
| Placebo | -8.02 |
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of sleep problem index overall score was 0 to 100, with higher scores indicating more of the attribute. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -9.70 |
| Placebo | -6.64 |
The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Mental component included mental health, role limitations due to emotional problems, vitality and general health perception. Score range for mental component summary score was 0 to 100 and higher scores reflected better participant status. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.68 |
| Placebo | 2.30 |
The Short-Form 36 Health Survey (SF-36) was a self-administered questionnaire that measured each of the following 8 health concepts: Physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. Physical component included physical functioning, role limitations due to physical problems, social functioning and bodily pain. Score range for physical component summary score was 0 to 100 and higher scores reflected better participant status. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.44 |
| Placebo | 3.66 |
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Sleep Quality parameter subjectively rated the quality of sleep during the past night by selecting a number between 0 (very poor) and 10 (excellent). Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.59 |
| Placebo | 0.82 |
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Latency to Sleep Onset (sLSO) parameter subjectively estimated the amount of time to fall asleep after lights out. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | -0.26 |
| Placebo | -0.28 |
"The Pain Visual Analog Scale (Pain VAS) was a horizontal line; 100 mm in length, self administered by the participants in order to rate pain from 0 no pain to 100 worst possible pain." (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -17.04 |
| Placebo | -13.43 |
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Total Sleep Time (sTST) parameter subjectively estimated the total amount of time the participant was asleep after lights out until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | 24.63 |
| Placebo | 17.23 |
The Patient Global Impression of Change (PGIC) was a participant-rated instrument that measured change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse), which was based on a validated scale, the Clinical Global Impression of Change (CGIC). Categories were defined based on the PGIC scores as followed: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. (NCT01387607)
Timeframe: Week 14
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 7.7 | 19.7 | 42.3 | 24.6 | 3.5 | 2.1 | 0.0 |
| Pregabalin | 9.9 | 25.4 | 40.1 | 17.6 | 4.9 | 2.1 | 0.0 |
The Multidimensional Assessment of Fatigue (MAF) scale was a self-administered survey that yielded a Global Fatigue Index by assessing the participant's level of fatigue and the degree to which fatigue interferes with activities of daily living. It contained 16 items and measured 4 dimensions of fatigue: severity (2 items), distress (1 item), degree of interference in activities of daily living (11 items), and timing (2 items). Index range was 1 to 50 and higher scores reflected greater impairment. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -4.09 |
| Placebo | -3.25 |
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. The endpoint mean pain score was defined as the mean of the Week 14 pain diary entries in the double-blind treatment phase. Baseline was defined as the mean of last 7 pain diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.01 |
| Placebo | -1.28 |
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Wake after Sleep Onset (sWASO) parameter subjectively estimated the total amount of time the participant was awake after initial sleep onset until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | -42.36 |
| Placebo | -25.19 |
The Subjective Sleep Questionnaire (SSQ) was included in the participant's diary and designed to capture subjective evaluation of sleep behavior in participants with disrupted sleep. It was administered to each participant approximately 30 - 60 minutes after arising each day in the morning. The Subjective Number of Awakenings after Sleep Onset (sNAASO) parameter subjectively estimated the total number of times the participant awakened during the night until final awakening. Baseline was defined as the mean of last 7 SSQ diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Awakenings (Least Squares Mean) |
|---|---|
| Pregabalin | -0.95 |
| Placebo | -0.30 |
The Daily Sleep Interference Scale was an 11-point numerical scale ranging from 0 (does not interfere with sleep) to 10 (completely interferes [unable to sleep due to pain]). Participants were asked to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily upon awakening. Baseline Mean Sleep Interference score was defined as the mean of all available last 7 sleep interference score diary entries up to and including Day 1. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.88 |
| Placebo | -1.00 |
The Fibromyalgia Impact Questionnaire (FIQ) was a 20-item participant-reported outcome instrument designed to assess health status, progress, and outcomes in participants with fibromyalgia. It contained 10 subscales. There were 11 questions that are related specifically to physical functioning. The remaining items assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. Score range for each subscale was 0 to 10. The 10 subscales were combined to yield a total score with range from 0 to 100. The total score provided an estimation of fibromyalgia impact with higher scores indicating greater impairment. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -11.14 |
| Placebo | -8.15 |
A mild Adverse Event (AE) was an AE that did not interfere with participant's usual function. A moderate AE was an AE that interfered participant's usual function to some extent. A severe AE was an AE that interfered significantly with participant's usual function. (NCT01387607)
Timeframe: Baseline to Follow up (Day 105)
| Intervention | Events (Number) | ||
|---|---|---|---|
| Mild AEs | Moderate AEs | Severe AEs | |
| Placebo | 162 | 30 | 25 |
| Pregabalin | 183 | 52 | 38 |
The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, score range was 0 to 21, with higher scores indicating greater impairment. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.03 |
| Placebo | -0.65 |
The Hospital Anxiety and Depression Scale (HADS) was a self-reported 14-item instrument that consisted of two 7-item subscales that measure the presence and severity of anxiety and depression. For each subscale, range was 0 to 21, with higher scores indicating greater impairment. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.11 |
| Placebo | -0.28 |
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A Serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect. Treatment-emergent AEs (TEAEs) were events between first dose of study drug and up to follow-up visit (Study Day 105) that were absent before treatment or that worsened after treatment. AEs included both SAEs and non-SAEs. (NCT01387607)
Timeframe: Baseline to Follow up (Day 105)
| Intervention | Participants (Number) | ||
|---|---|---|---|
| AEs | SAEs | Discontinuation due to AEs | |
| Placebo | 103 | 9 | 11 |
| Pregabalin | 119 | 0 | 22 |
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of scores represented for snoring, awaken short of breath and sleep adequacy was 0 to 100, with higher scores indicating more of the attribute. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | ||
|---|---|---|---|
| Snoring | Awaken Short of Breath | Sleep Adequacy | |
| Placebo | 2.08 | -4.41 | 5.20 |
| Pregabalin | 4.61 | -6.76 | 14.23 |
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. Range of quantity of sleep parameter was 0 to 24 and somnolence was 0 to 100, with higher scores indicating more of the attribute. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Quantity of Sleep | Somnolence | |
| Placebo | 0.32 | -5.48 |
| Pregabalin | 0.61 | -1.29 |
The Medical Outcomes Study (MOS)-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 41.2 |
| Placebo | 43.6 |
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 50% reduction in weekly mean pain score from baseline to Week 14 was defined as a 50% responder. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 27.2 |
| Placebo | 17.0 |
Assessment of mean pain score was based on participant's daily pain diary. The daily pain diary consisted of an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). The participants rated their pain during the past 24 hours by choosing the appropriate number between 0 and 10. Self-assessment was performed daily at awakening. Weekly mean pain score was calculated as mean value of the observations within the window for each week during the double-blind treatment phase. A participant with at least 30% reduction in weekly mean pain score from baseline to Week 14 was defined as a 30% responder. (NCT01387607)
Timeframe: Baseline, Week 14
| Intervention | Percentage of participants (Number) |
|---|---|
| Pregabalin | 47.5 |
| Placebo | 32.7 |
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study (NCT01389596)
Timeframe: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
| Intervention | T scores (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week -8 (n= 12, 14, 14) | Week -4 (n= 12, 14, 14) | Week 0 (n= 12, 14, 14) | Week 1 (n= 12, 13, 14) | Week 2 (n= 11, 13, 13) | Week 3 (n= 12, 14, 13) | Week 6 (n= 11, 13, 11) | Week 9 (n= 11, 13, 11) | Week 12 (n= 11, 14, 13) | Week 13 (n= 12, 14, 11) | |
| Placebo | 54.1 | 52.5 | 50.1 | 50.1 | 48.9 | 49.5 | 50.7 | 51.2 | 50.2 | 51.6 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 50.7 | 47.0 | 45.2 | 43.8 | 42.1 | 42.4 | 38.7 | 38.4 | 39.0 | 37.9 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 48.0 | 47.8 | 46.9 | 46.0 | 46.5 | 46.4 | 46.7 | 47.6 | 44.3 | 45.5 |
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study. (NCT01389596)
Timeframe: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
| Intervention | T scores (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week -8 (n= 12, 14, 14) | Week -4 (n= 12, 14, 14) | Week 0 (n= 12, 14, 14) | Week 1 (n= 12, 13, 14) | Week 2 (n= 11, 13, 13) | Week 3 (n= 12, 14, 13) | Week 6 (n= 11, 13, 11) | Week 9 (n= 11, 13, 11) | Week 12 (n= 11, 14, 13) | Week 13 (n= 12, 14, 11) | |
| Placebo | 54.9 | 52.6 | 50.6 | 50.7 | 48.3 | 49.6 | 47.5 | 51.0 | 50.5 | 50.8 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 55.1 | 50.9 | 49.1 | 48.7 | 45.6 | 44.2 | 42.1 | 40.6 | 40.8 | 39.9 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 48.3 | 48.1 | 46.4 | 46.3 | 46.5 | 45.6 | 45.5 | 46.0 | 42.1 | 44.3 |
CogState battery:computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. In this study, Cogstate battery consisted of 2 tasks which measured psychomotor function (detection task) and attention (paediatric identification task). Detection task was a measure of simple reaction time and provided a valid assessment of psychomotor function in participants. In this task, a playing card turning face up was presented in the center of the computer screen. As soon as this happened, the participant was to press the 'Yes' response key. There was no minimum or maximum scores since it was a time-based assessment. The software measured the speed of accurate responses to each event. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance. (NCT01389596)
Timeframe: Baseline (pre-dose at Day 1), Week 12
| Intervention | log10 milliseconds (Mean) | |
|---|---|---|
| Baseline (n= 68, 56, 60) | Change At Week 12 (n= 61, 45, 53) | |
| Placebo | 2.70 | 0.01 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 2.72 | -0.03 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2.71 | -0.00 |
"CogState battery: computerized test battery used to assess cognitive domains through cognition tests/tasks. The test battery was presented on computer with external response buttons. Paediatric identification task: a measure of choice reaction time and valid assessment of visual attention. In this task, a playing card turning face up was presented in center of the computer screen. As soon as this happened, participant had to decide whether color of card was black or not. If color was black, participants was to press Yes response key, otherwise no. There was no minimum/maximum scores since it was a time-based assessment. The software measured speed of accurate responses (correct identification of color) to each event. In this outcome measure, speed of performance of participants to correctly identify the color (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Lower scores indicated better performance." (NCT01389596)
Timeframe: Baseline (pre-dose at Day 1), Week 12
| Intervention | log10 milliseconds (Mean) | |
|---|---|---|
| Baseline (n= 67, 56, 59) | Change At Week 12 (n= 60, 44, 51) | |
| Placebo | 2.80 | 0.00 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 2.80 | 0.00 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2.81 | 0.00 |
Percentage of participants with 50 percent (%) or greater reduction from baseline in 28-day seizure rate during the 12 week treatment phase were reported. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. (NCT01389596)
Timeframe: Day 1 up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 29.1 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 40.6 |
| Placebo | 22.6 |
Criteria for abnormality: hematology (hemoglobin, hematocrit, red blood cells count:<]0.8*lower limit of normal [LLN],platelets:<0.5*LLN/greater than [>]1.75*upper limit of normal [ULN],leukocytes:<0.6*LLN or>1.5*ULN, lymphocytes, total neutrophils:<0.8*LLN or >1.2*ULN, basophils, eosinophil, monocytes:>1.2*ULN); Liver Function(aspartate aminotransferase ,alanine aminotransferase, alkaline phosphatase, Gamma glutamyl transferase:>0.3*ULN, total protein, albumin:<0.8*LLN or >1.2*ULN); bilirubin:>1.5*ULN; renal function(blood urea nitrogen, creatinine:>1.3*ULN); Electrolytes(sodium:<0.95*LLN or>1.05*ULN, potassium, chloride, calcium, bicarbonate:<0.9*LLN or >1.1*ULN); Lipids(cholesterol, triglycerides >1.3*ULN); creatine kinase:>2.0*ULN; glucose fasting:<0.6*LLN or >1.5*ULN, urine white blood corpuscles and RBC:>= 20/High Power Field [HPF];urine casts: >1/Low Power Field(LPF);urine bacteria:>20/HPF. Hormones (tetraiodothyronine and thyroid stimulating hormone:<0.8*LLN or >1.2*ULN). (NCT01389596)
Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
| Intervention | participants (Number) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 61 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 63 |
| Placebo | 61 |
Neurological examinations included: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation (the latter using a 128-Hertz tuning fork), coordination and gait. Clinical significance was based on investigator's discretion. (NCT01389596)
Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
| Intervention | participants (Number) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 0 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 1 |
| Placebo | 0 |
"All partial onset seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the treatment phase] divided by [number of days in treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)." (NCT01389596)
Timeframe: Day 1 up to Week 12
| Intervention | Seizures per 28 days (Least Squares Mean) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2.86 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 2.74 |
| Placebo | 2.96 |
"All partial onset seizures experienced during baseline phase were recorded by the participants or their parents/legal guardian, in a daily seizure diary. 28-day seizure rate for all partial onset seizures = ([number of seizures in the baseline phase] divided by [number of days in baseline phase minus {-} number of missing diary days in baseline phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)." (NCT01389596)
Timeframe: Baseline phase (up to 8 weeks prior to treatment phase [Day 1])
| Intervention | Seizures per 28 days (Mean) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 3.27 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 3.19 |
| Placebo | 3.18 |
Criteria for abnormalities in vital signs included: sitting systolic blood pressure (SBP) values: maximum increase and decrease of >=30 millimeter of mercury (mmHg) from baseline; sitting diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. (NCT01389596)
Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Maximum Increase from Baseline in Sitting SBP | Maximum Increase from Baseline in Sitting DBP | Maximum Decrease from Baseline in Sitting SBP | Maximum Decrease from Baseline in Sitting DBP | |
| Placebo | 1 | 11 | 1 | 10 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 1 | 8 | 1 | 6 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 2 | 6 | 5 | 15 |
Physical examinations evaluated the following body systems/organs: general appearance; dermatological; head and eyes; ears, nose, mouth, and throat; pulmonary; cardiovascular; abdominal; genitourinary (optional); lymphatic; musculoskeletal/extremities; and neurological. Clinical significance was determined by the investigator. (NCT01389596)
Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
| Intervention | participants (Number) |
|---|---|
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 5 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 5 |
| Placebo | 2 |
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. (NCT01389596)
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Placebo | 30 | 1 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 46 | 1 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 37 | 1 |
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal, were reported in this outcome measure. (NCT01389596)
Timeframe: Baseline (from 8 weeks prior to Day 1 of treatment) up to Week 13
| Intervention | participants (Number) | |
|---|---|---|
| Maximum PR Interval | Maximum QTCB Interval (Bazett's Correction) | |
| Placebo | 1 | 2 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 0 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 1 | 2 |
"C-SSRS (mapped to C-CASA):participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of Yes on actual attempt) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (Yes on preparatory acts or behavior)(C-CASA code 3); suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). Number of participants with positive response (response of yes) to C-SSRS (mapped to C-CASA categories 1, 2, 3, 4 and 7) during post baseline time period (Day 1 up to Week 13) were reported" (NCT01389596)
Timeframe: Day 1 up to Week 13
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Completed suicide (C-CASA code 1) | Suicide attempt (C-CASA code 2) | Preparatory acts towards ISB (C-CASA code 3) | Suicidal ideation (C-CASA code 4) | Self injurious behavior (C-CASA code 7) | |
| Placebo | 0 | 0 | 0 | 1 | 2 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 0 | 0 | 0 | 2 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 0 | 0 | 0 | 1 | 1 |
"The C-SSRS (mapped to C-CASA) is a participant-rated questionnaire to assess suicidal ideation and suicidal behavior. For suicidal ideation and behaviour, data from C-SSRS was mapped to C-CASA codes 1, 2, 3, 4 and 7. C-SSRS assessed whether participant experienced the following: completed suicide (C-CASA code 1); suicide attempt (response of Yes on actual attempt) (C-CASA code 2); preparatory acts toward imminent suicidal behavior (ISB) (Yes on preparatory acts or behavior)(C-CASA code 3); suicidal ideation (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent) (C-CASA code 4); any self-injurious behavior with no suicidal intent (C-CASA code 7). In this outcome, number of participants with positive response (response of yes) to C-SSRS (mapped to C-CASA categories 2, 3, 4 and 7) at baseline were reported." (NCT01389596)
Timeframe: Baseline (4 week prior to Day 1 of treatment)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Suicide attempt (C-CASA code 2) | Preparatory acts towards ISB (C-CASA code 3) | Suicidal ideation (C-CASA code 4) | Self injurious behavior (C-CASA code 7) | |
| Placebo | 0 | 0 | 0 | 1 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 0 | 0 | 0 | 1 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 0 | 0 | 0 | 1 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. (NCT01389596)
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
| Intervention | events (Number) | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Placebo | 126 | 21 | 5 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 162 | 31 | 3 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 144 | 33 | 7 |
CBCL assessed suicidal behavior in children below 6 years. It is 100-item questionnaire completed by parent/legal guardian, based on participant's behavior in past 2 months. All 100 items rated on 3-point scale: 0=not true for that child; 1=sometimes true; 2=very/often true. Total CBCL score ranges from 0 (not true) to 200 (very/often true). Higher scores=higher levels of problematic behaviors or dysfunction. Scores from all items were used to calculate 3 subscale scores: Withdrawn subscale scores, Internalizing problems subscale scores and total problem subscale scores. All subscale scores reported scaled to T Scores. Higher scores for each CBCL subscales indicated higher levels of problematic behaviors or dysfunction. In this study, a cut-off of >=68 on the T-scores was used for all 3 subscales. If a participant T Score was >=68 in any of the sub-scales, the participant was referred for Mental Health Risk Assessment that included assessment of participant continuation to the study (NCT01389596)
Timeframe: Week -8 (8 weeks prior to Day 1 of treatment), Week -4 (4 weeks prior to Day 1 of treatment), Day 1 (Week 0), Week 1, 2, 3, 6, 9, 12, end of study visit (Week 13)
| Intervention | T scores (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Week -8 (n= 12, 14, 14) | Week -4 (n= 12, 14, 14) | Week 0 (n= 12, 14, 14) | Week 1 (n= 12, 13, 14) | Week 2 (n= 11, 13, 13) | Week 3 (n= 12, 14, 13) | Week 6 (n= 11, 13, 11) | Week 9 (n= 11, 13, 11) | Week 12 (n= 11, 14, 13) | Week 13 (n= 12, 14, 11) | |
| Placebo | 63.1 | 61.9 | 60.9 | 59.5 | 59.2 | 60.8 | 54.5 | 60.0 | 59.6 | 57.9 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 64.0 | 61.3 | 60.6 | 60.9 | 60.2 | 58.6 | 56.6 | 57.1 | 57.3 | 56.1 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 56.4 | 55.4 | 56.6 | 56.8 | 56.3 | 54.8 | 55.5 | 56.1 | 54.0 | 55.1 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7 days after last dose of study drug (up to 13 weeks) that were absent before treatment or that worsened relative to pre- treatment state. AEs included both serious and non-serious adverse events. (NCT01389596)
Timeframe: Day 1 up to 7 days after last dose of study drug (up to 13 weeks)
| Intervention | participants (Number) | |
|---|---|---|
| AEs | SAEs | |
| Placebo | 56 | 7 |
| Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day | 68 | 10 |
| Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day | 67 | 5 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed at hospital discharge, an average of 3 days after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 4 |
| Placebo | 4 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed after discharge on the 14th day after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 3 |
| Placebo | 2 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed on the first postoperative day after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 4 |
| Placebo | 4 |
IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy (NCT01391858)
Timeframe: Participants received PCA pump, an average of 24 hrs after mastectomy
| Intervention | milligram (mg) (Median) |
|---|---|
| Pregabalin | 9 |
| Placebo | 7.5 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed after discharge on the 30th day after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 2 |
| Placebo | 2 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed after discharge on the 7th day after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 3 |
| Placebo | 3 |
Oral opioids consumption after mastectomy until hospital discharge. (NCT01391858)
Timeframe: Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy
| Intervention | milligram (mg) (Median) |
|---|---|
| Pregabalin | 5 |
| Placebo | 10 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) (NCT01391858)
Timeframe: Participants' pain score was assessed after discharge on the 90th day after mastectomy
| Intervention | units on a scale (Median) |
|---|---|
| Pregabalin | 1 |
| Placebo | 1 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). (NCT01432236)
Timeframe: End of Period 1 at Week 6
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 4.3 | 25.8 | 40.9 | 21.5 | 6.5 | 1.1 | 0 |
| Pregabalin | 10.8 | 35.5 | 28.0 | 17.2 | 4.3 | 3.2 | 1.1 |
Participant with at least a 30% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 30% responder, for the respective period. Similarly, a subject with at least a 50% reduction in mean pain score from baseline (at randomization) to the endpoint at the end of each period (Visits 6 and 12) is considered a 50% responder, for the respective period. (NCT01432236)
Timeframe: Visits 2, 6, and 12
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| 30% Responders | 50% Responders | |
| Placebo | 27.7 | 15.8 |
| Pregabalin | 45.3 | 26.0 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Because of the crossover design and PGIC recall period (since starting study medication), the Period 1 PGIC data were felt to provide the clearest comparison across treatments, whereas Period 2 PGIC data were felt to have a more complex interpretation. Thus PGIC at End of Period 2 was separately analyzed from PGIC at End of Period 1. (NCT01432236)
Timeframe: End of Period 2 at Week 14
| Intervention | Percentage of Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 8.6 | 25.9 | 38.3 | 14.8 | 8.6 | 2.5 | 1.2 |
| Pregabalin | 18.3 | 34.1 | 28.0 | 11.0 | 6.1 | 1.2 | 1.2 |
WPAI-SHP assessed work productivity and impairment. It was a participant-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past 7 days. Subscale scores included percent work time missed due to the health problem; percent impairment while working due to problem; percent overall work impairment due to problem; and percent activity impairment due to problem. Each subscale score was expressed as an impairment percentage (0-100) where higher numbers indicated greater impairment and less productivity. (NCT01432236)
Timeframe: Baseline
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| Percent Absenteeism (N= 86) | Percent Presenteeism (N= 83) | Percent Overall Work Impairment (N= 82) | Percent Activity Impairment (N=193) | |
| All Participants | 15.22 | 53.98 | 57.96 | 64.97 |
"C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has participant engaged in non-suicidal self-injurious behavior)." (NCT01432236)
Timeframe: Baseline
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wish to be Dead | Non-Specific Thoughts | Without Intent to Act | Some Intent to Act | Specific Plan and Intent | Actual Attempt | Non-Suicidal Self-Injurious Behavior | Interrupted Attempt | Aborted Attempt | Preparatory Acts or Behavior | Suicidal Behavior Present | Completed Suicide | |
| Placebo/Pregabalin | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin/Placebo | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.58 |
| Placebo | 0.56 |
The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. 'Time for help no payment' refers to time other people spent without receiving payment to help with activities the patient cannot perform due to fibromyalgia. (NCT01432236)
Timeframe: Baseline
| Intervention | Hours (Mean) |
|---|---|
| All Participants | 50.37 |
EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). (NCT01432236)
Timeframe: Baseline
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin/Placebo | 0.40 |
| Placebo/Pregabalin | 0.37 |
"The daily pain diary consists of an 11-point numeric scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Participants describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The endpoint mean pain scores for Period 1 and Period 2 are defined as the mean of the last 7 non-missing daily diary pain ratings while taking study medication in the double-blind phase during Period 1 and Period 2, respectively." (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.84 |
| Placebo | 5.45 |
PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point NRS ranging from 0 (very poor) to 10 (very good). (NCT01432236)
Timeframe: Baseline
| Intervention | Units on a scale (Mean) |
|---|---|
| Pregabalin/Placebo | 4.35 |
| Placebo/Pregabalin | 4.46 |
PSGA was a single-item self-rated instrument that measured the participant's overall status on an 11-point numeric rating scale (NRS) ranging from 0 (very poor) to 10 (very good). (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 5.83 |
| Placebo | 5.27 |
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective latency to sleep onset was the subjective estimate of the amount of time to fall asleep after lights out. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | 33.54 |
| Placebo | 39.33 |
Subjective Sleep Questionnaire included 5 items: participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (NRS) for the previous night. Subjective rating of quality of sleep during the past night was done by selecting a number between 0 (very poor) and 10 (excellent). Mean sleep quality was calculated as the mean of the last seven days, the potential range of responses was therefore 0-10. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 6.15 |
| Placebo | 5.57 |
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective total sleep time was the subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | 422.98 |
| Placebo | 414.63 |
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective wake after sleep onset was the subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Pregabalin | 33.38 |
| Placebo | 41.18 |
Subjective Sleep Questionnaire included, participants report latency (how long it took them to fall asleep), how many hours they slept, the number of times they woke up, the total wake time after sleep onset, and then rate the quality of their sleep (numeric rating scale) for the previous night. Subjective number of awakenings after sleep onset was the subjective estimate of the total number of times the participant awakened during the night until final awakening. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Number of times awakened (Least Squares Mean) |
|---|---|
| Pregabalin | 0.48 |
| Placebo | 0.61 |
This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe). (NCT01432236)
Timeframe: Baseline
| Intervention | Units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total (N=96, 96) | Physical Impairment (N=96, 97) | Feel Good (N=96, 97) | Work Missed (N=96, 97) | Do Work (N=96, 97) | Pain (N=96, 96) | Fatigue (N=96, 97) | Rested (N=96, 97) | Stiffness (N=96, 97) | Anxiety (N=96, 97) | Depression (N=96, 97) | |
| Placebo/Pregabalin | 62.75 | 4.44 | 7.43 | 3.49 | 6.38 | 7.09 | 8.08 | 7.82 | 7.64 | 5.60 | 4.84 |
| Pregabalin/Placebo | 63.83 | 4.58 | 7.78 | 3.38 | 6.61 | 6.98 | 8.17 | 7.90 | 7.56 | 5.65 | 5.23 |
This was a 20-item participant reported outcome instrument. It contained 10 subscales, which were combined to yield a total score. The first 11 questions were related specifically to physical functioning subscale, ranging from 0 to 10. The remaining 9 questions assessed pain, fatigue, stiffness, difficulty working, and symptoms of anxiety and depression ranging from 0 to 10. The higher values indicated greater impairment. All 20 were combined to form a total score ranging from 0 to 100, provides an estimation of fibromyalgia impact with higher scores indicating more impairment. The severity categorizations for the FIQ are: less than 40 (mild), 40-60 (moderate), and above 60 (severe). (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total (N=176, 172) | Physical impairment (N=176, 173) | Feel good (N=176, 173) | Work missed (N=176 , 173) | Do work (N=176, 172) | Pain (N=176, 173) | Fatigue (N=176, 173) | Rested (N=176, 173) | Stiffness (N=176, 173) | Anxiety (N=176, 173) | Depression (N=176, 173) | |
| Placebo | 50.38 | 3.77 | 5.53 | 2.62 | 5.31 | 5.54 | 6.76 | 6.41 | 5.95 | 4.35 | 4.13 |
| Pregabalin | 43.78 | 3.35 | 4.69 | 2.02 | 4.56 | 4.91 | 6.32 | 5.64 | 5.24 | 3.80 | 3.20 |
HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01432236)
Timeframe: End of each period, at Weeks 6 and 14
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| HADS-A (anxiety) | HADS-D (depression) | |
| Placebo | 6.96 | 7.05 |
| Pregabalin | 6.01 | 6.17 |
The healthcare utilization assessment was used to capture healthcare utilization data at Baseline. This assessment contained 10 questions related to aspects of healthcare services. (NCT01432236)
Timeframe: Baseline
| Intervention | Visits (Mean) | ||
|---|---|---|---|
| Total office visits (N= 193) | Number of hospitalizations (N= 0) | Number of emergency room visits (N= 12) | |
| All Participants | 5.01 | NA | 1.83 |
HADS: participant rated questionnaire with 2 subscales. HADS-A (anxiety) assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D (depression) assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT01432236)
Timeframe: Baseline
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| HADS-A (anxiety) | HADS-D (depression) | |
| Placebo/Pregabalin | 7.97 | 7.73 |
| Pregabalin/Placebo | 8.67 | 8.34 |
"C-SSRS assessed whether participant experienced following:completed suicide (1), suicide attempt (2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior (3) (Yes on preparatory acts or behavior), suicidal ideation (4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7) (Yes on Has subject engaged in non-suicidal self-injurious behavior). Below table indicated one participant (10141023) treated with Pregabalin reported preparatory act. However upon study unblinding it was clarified that preparatory act occurred while the participant was taking placebo. Since preparatory act was reported at first visit of Period 2, by convention statistical summaries classified this under Pregabalin treatment." (NCT01432236)
Timeframe: From Visit 3 to Visit 14
| Intervention | Participants (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wish to be Dead | Non-Specific Thoughts | Without Intent to Act | Some Intent to Act | Specific Plan and Intent | Actual Attempt | Non-Suicidal Self-Injurious Behavior | Interrupted Attempt | Aborted Attempt | Preparatory Acts or Behavior | Suicidal Behavior Present | Completed Suicide | |
| Placebo | 8 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pregabalin | 10 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.53 |
| Placebo | 1.51 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale (no problems, some/moderate problems, extreme problems) and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.65 |
| Placebo | 1.65 |
HADS is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.42 |
| Placebo | 4.50 |
The Hospital Anxiety and Depression Scale (HADS) is a 14- item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4- point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.90 |
| Placebo | 4.96 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). Activities of the daily living domain score should be summed as follow: Σ (12, 22, 23, 25, 26). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: 0 - 20). The QOL-DN version that was administered in the study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.82 |
| Placebo | 2.94 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The (sub)scales are calculated without weighting of any kind, and reported as the integer sum of listed questionnaire items (range: -4 - 136). The QOL-DN version that was administered in this study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 37.22 |
| Placebo | 38.30 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. Item 9 is scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The symptoms domain score should be summed as follow: Σ (1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 32). The QOL-DN version that was administered in this study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 7.51 |
| Placebo | 7.86 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The small fiber domain score should be summed as follow: Σ (10, 16, 17, 18). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of the listed questionnaire items (range: 0 - 16). The QOL-DN version that was administered in this study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.57 |
| Placebo | 2.58 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. With exception of questions 31 and 32, items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, middle item, is scored as 0, very good as -1 , excellent as -2, fair as 1, and poor as 2. In question 32, about the same, middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. Physical functioning / large fiber domain score should be summed as follow: Σ (8, 11, 13 - 15, 24, 27 - 35). Scales and subscales are calculated without weighting of any kind, and reported as integer sum of listed questionnaire items (range: -4 - 56). QOL-DN version that was administered in the study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 23.17 |
| Placebo | 23.66 |
"The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates does not interfere with sleep and 10 indicates completely interferes (unable to sleep due to pain). Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.11 |
| Placebo | 4.35 |
"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.980 |
| Placebo | 5.018 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Seven sub-questions evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on an 11-point scale (0: does not interfere; 10: completely interferes). Scores range from 0 - 10 with higher scores indicating greater interference. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.50 |
| Placebo | 3.59 |
"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. Four items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 10 with higher scores indicating greater pain severity." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.49 |
| Placebo | 4.48 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.30 |
| Placebo | 1.35 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.63 |
| Placebo | 0.65 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. The utility score is calculated using the Dolan 1997 algorithm and the revised version which was provided to the EuroQol Group by Dolan in 2001 - but later published in medical care in 2002. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.63 |
| Placebo | 0.64 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess the impact of diabetic neuropathy on quality of life of participants with diabetic neuropathy. The items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). The autonomic domain score should be summed as follow: Σ (19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items (range: 0 - 12). The QOL-DN version that was administered in this study was modified with a 2-week recall period." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.12 |
| Placebo | 1.26 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.03 |
| Placebo | 1.98 |
The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (7 different scores) and categorized scores (4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5). (NCT01455415)
Timeframe: End of Period 1 (V5)
| Intervention | percentage of participants (Number) | |||
|---|---|---|---|---|
| Very much/much improved | Any improvement | No change | Any worsening | |
| Placebo | 24.5 | 63.6 | 23.1 | 10.5 |
| Pregabalin | 35.8 | 75.0 | 14.9 | 9.5 |
The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V5). (NCT01455415)
Timeframe: End of Period 1 (V5)
| Intervention | percentage of participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | Missing | |
| Placebo | 4.9 | 19.6 | 39.2 | 23.1 | 7.0 | 1.4 | 2.1 | 2.8 |
| Pregabalin | 8.1 | 27.7 | 39.2 | 14.9 | 6.1 | 2.0 | 1.4 | 0.7 |
"Daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 20.22 |
| Placebo | 15.58 |
"Daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 34.56 |
| Placebo | 31.16 |
EQ-5D is a participant-completed 5-item questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension is rated on a 3-point response scale [1 = no problems, 2 = some/moderate problems, 3 = extreme problems] and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. (NCT01455415)
Timeframe: End of Period (includes both Visits 5 and 9)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.18 |
| Placebo | 1.18 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The snoring subscale score also ranged from 0 to 100, with lower scores indicating less snoring. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.00 |
| Placebo | -3.73 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS optimal sleep subscale was a binary outcome derived from the sleep quantity responses: the response was YES if sleep quantity was 7 or 8 hours per night. (NCT01455428)
Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 49.5 |
| Placebo | 40.6 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep problems index subscale score also ranged from 0 to 100, with lower scores indicating fewer sleep problems. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -7.38 |
| Placebo | -4.54 |
"The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. A 30% responder was a participant who had 30% reduction or more in mean pain score at the end of the fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint) compared to baseline." (NCT01455428)
Timeframe: End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin | 52.3 |
| Placebo | 30.6 |
"The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose." (NCT01455428)
Timeframe: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.81 |
| Placebo | -1.09 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. For sleep disturbance, the subscale score also ranged from 0 to 100, with higher scores representing greater sleep disturbance. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -11.97 |
| Placebo | -4.76 |
The daily pain rating scale (DPRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. (NCT01455428)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 5.93 |
| Placebo | 6.08 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The sleep adequacy subscale also ranged from 0 to 100, with higher scores indicating greater sleep adequacy. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 10.44 |
| Placebo | 8.64 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The awaken short of breath subscale also ranged from 0 to 100, with lower scores indicating less difficulty in breathing. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.10 |
| Placebo | 0.26 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The mean endpoint score was obtained from the last 7 available scores of the daily diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose. (NCT01455428)
Timeframe: Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.24 |
| Placebo | -0.70 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.65 |
| Placebo | -0.55 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale was comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.92 |
| Placebo | -0.71 |
The PGIC was a participant-rated global measure that provided a clinically relevant and easy to interpret account of a participant's perception of the clinical importance of their own improvement or worsening during their involvement in a clinical study. Participants rated their overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). (NCT01455428)
Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.68 |
| Placebo | 3.17 |
The CGIC was a clinician-rated global measure that provided a clinically relevant and easy to interpret account of a clinician's perception of the clinical importance of the participant's improvement or worsening during their involvement in a clinical study. Clinicians rated the participant's overall improvement on a 7-point scale where scores ranged from 1 (very much improved) to 7 (very much worse). (NCT01455428)
Timeframe: Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.55 |
| Placebo | 3.18 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The somnolence subscale score also ranged from 0 to 100, with lower scores indicating less somnolence. (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.33 |
| Placebo | -0.54 |
The VAS was part of the SF-MPQ scale and reflected the overall pain intensity score. The pain VAS was a horizontal line; 100 mm in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). (NCT01455428)
Timeframe: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -20.71 |
| Placebo | -12.53 |
The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). (NCT01455428)
Timeframe: Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -0.79 |
| Placebo | -0.42 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean score was the sum of the daily scores divided by the number of diary entries during that week. (NCT01455428)
Timeframe: Baseline and weekly from Weeks 1 to 8
| Intervention | units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 change from baseline | Week 2 change from baseline | Week 3 change from baseline | Week 4 change from baseline | Week 5 change from baseline | Week 6 change from baseline | Week 7 change from baseline | Week 8 change from baseline | |
| Placebo | 0.01 | -0.16 | -0.35 | -0.51 | -0.62 | -0.74 | -0.79 | -0.84 |
| Pregabalin | -0.52 | -0.82 | -0.92 | -0.96 | -1.02 | -1.13 | -1.27 | -1.31 |
Pain-related sleep interference was assessed on an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10. (NCT01455428)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 3.81 |
| Placebo | 4.54 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. The MOS Sleep Quantity sub-scale scores ranged from 0 to 24 (number of hours slept). (NCT01455428)
Timeframe: Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.69 |
| Placebo | 0.25 |
"The DPRS consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10. The weekly mean pain score was the sum of the daily scores divided by the number of diary entries during that week." (NCT01455428)
Timeframe: Baseline and weekly from Weeks 1 to 8
| Intervention | units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Week 1 change from baseline | Week 2 change from baseline | Week 3 change from baseline | Week 4 change from baseline | Week 5 change from baseline | Week 6 change from baseline | Week 7 change from baseline | Week 8 change from baseline | |
| Placebo | -0.12 | -0.35 | -0.65 | -0.85 | -0.99 | -1.11 | -1.07 | -1.21 |
| Pregabalin | -0.62 | -1.00 | -1.23 | -1.36 | -1.50 | -1.70 | -1.78 | -1.91 |
SF-MPQ was assessed according to the participant's answer to the SF-MPQ questionnaire. The score for each composite scale (sensory, affective, and total) was derived by summing the reported intensity value for each item within a particular scale where None=0, Mild=1, Moderate=2, and Severe=3. The sensory score was the sum of the scores of the first 11 pain descriptors (throbbing, shooting, stabbing, sharp, cramping, gnawing, hot-burning, aching, heavy, tender, and splitting) and could range from 0-33. The affective score was the sum of the scores of the last 4 pain descriptors (tiring-exhausting, sickening, fearful, and punishing-cruel) and could range from 0-12. The total score was the sum of the scores of all 15 pain descriptors and could range from 0 to 45. Higher scores indicated greater pain. (NCT01455428)
Timeframe: Baseline; Weeks 1, 3, 5, and 8
| Intervention | units on a scale (Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sensory score, Baseline | Sensory score, Week 1 change (N=111, 106) | Sensory score, Week 3 change (N=107, 101) | Sensory score, Week 5 change (N=102, 96) | Sensory score, Week 8 change (N=98, 93) | Affective score, Baseline | Affective score, Week 1 change (N=111, 105) | Affective score, Week 3 change (N=107, 100) | Affective score, Week 5 change (N=102, 95) | Affective score, Week 8 change (N=97,90) | Total score, Baseline | Total score, Week 1 change (N=111, 106) | Total score, Week 3 change (N=107, 101) | Total score, Week 5 change (N=102, 96) | Total score, Week 8 change (N=98, 93) | |
| Placebo | 8.00 | -0.29 | -1.05 | -1.79 | -1.94 | 1.31 | -0.28 | -0.46 | -0.59 | -0.66 | 9.29 | -0.57 | -1.51 | -2.37 | -2.53 |
| Pregabalin | 8.24 | -1.68 | -2.97 | -3.31 | -3.61 | 1.25 | -0.61 | -0.80 | -0.85 | -0.96 | 9.50 | -2.29 | -3.77 | -4.17 | -4.57 |
The VAS was part of the Short Form McGill Pain Questionnaire (SF-MPQ) scale and reflected the overall pain intensity score, The pain VAS was a horizontal line; 100 millimeters (mm) in length, was self-administered by the participant in order to rate pain from 0 (no pain) to 100 (worst possible pain). The PPI was part of the SF-MPQ scale and measured the participant's present pain intensity on a 6-point scale ranging from 0 (no pain) to 5 (excruciating). (NCT01455428)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | |
|---|---|---|
| VAS | PPI | |
| Placebo | 62.60 | 2.42 |
| Pregabalin | 60.39 | 2.33 |
The MOS-Sleep Scale was a participant-rated questionnaire consisting of 12 items that assessed key constructs of sleep. Instrument scoring yielded 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. The total score ranged from 0 to 100. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflected greater impairment in the MOS-Sleep subscales. The MOS-Sleep Scale was used to evaluate sleep during the previous week. (NCT01455428)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Sleep disturbance score | Snoring score | Awaken short of breath score | Quantity of sleep score | Sleep adequacy score | Somnolence score | Sleep problems index score | |
| Placebo | 35.08 | 30.83 | 8.07 | 5.97 | 60.46 | 30.89 | 29.27 |
| Pregabalin | 36.09 | 29.19 | 9.91 | 6.05 | 57.66 | 32.25 | 31.38 |
The HADS was a self-administered questionnaire that consisted of 2 subscales, 1 measuring anxiety (HADS-A Scale) and the other measuring depression (HADS-D Scale). Each subscale comprised of 7 items; participants assessed how each item applied to them on a scale of 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Subscores from HADS-A (Anxiety) and HADS-D (Depression) were not to be combined. The interpretation of each HADS subscales was as follows: 0-7 normal, 8-10 mild, 11-14 moderate and 15-21 severe. (NCT01455428)
Timeframe: Baseline
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Anxiety total score | Depression total score | |
| Placebo | 3.37 | 3.47 |
| Pregabalin | 3.22 | 3.45 |
"Number of participants with C-CASA code 4 are reported. C-SSRS responses mapping to C-CASA suicidal ideation code 4 are as follows: Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with some intent to act, without specific plan." (NCT01463306)
Timeframe: Baseline (Day 1), Post-baseline on Day 1 up to 12 Months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Baseline | Post-baseline on Day 1 up to 12 Months | |
| Direct Pregabalin | 1 | 0 |
| Placebo-Previous to Pregabalin-Current | 2 | 2 |
| Pregabalin: Previous and Current | 3 | 3 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 9
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 3.00 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 9
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 43.13 | 0.62 |
| Pregabalin: Previous and Current | 38.17 | 0.96 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Week 1
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 190.45 | 2.39 |
| Pregabalin: Previous and Current | 102.89 | 2.07 |
(NCT01463306)
Timeframe: Baseline
| Intervention | Centimeters (Mean) | |
|---|---|---|
| Age: 4 Years to <10 Years | Age: 10 Years to 16 Years | |
| Direct Pregabalin | 126.0 | 153.4 |
(NCT01463306)
Timeframe: Baseline
| Intervention | Centimeters (Mean) | ||||
|---|---|---|---|---|---|
| Age: 1 Month to <2 Years | Age: 2 Years to <4 Years | Age: 4 Years to <10 Years | Age: 10 Years to 16 Years | Age: >=17 Years | |
| Placebo-Previous to Pregabalin-Current | 74.8 | 91.0 | 118.5 | 154.7 | 170.7 |
| Pregabalin: Previous and Current | 74.7 | 92.2 | 119.3 | 153.5 | 170.4 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 4
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 58.33 | 0.72 |
| Pregabalin: Previous and Current | 67.32 | 1.09 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Week 1
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 17.83 |
(NCT01463306)
Timeframe: Month 12
| Intervention | Centimeters (Mean) | |
|---|---|---|
| Age: 4 Years to <10 Years | Age: 10 Years to 16 Years | |
| Direct Pregabalin | 128.2 | 153.7 |
(NCT01463306)
Timeframe: Month 12
| Intervention | Centimeters (Mean) | ||||
|---|---|---|---|---|---|
| Age: 1 Month to <2 Years | Age: 2 Years to <4 Years | Age: 4 Years to <10 Years | Age: 10 Years to 16 Years | Age: >=17 Years | |
| Placebo-Previous to Pregabalin-Current | 85.3 | 98.1 | 126.6 | 160.5 | 170.6 |
| Pregabalin: Previous and Current | 84.4 | 99.3 | 128.2 | 158.1 | 170.8 |
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). (NCT01463306)
Timeframe: Month 12
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pubic Hair72061229 | Pubic Hair72061230 | Pubic Hair72061231 | Breast72061229 | Breast72061231 | Breast72061230 | Genitalia72061230 | Genitalia72061229 | Genitalia72061231 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stage 2 | Stage 3 | Stage 1 | Stage 5 | Not Done | Missing | Stage 4 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 68 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 38 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 35 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 38 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 21 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 11 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 23 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 27 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 15 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 19 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 40 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 19 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 22 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 13 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 6 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Tanner stage defines physical measurements of development based on external primary and secondary sex characteristics. Participants were evaluated for pubic hair distribution, breast development (only females) and genital development (only males), with values ranging from stage 1 (pre-pubertal characteristics) to stage 5 (adult or mature characteristics). (NCT01463306)
Timeframe: Baseline (Day 1)
| Intervention | Participants (Count of Participants) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pubic Hair72061229 | Pubic Hair72061230 | Pubic Hair72061231 | Breast72061229 | Breast72061230 | Breast72061231 | Genitalia72061229 | Genitalia72061231 | Genitalia72061230 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Missing | Stage 1 | Stage 2 | Stage 3 | Stage 4 | Stage 5 | Not Done | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 95 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 44 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 4 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 34 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 33 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 16 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 15 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 16 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 6 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 37 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 18 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 17 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 8 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 15 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 19 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 50 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 23 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 2 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 24 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 11 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 13 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Pregabalin: Previous and Current | 7 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 3 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 0 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Direct Pregabalin | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Placebo-Previous to Pregabalin-Current | 9 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 28 days after last dose of study drug (up to 13 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. (NCT01463306)
Timeframe: Baseline (Day 1) up to 13 Months
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Participants With AEs | Participants With SAEs | Participants With Treatment Related AEs | Participants With Treatment Related SAEs | |
| Direct Pregabalin | 10 | 1 | 9 | 0 |
| Placebo-Previous to Pregabalin-Current | 140 | 23 | 65 | 1 |
| Pregabalin: Previous and Current | 252 | 53 | 104 | 0 |
"Number of participants with C-CASA code 1 or 2 or 3 are reported. C-SSRS responses mapping to C-CASA suicidal behavior codes 1, 2, or 3 are as follows: (1) completed suicide; (2) suicide attempt (response of Yes on actual attempt); (3) preparatory acts toward imminent suicidal behavior (Yes on aborted attempt, interrupted attempt, preparatory acts or behavior)." (NCT01463306)
Timeframe: Baseline (Day 1), Post-baseline up to 12 Months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Baseline | Post-baseline on Day 1 up to 12 Months | |
| Direct Pregabalin | 0 | 0 |
| Placebo-Previous to Pregabalin-Current | 1 | 0 |
| Pregabalin: Previous and Current | 1 | 2 |
Categories for which data is reported are: 1) maximum (max) PR interval increase from baseline (IFB) (millisecond [msec]) percent change (PctChg) >=25/50%; 2) maximum QRS complex increase from baseline (msec) PctChg>=50%; 3) maximum QTcB interval (Bazett's correction) increase from baseline (msec): change >=30 to <60; change >=60; 4) maximum QTcF interval (Fridericia's correction) increase from baseline (msec): change >=30 to <60; change >=60. 'PctChg>=25/50%': >= 25% increase from baseline when baseline ECG parameter is > 200 msec, and is >= 50% increase from baseline when baseline ECG parameter is non-missing and <=200 msec. (NCT01463306)
Timeframe: Baseline up to 12 Months
| Intervention | Participants (Count of Participants) | |||||
|---|---|---|---|---|---|---|
| Max PR interval IFB PctChg >=25/50% | Max QRS complex IFB PctChg >=50% | Max QTcB interval IFB change >=30 - <60 | Max QTcB interval IFB change >=60 | Max QTcF interval IFB change >=30 - <60 | Max QTcF interval IFB change >=60 | |
| Direct Pregabalin | 0 | 0 | 0 | 0 | 1 | 0 |
| Placebo-Previous to Pregabalin-Current | 0 | 0 | 11 | 0 | 9 | 0 |
| Pregabalin: Previous and Current | 1 | 0 | 29 | 0 | 18 | 1 |
Physical examination assessed: general appearance, dermatological, head and eyes, ears, nose, mouth, and throat, pulmonary, cardiovascular, abdominal, genitourinary (optional), lymphatic, musculoskeletal/extremities. Neurological examination assessed: level of consciousness, mental status, cranial nerve assessment, muscle strength and tone, reflexes, pin prick and vibratory sensation, coordination and gait. Investigator judged clinically significant change from baseline in physical and neurological examination findings. (NCT01463306)
Timeframe: Baseline up to 12 Months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Physical Examination | Neurological Examination | |
| Direct Pregabalin | 0 | 2 |
| Placebo-Previous to Pregabalin-Current | 6 | 4 |
| Pregabalin: Previous and Current | 8 | 10 |
In this outcome measure number of participants with increase and decrease of >=7% in body weight, from baseline up to 12 months are reported. (NCT01463306)
Timeframe: Baseline up to 12 Months
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Weight increase from baseline >=7% | Weight decrease from baseline >=7% | |
| Direct Pregabalin | 8 | 0 |
| Placebo-Previous to Pregabalin-Current | 147 | 4 |
| Pregabalin: Previous and Current | 290 | 2 |
Pre-defined criteria of vital signs abnormalities: maximum (max.) increase or decrease from baseline in sitting/supine systolic blood pressure (SBP) >=30 millimeter of mercury (mmHg); maximum increase or decrease from baseline in sitting/supine diastolic blood pressure (DBP) >=20 mmHg. (NCT01463306)
Timeframe: Baseline up to 12 months
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Max. increase from baseline in SBP>=30 mmHg | Max. decrease from baseline in SBP>=30 mmHg | Max. increase from baseline in DBP>=20 mmHg | Max. decrease from baseline in DBP>=20 mmHg | |
| Direct Pregabalin | 0 | 0 | 1 | 0 |
| Placebo-Previous to Pregabalin-Current | 1 | 5 | 16 | 6 |
| Pregabalin: Previous and Current | 9 | 8 | 34 | 22 |
"CogState brief battery consisted of 2 tasks-detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Pediatric identification task: measured choice reaction time to assess visual attention. An event (a card turning face up) occurred in center of computer screen and participant decided if event met a predefined and unchanging criterion (is the color of the card black?); answered YES if criterion was met. A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD),WSD=within-subject standard deviation from Cogstate task normative data. Improvement in cognition: RCI <=-1.65, decline in cognition: RCI =>1.65." (NCT01463306)
Timeframe: Month 12
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improvement (RCI <=-1.65) | Decline (RCI =>1.65) | |
| Direct Pregabalin | 2 | 2 |
| Placebo-Previous to Pregabalin-Current | 9 | 6 |
| Pregabalin: Previous and Current | 17 | 16 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 1
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 178.53 | 1.66 |
| Pregabalin: Previous and Current | 96.39 | 1.43 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 1
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 33.42 |
Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit, red blood cell(RBC) count: <0.8*lower limit of normal(LLN), platelet: <0.5*LLN/greater than (>)1.75*upper limit of normal (ULN), white blood cell (WBC): <0.6*LLN/>1.5*ULN, lymphocyte, neutrophil- absolute/%:<0.8*LLN/>1.2*ULN, basophil, eosinophil, monocyte- absolute/%:>1.2*ULN; total/direct/indirect bilirubin >1.5*ULN, aspartate aminotransferase (AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:> 3.0*ULN, total protein, albumin: <0.8*LLN/>1.2*ULN; thyroxine, thyroid stimulating hormone <0.8*LLN/>1.2*ULN; cholesterol, triglycerides:> >1.3*ULN; blood urea nitrogen, creatinine:>1.3*ULN; sodium <0.95*LLN/>1.05*ULN, potassium, chloride, calcium: <0.9*LLN or >1.1*ULN; glucose <0.6*LLN/>1.5*ULN, creatine kinase>2.0*ULN; urine (specific gravity <1.003/>1.030, pH <4.5/>8, glucose, ketones, protein: >=1, WBC, RBC:>=20, bacteria >20, hyaline casts/casts >1); prothrombin (PT), PT international ratio>1.1*ULN. (NCT01463306)
Timeframe: Baseline up to 12 Months
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin: Previous and Current | 297 |
| Placebo-Previous to Pregabalin-Current | 164 |
| Direct Pregabalin | 8 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 2
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 89.09 | 1.36 |
| Pregabalin: Previous and Current | 79.33 | 1.27 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 12/Early Termination
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 11.08 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 2
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 22.16 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 4
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 15.45 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 12/Early Termination
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 117.88 | 1.33 |
| Pregabalin: Previous and Current | 56.04 | 1.02 |
"CogState brief battery consisted of 2 tasks- detection and pediatric identification task using a laptop computer with external response buttons. Prior tasks, participants were briefed rules, given an interactive demonstration and a sufficient number of practice trials. For each task, participant responded yes using a response button with dominant hand. Participants had to respond as fast and as accurately as possible. Detection task: measured simple reaction time to assess psychomotor function. Participant pressed a YES response key as soon as they detected an event (ie, a card turning face up presented in the center of the computer screen). A participant's RCI was calculated by dividing the change from individual baseline score by ([square root 2] times WSD), where WSD is within-subject standard deviation from Cogstate detection task normative data. Improvement in cognition when RCI <=-1.65, decline in cognition when RCI =>1.65." (NCT01463306)
Timeframe: Month 12
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Improvement (RCI <= -1.65) | Decline (RCI =>1.65) | |
| Direct Pregabalin | 2 | 1 |
| Placebo-Previous to Pregabalin-Current | 8 | 6 |
| Pregabalin: Previous and Current | 21 | 13 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 6
| Intervention | Seizures Per 28-Days (Mean) |
|---|---|
| Partial Onset Seizures | |
| Direct Pregabalin | 4.25 |
28-days seizure rate was defined as number of seizures per 28-day period. 28-days seizure rate have been reported separately for partial onset seizure and primary generalized tonic clonic seizure. Partial onset seizure: a seizure that starts in one area of the brain. This kind of seizure is brief, lasting seconds to less than 2 minutes. Primary generalized tonic clonic seizure: a seizure that starts in one area of the brain, then spreads to both sides of the brain as a tonic-clonic seizure and usually last 1 to 3 minutes. (NCT01463306)
Timeframe: Month 6
| Intervention | Seizures Per 28-Days (Mean) | |
|---|---|---|
| Partial Onset Seizures | Primary Generalized Tonic Clonic Seizures | |
| Placebo-Previous to Pregabalin-Current | 51.10 | 0.79 |
| Pregabalin: Previous and Current | 50.18 | 1.02 |
"The daily sleep diary consists of an 11-point numeric rating scale with which the participant rates how painful DPN pain has interfered with their sleep during the past 24 hours. Zero indicates does not interfere with sleep and 10 indicates completely interferes (unable to sleep due to pain). Self-assessment was performed daily in the evening before bedtime on a telephone via IVRS (time window for completion between 6.00 pm to midnight) after completion of the daily pain diary." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.66 |
| Placebo | 4.05 |
The HADS is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression. (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.73 |
| Placebo | 3.97 |
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-administered questionnaire that consists of 2 scales, one measuring anxiety (HADS-A), and the other measuring depression (HADS-D). Each subscale consists of 7 statements and the participant responds as to how each item applies to him/her over the past week on 4-point response scale. Separate scores are calculated for anxiety and depression and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score, the more severe the anxiety or depression. (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.65 |
| Placebo | 4.92 |
"The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.28 |
| Placebo | 4.41 |
"Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. Activity counts are the units of motion. It is equal to the sum of peak accelerations each second during the epoch (60 seconds). Total activity counts per day is the sum of the activity counts for each epoch (60 seconds) during the day (non-sleep period). Actigraphy was performed with an accelerometer that was worn on the hip during the waking hours. It was programmed to record movements while the device was being worn." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | counts (Least Squares Mean) |
|---|---|
| Pregabalin | 64703.14 |
| Placebo | 64139.75 |
The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference. The sub-score pain interference with walking ability was evaluated, as it was considered to be the most relevant in the context of this study. (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 3.75 |
| Placebo | 3.93 |
"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 22.58 |
| Placebo | 23.75 |
"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 4.73 |
| Placebo | 4.96 |
"The BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during a 24 hour period prior to evaluation. The BPI-sf consists of 5 questions: 4 items measure pain (0: no pain; 10: worst pain possible) at its worst, least, average, and now (current pain) on an 11-point scale. Scores range from 0 - 40 with higher scores indicating greater pain severity. Another item, containing 7 sub-questions, evaluates the level of interference of pain on daily functioning (general activity, walking, work ability, mood, enjoyment of life, relations with other people, and sleep) on 11-point scales (0: does not interfere; 10: completely interferes). Scores range from 0 - 70 with higher scores indicating greater interference." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 16.76 |
| Placebo | 17.56 |
The PGIC is a participant-rated instrument that measures the participant's assessment of change in his/her overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). Original scores (OS; 7 different scores) and categorized scores (CS; 4 different scores) were provided. Categorized scores were very much improved (consisting of very much improved and much improved); any improvement (consisting of very much improved, much improved, and minimally improved); no change (consisting of no change); and any worsening (consisting of minimally worse, much worse, and very much worse). Due to the crossover design, PGIC was analyzed at the end of period 1 (V6). (NCT01474772)
Timeframe: End of Period 1 (V6)
| Intervention | percentage of participants (Number) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| OS: Very much improved | OS: Much improved | OS: Minimally improved | OS: No change | OS: Minimally worse | OS: Much worse | OS: Very much worse | CS: Very much improved | CS: Any improvement | CS: No change | CS: Any worsening | |
| Placebo | 5.9 | 25.5 | 27.5 | 33.3 | 5.9 | 1.0 | 1.0 | 31.4 | 58.8 | 33.3 | 7.8 |
| Pregabalin | 11.2 | 39.8 | 30.6 | 13.3 | 2.0 | 2.0 | 1.0 | 51.0 | 81.6 | 13.3 | 5.1 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The autonomic domain score should be summed as follow: Σ(19, 20, 21). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 1.07 |
| Placebo | 1.08 |
The Walk-12 is a self-administered questionnaire that assesses the impact of the participant's diabetic neuropathy over the past 2 weeks on parameters associated with walking (12 questions) based on a 5-point scale (from not at all to extremely). The total score is the sum of scores from the 12 questions, which then gets transferred to a 0-100 scale with higher scores indicating greater impairment (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 35.72 |
| Placebo | 37.08 |
Actigraphy data which measured steps and daytime activity during waking hours were assessed for the last 7 days at Baseline, Visit 6, and Visit 11. The participants were instructed to wear the device on their hip during the waking hours. (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | steps (Least Squares Mean) |
|---|---|
| Pregabalin | 3785.65 |
| Placebo | 3788.28 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. TQOL score should be summed as follow: sum (Σ) (1 - 7, 8 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 29.31 |
| Placebo | 30.77 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The symptoms domain score should be summed as follow: Σ(1 - 7, 9). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 7.65 |
| Placebo | 7.99 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The activities of daily living domain score should be summed as follow: Σ(12, 22, 23, 25, 26). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.36 |
| Placebo | 2.42 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The small fiber domain score should be summed as follow: Σ(10, 16, 17, 18). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.77 |
| Placebo | 2.53 |
"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The longitudinal mean weekly DPN pain scores were defined as the mean of 7 daily diary pain ratings. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01474772)
Timeframe: Baseline, 6 weeks in Period 1, 2 weeks washout and 6 weeks in Period 2
| Intervention | units on a scale (Mean) | |
|---|---|---|
| V6 (N: 101, 102) | V11 (N: 97, 84) | |
| Placebo | 5.29 | 4.38 |
| Pregabalin | 4.66 | 4.57 |
"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| V6 (N: 101, 102) | V11 (N: 97, 84) | |
| Placebo | 13.7 | 32.1 |
| Pregabalin | 23.8 | 27.8 |
"The daily pain diary consisted of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self-assessment was performed daily each evening before bedtime (6.00 pm to midnight) on the telephone via IVRS. The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication in each treatment period - Period 1 and Period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| V6 (N: 101, 102) | V11 (N: 97, 84) | |
| Placebo | 24.5 | 47.6 |
| Pregabalin | 38.6 | 46.4 |
The EQ-5D describes participant's health status based on 5 attributes producing an 5 digit index score. The 5 dimensions are: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Dolan 1997 advised how to transfer this index score to a single score for clinical trials, a revised single index was published in 2001. The index uses general population weighted estimates for various health states. In general, the range of the single index tends to vary between 0 = death and 1 = perfect health and there are some states that have been rated by the general population to be worse than death which may result in numbers below 0. (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) | |
|---|---|---|
| Index score Dolan 1997 | Index score Dolan 2001 | |
| Placebo | 0.643 | 0.641 |
| Pregabalin | 0.649 | 0.650 |
"Norfolk QOL-DN is a 35-item participant-rated questionnaire used to assess impact of diabetic neuropathy on the quality of life of participants with diabetic neuropathy. All symptoms (1 - 7) are scored as either 1 or 0, indicating presence or absence of the symptom. With the exception of questions 31 and 32, the other items are scored according to the 5-point Likert Scale (0 - 4, no problem to severe problem). In question 31, good, the middle item, is scored as 0, very good as -1, excellent as -2, fair as 1, and poor as 2. In question 32, about the same, the middle item, is scored as 0, somewhat better as -1, much better as -2, somewhat worse as 1, and much worse as 2. The physical functioning / large fiber domain score should be summed as follow: Σ(8, 11, 13 - 15, 24, 27 - 35). The scales and subscales are calculated without weighting of any kind, and reported as the integer sum of the listed questionnaire items." (NCT01474772)
Timeframe: End of Period (includes both Visits 6 and 11)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 15.51 |
| Placebo | 16.78 |
In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the 7 day treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT01485094)
Timeframe: Day 7 (end of double blind treatment)
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| GRT6010 | 2 | 6 | 8 | 2 | 1 | 0 | 0 |
| Matching Placebo | 5 | 4 | 5 | 5 | 0 | 0 | 0 |
| Pregabalin | 5 | 4 | 8 | 1 | 0 | 1 | 0 |
"Allodynia is pain due to a stimulus that does not normally provoke pain. Dynamic mechanical allodynia was assessed using a set of 3 light tactile stimulators as moving innocuous stimuli.~Each participant gave numerical pain ratings for each of 15 stimuli at the affected side.~Mechanical pain sensitivity was assessed using a set of 7 weighted pinprick stimuli to obtain the stimulus-response function for pinprick-evoked pain.~The participant gave a numerical pain ratings for each of 35 pinprick stimuli at the affected site.~Dynamic mechanical allodynia and mechanical pain sensitivity was calculated as the geometric mean of all numerical ratings. The values obtained on Day -2 and -1 were taken as the baseline and values on Day 6 and 7 were taken as the end of treatment. A negative change indicates an improvement on the 0 (no pain) to 100 point scale, where 100 indicates the worst imaginable pain." (NCT01485094)
Timeframe: Day 7 (end of double blind treatment)
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Mechanical pain sensitivity (Affected side) | Dynamic mechanical allodynia (Affected side) | |
| GRT6010 | -14.60 | -13.81 |
| Matching Placebo | -12.26 | -11.12 |
| Pregabalin | -13.86 | -9.63 |
"The assessment was performed on Day 7.~The percentage of change from baseline (Day -3 to Day -1, i.e. the 3 days in the days prior to first dose) in the daily ongoing pain intensity was calculated at Day 7.~The percentage of change from baseline in the daily ongoing pain intensity was calculated at Day 7 as follows:~% change = (Baseline Pain Intensity - Daily pain intensity at treatment visit) / Baseline Pain Intensity × 100~The threshold values represent an improvement in ongoing pain intensity greater than 20, 30, 40, 50, 60, 70, 80 or 90% as per calculation.~Participants who showed a worsening in their daily pain intensity or who prematurely discontinued the trial were regarded as non-responders in terms of the respective treatment." (NCT01485094)
Timeframe: Day 7 (end of double blind treatment)
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| 20% Threshold | 30% Threshold | 40% Threshold | 50% Threshold | 60% Threshold | 70% Threshold | 80% Threshold | 90% Threshold | |
| GRT6010 | 14 | 10 | 9 | 7 | 4 | 1 | 0 | 0 |
| Matching Placebo | 12 | 11 | 8 | 5 | 4 | 4 | 3 | 1 |
| Pregabalin | 13 | 8 | 6 | 4 | 4 | 2 | 2 | 2 |
The baseline pain intensity score was calculated as a mean of pain intensity scores during the Baseline Period (from Day -3 to Day -1). The ongoing pain intensity data from Day-3 to Day 7 was used. For the analysis, only pain scores on days where participants received study drug were considered. The primary efficacy analysis of the ongoing pain intensity score were analyzed in a Bayesian framework, via a mono exponential decay model, with the baseline Numeric Rating Score (NRS) as intercept. Considering the inclusion criteria of baseline pain intensity being in the range from 4 to 9, the range in ongoing pain intensity difference between baseline and end-of-double-blind treatment can be from 6 (worst possible value) to -9 (best possible value). A negative value indicates improvement whilst on the treatment. (NCT01485094)
Timeframe: Baseline; Day 7 (end of double blind treatment)
| Intervention | units on a scale (Mean) |
|---|---|
| Matching Placebo | -2.55 |
| GRT6010 | -2.30 |
| Pregabalin | -2.33 |
"The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-100 point NRS (measured as part of the dynamic mechanical allodynia assessments).~Each participant rated each brush-evoked pain intensity on a 0 to 100 point Numerical Pain Rating Scale, with 0 indicating 'No Pain' and 100 indicating 'most intense pain imaginable'. Lower values compared to an individual subject's baseline are an improvement in symptoms.~The baseline brush-evoked pain intensity score was defined as the average of the geometric mean of all of the values obtained on Day -2 and Day -1, and compared with the scores obtained on day 6 and 7.~For the analysis, only pain scores on days where participants received study drug were considered.~A negative change indicates a decrease in brush-evoked pain intensity from baseline." (NCT01485094)
Timeframe: Baseline and day 7 (end of double blind treatment)
| Intervention | units on a scale (Mean) |
|---|---|
| Matching Placebo | -11.17 |
| GRT6010 | -14.31 |
| Pregabalin | -9.79 |
"Allodynia is pain due to a stimulus that does not normally provoke pain. To measure the areas of dynamic and static allodynia, a point lying in the center of the area of maximum pain was marked at baseline (Day -2 and -1). From the baseline point, 8 radii were drawn.~The area of dynamic allodynia was determined by gently stroking the skin with a standardized brush along the lines. The participant was asked to report when the sensation became unpleasant.~The area of static allodynia was determined by a 128 mN (millinewton) pinprick stimulus along the lines of the 8 radii while asking the subject to report when the sensation became unpleasant.~The area was calculated from the summing of the 8 triangles that are generated from the points along each of the 8 radii at which unpleasantness was reported. The larger the area in square centimeters the more allodynia. A reduction in the area of allodynia indicates improvement." (NCT01485094)
Timeframe: Baseline; Day 7 (end of double blind treatment)
| Intervention | square centimeters (Mean) | |||
|---|---|---|---|---|
| Dynamic allodynia area at baseline | Change in area of dynamic allodynia | Static allodynia area at baseline | Change in area of static allodynia | |
| GRT6010 | 152.11 | -73.98 | 286.21 | -137.47 |
| Matching Placebo | 154.79 | 11.36 | 352.97 | -58.01 |
| Pregabalin | 98.4 | -32.78 | 244.75 | -95.16 |
"The Neuropathic Pain Symptom Inventory (NPSI) Score is an assessment of neuropathic pain symptoms.~A participant answered 10 questions on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable).~The total NPSI score is the sum of all ten responses and ranges between 0 and 100.~The baseline score and the mean NPSI change is reported over the double-blind treatment period. A negative mean change in score on Day 7 indicates an improvement on this 0 to 100 point scale from baseline for the total score.~For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) subscores a negative mean change indicate an improvement on the 11 point scale. A participant will score 10 to indicates the worst imaginable symptom, e.g. worst burning imaginable. A participant will score 0 if there is no burning, i.e. the symptom is absent." (NCT01485094)
Timeframe: Day -1; Day 7 (end of double blind treatment)
| Intervention | units on a scale (Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day -1 Baseline NPSI total score | Day 7 Change in NPSI total score | Day -1 Baseline Burning spontaneous pain | Day 7 Change in burning spontaneous pain | Day -1 Baseline pressing spontaneous pain | Day 7 Change in pressing spontaneous pain | Day -1 Baseline paroxysmal pain | Day 7 Change in paroxysmal pain | Day -1 Baseline evoked pain | Day 7 Change in evoked pain | Day -1 Baseline paresthesia or dysesthesia | Day 7 Change in paresthesia or dysesthesia | |
| GRT6010 | 58.05 | -18.95 | 5.68 | -1.58 | 4.97 | -1.68 | 6.03 | -1.82 | 5.83 | -2.03 | 6.45 | -2.13 |
| Matching Placebo | 59.11 | -23.89 | 5.79 | -2.53 | 4.47 | -1.74 | 6.39 | -2.92 | 6.02 | -2.16 | 6.76 | -2.79 |
| Pregabalin | 55.84 | -16.79 | 5.63 | -2.0 | 4.45 | -0.58 | 6.76 | -2.26 | 5.67 | -2.05 | 5.39 | -1.47 |
"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated between 0 and 38 for each participant. Participants with a score between 0 and 12 are graded as negative and having no neuropathic pain component. Scores between 19 and 38 result in a positive grading, in other words having presence of neuropathic component. Values from 13 to 18 result in participants being graded as having an unclear neuropathic component to their pain. The painDETECT questionnaire was first administered on Day-1 (baseline). The data reported is for before treatment start (Day -1) and the change from baseline on Day 7 (end of the double-blind period)." (NCT01485094)
Timeframe: Day 7 (end of double blind treatment)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Day -1 no neuropathic pain component | Day 7 no neuropathic pain component | Day -1 Unclear neuropathic component | Day 7 Unclear neuropathic component | Day -1 Presence of neuropathic component | Day 7 Presence of neuropathic component | |
| GRT6010 | 0 | 2 | 1 | 4 | 18 | 12 |
| Matching Placebo | 0 | 1 | 2 | 4 | 17 | 12 |
| Pregabalin | 0 | 2 | 5 | 3 | 14 | 12 |
"Participants recorded their current pain intensity score 3 times a day, using a 0 -10 (11 point) Numeric Rating Scale where a rating of 0 corresponded to No Pain and a rating of 10 to Pain as bad as you can imagine.~The daily current pain intensity reported was derived as the mean of the 3 current pain intensity assessments taken on the day from all participants in the treatment group.~The lower the value on the 11 point scale the less pain was reported on a treatment." (NCT01485094)
Timeframe: Baseline; Day 10
| Intervention | units on a scale (Mean) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Day 1 | Day 2 | Day 3 | Day 4 | Day 5 | Day 6 | Day 7 | Day 8 | Day 9 | Day 10 | |
| GRT6010 | 6.52 | 5.74 | 5.19 | 4.68 | 4.75 | 4.61 | 4.16 | 3.84 | 3.76 | 4.28 | 4.35 |
| Matching Placebo | 6.32 | 4.82 | 4.49 | 4.46 | 4.09 | 3.82 | 4.13 | 3.64 | 3.68 | 4.21 | 4.06 |
| Pregabalin | 6.13 | 5.37 | 4.58 | 4.61 | 4.47 | 3.95 | 4.08 | 3.63 | 3.85 | 4.05 | 4.15 |
"On the last day of the double-blind treatment period sleep was evaluated using the Leeds sleep evaluation questionnaire. This questionnaire has 10 self-rating 100 mm line analogue questions concerning sleep and early morning behavior. The higher the score, i.e. the closer the value is to 100 the worse the rating by the participant.~The 10 responses are grouped into 4 subscores:~The ease of getting to sleep.~The perceived quality of sleep.~The ease of awakening from sleep.~The integrity of behavior following wakefulness." (NCT01485094)
Timeframe: Day 7
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Day 7 ease of getting to sleep | Day 7 perceived quality of sleep | Day 7 ease of awakening from sleep | Day 7 integrity of behavior following wakefulness | |
| GRT6010 | 41.25 | 42.33 | 48.29 | 44.88 |
| Matching Placebo | 36.37 | 42.69 | 44.94 | 46.91 |
| Pregabalin | 32.57 | 37.06 | 46.56 | 44.35 |
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1. (NCT01496365)
Timeframe: From the time of signing the informed consent form (ICF) up to 10 months postdose
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug-related TEAEs | Participants with ≥1 drug-related TEAEs | Nervous System Disorders | Dizziness | Somnolence | Headache | Balance disorder | Amnesia | General Disorders & Administration Site Conditions | Fatigue | Oedema peripheral | Gastrointestinal Disorders | Nausea | Constipation | Dry mouth | Psychiatric Disorders | Insomnia | Investigations | Weight increased | Blood creatinine phosphokinase increased | Eye Disorders | Vision blurred | Reproductive System and Breast Disorders | Erectile dysfunction | |
| DS-5565 10 mg BID | 34 | 18 | 14 | 4 | 5 | 2 | 3 | 0 | 4 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 0 | 2 | 2 | 0 | 1 | 0 | 1 | 1 |
| DS-5565 10 mg QD | 21 | 12 | 7 | 5 | 1 | 3 | 0 | 0 | 1 | 1 | 0 | 3 | 1 | 2 | 0 | 2 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| DS-5565 15 mg BID | 37 | 19 | 13 | 7 | 4 | 1 | 2 | 2 | 6 | 2 | 1 | 2 | 1 | 2 | 0 | 5 | 1 | 2 | 1 | 0 | 2 | 2 | 1 | 1 |
| DS-5565 15 mg QD | 40 | 17 | 9 | 5 | 3 | 0 | 1 | 0 | 6 | 2 | 1 | 5 | 1 | 1 | 2 | 3 | 2 | 3 | 0 | 0 | 2 | 2 | 2 | 2 |
| DS-5565 5mg QD | 24 | 13 | 4 | 0 | 1 | 3 | 0 | 0 | 2 | 0 | 2 | 3 | 2 | 0 | 1 | 2 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 |
| Placebo | 31 | 20 | 3 | 1 | 1 | 1 | 0 | 0 | 4 | 1 | 0 | 5 | 1 | 1 | 0 | 3 | 1 | 4 | 1 | 2 | 2 | 2 | 0 | 0 |
| Pregabalin 150 mg BID | 35 | 14 | 7 | 1 | 4 | 0 | 2 | 0 | 4 | 2 | 2 | 2 | 0 | 0 | 1 | 5 | 1 | 2 | 0 | 1 | 1 | 1 | 0 | 0 |
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo). (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Least Squares Mean) | ||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | End of treatment | |
| DS-5565 10 mg BID | -1.26 | -1.72 | -2.38 | -2.68 | -2.87 |
| DS-5565 10 mg QD | -0.95 | -1.56 | -1.78 | -2.41 | -2.40 |
| DS-5565 15 mg BID | -1.40 | -2.33 | -2.55 | -2.72 | -2.79 |
| DS-5565 15 mg QD | -1.13 | -1.76 | -2.30 | -2.46 | -2.90 |
| DS-5565 5mg QD | -0.68 | -1.38 | -1.62 | -2.01 | -2.05 |
| Placebo | -0.55 | -1.12 | -1.47 | -1.67 | -1.91 |
| Pregabalin 150 mg BID | -1.10 | -1.75 | -1.79 | -1.83 | -1.87 |
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo). (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.86 |
| Pregabalin 150 mg BID | -1.79 |
| DS-5565 5mg QD | -2.04 |
| DS-5565 10 mg QD | -2.32 |
| DS-5565 15 mg QD | -2.66 |
| DS-5565 10 mg BID | -2.64 |
| DS-5565 15 mg BID | -2.79 |
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2). (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall status is much improved or better (score ≤2)72051793 | Overall status is much improved or better (score ≤2)72051794 | Overall status is much improved or better (score ≤2)72051795 | Overall status is much improved or better (score ≤2)72051799 | Overall status is much improved or better (score ≤2)72051796 | Overall status is much improved or better (score ≤2)72051797 | Overall status is much improved or better (score ≤2)72051798 | Overall status is minimally improved or better (score ≤3)72051793 | Overall status is minimally improved or better (score ≤3)72051794 | Overall status is minimally improved or better (score ≤3)72051795 | Overall status is minimally improved or better (score ≤3)72051798 | Overall status is minimally improved or better (score ≤3)72051796 | Overall status is minimally improved or better (score ≤3)72051797 | Overall status is minimally improved or better (score ≤3)72051799 | |||||||||||||||
| No | Yes | |||||||||||||||||||||||||||
| Placebo | 33 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 19 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 27 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 30 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 24 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 25 | |||||||||||||||||||||||||||
| DS-5565 15 mg BID | 28 | |||||||||||||||||||||||||||
| Placebo | 73 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 31 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 28 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 25 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 26 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 27 | |||||||||||||||||||||||||||
| Placebo | 66 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 33 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 45 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 46 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 37 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 38 | |||||||||||||||||||||||||||
| DS-5565 15 mg BID | 44 | |||||||||||||||||||||||||||
| Placebo | 40 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 17 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 10 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 9 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 13 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 14 | |||||||||||||||||||||||||||
| DS-5565 15 mg BID | 12 | |||||||||||||||||||||||||||
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Responder rate: ≥30% decrease from baseline72051795 | Responder rate: ≥30% decrease from baseline72051796 | Responder rate: ≥30% decrease from baseline72051797 | Responder rate: ≥30% decrease from baseline72051798 | Responder rate: ≥30% decrease from baseline72051799 | Responder rate: ≥30% decrease from baseline72051793 | Responder rate: ≥30% decrease from baseline72051794 | Responder Rate: ≥50% decrease from baseline72051794 | Responder Rate: ≥50% decrease from baseline72051795 | Responder Rate: ≥50% decrease from baseline72051796 | Responder Rate: ≥50% decrease from baseline72051797 | Responder Rate: ≥50% decrease from baseline72051798 | Responder Rate: ≥50% decrease from baseline72051793 | Responder Rate: ≥50% decrease from baseline72051799 | |||||||||||||||
| Yes | No | |||||||||||||||||||||||||||
| Placebo | 45 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 19 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 22 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 32 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 34 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 34 | |||||||||||||||||||||||||||
| Placebo | 63 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 31 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 33 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 24 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 17 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 22 | |||||||||||||||||||||||||||
| DS-5565 15 mg BID | 25 | |||||||||||||||||||||||||||
| Placebo | 26 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 14 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 11 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 16 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 20 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 24 | |||||||||||||||||||||||||||
| Placebo | 82 | |||||||||||||||||||||||||||
| Pregabalin 150 mg BID | 36 | |||||||||||||||||||||||||||
| DS-5565 5mg QD | 44 | |||||||||||||||||||||||||||
| DS-5565 10 mg QD | 40 | |||||||||||||||||||||||||||
| DS-5565 15 mg QD | 31 | |||||||||||||||||||||||||||
| DS-5565 10 mg BID | 32 | |||||||||||||||||||||||||||
| DS-5565 15 mg BID | 32 | |||||||||||||||||||||||||||
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Total score | VAS pain | |
| DS-5565 10 mg BID | -7.96 | -25.45 |
| DS-5565 10 mg QD | -11.16 | -28.56 |
| DS-5565 15 mg BID | -10.79 | -32.82 |
| DS-5565 15 mg QD | -8.71 | -28.73 |
| DS-5565 5mg QD | -10.36 | -27.40 |
| Placebo | -8.39 | -20.84 |
| Pregabalin 150 mg BID | -7.92 | -19.28 |
"The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3:~throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores." (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Sensory score | Affective score | |
| DS-5565 10 mg BID | -6.56 | -1.40 |
| DS-5565 10 mg QD | -8.73 | -2.44 |
| DS-5565 15 mg BID | -8.55 | -2.23 |
| DS-5565 15 mg QD | -6.86 | -1.84 |
| DS-5565 5mg QD | -8.02 | -2.35 |
| Placebo | -6.29 | -2.10 |
| Pregabalin 150 mg BID | -5.94 | -1.98 |
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| Worst Pain Intensity | Least Pain Intensity | Average Pain Intensity | |
| DS-5565 10 mg BID | -2.3 | -1.0 | -1.8 |
| DS-5565 10 mg QD | -2.6 | -1.7 | -2.3 |
| DS-5565 15 mg BID | -3.0 | -1.9 | -2.3 |
| DS-5565 15 mg QD | -2.7 | -2.0 | -2.0 |
| DS-5565 5mg QD | -2.0 | -1.6 | -1.7 |
| Placebo | -2.1 | -1.3 | -1.7 |
| Pregabalin 150 mg BID | -1.9 | -0.9 | -1.5 |
"Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep." (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.98 |
| Pregabalin 150 mg BID | -1.94 |
| DS-5565 5mg QD | -2.19 |
| DS-5565 10 mg QD | -2.35 |
| DS-5565 15 mg QD | -2.97 |
| DS-5565 10 mg BID | -2.52 |
| DS-5565 15 mg BID | -2.69 |
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -2.0 |
| Pregabalin 150 mg BID | -1.8 |
| DS-5565 5mg QD | -2.0 |
| DS-5565 10 mg QD | -2.5 |
| DS-5565 15 mg QD | -2.5 |
| DS-5565 10 mg BID | -2.0 |
| DS-5565 15 mg BID | -2.5 |
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | score on a scale (Mean) |
|---|---|
| Placebo | 26.4 |
| Pregabalin 150 mg BID | 20.4 |
| DS-5565 5mg QD | 31.5 |
| DS-5565 10 mg QD | 32.0 |
| DS-5565 15 mg QD | 23.0 |
| DS-5565 10 mg BID | 35.3 |
| DS-5565 15 mg BID | 33.0 |
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.5 |
| Pregabalin 150 mg BID | -1.7 |
| DS-5565 5mg QD | -1.6 |
| DS-5565 10 mg QD | -2.5 |
| DS-5565 15 mg QD | -2.4 |
| DS-5565 10 mg BID | -2.1 |
| DS-5565 15 mg BID | -2.6 |
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity. (NCT01496365)
Timeframe: Baseline up to Week 5 postdose, up to 10 months total follow up
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -0.85 |
| Pregabalin 150 mg BID | -0.84 |
| DS-5565 5mg QD | -1.00 |
| DS-5565 10 mg QD | -1.04 |
| DS-5565 15 mg QD | -0.90 |
| DS-5565 10 mg BID | -0.73 |
| DS-5565 15 mg BID | -1.02 |
The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries. Greater mean changes (improvements) in ADPS indicated better outcomes. A minimally meaningful effect was a mean decrease of at least 1.0 point [scale of 0 to 10] versus placebo. (NCT01504412)
Timeframe: Baseline to Week 7 postdose
| Intervention | units on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Baseline to Week 1 | Baseline to Week 2 | Baseline to Week 3 | Baseline to Week 4 | Baseline to Week 5 | Baseline to Week 6 | Baseline to Week 7 | |
| DS-5565 10 mg/Day | -0.69 | -1.16 | -1.32 | -1.50 | -1.62 | -1.79 | -1.82 |
| DS-5565 20 mg/Day | -0.88 | -1.21 | -1.50 | -1.65 | -1.68 | -1.78 | -1.91 |
| DS-5565 30 mg/Day | -0.60 | -1.06 | -1.35 | -1.56 | -1.47 | -1.68 | -1.75 |
| Placebo | -0.59 | -0.86 | -1.05 | -1.12 | -1.28 | -1.41 | -1.50 |
| Pregabalin | -0.71 | -0.92 | -1.06 | -1.29 | -1.44 | -1.40 | -1.55 |
"The Short Form-McGill Pain Questionnaire (SF-MPQ) Visual Analog Scale (VAS) is reported. For VAS, participants rated pain intensity on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.~Greater mean changes (improvements) in SF-MPQ indicated better outcomes." (NCT01504412)
Timeframe: at Week 7 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -16.7 |
| Pregabalin | -17.2 |
| DS-5565 10 mg/Day | -21.9 |
| DS-5565 20 mg/Day | -22.1 |
| DS-5565 30 mg/Day | -24.2 |
The reinforcing effects of cannabis were determined using a modified progressive ratio procedure in which subjects made 8 choices between puffs of each available cannabis dose and money (US$0.50). The numbered of self-administered puffs of smoked cannabis are measured for each cannabis concentration (0 and 5.9% THC) during active (300 and 450 mg) and placebo (0 mg and 0 mg) pregabalin maintenance. (NCT01511640)
Timeframe: 9 consecutive choice trials (i.e., no time out between trials) per cannabis dose level.
| Intervention | Cannabis puffs (Mean) | |
|---|---|---|
| 0% placebo Cannabis | 5.9% active Cannabis | |
| 0 mg/Day Pregabalin (Placebo 1) | 2.67 | 5.67 |
| 0 mg/Day Pregabalin (Placebo 2) | 4.00 | 4.80 |
| 300 mg/Day Pregabalin | 2.00 | 5.75 |
| 450 mg/Day Pregabalin | 3.60 | 5.40 |
"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT01524796)
Timeframe: Baseline, Month 3 Telephonic Interview
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Month 3 Telephonic Interview | |
| Pregabalin | 4.1 | -1.5 |
"Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT01524796)
Timeframe: Baseline, Month 3 Telephonic Interview
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Month 3 Telephonic Interview | |
| Pregabalin | 6.7 | -2.2 |
"Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated pain did not interfere with sleep and a score of 10 indicated pain completely interfered with sleep. Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview." (NCT01524796)
Timeframe: Baseline, Month 1, 2, 3, Month 3 telephonic interview
| Intervention | Units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n = 71) | Month 1 (n= 58) | Month 2 (n= 37) | Month 3 (n= 52) | Month 3 telephonic interview (n= 86) | |
| Pregabalin | 5.3 | 4.2 | 4.0 | 4.3 | 2.3 |
"Here, n signifies Number of participants for Baseline and Month 3 telephone interview whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview." (NCT01524796)
Timeframe: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
| Intervention | Milligram (mg) per day (Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Dose Prior To Visit: Month 1 (n= 64) | Dose Prior To Visit: Month 2 (n= 48) | Dose Prior To Visit: Month 3 (n= 48) | Dose Prior To Month 3 telephonic interview (n=86) | Dose After Visit: Baseline (n=84) | Dose After Visit: Month 1 (n= 64) | Dose After Visit: Month 2 (n= 48) | Dose After Visit: Month 3 (n= 48) | |
| Pregabalin | 107.4 | 123.4 | 164.6 | 240.7 | 81.5 | 148.4 | 145.3 | 169.3 |
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported. (NCT01524796)
Timeframe: Month 3 telephonic interview
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very Much Improved | Much Improved | Minimally Improved | No Change | Minimally Worse | Much Worse | Very Much Worse | |
| Pregabalin | 18 | 35 | 26 | 4 | 3 | 0 | 0 |
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category. (NCT01524796)
Timeframe: Before Baseline, Month 1, 2, 3 Visit
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Before Baseline Visit: No drug treatment (n= 143) | Before Baseline Visit: TCA (n= 143) | Before Baseline Visit: Gabapentin (n= 143) | Before Baseline Visit: NSAIDs (n= 143) | Before Baseline Visit: Weak Opioids (n= 143) | Before Baseline Visit: Strong Opioids (n= 143) | Before Baseline Visit: SNRIs (n= 143) | Before Baseline Visit: L/C (n= 143) | Before Baseline Visit: Other (n= 143) | Before Month 1 Visit: No drug treatment (n= 71) | Before Month 1 Visit: TCA (n= 71) | Before Month 1 Visit: Gabapentin (n= 71) | Before Month 1 Visit: NSAIDs (n= 71) | Before Month 1 Visit: Weak Opioids (n= 71) | Before Month 1 Visit: Strong Opioids (n= 71) | Before Month 1 Visit: SNRIs (n= 71) | Before Month 1 Visit: L/C (n= 71) | Before Month 1 Visit: Other (n= 71) | Before Month 2 Visit: No drug treatment (n= 60) | Before Month 2 Visit: TCA (n= 60) | Before Month 2 Visit: Gabapentin (n= 60) | Before Month 2 Visit: NSAIDs (n= 60) | Before Month 2 Visit: Weak Opioids (n= 60) | Before Month 2 Visit: Strong Opioids (n= 60) | Before Month 2 Visit: SNRIs (n= 60) | Before Month 2 Visit: L/C (n= 60) | Before Month 2 Visit: Other (n= 60) | Before Month 3 Visit: No drug treatment (n= 58) | Before Month 3 Visit: TCA (n= 58) | Before Month 3 Visit: Gabapentin (n= 58) | Before Month 3 Visit: NSAIDs (n= 58) | Before Month 3 Visit: Weak Opioids (n= 58) | Before Month 3 Visit: Strong Opioids (n= 58) | Before Month 3 Visit: SNRIs (n= 58) | Before Month 3 Visit: L/C (n= 58) | Before Month 3 Visit: Other (n= 58) | |
| Pregabalin | 5 | 14 | 33 | 25 | 35 | 18 | 6 | 1 | 6 | 23 | 11 | 2 | 5 | 17 | 11 | 0 | 1 | 1 | 14 | 13 | 2 | 4 | 14 | 10 | 2 | 0 | 1 | 12 | 13 | 0 | 4 | 16 | 12 | 0 | 0 | 1 |
"WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview." (NCT01524796)
Timeframe: Baseline, Month 1, 2, 3
| Intervention | Units on a scale (Mean) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PWP Baseline (n= 25) | PWP Month 1 (n= 25) | PWP Month 2 (n=12) | PWP Month 3 (n= 18) | PWI Baseline (n= 23) | PWI Month 1 (n= 24) | PWI Month 2 (n=11) | PWI Month 3 (n= 15) | PWPI Baseline (n= 25) | PWPI Month 1 (n= 25) | PWPI Month 2 (n=12) | PWPI Month 3 (n=19) | PAI Baseline (n= 29) | PAI Month 1 (n= 27) | PAI Month 2 (n=13) | PAI Month 3 (n= 23) | |
| Pregabalin | 28.4 | 28.7 | 17.8 | 29.9 | 70.0 | 58.2 | 48.1 | 56.3 | 63.2 | 52.0 | 45.8 | 48.9 | 68.3 | 63.7 | 55.4 | 53.0 |
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category. (NCT01524796)
Timeframe: After Baseline, Month 1, 2, 3 visit
| Intervention | Participants (Number) | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| After Baseline Visit: No drug treatment (n= 112) | After Baseline Visit: TCA (n= 112) | After Baseline Visit: Gabapentin (n= 112) | After Baseline Visit: NSAIDs (n= 112) | After Baseline Visit: Weak Opioids (n= 112) | After Baseline Visit: Strong Opioids (n= 112) | After Baseline Visit: SNRIs (n= 112) | After Baseline Visit: L/C (n= 112) | After Baseline Visit: Other (n= 112) | After Month 1 Visit: No drug treatment (n= 70) | After Month 1 Visit: TCA (n= 70) | After Month 1 Visit: Gabapentin (n= 70) | After Baseline Visit: NSAIDs (n= 70) | After Month 1 Visit: Weak Opioids (n= 70) | After Month 1 Visit: Strong Opioids (n= 70) | After Month 1 Visit: SNRIs (n= 70) | After Month 1 Visit: L/C (n= 70) | After Month 1 Visit: Other (n= 70) | After Month 2 Visit: No drug treatment (n= 60) | After Month 2 Visit: TCA (n= 60) | After Month 2 Visit: Gabapentin (n= 60) | After Month 2 Visit: NSAIDs (n= 60) | After Month 2 Visit: Weak Opioids (n= 60) | After Month 2 Visit: Strong Opioids (n= 60) | After Month 2 Visit: SNRIs (n= 60) | After Month 2 Visit: L/C (n= 60) | After Month 2 Visit: Other (n= 60) | After Month 3 Visit: No drug treatment (n= 58) | After Month 3 Visit: TCA (n= 58) | After Month 3 Visit: Gabapentin (n= 58) | After Baseline Visit: NSAIDs (n= 58) | After Month 3 Visit: Weak Opioids (n= 58) | After Month 3 Visit: Strong Opioids (n= 58) | After Month 3 Visit: SNRIs (n= 58) | After Month 3 Visit: L/C (n= 58) | After Month 3 Visit: Other (n= 58) | |
| Pregabalin | 25 | 12 | 6 | 16 | 24 | 17 | 5 | 0 | 7 | 23 | 14 | 0 | 1 | 15 | 15 | 0 | 1 | 1 | 13 | 15 | 1 | 4 | 16 | 9 | 2 | 0 | 0 | 13 | 13 | 0 | 3 | 15 | 13 | 0 | 0 | 1 |
"Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, n signifies Number of participants for Baseline whereas n signifies number of observations for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview." (NCT01524796)
Timeframe: Baseline, Month 1, 2, 3
| Intervention | Units on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline (n= 104) | Month 1 (n= 81) | Month 2 (n= 52) | Month 3 (n= 64) | |
| Pregabalin | 0.47 | 0.58 | 0.58 | 0.63 |
"Pain was assessed on an 11-point NRS where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT01524796)
Timeframe: Baseline, Month 3 Telephonic Interview
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Baseline | Change at Month 3 Telephonic Interview | |
| Pregabalin | 8.4 | -2.1 |
"The worst pain reported at the end of the week for the overall week (New aches and pains at their worst over the past week) are reported below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not. The worst pain reported at the end of the week for the overall week (item 2 appendix V: Please rate any aches/pains that you have by circling ONE number that best describes your aches/pains at its worst over the last week.) Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)." (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Pregabalin) | 2.4 |
| Arm II (Placebo) | 4.7 |
The percentage of patients taking opioid medications are reported below by arm. (NCT01637077)
Timeframe: From treatment initiation to 6 months.
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 15.8 |
| Arm II (Placebo) | 18.2 |
"Average Area Under the Curve per assessment (aAUCpa) of worst, average, and least pain (items 1-3 app. IV; Please rate any aches/pains that are NEW since your last dose of paclitaxel, and that you think might be related to your chemotherapy treatment by circling ONE number that best describes your aches/pains at its WORST in the last 24 hours., Please rate the same aches/pains by circling the ONE number that best describes your aches/pains at its LEAST in the last 24 hours., Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment from treatment-initiation to the day-6 assessment." (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | average(subscale value*assessment) (Mean) | ||
|---|---|---|---|
| Worst pain over the past 24 hours | Average pain over the past 24 hours | Least pain over the past 24 hours | |
| Arm I (Pregabalin) | 80.7 | 82.8 | 82.6 |
| Arm II (Placebo) | 82.6 | 86.8 | 91.3 |
"Maximum of average pain scores over 6 days following initiation of treatment. Average pain over the first 6 days following treatment initiation. Maximum of the average pain scores (item 3, appendix IV; Please rate the same aches/pain by circling the ONE number that best describes your aches/pains on the AVERAGE in the last 24 hours.) over the period from treatment initiation to day 7 (for cycle 1). Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be)." (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Pregabalin) | 2.6 |
| Arm II (Placebo) | 2.2 |
"The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either unrelated or unlikely to be related to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below." (NCT01637077)
Timeframe: Baseline, day 8 prior to each paclitaxel course, and then every 30 days for 6 months after completion of study treatment
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 2.2 |
| Arm II (Placebo) | 0 |
The percentage of patients who report the development of new aches/pains that they attribute to paclitaxel in the first week of chemotherapy are reported by arm below. (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 23.5 |
| Arm II (Placebo) | 59.1 |
"The percentage of patients who report, at week's end, using non-prescription pain medications (Have you used non-prescription meds like aspirin, Tylenol, Motrin, Ibuprofen, or Advil over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not." (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 66.7 |
| Arm II (Placebo) | 60. |
"The percentage of patients who report, at week's end, using opioids (Have you used opioids like codeine, oxycodone, or morphine for this pain over the past week?) are reported by arm below. This question was only supposed to be answered by patients who responded yes to the first question. Currently, all responses are included, regardless of whether the patient should've responded or not." (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 0 |
| Arm II (Placebo) | 26.7 |
The percentage of patients who use non-prescription pain medications are reported by arm below. (NCT01637077)
Timeframe: From treatment initiation to 6 months.
| Intervention | percentage of patients (Number) |
|---|---|
| Arm I (Pregabalin) | 52.6 |
| Arm II (Placebo) | 50 |
Worst of the pain scores for the week following the first cycle of paclitaxel administration, as measured by a question on the daily post-paclitaxel questionnaire. Worst pain over the first 6 days following treatment initiation. Higher scores represent more pain (0: No aches or pains -10: Aches or pains as bad as can be). (NCT01637077)
Timeframe: From treatment initiation to 6 days following treatment initiation; up to 7 days
| Intervention | units on a scale (Mean) |
|---|---|
| Arm I (Pregabalin) | 2.6 |
| Arm II (Placebo) | 3.2 |
Average Area Under the Curve per assessment (aAUCpa) of EORTC Chemotherapy-Induced Peripheral Neurophathy Module (EORTC QLQ-CIPN20) Sensory, Autonomic, and Motor Neuropathy Subscales. The EORTC CIPN20 scoring algorithm was used for the sensory (items 31-36, 39, 40 and 48), motor (items 37, 38, 41-45, 49), and autonomic (items 46, 47, 50) subscale scores on a 0-100 scale, with higher scores represent fewer symptoms (better QOL). The aAUCpa for each subscale is calculated as the average of each AUC between each sequential assessment from treatment-initiation to the 6-month assessment. For example; for each patient and each subscale, the subscale values at treatment-initiation and assessment-1 are used to calculate an Area Under the Curve (AUC) for that assessment time-period. Then these AUCs for all available assessment time-periods up to 6-months are averaged to yield the aAUCpa per patient per subcale. (NCT01637077)
Timeframe: From treatment initiation to 6 months.
| Intervention | average(subscale value*assessment) (Mean) | ||
|---|---|---|---|
| Sensory | Autonomic | Motor | |
| Arm I (Pregabalin) | 88.4 | 88.4 | 92.0 |
| Arm II (Placebo) | 84.5 | 88.6 | 90.2 |
A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale. (NCT01701362)
Timeframe: Week 15
| Intervention | Units on a scale (Least Squares Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Mobility | Self-care | Usual activities | Pain/Discomfort | Anxiety/Depression | Dolan 1997 Index Score | Dolan 2001 Index Score | |
| Placebo | -0.09 | -0.06 | -0.13 | -0.29 | -0.02 | 0.11 | -0.12 |
| Pregabalin | -0.10 | -0.08 | -0.12 | -0.35 | 0.01 | 0.12 | -0.13 |
"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours." (NCT01701362)
Timeframe: Week 15
| Intervention | Units on a scale (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sleep Disturbance Score (N = 257, 245) | Sleep Adequancy Score (N=257, 245) | Snoring Score (N = 257, 245) | Awaken Short of Breath Score (N = 257, 245) | Quantity of Sleep Score (hours) (N = 257, 245) | Somnolence Score (N = 257, 245) | Sleep Problem Index (9) Score (N = 257, 245) | Optimal Sleep Score (N = 256, 245) | |
| Placebo | -11.24 | 8.16 | -3.27 | -3.03 | 0.26 | -3.74 | -8.19 | 0.04 |
| Pregabalin | -14.71 | 10.13 | -2.22 | -3.61 | 0.42 | -1.61 | -9.86 | 0.11 |
"BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.~It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).~The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores." (NCT01701362)
Timeframe: Week 15
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -1.72 |
| Placebo | -1.33 |
A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale. (NCT01701362)
Timeframe: Week 15
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | Very much worse | |
| Placebo | 41 | 79 | 62 | 51 | 9 | 4 | 0 |
| Pregabalin | 52 | 105 | 61 | 34 | 5 | 0 | 1 |
MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable. (NCT01701362)
Timeframe: Week 15
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Any Improvements | No Change | Any Worsening | Not applicable | |
| Placebo | 18.5 | 60.8 | 13.2 | 7.5 |
| Pregabalin | 21.2 | 66.1 | 6.2 | 6.6 |
Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain. (NCT01701362)
Timeframe: Week 15
| Intervention | Percentage of participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (N = 260, 258) | Week 2 (N = 254, 244) | Week 3 (N = 252, 245) | Week 4 (N = 246, 229) | Week 5 (N = 241, 226) | Week 6 (N = 244, 227) | Week 7 (N = 240, 216) | Week 8 (N = 236, 213) | Week 9 (N = 232, 214) | Week 10 (N = 229, 212) | Week 11 (N = 231, 211) | Week 12 (N = 227, 209) | Week 13 (N = 226, 204) | Week 14 (N = 223, 208) | Week 15 (N = 196, 187) | |
| Placebo | 5.04 | 20.08 | 30.20 | 34.50 | 38.05 | 41.41 | 43.06 | 46.48 | 47.66 | 47.17 | 51.18 | 52.63 | 54.41 | 54.33 | 58.29 |
| Pregabalin | 11.92 | 27.17 | 38.89 | 41.87 | 45.64 | 48.77 | 49.58 | 50.42 | 50.86 | 52.84 | 52.38 | 54.63 | 57.08 | 57.40 | 57.65 |
Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain. (NCT01701362)
Timeframe: Week 15
| Intervention | Percentage of participants (Number) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 (N = 260, 258) | Week 2 (N = 254, 244) | Week 3 (N = 252, 245) | Week 4 (N = 246, 229) | Week 5 (N = 241, 226) | Week 6 (N = 244, 227) | Week 7 (N= 240, 216) | Week 8 (N = 236, 213) | Week 9 (N = 232, 214) | Week 10 (N = 229, 212) | Week 11 (N = 231, 211) | Week 12 (N = 227, 209) | Week 13 (N = 226, 204) | Week 14 (N = 223, 208) | Week 15 (N = 196, 187) | |
| Placebo | 2.33 | 6.97 | 13.47 | 17.90 | 19.47 | 22.91 | 22.22 | 27.70 | 26.17 | 26.42 | 25.59 | 26.79 | 27.45 | 29.81 | 34.22 |
| Pregabalin | 4.62 | 11.42 | 22.62 | 25.20 | 28.22 | 29.51 | 30.42 | 33.05 | 34.05 | 32.75 | 34.20 | 37.89 | 35.84 | 37.67 | 39.80 |
A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome. (NCT01701362)
Timeframe: Week 15
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.40 |
| Placebo | -1.95 |
"This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10." (NCT01701362)
Timeframe: up to Week 15
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.12 |
| Placebo | -1.90 |
"This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10." (NCT01701362)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 6.41 |
| Placebo | 6.54 |
"MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.~Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.~Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.~Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.~Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours." (NCT01701362)
Timeframe: Baseline
| Intervention | Units on a scale (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Sleep Disturbance Score (N = 274, 265) | Sleep Adequancy Score (N = 274, 265) | Snoring Score (N = 272, 263) | Awaken Short of Breath Score (N = 274, 265) | Quantity of Sleep Score (hours) (N = 273, 265) | Somnolence Score (N = 274, 265) | Sleep Problem Index (9) Score (N = 274, 265) | Optimal Sleep Score (N = 273, 265) | |
| Placebo | 43.75 | 40.0 | 20.0 | 0.0 | 6.0 | 26.67 | 41.11 | 0.0 |
| Pregabalin | 42.50 | 40.0 | 20.0 | 0.0 | 6.0 | 26.67 | 40.56 | 0.0 |
"This is an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.~Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.~Overall is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks." (NCT01701362)
Timeframe: up to Week 15
| Intervention | units on a scale (Mean) | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline (raw scores) (N = 274, 265) | Week 1 (N = 260, 258) | Week 2 (N = 254, 244) | Week 3 (N = 252, 245) | Week 4 (N = 245, 229) | Week 5 (N = 241, 226) | Week 6 (N = 244, 227) | Week 7 (N = 240, 216) | Week 8 (N = 236, 212) | Week 9 (N = 232, 214) | Week 10 (N = 229, 212) | Week 11 (N = 230, 211) | Week 12 (N = 227, 209) | Week 13 (N = 225, 204) | Week 14 (N = 222, 208) | Week 15 (N = 196, 186) | Overall (N = 269, 262) | |
| Placebo | 4.99 | -0.28 | -0.81 | -1.14 | -1.30 | -1.40 | -1.46 | -1.50 | -1.52 | -1.55 | -1.55 | -1.64 | -1.68 | -1.70 | -1.79 | -1.83 | -1.37 |
| Pregabalin | 4.97 | -0.66 | -1.15 | -1.55 | -1.73 | -1.87 | -1.94 | -2.01 | -2.05 | -2.09 | -2.04 | -2.09 | -2.17 | -2.19 | -2.19 | -2.13 | -1.83 |
Aetauurine was the amount excreted in urine over the dosing interval tau (12 hours). It was calculated as the sum of (urine concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Here, sample volume was based on the ratio of volume weight and density. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mg (Geometric Mean) |
|---|---|
| Pregabalin | 133.1 |
Tmax (breast milk) was time of the maximum observed breast milk concentration Day 3 post-dose. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
| Intervention | hr (Median) |
|---|---|
| Pregabalin | 4.63 |
The terminal half-life for breast milk (t1/2 [breast milk]) was the time measured for breast milk concentration to decrease by one-half. For the first 5 participants enrolled under protocol amendment dated: 18 Sep 2012, breast milk was collected up to 24 hours after Day 3 dosing over the following time intervals: 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24 hours. Terminal half-life was determined over those points characterizing the elimination phase. For the remaining 5 participants, there were 3 additional collection intervals (24 to 32, 32 to 40, 40 to 48 hours) for characterizing the terminal elimination phase. The t1/2 (breast milk) is based on the terminal elimination phase time points from this timeframe. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
| Intervention | hr (Mean) |
|---|---|
| Pregabalin | 8.117 |
Renal clearance (CLr) was the volume of plasma from which the drug was completely removed by the kidney in a given amount of time. It was calculated by dividing Aetauurine (sum of [urine concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) with the plasma AUCtau, where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Urine: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8 and 8 to 12 hours post-dose on Day 3
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Pregabalin | 68.16 |
Plasma decay half-life (t1/2) was the time for the plasma concentration to decrease by one-half. The t1/2 is based on the terminal elimination phase time points from this timeframe. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
| Intervention | hr (Mean) |
|---|---|
| Pregabalin | 5.624 |
Percentage of dose excreted in breast milk during the dosing interval tau (Aetaubm percent) was calculated by using the formula: 100*(Aetaubm [sum of {breast milk concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by dose), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | percentage of dose (Geometric Mean) |
|---|---|
| Pregabalin | 0.1913 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. (NCT01727791)
Timeframe: Baseline up to 28 days after last dose of study drug
| Intervention | participants (Number) | |
|---|---|---|
| Number of Participants with AEs | Number of Participants with SAEs | |
| Pregabalin | 8 | 0 |
Tmax was the time to peak concentration in plasma post Day 3 dose. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
| Intervention | hr (Median) |
|---|---|
| Pregabalin | 2.01 |
MPAUCtau was the ratio of AUCtau (breast milk) to AUCtau (plasma), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | ratio (Mean) |
|---|---|
| Pregabalin | 0.769 |
Percent of dose recovered in urine during the dosing interval tau (Aetauurine percent) was calculated as 100* (Aetau [sum of {urine concentration * sample volume} for each collection interval from 0 to 12 hours post-dose] divided by the dose), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | percentage of dose (Geometric Mean) |
|---|---|
| Pregabalin | 88.6 |
The following parameters were analyzed for laboratory abnormalities: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume [MCV], mean corpuscular hemoglobin [MCH], mean corpuscular hemoglobin concentration [MCHC], platelets, white blood cell count, lymphocytes, total neutrophils, basophils, eosinophils, monocytes); liver function (bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, albumin); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, bicarbonate); clinical chemistry (glucose); urinalysis (urine pH, glucose, ketones, protein, urine blood/hemoglobin, nitrite). (NCT01727791)
Timeframe: Baseline up to 28 days after last dose of study drug
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 4 |
Milk to plasma ratio for maximum observed concentration (MPCmax) was calculated as the ratio of Cmax (breast milk) to Cmax (plasma). (NCT01727791)
Timeframe: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
| Intervention | ratio (Mean) |
|---|---|
| Pregabalin | 0.5413 |
The following parameters were analyzed for examination of vital signs: electrocardiogram (ECG), systolic and diastolic blood pressure, temperature, pulse rate, respiratory rate, radial pulse and body temperature. (NCT01727791)
Timeframe: Baseline up to 28 days after last dose of study drug
| Intervention | participants (Number) |
|---|---|
| Pregabalin | 0 |
Cmin was the minimum observed plasma concentration of a drug after post Day 3 dose. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| Pregabalin | 1.246 |
Cmax was the peak concentration in plasma post Day 3 dose. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12, 18, 24 hours post-dose on Day 3
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| Pregabalin | 4.67 |
Cmax (breast milk) was the maximum observed concentration in breast milk post Day 3 dose. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 hours post-dose on Day 3
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| Pregabalin | 2.474 |
Infant dose expressed as percentage of body weight normalized maternal dose (BWNIDPCM) was the relative infant dose (relative to maternal dose) calculated by the formula: 100 * BWNID (Body Weight Normalized Infant Dose) / Body Weight Normalized Maternal Dose (BWNMD), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose to 24 hours post-dose on Day 3
| Intervention | percentage of dose (Mean) |
|---|---|
| Pregabalin | 7.341 |
Ae24bm was the daily amount of pregabalin excreted in breast milk. It was calculated by the formula: 2 * Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mcg (Mean) |
|---|---|
| Pregabalin | 664.6 |
Breast milk clearance (CLbm) was calculated by dividing Aetaubm (sum of [breast milk concentration * sample volume] for each collection interval from 0 to 12 hours post-dose) by plasma AUCtau, where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mL/min (Geometric Mean) |
|---|---|
| Pregabalin | 0.1473 |
Body weight normalized maternal dose (BWNMD) was calculated as the maternal dose in microgram per day (mcg/day) divided by maternal weight in kilogram (kg) at screening. (NCT01727791)
Timeframe: Pre-dose to 24 hours post-dose on Day 3
| Intervention | mcg/kg/day (Mean) |
|---|---|
| Pregabalin | 4343.6 |
Body weight normalized infant dose (BWNID) of pregabalin was the dose that an infant received from breast-feeding and was calculated from the milk to plasma AUCtau ratio multiplied by the average maternal plasma pregabalin concentration (Cav) multiplied by the standardized milk consumption for an infant (150 milliliter/kilogram/day [mL/kg/day]), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Plasma: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3. Breast milk: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mcg/kg/day (Mean) |
|---|---|
| Pregabalin | 317.3 |
Average plasma concentration during the dosing interval (Cav) was calculated by dividing AUCtau (plasma) with tau, where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
| Intervention | mcg/mL (Geometric Mean) |
|---|---|
| Pregabalin | 2.709 |
Average breast milk concentration during the dosing interval (Cav) was calculated by dividing AUCtau (breast milk) with tau, where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mcg/mL (Mean) |
|---|---|
| Pregabalin | 2.116 |
AUCtau (breast milk) was the area under the curve for breast milk, from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mcg*hr/mL (Geometric Mean) |
|---|---|
| Pregabalin | 24.64 |
Area under the plasma concentration-time profile from time 0 to tau (AUCtau), where tau was the dosing interval of 12 hours. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
| Intervention | microgram*hour/milliliter (mcg*hr/mL) (Geometric Mean) |
|---|---|
| Pregabalin | 32.50 |
Apparent oral clearance (CL/F) was calculated by dividing dose by the AUCtau, where tau was the dosing interval of 12 hours. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0.5, 1, 2, 3, 4, 6, 10, 12 hours post-dose on Day 3
| Intervention | mL/minute (Geometric Mean) |
|---|---|
| Pregabalin | 76.90 |
Aetaubm was the amount excreted in breast milk over the dosing interval tau (12 hours). It was calculated as the sum of (breast milk concentration * sample volume) for each collection interval from 0 to 12 hours post-dose, where tau was the dosing interval of 12 hours. Sample volume was based on ratio of volume weight and density. (NCT01727791)
Timeframe: Pre-dose on Day 3; 0 to 2, 2 to 4, 4 to 8, 8 to 12 hours post-dose on Day 3
| Intervention | mcg (Geometric Mean) |
|---|---|
| Pregabalin | 286.9 |
"All PGTC seizures experienced during treatment phase were recorded by the participants or their parents/legal guardian in a daily seizure diary. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. For log-transformation, the quantity 1 was added to the 28-day seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (28-day seizure rate +1)." (NCT01747915)
Timeframe: Day 1 up to Week 12
| Intervention | Seizure per 28 days (Least Squares Mean) |
|---|---|
| Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | 1.17 |
| Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | 1.13 |
| Placebo | 1.14 |
Percentage of participants with 50% or greater reduction from baseline in 28-day seizure rate during the 12 week double blind treatment phase were reported. 28-day seizure rate for all PGTC seizures= ([number of seizures in the double blind treatment phase] divided by [number of days in double blind treatment phase minus {-} number of missing diary days in treatment phase])*28. (NCT01747915)
Timeframe: Day 1 up to Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 5 mg/kg/Day or 7 mg/kg/Day or 300 mg/Day | 41.3 |
| Pregabalin 10 mg/kg/Day or 14 mg/kg/Day or 600 mg/Day | 38.9 |
| Placebo | 41.7 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated. (NCT01773993)
Timeframe: From Week 1 to 52 weeks
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 6 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated. (NCT01773993)
Timeframe: From Week 1 to 52 weeks
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 5 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01773993)
Timeframe: From Week 1 to 52 weeks at maximum
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 25.45 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01773993)
Timeframe: From Week 1 to 52 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 3.41 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician. (NCT01773993)
Timeframe: From Week 1 to52 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.20 |
The patient's impression (patient global impression of change [PGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale. (NCT01773993)
Timeframe: At Week 52
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 34 | 79 | 119 | 65 | 6 | 3 | 1 | 109 |
"JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient's health. It consists of three linked sets of domains: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for function (ranged from 0 to 90) was divided by 3 and the summed score for symptoms (ranged from 0 to 100) was divided by 2. The summed score for overall impact (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation." (NCT01773993)
Timeframe: At Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -15.2 |
The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation. (NCT01773993)
Timeframe: Baseline and at Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -1.4 |
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated. (NCT01773993)
Timeframe: From Week 1 to 52 weeks
| Intervention | Participants (Number) |
|---|---|
| LYRICA Capsules (Pregabalin) | 65 |
FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation. (NCT01773993)
Timeframe: At Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -5.2 |
"Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives no problems, some problems, or extreme problems. For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation." (NCT01773993)
Timeframe: Baseline and at Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | 0.1 |
The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation. (NCT01773993)
Timeframe: Baseline and at Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -2.4 |
The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation. (NCT01773993)
Timeframe: Baseline and at Week 52
| Intervention | Units on a scale (Mean) |
|---|---|
| LYRICA Capsules (Pregabalin) | -3.4 |
The physician's impression (clinical global impression of change [CGIC]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale. (NCT01773993)
Timeframe: At Week 52
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Markedly improved | Improved | Slightly improved | Unchanged | Slightly worsened | Worsened | Markedly worsened | Not assessed | |
| LYRICA Capsules (Pregabalin) | 45 | 105 | 121 | 59 | 4 | 2 | 1 | 72 |
Length of stay in days after surgical procedure (NCT01801189)
Timeframe: Days in hospital following surgical procedure, up to 5 days
| Intervention | Days (Mean) |
|---|---|
| Pregabalin | 2.19 |
| Sugar Pill | 2.24 |
(NCT01801189)
Timeframe: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
| Intervention | MME (Mean) | ||
|---|---|---|---|
| POD 0 | POD 1 | POD 2 | |
| Pregabalin | 13.76 | 40.89 | 33.62 |
| Sugar Pill | 17.32 | 46.63 | 29.74 |
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | percentage of participants (Number) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 5 - very much improved(n=84, 82) | Week 5 - much worse(n=84, 82) | Week 5 - much improved(n=84, 82) | Week 5 - minimally improved(n=84, 82) | Week 5 - no change(n=84, 82) | Week 5 - minimally worse(n=84, 82) | Week 5 - very much worse(n=84, 82) | Week 5 - missing(n=84, 82) | Week 10 - very much improved(n=81, 76) | Week 10 - much improved(n=81, 76) | Week 10 - minimally improved(n=81, 76) | Week 10 - no change(n=81, 76) | Week 10 - minimally worse(n=81, 76) | Week 10 - much worse(n=81, 76) | Week 10 - very much worse(n=81, 76) | Week 10 - missing(n=81, 76) | |
| Arm A | 11.9 | 44.0 | 31.0 | 8.3 | 4.8 | 0.0 | 0.0 | 0.0 | 25.9 | 46.9 | 21.0 | 4.9 | 0.0 | 1.2 | 0.0 | 0.0 |
| Arm B | 12.2 | 43.9 | 32.9 | 9.8 | 1.2 | 0.0 | 0.0 | 0.0 | 31.6 | 51.3 | 15.8 | 0.0 | 1.3 | 0.0 | 0.0 | 0.0 |
"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain." (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Arm B | 1.42 |
"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain." (NCT01838044)
Timeframe: Baseline and Week 5
| Intervention | Units on a scale (Mean) |
|---|---|
| Arm A | -2.18 |
| Arm B | -2.03 |
"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain." (NCT01838044)
Timeframe: Baseline and Week 10
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Arm A | -3.21 |
| Arm B | -3.45 |
The PGIC is a single-item, self-rated instrument that measures change in the patient's overall status since starting study medication on a scale from 1 (very much improved) to 7 (very much worse), where lower scores indicate greater improvement. This scale was administered at Visit 4 and Visit 6. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Week 5 (n=84, 82) | Week 10 (n=81, 76) | |
| Arm A | 2.69 | 2.31 |
| Arm B | 2.64 | 2.11 |
The HADS is a self-administered questionnaire measuring anxiety. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No anxiety, to 3 = Severe feelings of anxiety). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the anxiety. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Week 5 (n=84, 82) | Week 10 (n=81, 76) | |
| Arm A | -2.23 | -3.09 |
| Arm B | -1.91 | -2.68 |
BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the past 24 hours. The Pain severity domain: The BPI severity domain includes pain at its 'worst,' 'least,' 'average,' and 'now' (current pain) on 0-10 NRS scales and takes the mean of these 4 items. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine), therefore higher scores indicate greater pain severity. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Week 5 (n=84, 82) | Week 10 (n=81, 76) | |
| Arm A | -1.75 | -2.83 |
| Arm B | -1.68 | -2.99 |
The BSW consists of 3, single-item measures designed to capture the participant's perception of the effect of treatment in terms of the relative benefit, their satisfaction, and their intention or willingness to continue on therapy. The BSW was administered by the investigator or designated site personnel in the local language as a standardized interview during the follow-up visits. The BSW can potentially be self-administered; however, this method of administration has not been tested. Participants completed this questionnaire at Visit 4 and Visit 6. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Percentage of participants (Number) | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Benefit from Treatment - No benefit (Week 5) | Benefit from Treatment - Little benefit (Week 5) | Benefit from Treatment - Much benefit (Week 5) | Satisfaction from Treatment - DVN (Week 5) - Yes | Satisfaction from Treatment - DVN (Week 5) - No | A Little Satisfied (Week 5) | Very Satisfied (Week 5) | A Little Dissatisfied (Week 5) | Very Dissatisfied (Week 5) | Willingness to Continue - DVN (Week 5) - Yes | Willingness to Continue - DVN (Week 5) - No | A Little Bit Willing (Week 5) | Very Willing (Week 5) | A Little Unwilling (Week 5) | Very Unwilling (Week 5) | Benefit from Treatment - No benefit (Week 10) | Benefit from Treatment - Little benefit (Week 10) | Benefit from Treatment - Much benefit (Week 10) | Satisfaction from Treatment - DVN (Week 10) - Yes | Satisfaction from Treatment - DVN (Week 10) - No | A Little Satisfied (Week 10) | Very Satisfied (Week 10) | A Little Dissatisfied (Week 10) | Very Dissatisfied (Week 10) | Willingness to Continue - DVN (Week 10) - Yes | Willingness to Continue - DVN (Week 10) - No | A Little Bit Willing (Week 10) | Very Willing (Week 10) | A Little Unwilling (Week 10) | Very Unwilling (Week 10) | |
| Arm A | 10.1 | 22.5 | 61.8 | 78.7 | 15.7 | 20.2 | 58.4 | 12.4 | 3.4 | 94.4 | 0 | 5.6 | 88.8 | 0 | 0 | 4.5 | 14.6 | 71.9 | 83.1 | 7.9 | 9.0 | 74.2 | 5.6 | 2.2 | 88.8 | 2.2 | 4.5 | 84.3 | 0 | 2.2 |
| Arm B | 6.6 | 29.7 | 53.8 | 84.6 | 5.5 | 26.4 | 58.2 | 4.4 | 1.1 | 89.0 | 1.1 | 4.4 | 84.6 | 0 | 1.1 | 3.3 | 9.9 | 70.3 | 80.2 | 3.3 | 11.0 | 69.2 | 2.2 | 1.1 | 81.3 | 2.2 | 4.4 | 76.9 | 0 | 2.2 |
"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain." (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Yes (Week 5) | No (Week 5) | Yes (Week 10) | No (Week 10) | |
| Arm A | 25.0 | 75.0 | 42.0 | 53.4 |
| Arm B | 20.0 | 80.0 | 37.8 | 52.2 |
Period 1 indicates from Visit 2 (baseline) to Visit 4 (Week 5). Period 2 indicates from Visit 4 (Week 5) to Visit 6 (Week 10). A rating of 0 is considered no pain; 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain. (NCT01838044)
Timeframe: Period 1 and Period 2
| Intervention | % of days (Mean) | |||||
|---|---|---|---|---|---|---|
| Period 1 (n=88, 90) (Mild) | Period 2 (n=84, 81) (Mild) | Period 1 (n=88, 90) (Moderate) | Period 2 (n=84, 81) (Moderate) | Period 1 (n=88, 90) (Severe) | Period 2 (n=84, 81) (Severe) | |
| Arm A | 19.1 | 33.5 | 40.2 | 33.2 | 38.8 | 26.5 |
| Arm B | 15.3 | 25.0 | 37.6 | 44.2 | 44.8 | 21.8 |
"The Daily Sleep Interference Rating Scale (SIRS) consists of an 11-point NRS ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep [unable to sleep due to pain]). Participants described how pain had interfered with their sleep during the past 24 hours: Select the number that best describes how your pain has interfered with your sleep during the past 24 hours on a scale from 0 to 10 where 0 represents 'does not interfere with sleep' and 10 represents 'completely interferes' which means you are unable to sleep due to pain." (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Week 5(n= 85, 79) | Week 10(n=81, 75) | |
| Arm A | -2.46 | -3.69 |
| Arm B | -2.12 | -3.38 |
The MOS-Sleep Scale is a self-administered questionnaire consisting of 12 items that assess key constructs of sleep. Instrument scoring yields 7 subscales (sleep disturbance, snoring, awaken short of breath or with a headache, quantity of sleep, optimal sleep, sleep adequacy, and somnolence) as well as a 9-item overall sleep problems index. With the exception of sleep adequacy, optimal sleep, and quantity, higher scores reflect greater impairment in the MOS-Sleep subscales. Sleep Disturbance: Range=0 to 100; higher scores indicate greater sleep disturbance. Negative changes indicate improvement. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Week 5 (n= 84, 82) | Week 10 (n= 81, 76) | |
| Arm A | -21.3 | -27.1 |
| Arm B | -16.5 | -22.8 |
The HADS is a self-administered questionnaire measuring depression. Each subscale consists of 7 statements and the participants respond as to how each item applies to them on a scale of 0 to 3 (0 = No depression, to 3 = Severe feelings of depression). Separate scores are calculated for each subscale and a score (ranging from 0 to 21) is obtained for each subscale. The higher the score the more severe the depression. (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Units on a scale (Mean) | |
|---|---|---|
| Week 5 (n=84, 82) | Week 10 (n=81, 76) | |
| Arm A | -1.87 | -2.57 |
| Arm B | -1.35 | -2.01 |
"The Daily Pain diary consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain." (NCT01838044)
Timeframe: Week 5 and Week 10
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Yes (Week 5) | No (Week 5) | Yes (Week 10) | No (Week 10) | |
| Arm A | 51.1 | 48.9 | 63.6 | 31.8 |
| Arm B | 35.6 | 64.4 | 58.9 | 31.1 |
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period) (NCT01928381)
Timeframe: 3 weeks of treatment
| Intervention | Average daily pain score (Least Squares Mean) |
|---|---|
| Part 2 - Placebo | 4.24 |
| Part 2 - Pregabalin + AZD5213 | 4.41 |
| Part 2 - Pregabalin | 4.27 |
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day home diary + in clinic assessment at end of 3 week treatment) (NCT01928381)
Timeframe: 3 weeks of treatment
| Intervention | Average daily pain score (Least Squares Mean) |
|---|---|
| Part 2 - Placebo | 4.46 |
| Part 2 - Pregabalin + AZD5213 | 4.35 |
| Part 2 - Pregabalin | 4.04 |
"Participants will be asked to record their pain intensity in the evening. Participants are asked to rate how much pain they had on average in the past 24 hours. The participant scores their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. Baseline average pain scores are calculated from the averages of all scores recorded during the 3 days prior to randomization. The average pain at week 6 will be the average pain scores calculated from all pain scores measured during week 6." (NCT01939366)
Timeframe: Baseline; to End of Week 6 of the Maintenance Phase
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Cebranopadol 100 µg | -2.24 |
| Cebranopadol 300 µg | -2.28 |
| Cebranopadol 600 µg | -2.56 |
| Pregabalin | -2.79 |
| Matching Placebo | -1.55 |
"Weighted needle (pain) threshold (WNT) in the secondary flare area of capsaicin-irritated skin. The weighted needle (pain) threshold (WNT) will be determined (with regard to investigation of mechanical hyperalgesia in the secondary hyperalgesia zone around the primary capsaicin application zone) by fixed weight steps - contact made by rounded needle tip to skin (ranging from 1 mN to 512 mN)." (NCT02037165)
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | millinewton (mN) (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -1:20h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 150 mg Pregabalin (Prega) | 347.12 | 301.48 | 280.38 | 254.70 | 265.51 | 255.45 | 266.83 | 273.42 | 330.26 | 340.76 |
| 200 mg BI 1026706 | 369.98 | 285.78 | 262.20 | 225.48 | 222.66 | 235.15 | 228.09 | 234.30 | 274.92 | 277.38 |
| 50 mg BI 1026706 | 366.65 | 295.65 | 285.35 | 287.94 | 265.58 | 265.77 | 270.27 | 281.21 | 313.77 | 312.85 |
| Placebo | 348.72 | 312.88 | 290.28 | 269.70 | 274.30 | 268.38 | 261.50 | 292.30 | 331.76 | 323.38 |
"Single peripheral N2-component amplitudes - measured in capsaicin-irritated skin type." (NCT02037165)
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | µv (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -1:20h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 150 mg Pregabalin (Prega) | 10.99 | 12.17 | 12.03 | 12.18 | 12.51 | 10.86 | 11.49 | 12.03 | 11.77 | 11.35 |
| 200 mg BI 1026706 | 9.27 | 12.17 | 11.50 | 12.36 | 13.39 | 12.63 | 12.84 | 12.27 | 11.53 | 11.70 |
| 50 mg BI 1026706 | 9.65 | 12.73 | 11.43 | 11.85 | 12.71 | 13.54 | 13.01 | 12.27 | 12.84 | 11.71 |
| Placebo | 10.42 | 13.95 | 13.70 | 13.77 | 13.44 | 13.52 | 12.93 | 12.36 | 13.59 | 13.18 |
"Single central P2-component amplitudes - measured in UVB-irradiated skin type." (NCT02037165)
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | µv (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| UVB, at -2:05h | UVB, at 0:30h | UVB, at 1:00h | UVB, at 2:00h | UVB, at 3:00h | UVB, at 4:00h | UVB, at 5:00h | UVB, at 6:00h | UVB, at 22:00h | UVB, at 24:00h | |
| 200 mg BI 1026706 | 14.68 | 12.18 | 13.32 | 13.97 | 14.44 | 14.49 | 13.87 | 13.74 | 15.57 | 14.40 |
| 200 mg Celecoxib (Cele) | 12.90 | 12.98 | 13.31 | 12.65 | 12.44 | 12.10 | 12.03 | 12.73 | 16.07 | 13.36 |
| 50 mg BI 1026706 | 13.31 | 14.23 | 12.69 | 13.88 | 14.08 | 14.49 | 13.23 | 12.61 | 15.40 | 15.09 |
| Placebo | 14.59 | 14.06 | 13.03 | 12.34 | 13.40 | 14.01 | 14.54 | 14.71 | 15.77 | 15.43 |
"Single central P2-component amplitudes - measured in capsaicin-irritated skin type." (NCT02037165)
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | µv (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -1:20h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 150 mg Pregabalin (Prega) | 11.45 | 13.03 | 12.77 | 12.65 | 11.94 | 11.90 | 11.51 | 11.27 | 11.38 | 11.24 |
| 200 mg BI 1026706 | 10.30 | 13.18 | 11.61 | 12.62 | 12.74 | 12.63 | 12.47 | 11.78 | 12.00 | 12.21 |
| 50 mg BI 1026706 | 8.88 | 12.27 | 12.24 | 12.09 | 12.97 | 13.20 | 12.79 | 11.87 | 11.62 | 11.24 |
| Placebo | 10.75 | 13.83 | 14.25 | 14.20 | 14.25 | 14.01 | 13.32 | 13.41 | 13.16 | 11.65 |
"Electronic Visual Analogue Scale (100mm VAS Post Laser Pain scales) - measured in the UVB-irradiated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'." (NCT02037165)
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | units on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -2:05h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 200 mg BI 1026706 | 30.16 | 32.24 | 37.16 | 46.88 | 55.52 | 62.04 | 65.48 | 66.60 | 57.76 | 61.13 |
| 200 mg Celecoxib (Cele) | 35.08 | 38.00 | 38.28 | 44.00 | 52.72 | 56.68 | 56.52 | 56.48 | 59.28 | 61.96 |
| 50 mg BI 1026706 | 28.42 | 32.46 | 36.67 | 42.92 | 53.25 | 56.33 | 63.71 | 65.46 | 57.13 | 61.96 |
| Placebo | 30.40 | 39.24 | 41.48 | 50.56 | 56.40 | 62.16 | 66.60 | 69.24 | 61.68 | 65.00 |
"Electronic Visual Analogue Scale (100mm VAS Post Laser Pain scales) - measured in the capsaicin-irritated skin type, where 0mm = 'no pain' and 100mm = 'severe pain'." (NCT02037165)
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | units on a scale (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -1:20h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 150 mg Pregabalin (Prega) | 22.60 | 31.28 | 32.80 | 32.16 | 37.16 | 40.92 | 43.92 | 41.56 | 36.32 | 37.80 |
| 200 mg BI 1026706 | 20.36 | 27.92 | 33.76 | 36.92 | 44.52 | 48.40 | 47.56 | 47.00 | 39.48 | 38.60 |
| 50 mg BI 1026706 | 16.79 | 25.96 | 30.08 | 32.79 | 38.79 | 41.79 | 44.29 | 47.21 | 34.29 | 36.83 |
| Placebo | 18.64 | 30.64 | 35.48 | 39.52 | 46.44 | 47.48 | 49.16 | 50.48 | 38.52 | 39.92 |
"Single peripheral N2-component amplitudes - measured in UVB-irradiated skin type." (NCT02037165)
Timeframe: up to 24 hours(h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | µv (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -2:05h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 200 mg BI 1026706 | 14.25 | 12.70 | 13.45 | 15.06 | 14.58 | 16.95 | 16.93 | 15.30 | 18.93 | 18.58 |
| 200 mg Celecoxib (Cele) | 13.45 | 13.62 | 14.29 | 12.22 | 12.61 | 11.87 | 12.07 | 14.04 | 16.99 | 16.67 |
| 50 mg BI 1026706 | 12.78 | 13.77 | 14.42 | 14.90 | 16.85 | 16.92 | 16.87 | 15.51 | 17.12 | 17.74 |
| Placebo | 14.62 | 14.48 | 12.54 | 14.40 | 16.08 | 16.52 | 17.20 | 17.46 | 18.71 | 19.01 |
Overall Peak-to-Peak (PtP) N2/P2-component amplitude of (LEP) in capsaicin-irritated skin. (NCT02037165)
Timeframe: up to 24 hours(h): -1:20h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | µv (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -1:20h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 150 mg Pregabalin (Prega) | 22.44 | 25.20 | 24.80 | 24.83 | 24.46 | 22.76 | 23.00 | 23.30 | 23.15 | 22.59 |
| 200 mg BI 1026706 | 19.57 | 25.35 | 23.11 | 24.98 | 26.13 | 25.26 | 25.31 | 24.06 | 23.53 | 23.91 |
| 50 mg BI 1026706 | 18.53 | 25.00 | 23.67 | 23.94 | 25.68 | 26.74 | 25.81 | 24.14 | 24.46 | 22.94 |
| Placebo | 21.17 | 27.21 | 27.96 | 27.97 | 27.69 | 27.53 | 26.25 | 25.77 | 26.75 | 24.83 |
"Overall Peak-to-Peak (PtP) N2/P2-component amplitude of Laser (somatosensory/radiant heat) evoked potentials (LEP) in UVB-irradiated skin.~Treated set (TS)" (NCT02037165)
Timeframe: up to 24 hours (h): -2:05h, 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 22:00h, 24:00h (relative to study drug administration [h:min])
| Intervention | Microvolts (µv) (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| at -2:05h | at 0:30h | at 1:00h | at 2:00h | at 3:00h | at 4:00h | at 5:00h | at 6:00h | at 22:00h | at 24:00h | |
| 200 mg BI 1026706 | 28.93 | 24.88 | 26.77 | 29.03 | 29.02 | 31.44 | 30.79 | 29.04 | 34.50 | 32.98 |
| 200 mg Celecoxib (Cele) | 26.35 | 26.60 | 27.60 | 24.87 | 25.05 | 23.97 | 24.10 | 26.77 | 33.06 | 30.03 |
| 50 mg BI 1026706 | 26.08 | 28.00 | 27.11 | 28.78 | 30.93 | 31.40 | 30.10 | 28.12 | 32.51 | 32.83 |
| Placebo | 29.22 | 27.84 | 25.57 | 26.74 | 29.48 | 30.54 | 31.74 | 32.16 | 34.48 | 34.43 |
Neurological examinations included: coordination; cranial nerve function (CNF); gait and station; level of consciousness (LOC); lower and upper extremity sensation; muscle strength; muscle tone; nystagmus; reflexes and speech. Abnormalities in neurological examination were based on investigator's discretion and also, some components of the neurological examination were not done for certain participants due to participant age or significant developmental impairment. Only those categories of neurological examination in which at least 10% of participants had an abnormality in any treatment group at any time point were reported in this outcome measure. (NCT02072824)
Timeframe: Baseline (BL) and EOS (maximum Day 25)
| Intervention | percentage of participants (Number) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Coordination- left hand movement (BL) | Coordination-left hand movement (EOS) | Coordination- right hand movement (EOS) | Coordination- romberg test (BL) | Coordination- romberg test (EOS) | CNF- left eye visual field (BL) | CNF- left eye visual field (EOS) | CNF: right eye visual field (BL) | CNF: right eye visual field (EOS) | CNF: left fundoscopic exam (BL) | CNF: left fundoscopic exam (EOS) | CNF: right fundoscopic exam (BL) | CNF: right fundoscopic exam (EOS) | CNF: left visual acuity (BL) | CNF: left visual acuity (EOS) | CNF: right visual acuity (BL) | CNF: right visual acuity (EOS) | CNF: finger tracking (BL) | CNF: finger tracking (EOS) | CNF: swallowing (BL) | CNF: swallowing (EOS) | CNF:Left shoulder,head turn strength (BL) | CNF: Left shoulder shrug,head turn strength (EOS) | Gait and station - gait (BL) | Gait and station - gait (EOS) | Level of consciousness (BL) | Level of consciousness (EOS) | Muscle strength -lower extremities (BL) | Muscle strength -lower extremities (EOS) | Muscle strength - upper extremities (BL) | Muscle strength - upper extremities (EOS) | Muscle strength - trunk (BL) | Muscle strength - trunk (EOS) | Muscle tone - lower extremities (BL) | Muscle tone - lower extremities (EOS) | Muscle tone - upper extremities (BL) | Muscle tone - upper extremities (EOS) | Nystagmus - horizontal (BL) | Nystagmus - horizontal (EOS) | Reflexes - left ankle (BL) | Reflexes - left ankle (EOS) | Reflexes - right ankle (BL) | Reflexes - right ankle (EOS) | Reflexes - left babinski (BL) | Reflexes - left babinski (EOS) | Reflexes - right babinski (BL) | Reflexes - right babinski (EOS) | Reflexes - left biceps (BL) | Reflexes - left biceps (EOS) | Reflexes - right biceps (BL) | Reflexes - right biceps (EOS) | Reflexes - left brachioradialis (BL) | Reflexes - left brachioradialis (EOS) | Reflexes - right brachioradialis (BL) | Reflexes - right brachioradialis (EOS) | Reflexes - left knee (BL) | Reflexes - left knee (EOS) | Reflexes - right knee (BL) | Reflexes - right knee (EOS) | Reflexes - left triceps (BL) | Reflexes - left triceps (EOS) | Reflexes - right triceps (BL) | Reflexes - right triceps (EOS) | Speech - articulation (BL) | Speech - articulation (EOS) | Speech - language (BL) | Speech - language (EOS) | |
| Placebo | 8.6 | 10.1 | 10.1 | 10.0 | 11.6 | 10.0 | 10.1 | 10.0 | 10.1 | 12.9 | 14.5 | 14.3 | 14.5 | 12.9 | 13.0 | 11.4 | 11.6 | 24.3 | 26.1 | 14.3 | 14.5 | 7.1 | 10.1 | 45.7 | 46.4 | 5.7 | 2.9 | 51.4 | 53.6 | 50.0 | 52.2 | 44.3 | 42.0 | 63.8 | 66.2 | 63.8 | 66.2 | 7.1 | 5.8 | 47.1 | 46.4 | 47.1 | 46.4 | 47.1 | 47.8 | 50.0 | 50.7 | 50.0 | 49.3 | 52.9 | 52.2 | 48.6 | 47.8 | 50.0 | 50.7 | 57.1 | 56.5 | 61.4 | 59.4 | 45.7 | 44.9 | 48.6 | 47.8 | 45.7 | 47.8 | 65.7 | 66.7 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 11.8 | 8.8 | 5.9 | 8.8 | 5.9 | 8.8 | 8.8 | 5.9 | 5.9 | 26.5 | 23.5 | 20.6 | 17.6 | 11.8 | 11.8 | 11.8 | 11.8 | 26.5 | 23.5 | 14.7 | 14.7 | 2.9 | 2.9 | 50.0 | 52.9 | 20.6 | 20.6 | 58.8 | 58.8 | 58.8 | 58.8 | 38.2 | 38.2 | 73.5 | 73.5 | 73.5 | 73.5 | 11.8 | 11.8 | 52.9 | 52.9 | 58.8 | 58.8 | 47.1 | 47.1 | 55.9 | 55.9 | 52.9 | 52.9 | 58.8 | 58.8 | 52.9 | 52.9 | 58.8 | 58.8 | 55.9 | 58.8 | 61.8 | 64.7 | 52.9 | 52.9 | 58.8 | 58.8 | 47.1 | 44.1 | 76.5 | 73.5 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 1.4 | 1.4 | 2.8 | 2.8 | 2.8 | 12.7 | 12.7 | 12.7 | 12.7 | 12.7 | 12.7 | 11.3 | 11.3 | 11.3 | 11.3 | 11.3 | 11.3 | 22.5 | 21.1 | 14.1 | 14.1 | 11.3 | 11.3 | 52.1 | 52.1 | 5.6 | 7.0 | 49.3 | 49.3 | 47.9 | 49.3 | 43.7 | 39.4 | 64.3 | 64.8 | 64.8 | 64.8 | 9.9 | 8.5 | 46.5 | 46.5 | 46.5 | 45.1 | 42.3 | 40.8 | 42.3 | 40.8 | 47.9 | 47.9 | 46.5 | 46.5 | 45.1 | 45.1 | 43.7 | 43.7 | 53.5 | 52.1 | 52.1 | 50.7 | 46.5 | 46.5 | 45.1 | 45.1 | 53.5 | 54.9 | 69.0 | 69.0 |
Physical examinations evaluated the following body systems/organs: abdomen; ears; extremities; eyes; general appearance; head; heart; lungs; lymph nodes; mouth; musculoskeletal; nose; skin and throat. Abnormalities in physical examination were based on investigator's discretion. (NCT02072824)
Timeframe: Screening and EOS (maximum Day 25)
| Intervention | percentage of participants (Number) | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abdomen: Screening | Abdomen: EOS | Ears: Screening | Ears: EOS | Extremities: Screening | Extremities: EOS | Eyes: Screening | Eyes: EOS | General appearance: Screening | General appearance: EOS | Head: Screening | Head: EOS | Heart: Screening | Heart: EOS | Lungs: Screening | Lungs: EOS | Lymph nodes: Screening | Lymph nodes: EOS | Mouth: Screening | Mouth: EOS | Musculoskeletal: Screening | Musculoskeletal: EOS | Nose: Screening | Nose: EOS | Skin: Screening | Skin: EOS | Throat: Screening | Throat: EOS | |
| Placebo | 2.9 | 1.4 | 1.4 | 1.4 | 15.7 | 18.8 | 17.1 | 18.8 | 15.7 | 15.9 | 31.4 | 31.9 | 4.3 | 4.3 | 4.3 | 5.8 | 0 | 0 | 5.7 | 5.8 | 35.7 | 37.7 | 0 | 5.8 | 21.4 | 21.7 | 0 | 2.9 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 5.9 | 5.9 | 0 | 0 | 26.5 | 26.5 | 20.6 | 20.6 | 26.5 | 23.5 | 47.1 | 47.1 | 8.8 | 5.9 | 8.8 | 8.8 | 8.8 | 2.9 | 2.9 | 2.9 | 38.2 | 38.2 | 2.9 | 0 | 14.7 | 14.7 | 2.9 | 5.9 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 4.2 | 4.2 | 1.4 | 1.4 | 14.1 | 14.1 | 9.9 | 9.9 | 15.5 | 15.5 | 31.0 | 33.8 | 1.4 | 1.4 | 2.8 | 2.8 | 0 | 0 | 9.9 | 7.1 | 31.0 | 33.8 | 0 | 0 | 9.9 | 8.5 | 1.4 | 0 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. (NCT02072824)
Timeframe: Day 1 up to End of study (EOS) (maximum Day 25)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| AEs | SAEs | |
| Placebo | 38 | 4 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 17 | 1 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 32 | 0 |
"All partial onset seizures experienced during treatment phase were recorded by central reader during the 48 to 72 hour video-electroencephalogram (EEG). Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. For log-transformation, the quantity 1 was added to the double blind 24 hour EEG seizure rate for all participants to account for any possible 0 seizure incidence. This resulted in final calculation as: log transformed (double-blind 24-hour EEG seizure rate + 1)." (NCT02072824)
Timeframe: Day 1 up to Day 14
| Intervention | seizures per 24 hours (Least Squares Mean) |
|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 1.69 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 1.15 |
| Placebo | 1.58 |
Criteria for abnormalities in ECG findings: 1) Time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS complex): >=140 milliseconds (msec); 2) The interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval): >=200 msec; 3) Time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula (QTCF interval): absolute value 450 to <480 msec, 480 to <500 msec, >=500 msec; 4) Maximum QT interval: >=500 msec; 5) Maximum QTCB interval (Bazett's correction): 450 to< 480 msec, 480 to <500 msec, >=500 msec. Only those categories of ECG abnormalities in which participants were found abnormal (maximum QTCB interval 450-<480 msec), were reported in this outcome measure. (NCT02072824)
Timeframe: From screening up to EOS (maximum Day 25)
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 0 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 2 |
| Placebo | 0 |
Abnormality Criteria: hemoglobin,hematocrit,red blood cells(RBC)count:<0.8*lower limit of normal[LLN],platelets:<0.5*LLN/>1.75*upper limit of normal[ULN]; leukocytes:<0.6*LLN/>1.5*ULN; lymphocytes,neutrophils, total protein,albumin, tetraiodothyronine,thyroid stimulating hormone:<0.8*LLN/>1.2*ULN; basophils,eosinophils,monocytes:>1.2*ULN; prothrombin [PT],PT international ratio:>1.1*ULN; aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase,gamma glutamyl transferase:>0.3*ULN; bilirubin:>1.5*ULN; blood urea nitrogen,creatinine, cholesterol,triglycerides:>1.3*ULN; sodium: <0.95*LLN/>1.05*ULN; potassium,chloride,calcium,bicarbonate:<0.9*LLN/>1.1*ULN; glucose fasting:<0.6*LLN/>1.5*ULN; creatine kinase:>2*ULN;urine glucose,ketone,protein:>=1;urine WBC,RBC:>= 20/High Power Field[HPF]; urine casts,hyaline casts:>1/Low Power Field; urine bacteria:>20/HPF. (NCT02072824)
Timeframe: From Baseline up to EOS (maximum Day 25)
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 65 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 29 |
| Placebo | 61 |
Responder Rate was defined as percentage of participants who had a 50% or greater reduction from baseline in 24-hour seizure rate during the double-blind treatment phase. Double Blind 24 hour EEG seizure rate for all partial onset seizures = ([Number of seizures in double blind 48 to 72 hour EEG assessment] divided by [number of hours of video-EEG monitoring])*24. The EEG assessment was done at the end of the fixed dose treatment. (NCT02072824)
Timeframe: Day 1 up to Day 14
| Intervention | percentage of participants (Number) |
|---|---|
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 30.51 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 53.57 |
| Placebo | 41.51 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild: AEs does not interfere with participant's usual function b) moderate: AEs interferes to some extent with participant's usual function c) severe: AEs interferes significantly with participant's usual function. (NCT02072824)
Timeframe: Day 1 up to EOS (maximum Day 25)
| Intervention | events (Number) | ||
|---|---|---|---|
| Mild | Moderate | Severe | |
| Placebo | 67 | 19 | 0 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 23 | 13 | 0 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 60 | 3 | 0 |
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events which occurred between first dose of study drug and up to end of study (up to Day 25) that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to drug was assessed by the investigator. AEs included both serious and non-serious adverse events. (NCT02072824)
Timeframe: Day 1 up to EOS (maximum Day 25)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| AEs | SAEs | |
| Placebo | 13 | 1 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 8 | 0 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 15 | 0 |
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: maximum increase and decrease of greater than or equal to (>=) 30 millimeter of mercury (mmHg) from baseline; sitting/supine diastolic blood pressure (DBP) value: maximum increase and decrease of >=20 mmHg from baseline. (NCT02072824)
Timeframe: From Baseline (BL) up to EOS (maximum Day 25)
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| Maximum Increase from BL(>=30):sitting/supine SBP | Maximum Increase from BL(>=20):sitting/supine DBP | Maximum Decrease from BL(>=30):sitting/supine SBP | Maximum Decrease from BL(>=20):sitting/supine DBP | |
| Placebo | 1 | 3 | 1 | 1 |
| Pregabalin 14 mg/kg/Day or 12 mg/kg/Day | 0 | 1 | 0 | 2 |
| Pregabalin 7 mg/kg/Day or 6 mg/kg/Day | 2 | 7 | 1 | 2 |
"The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.~For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health." (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.0779 |
| Pregabalin 150 mg BID | 0.0712 |
| DS-5565 15 mg QD | 0.0740 |
| DS-5565 15 mg BID | 0.0696 |
Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. Higher scores indicate worse outcomes. The number of participants with 'much improved or better' status (≤2) is being reported. (NCT02146430)
Timeframe: Baseline up Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 83 |
| Pregabalin 150 mg BID | 105 |
| DS-5565 15 mg QD | 104 |
| DS-5565 15 mg BID | 82 |
Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. (NCT02146430)
Timeframe: Baseline up Week 13 postdose
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.67 |
| Pregabalin 150 mg BID | -2.22 |
| DS-5565 15 mg QD | -2.30 |
| DS-5565 15 mg BID | -2.52 |
"MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).~For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue." (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.9 |
| Pregabalin 150 mg BID | -2.0 |
| DS-5565 15 mg QD | -2.0 |
| DS-5565 15 mg BID | -1.6 |
Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported. (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.66 |
| Pregabalin 150 mg BID | -1.90 |
| DS-5565 15 mg QD | -1.97 |
| DS-5565 15 mg BID | -1.93 |
"The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.~For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment." (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -13.20 |
| Pregabalin 150 mg BID | -16.60 |
| DS-5565 15 mg QD | -14.48 |
| DS-5565 15 mg BID | -13.13 |
The MOS Sleep Scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), and sleep quantity scale (1 item) were determined. Most subscales range from 0 to 100, where higher scores indicate more of the concept begin measured (eg., higher sleep disturbance scores indicate greater sleep disturbances). (NCT02146430)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 87 |
| Pregabalin 150 mg BID | 117 |
| DS-5565 15 mg QD | 93 |
| DS-5565 15 mg BID | 109 |
Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - (date of first study drug administration + 1). (NCT02146430)
Timeframe: Week 1 to Week 13 postdose
| Intervention | proportion of days (Mean) |
|---|---|
| Placebo | 0.23 |
| Pregabalin 150 mg BID | 0.18 |
| DS-5565 15 mg QD | 0.22 |
| DS-5565 15 mg BID | 0.19 |
The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression). (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline to Week 13: Anxiety | Change from baseline to Week 13: Depression | |
| DS-5565 15 mg BID | -1.1 | -0.6 |
| DS-5565 15 mg QD | -1.0 | -0.8 |
| Placebo | -1.0 | -0.8 |
| Pregabalin 150 mg BID | -0.8 | -1.1 |
The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported. (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline to Week 13:Physical Component | Change from baseline to Week 13: Mental Component | |
| DS-5565 15 mg BID | 7.099 | 1.286 |
| DS-5565 15 mg QD | 8.598 | 1.163 |
| Placebo | 8.052 | 1.506 |
| Pregabalin 150 mg BID | 9.898 | 1.995 |
The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes. (NCT02146430)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Least Squares Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Worst pain | Least pain | Average pain | Pain right now | Severity score | Relief (%) by treatment pain | Interference (%) | General activity | Mood | Walking ability | Normal work | Relations with other people | Sleep | Enjoyment of life | |
| DS-5565 15 mg BID | 6.6 | -1.3 | -1.4 | -1.7 | -1.5 | 15.6 | -15.65 | -1.6 | -1.3 | -1.1 | -1.5 | -1.3 | -2.6 | -1.5 |
| DS-5565 15 mg QD | 6.5 | -1.3 | -1.4 | -1.7 | -1.5 | 17.1 | -15.46 | -1.6 | -1.3 | -1.1 | -1.5 | -1.3 | -2.5 | -1.6 |
| Placebo | 6.6 | -1.2 | -1.2 | -1.7 | -1.4 | 15.9 | -14.04 | -1.5 | -1.1 | -1.1 | -1.5 | -0.9 | -2.1 | -1.6 |
| Pregabalin 150 mg BID | 6.3 | -1.5 | -1.5 | -1.9 | -1.7 | 18.5 | -17.91 | -1.9 | -1.6 | -1.5 | -1.8 | -1.3 | -2.7 | -1.9 |
The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported. (NCT02146430)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 30% responders | 50% responders | |
| DS-5565 15 mg BID | 100 | 57 |
| DS-5565 15 mg QD | 106 | 71 |
| Placebo | 101 | 57 |
| Pregabalin 150 mg BID | 118 | 71 |
The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances). (NCT02187159)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 90 |
| Pregabalin 150 mg BID | 94 |
| DS-5565 15 mg QD | 101 |
| DS-5565 15 mg BID | 106 |
The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression). (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline to Week 13: Anxiety | Change from baseline to Week 13: Depression | |
| DS-5565 15 mg BID | -0.8 | -0.8 |
| DS-5565 15 mg QD | -0.7 | -1.1 |
| Placebo | -0.5 | -0.8 |
| Pregabalin 150 mg BID | -1.4 | -1.6 |
The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes. (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Worst pain | Least pain | Average pain | Pain right now | Severity score | Relief (%) by treatment of pain | Interference (%) | General activity | Mood | Walking ability | Normal work | Relations with other people | Sleep | Enjoyment of life | |
| DS-5565 15 mg BID | -2.1 | -1.6 | -1.8 | -2.2 | -1.91 | 25.9 | -18.35 | -2.1 | -1.6 | -1.4 | -1.9 | -1.2 | -3.0 | -1.7 |
| DS-5565 15 mg QD | -2.2 | -1.5 | -1.8 | -2.3 | -1.96 | 24.2 | -19.97 | -2.1 | -1.6 | -1.8 | -1.9 | -1.6 | -3.1 | -1.9 |
| Placebo | -1.7 | -1.4 | -1.5 | -1.8 | -1.59 | 20.1 | -14.79 | -1.6 | -1.3 | -1.5 | -1.6 | -1.2 | -1.9 | -1.3 |
| Pregabalin 150 mg BID | -2.6 | -1.9 | -2.1 | -2.8 | -2.33 | 31.1 | -23.76 | -2.5 | -2.2 | -2.1 | -2.3 | -1.8 | -3.3 | -2.4 |
The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported. (NCT02187159)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 30% Responders | 50% Responders | |
| DS-5565 15 mg BID | 118 | 68 |
| DS-5565 15 mg QD | 123 | 79 |
| Placebo | 113 | 61 |
| Pregabalin 150 mg BID | 139 | 90 |
The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 scale ranges from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) scores are reported. (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline to Week 13:Physical Component | Change from baseline to Week 13: Mental Component | |
| DS-5565 15 mg BID | 4.833 | 1.198 |
| DS-5565 15 mg QD | 5.000 | 1.675 |
| Placebo | 4.395 | 1.371 |
| Pregabalin 150 mg BID | 5.815 | 3.093 |
The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS. (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.86 |
| Pregabalin 150 mg BID | -2.47 |
| DS-5565 15 mg QD | -2.24 |
| DS-5565 15 mg BID | -2.09 |
"Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with much improved or better (≤2 scores) are reported." (NCT02187159)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 91 |
| Pregabalin 150 mg BID | 141 |
| DS-5565 15 mg QD | 116 |
| DS-5565 15 mg BID | 117 |
Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Placebo | -1.92 |
| Pregabalin 150 mg BID | -2.41 |
| DS-5565 15 mg QD | -2.48 |
| DS-5565 15 mg BID | -2.44 |
"The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.~For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health." (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.060 |
| Pregabalin 150 mg BID | 0.10 |
| DS-5565 15 mg QD | 0.08 |
| DS-5565 15 mg BID | 0.07 |
"The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.~For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment." (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -13.88 |
| Pregabalin 150 mg BID | -21.46 |
| DS-5565 15 mg QD | -17.41 |
| DS-5565 15 mg BID | -16.45 |
"MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).~For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue." (NCT02187159)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.4 |
| Pregabalin 150 mg BID | -2.8 |
| DS-5565 15 mg QD | -2.3 |
| DS-5565 15 mg BID | -2.1 |
Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1). (NCT02187159)
Timeframe: Week 1 to Week 13 postdose
| Intervention | proportion of days (Mean) |
|---|---|
| Placebo | 0.23 |
| Pregabalin 150 mg BID | 0.21 |
| DS-5565 15 mg QD | 0.22 |
| DS-5565 15 mg BID | 0.21 |
"The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and an numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.~For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health." (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | 0.09 |
| Pregabalin 150 mg BID | 0.1274 |
| DS-5565 15 mg QD | 0.10 |
| DS-5565 15 mg BID | 0.11 |
"The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.~For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment." (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -15.02 |
| Pregabalin 150 mg BID | -19.42 |
| DS-5565 15 mg QD | -16.61 |
| DS-5565 15 mg BID | -20.44 |
Pain-associated sleep interference will be assessed using the Average Daily Sleep Interference Score that utilize electronic daily diaries with an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). Higher scores indicate worse outcomes. (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.76 |
| Pregabalin 150 mg BID | -2.71 |
| DS-5565 15 mg QD | -2.31 |
| DS-5565 15 mg BID | -2.64 |
Patient global impression of change (PGIC) on a 7-point categorical scale, where 1 = very much improved and 7 = very much worse. Higher scores indicate worse outcomes. The number of participants with 'much improved or better' status (≤2) is being reported. (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 88 |
| Pregabalin 150 mg BID | 145 |
| DS-5565 15 mg QD | 127 |
| DS-5565 15 mg BID | 134 |
The HADS questionnaire is a reliable, widely-used self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity. (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline at Week 13: Anxiety | Change from baseline at Week 13: Depression | |
| DS-5565 15 mg BID | -1.0 | -1.2 |
| DS-5565 15 mg QD | -1.0 | -1.0 |
| Placebo | -1.0 | -0.8 |
| Pregabalin 150 mg BID | -0.9 | -1.0 |
Average daily pain scores (ADPS) reported by the participant that best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale where 0 = no pain to 10 = worst possible pain. Higher scores indicate a worse outcome. For participants with no Week 13 data, the baseline observation was carried forward (BOCF). The mean (multiple imputation estimate) and standard error (multiple imputation) are reported. (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.90 |
| Pregabalin 150 mg BID | -2.64 |
| DS-5565 15 mg QD | -2.04 |
| DS-5565 15 mg BID | -2.30 |
The ADPS responder rate was defined a priori as the proportion of participants who met the clinically relevant reductions (ie, ≥30% and ≥50%) in ADPS at Week 13 (baseline observation carried forward) compared to Baseline. (NCT02187471)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 30% Responders | 50% Responders | |
| DS-5565 15 mg BID | 125 | 89 |
| DS-5565 15 mg QD | 121 | 77 |
| Placebo | 122 | 68 |
| Pregabalin 150 mg BID | 144 | 95 |
The SF-36 is a generic health survey that asks 36 questions to measure functional health and well-being from the patient's point of view. The SF-36 provides scores for 8 health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) as well as psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores. Each scale is transformed into a 0-100 scale with each question carrying the same weight. The lower the score indicates more disability (ie, worse outcome). (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Change from baseline to Week 13:Physical Component | Change from baseline to Week 13: Mental Component | |
| DS-5565 15 mg BID | 6.22 | 2.71 |
| DS-5565 15 mg QD | 5.94 | 1.56 |
| Placebo | 3.78 | 2.23 |
| Pregabalin 150 mg BID | 6.46 | 1.97 |
The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes. (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Worst pain | Least pain | Average pain | Pain right now | Severity score | Percentage of relief by treatment of pain | Interference (%) | General activity | Mood | Walking ability | Normal work | Relations with other people | Sleep | Enjoyment of life | |
| DS-5565 15 mg BID | -2.7 | -2.1 | -2.3 | -2.9 | -2.51 | 36.0 | -25.97 | -2.6 | -2.4 | -2.1 | -2.7 | -2.0 | -3.9 | -2.4 |
| DS-5565 15 mg QD | -2.2 | -2.0 | -2.0 | -2.5 | -2.16 | 31.8 | -21.66 | -2.3 | -1.9 | -1.8 | -2.1 | -1.6 | -3.1 | -2.3 |
| Placebo | -1.9 | -1.5 | -1.5 | -2.1 | -1.75 | 23.1 | -16.19 | -1.7 | -1.6 | -1.4 | -1.6 | -1.3 | -2.1 | -1.6 |
| Pregabalin 150 mg BID | -2.7 | -2.3 | -2.3 | -2.8 | -2.55 | 32.6 | -23.55 | -2.5 | -2.1 | -1.7 | -2.3 | -1.9 | -3.6 | -2.4 |
Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - (date of first study drug administration + 1). (NCT02187471)
Timeframe: Week 1 to Week 13 postdose
| Intervention | proportion of days (Mean) |
|---|---|
| Placebo | 0.23 |
| Pregabalin | 0.15 |
| DS-5565 15 mg QD | 0.21 |
| DS-5565 15 mg BID | 0.16 |
The MOS Sleep Scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), and sleep quantity scale (1 item) were determined. Most subscales range from 0 to 100, where higher scores indicate more of the concept begin measured (eg., higher sleep disturbance scores indicate greater sleep disturbances). (NCT02187471)
Timeframe: Week 13 postdose
| Intervention | Participants (Count of Participants) |
|---|---|
| Placebo | 78 |
| Pregabalin 150 mg BID | 107 |
| DS-5565 15 mg QD | 102 |
| DS-5565 15 mg BID | 119 |
"MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).~For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue." (NCT02187471)
Timeframe: Baseline up to Week 13 postdose
| Intervention | units on a scale (Mean) |
|---|---|
| Placebo | -1.6 |
| Pregabalin 150 mg BID | -2.6 |
| DS-5565 15 mg QD | -2.4 |
| DS-5565 15 mg BID | -3.4 |
Percentage Change from Baseline in Fasted Total Cholesterol values (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Percent change (Mean) | |
|---|---|---|
| Week 2 (n = 41, 37, 41) | Week 4 (n = 40, 33, 39) | |
| PF-05089771 150 mg BID | 3.46 | 6.59 |
| Placebo | -0.43 | -1.71 |
| Pregabalin | -1.45 | -0.11 |
Number of days participants take rescue medication per week. (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4
| Intervention | days (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 1 (n = 44, 46, 45) | Week 2 (n = 44, 45, 44) | Week 3 (n = 42, 42, 43) | Week 4 (n = 42, 38, 43) | |
| PF-05089771 150 mg BID | 2.8 | 2.3 | 2.0 | 2.1 | 1.9 |
| Placebo | 1.6 | 1.5 | 1.2 | 1.0 | 1.1 |
| Pregabalin | 2.1 | 1.8 | 1.7 | 1.2 | 1.6 |
The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. Clinical laboratory tests included hematology, chemistry, urinalysis and some other tests. (NCT02215252)
Timeframe: Screening, Day 1, Day 15 and Day 29
| Intervention | Participants (Number) |
|---|---|
| PF-05089771 150 mg BID | 38 |
| Pregabalin | 35 |
| Placebo | 37 |
The endpoint average pain score, based on the mean of the last 7 days' daily pain numeric rating scale (NRS) scores at (NRS is an 11-point scale where 0 = no pain and 10 = worst possible pain) from the daily pain diaries while receiving study medication during the treatment period. (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4
| Intervention | Unit on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 1 (n = 44, 46, 44) | Week 2 (n = 43, 44, 40) | Week 3 (n = 38, 40, 41) | Week 4 (n = 41, 38, 39) | |
| PF-05089771 150 mg BID | 6.17 | 5.45 | 5.14 | 5.01 | 4.83 |
| Placebo | 6.35 | 6.07 | 6.10 | 5.76 | 5.61 |
| Pregabalin | 6.62 | 5.87 | 5.26 | 5.36 | 5.14 |
Participant rated 11-point Likert scale ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep) during past 24-hour period. Higher score indicates a greater level of sleep disturbance. Self-assessment performed daily on awakening prior to taking study medication. This score was measured as a weekly average. (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4
| Intervention | number on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 1 (n= 44, 46, 44) | Week 2 (n = 43, 44, 40) | Week 3 (n = 38, 40, 41) | Week 4 (n = 41, 38, 39) | |
| PF-05089771 150 mg BID | 4.7 | 4.1 | 4.0 | 3.6 | 3.4 |
| Placebo | 4.9 | 4.7 | 4.7 | 4.3 | 4.3 |
| Pregabalin | 5.6 | 4.7 | 4.1 | 4.4 | 4.2 |
Total amount of rescue medication participants take per week (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4
| Intervention | mg (Mean) | ||||
|---|---|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 1 (n = 44, 46, 45) | Week 2 (n = 44, 45, 44) | Week 3 (n = 42, 42, 43) | Week 4 (n = 42, 38, 43) | |
| PF-05089771 150 mg BID | 2726 | 2272 | 1669 | 1851 | 1617 |
| Placebo | 1863 | 1694 | 1391 | 1306 | 1372 |
| Pregabalin | 3398 | 2897 | 2952 | 1885 | 2328 |
Percentage Change from Baseline in LDL cholesterol Friedewald by PEG (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Perecent change (Mean) | |
|---|---|---|
| Week 2 (n = 38, 34, 39) | Week 4 (n = 37, 31, 36) | |
| PF-05089771 150 mg BID | 8.17 | 13.61 |
| Placebo | 0.81 | 1.48 |
| Pregabalin | -1.73 | 0.85 |
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2, and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 2 (n = 42, 41, 43) | Week 4 (n = 42, 38, 42） | |
| PF-05089771 150 mg BID | 4.5 | 4.1 | 3.9 |
| Placebo | 5.6 | 4.9 | 4.8 |
| Pregabalin | 5.8 | 4.7 | 4.6 |
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 2 (n = 42, 41, 43) | Week 4 (n = 42, 38, 42) | |
| PF-05089771 150 mg BID | 5.7 | 4.8 | 4.9 |
| Placebo | 6.6 | 5.9 | 5.9 |
| Pregabalin | 6.1 | 5.3 | 5.4 |
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 2 (n = 42, 41, 43) | Week 4 (n = 42, 38, 42) | |
| PF-05089771 150 mg BID | 3.8 | 3.3 | 3.4 |
| Placebo | 4.5 | 4.2 | 4.0 |
| Pregabalin | 4.9 | 4.4 | 3.9 |
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 45, 45) | Week 2 (n = 42, 40, 43) | Week 4 (n = 42, 37, 42) | |
| PF-05089771 150 mg BID | 2.7 | 2.0 | 2.3 |
| Placebo | 4.2 | 3.5 | 3.6 |
| Pregabalin | 5.0 | 4.0 | 3.8 |
Percentage of participants that received ≥50% improvement from baseline in mean pain response (from the daily pain diary). (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3, and Week 4
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 (n = 44, 46, 45) | Week 2 (n = 44, 45, 44) | Week 3 (n = 42, 42, 43) | Week 4 (n = 42, 38, 43) | |
| PF-05089771 150 mg BID | 0 | 11.36 | 7.14 | 9.52 |
| Placebo | 4.44 | 2.27 | 2.33 | 6.98 |
| Pregabalin | 4.35 | 15.56 | 19.05 | 23.68 |
Participants rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2, and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 46, 45) | Week 2 (n = 42, 41, 43) | Week 4 (n = 42, 38, 42) | |
| PF-05089771 150 mg BID | 4.6 | 3.7 | 3.4 |
| Placebo | 4.8 | 4.2 | 4.5 |
| Pregabalin | 5.3 | 4.3 | 4.3 |
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. (NCT02215252)
Timeframe: Screening to Day 36, and Day 64
| Intervention | Participants (Number) | ||
|---|---|---|---|
| Participants with TEAEs | Participants with SAE | Withdrawals due to AEs | |
| PF-05089771 150 mg BID | 16 | 1 | 1 |
| Placebo | 17 | 0 | 2 |
| Pregabalin | 24 | 1 | 5 |
Percentage of participants that received ≥30% improvement from baseline in mean pain response (from the daily pain diary). (NCT02215252)
Timeframe: Baseline, Week 1, Week 2, Week 3 and Week 4
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Week 1 (n = 44, 46, 45) | Week 2 (n = 44, 45, 44) | Week 3 (n = 42, 42, 43) | Week 4 (n = 42, 38, 43) | |
| PF-05089771 150 mg BID | 9.09 | 22.73 | 23.81 | 28.57 |
| Placebo | 4.44 | 9.09 | 11.63 | 16.28 |
| Pregabalin | 15.22 | 31.11 | 26.19 | 31.58 |
All participants in this group were analysed. Only plasma PK concentration of PF-05089771 was analysed. (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | ng/ml (Mean) | ||
|---|---|---|---|
| Baseline (n = 43) | Week 2 (n = 41) | Week 4 (n = 41) | |
| PF-05089771 150 mg BID | NA | 7673 | 8784 |
"Participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse) at week 4. The PGIC was combined to produce a 3-point scale, Improved, No Change and Worse." (NCT02215252)
Timeframe: Baseline, Week 2, and Week 4
| Intervention | Number of participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Improved (Baseline, n = 43, 46, 45) | Improved (Week 2, n = 42, 41, 43) | Improved (Week 4, n = 42, 38, 42) | No change (Baseline, n = 43, 46, 45) | No change (Week 2, n = 42, 41, 43) | No change (Week 4, n = 42, 38, 42) | Worse (Baseline, n = 43, 46, 35) | Worse (Week 2, n = 42, 41, 43) | Worse (Week 4, n = 42, 38, 42) | |
| PF-05089771 150 mg BID | 20 | 27 | 28 | 19 | 10 | 12 | 4 | 5 | 2 |
| Placebo | 16 | 26 | 24 | 25 | 13 | 14 | 4 | 4 | 4 |
| Pregabalin | 11 | 30 | 27 | 30 | 7 | 9 | 5 | 4 | 2 |
Participant rated questionnaire to evaluate different symptoms of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia [P/D]) including 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. A score in each dimension and also a total score (from 0-100) is generated using data from the questionnaire. Higher score indicates a greater intensity of pain. (NCT02215252)
Timeframe: Baseline, Week 2 and Week 4
| Intervention | Unit on a scale (Mean) | ||
|---|---|---|---|
| Baseline (n = 44, 45, 45） | Week 2 (n = 42, 40, 34) | Week 4 (n = 42, 37, 42) | |
| PF-05089771 150 mg BID | 40.6 | 34.2 | 34.7 |
| Placebo | 50.7 | 44.7 | 44.5 |
| Pregabalin | 53.4 | 44.6 | 42.7 |
"Higher scores for fatigue represents worse outcome (more fatigue). T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population." (NCT02260388)
Timeframe: 12 Weeks
| Intervention | T-Score (Mean) |
|---|---|
| Nortriptyline | 53.6 |
| Duloxetine | 55.4 |
| Pregabalin | 56.7 |
| Mexiletine | 51.6 |
"Higher scores for pain interference represents worse outcome (more pain interference) T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population." (NCT02260388)
Timeframe: 12 weeks
| Intervention | T-Score (Mean) |
|---|---|
| Nortriptyline | 56.4 |
| Duloxetine | 56.5 |
| Pregabalin | 60.0 |
| Mexiletine | 54.5 |
"SF-12v2® Health Survey Standard The Optum™ SF-12v2® Health Survey is a shorter version of the SF-36v2® Health Survey that uses just 12 questions to measure functional health and well-being from the patient's point of view.~Survey provides psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores.~Scores are calibrated so that 50 is the average score or norm, standard deviation = 10.~Higher scores indicate better health for both mental and physical component summary scores." (NCT02260388)
Timeframe: 12 weeks
| Intervention | Norm-Based Standardization Score (Mean) | |
|---|---|---|
| Mental Component Score | Physical Component Score | |
| Duloxetine | 50.9 | 42.1 |
| Mexiletine | 51.3 | 43.7 |
| Nortriptyline | 51.0 | 42.8 |
| Pregabalin | 47.2 | 40.0 |
"Higher scores for sleep disturbance represents worse outcome (more sleep disturbance).~T-score metric: 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.~On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.~Higher scores equals more of the concept being measured" (NCT02260388)
Timeframe: 12 weeks
| Intervention | T-Score (Mean) |
|---|---|
| Nortriptyline | 58.9 |
| Duloxetine | 58.9 |
| Pregabalin | 58.3 |
| Mexiletine | 59.1 |
(NCT02277548)
Timeframe: 18 months
| Intervention | mg (Mean) |
|---|---|
| Lyrica at 300 mg Per Day | 32.65306 |
| Placebo | 31.60714 |
Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire (NCT02285010)
Timeframe: 24 hours
| Intervention | Participants (Count of Participants) | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pruritus72177998 | Pruritus72177999 | Nausea72177998 | Nausea72177999 | Vomiting72177998 | Vomiting72177999 | Dizziness72177998 | Dizziness72177999 | Visual disturbance72177998 | Visual disturbance72177999 | |||||||||||||||||||||||||||||||
| No | Mild | Moderate | Severe | |||||||||||||||||||||||||||||||||||||
| Pregabalin | 17 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 35 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 31 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 15 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 10 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 1 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 3 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 18 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 23 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 24 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 21 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 16 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 31 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 38 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 10 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 9 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 12 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 8 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 5 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 6 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 14 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 39 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 9 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 7 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 1 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 51 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 45 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 7 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 16 | |||||||||||||||||||||||||||||||||||||||
| Placebo | 0 | |||||||||||||||||||||||||||||||||||||||
| Pregabalin | 0 | |||||||||||||||||||||||||||||||||||||||
"Pain score is evaluated by nurses using Numerical Rating Scale (NRS)~Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome" (NCT02285010)
Timeframe: 24 hours
| Intervention | score on a scale (Median) | |
|---|---|---|
| At rest | At movement | |
| Placebo | 2 | 4 |
| Pregabalin | 2 | 4 |
Time to first analgesia is recorded from IV PCA. (NCT02285010)
Timeframe: 24 hours
| Intervention | hour (Median) |
|---|---|
| Placebo | 4.6 |
| Pregabalin | 7.7 |
Cumulative morphine consumption in the first 24 hours is recorded from IV PCA (NCT02285010)
Timeframe: 6, 12, and 24 hours after operation
| Intervention | mg (Median) | ||
|---|---|---|---|
| Morphine consumption 6 hr | Morphine consumption 12 hr | Morphine consumption 24 hr | |
| Placebo | 1 | 1 | 4 |
| Pregabalin | 0 | 1 | 5 |
Change from baseline to week 4 in total NPSI (Neuropathic Pain Symptom Inventory) score The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-100 scale; 0-minimum (least), and 100 maximum (worst) score (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | units on a scale (0-100 NPSI score) (Mean) |
|---|---|
| Pregabalin | -9.8 |
| Placebo | 1.8 |
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain severity severity score BPI severity score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain severity (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | units on a scale (0-10 BPI severity) (Mean) |
|---|---|
| Pregabalin | -0.8 |
| Placebo | -0.1 |
Change from baseline to week 4 in BPI (Brief Pain Inventory) pain interference score BPI interference score is expressed on 0-10 scale, with 0 being the minimum (least), and 10 being the maximum (worst) pain interference (NCT02394951)
Timeframe: baseline to week 4
| Intervention | units on a scale (0-10 BPI interference) (Mean) |
|---|---|
| Pregabalin | -0.6 |
| Placebo | -0.2 |
Absolute change in pain intensity on 0-10 numerical rating scale (NRS) from baseline to 4 weeks with pregabalin vs. placebo NRS: 0= no pain, 10= worst pain (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | units on a scale (0-10 NRS) (Mean) |
|---|---|
| Pregabalin | -1.0 |
| Placebo | 0.3 |
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at the end of 4-week treatment. The slopes (Pearson coefficients) of the correlation obtained from pregabalin vs. placebo will be compared. (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | Pearson correlation coefficient (Number) |
|---|---|
| Pregabalin | -0.0179 |
| Placebo | -0.0172 |
Number of patients who experienced 50% or more reduction in average daily pain (on 0-10 NRS, Numerical Rating Scale, where 0=least pain, 10=worst pain) (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin | 5 |
| Placebo | 3 |
Change from baseline to week 4 in SPI (Sleep Problem Index) score, on 0-100 scale, where 0= best (least) score, and 100= maximum (worst) score (NCT02394951)
Timeframe: Baseline to week 4
| Intervention | units on a scale (0-100 SPI) (Mean) |
|---|---|
| Pregabalin | -5.1 |
| Placebo | -4.1 |
"11-point NRS measures the severity of pain over the previous 24 hours. Participants were asked to provide 24-hour average pain scores in the daily Participant diary and among these, the weekly mean of the 24-hour average pain score was calculated. Scores range from 0 (no pain) to 10 (pain as bad as you can imagine).~Mixed Model Repeated Measures (MMRM) model with baseline value, Duration of diabetic peripheral neuropathic pain (DPNP), treatment, week, treatment-by-week interaction as fixed effects was used to produce Least Square Mean (LS Mean)." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.358 |
| Duloxetine | -2.286 |
"24-hour worst pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the worst pain score was calculated based on the daily score.~MMRM model with baseline value, duration of DPNP, treatment, week, treatment-by-week interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.553 |
| Duloxetine | -2.416 |
"Beck Depression Inventory-II: BDI-II is a 21-item, participant-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to symptoms of depression were scored on a 4-point scale ranging from 0 to 3 and was summed to give a single score. A total score of 0-13 was considered minimal range, 14-19 was mild, 20-28 was moderate, and 29-63 was severe.~MMRM model with baseline value, duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.5 |
| Duloxetine | -2.3 |
"The EQ-5D is a self-reported, 5-item scale used to assess the patient's health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale.These combinations of attributes were converted into a weighted health-state Index Score according to the Japan population-based algorithm (range of the Index score is -0.111 - 1).A higher score indicates better health state.~ANCOVA model with LOCF with baseline value, treatment and duration of DPNP as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 0.1004 |
| Duloxetine | 0.1144 |
"CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit and treatment-by-visit interaction as fixed effects was used to produce LS Mean." (NCT02417935)
Timeframe: Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.6 |
| Duloxetine | 2.5 |
"Night pain severity scores were recorded on an 11-point NRS in the daily patient diary, ranging from 0 (no pain) to 10 (pain as bad as you can imagine).The weekly mean of the night pain score was calculated based on the daily pain score.~MMRM model with baseline value, treatment, week, duration of DPNP and treatment-by-week interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | -2.166 |
| Duloxetine | -2.160 |
11-point NRS measures the severity of pain over the previous 24 hours. Patients were asked to provide 24-hour average pain scores in the daily patient diary. scores range from 0 (no pain) to 10 (pain as bad as you can imagine) and among these, the weekly mean of the 24-hour average pain score was calculated based on daily score. (NCT02417935)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| 30% Reduction | 50% Reduction | |
| Duloxetine | 100 | 62 |
| Pregabalin | 94 | 62 |
"NPSI questionnaire is a 12-item self-administered questionnaire that will be completed by the participant. It assesses 5 different dimensions of neuropathic pain on a scale of 0 (no symptom) to 10 (worst imaginable symptom): burning spontaneous pain, pressing spontaneous pain, paroxysmal pain, evoked pain, and paresthesias/dysesthesias. The NPSI includes 12 items: 10 descriptors of the different symptoms and 2 items for assessing the duration of spontaneous ongoing and paroxysmal pain. A total score can be calculated as the sum of the scores of the 10 descriptors with scale range: 0 (no pain) -100 (worst pain imaginable).~Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) with baseline, treatment, and duration of DPNP as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) | |||||
|---|---|---|---|---|---|---|
| Total Score | Burning Pain | Pressing Pain | Paroxysmal Pain | Evoked Pain | Paresthesia/Dysesthesia | |
| Duloxetine | -16.1 | -1.3 | -1.4 | -1.7 | -1.2 | -2.6 |
| Pregabalin | -15.4 | -1.1 | -1.4 | -1.7 | -1.0 | -2.5 |
"Brief Pain Inventory Severity and Interference Scores: BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (pain as bad as you can imagine) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.~MMRM model with baseline, duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS mean." (NCT02417935)
Timeframe: Baseline, Week 12
| Intervention | units on a scale (Least Squares Mean) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Worst Pain | Least Pain | Average Pain | Pain Right Now | General Activity | Mood | Walking Ability | Normal Work | Relations with Other People | Sleep | Enjoyment of Life | Average Interference | |
| Duloxetine | -2.7 | -1.9 | -2.4 | -2.4 | -2.1 | -2.1 | -1.9 | -1.8 | -0.9 | -1.7 | -1.8 | -1.77 |
| Pregabalin | -2.8 | -1.7 | -2.5 | -2.4 | -1.9 | -1.9 | -1.8 | -1.6 | -0.7 | -1.7 | -1.6 | -1.60 |
"PGI-I assessments was completed by the participant. The participant records how he/she perceives the degree of improvement (or worsening) at the time of assessment since taking treatment. The score ranges from 1 (very much better) to 7 (very much worse).~MMRM model with duration of DPNP, treatment, visit, treatment-by-visit interaction as fixed effects was used to produce LS Mean." (NCT02417935)
Timeframe: Week 12
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Pregabalin | 2.6 |
| Duloxetine | 2.4 |
The primary outcome is change in visual analogue score for pain, with 0 being no pain at all and 10 being the most severe pain and a higher score meaning more pain, after 8 weeks of treatment phase and 4 weeks of randomized withdrawal phase. (NCT02607254)
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
| Intervention | score on visual analogue score (Mean) | ||
|---|---|---|---|
| Basline | After 8 weeks of Pregabalin | After 4 weeks of Withdrawal phase | |
| Pregabalin Treatment/ Placebo Withdrawal | 6.9 | 5.1 | 7.4 |
| Pregabalin Treatment/No Withdrwal | 7.3 | 7.6 | NA |
| Pregabalin Treatment/Pregabalin Withdrawal | 7.1 | 5.4 | 6.1 |
a scoring system describing sleep quality between 0-10 with 0 having no problem with sleep and 10 not being to sleep at all. (NCT02607254)
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
| Intervention | score on Sleep Interference Rating scale (Mean) | ||
|---|---|---|---|
| Basline | After 8 weeks of Pregabalin | After 4 weeks of Withdrawal phase | |
| Pregabalin Treatment/ Placebo Withdrawal | 5.3 | 2.8 | 4.3 |
| Pregabalin Treatment/No Withdrwal | 5.9 | 5.1 | NA |
| Pregabalin Treatment/Pregabalin Withdrawal | 4.5 | 3.1 | 3.9 |
patient assign a number between 1-7 to the level of improvement, 1 showing substantial improvement and 7 showing no improvement at all. (NCT02607254)
Timeframe: At 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
| Intervention | score on PGIC scale (Mean) | |
|---|---|---|
| After 8 weeks of pregabalin | After Withdrawal phase | |
| Pregabalin Treatment/ Placebo Withdrawal | 5.4 | 4.2 |
| Pregabalin Treatment/No Withdrwal | 1.8 | NA |
| Pregabalin Treatment/Pregabalin Withdrawal | 4.1 | 3.9 |
Brief pain inventory is a scoring system for average pain intensity on scale of 0-10 with higher number meaning more pain. (NCT02607254)
Timeframe: Baseline, at 8 weeks after treatment phase and at 12 weeks for subjects completing the withdrawal phase
| Intervention | score in brief pain inventory scale (Mean) | ||
|---|---|---|---|
| Basline | After 8 weeks of Pregabalin | After 4 weeks of Withdrawal phase | |
| Pregabalin Treatment/ Placebo Withdrawal | 6.3 | 4.5 | 5.6 |
| Pregabalin Treatment/No Withdrwal | 7.2 | 6.8 | NA |
| Pregabalin Treatment/Pregabalin Withdrawal | 6.7 | 4.9 | 5.8 |
Participant will have 5 μl of preservative free fluorescein placed on their eye. The participant will then be positioned in the head rest of the slit lamp instrument and will be instructed to blink three times naturally and then not blink. The integrity of the tear film will be measured and, using a stopwatch, the time from the last blink until one or more black (dry) spots appear in the precorneal tear film will be recorded as TBUT. The absolute scores for TBUT completed on the 3 and 6 month visit will be reported. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | Seconds (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 9.54 | 9.05 |
| Pregabalin | 7.10 | 8.35 |
sf-MPQ Sensory has a total score ranging from 0-33 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Sensory questionnaire completed at 3 and 6 month visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 0.36 | 0.81 |
| Pregabalin | 0.65 | 0.48 |
NRS total score ranges from 0-10 over a one week recall period with the higher score indicating increased pain. Absolute scores will be reported from NRS questionnaire completed at 3 and 6 month visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 0.27 | 0.38 |
| Pregabalin | 0.85 | 1.10 |
sf-MPQ Affective has a total score ranging from 0-12 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Affective questionnaire completed at 3 and 6 month visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 0.18 | 0.43 |
| Pregabalin | 0.30 | 0.29 |
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit. (NCT02701764)
Timeframe: 6 months
| Intervention | score on a scale (Mean) |
|---|---|
| Pregabalin | 6.6 |
| Placebo | 4.5 |
OSDI total score ranges from 0-100 with a higher score indicating greater disability. Absolute scores will be reported from OSDI questionnaire completed at 3 and 6 month visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 11.0 | 12.3 |
| Pregabalin | 11.9 | 12.6 |
NPSI-E total score ranges from 0-100 with a higher score indicating increased eye pain. Absolute scores will be reported from NPSI-Eye questionnaire completed at 3 and 6 month visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | score on a scale (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 1.86 | 3.14 |
| Pregabalin | 2.70 | 2.81 |
Tear production will be measured via Schirmers score. Schirmer strips will be placed in the outer 1/3 of the lower conjunctivae. The Schirmer score will be evaluated as the length of wetting in mm in the Schirmer strips after 5 minutes. Absolute scores will be reported for the tear production evaluation at the 3 and 6 months visit. (NCT02701764)
Timeframe: 3 months, 6 months
| Intervention | mm wetting (Mean) | |
|---|---|---|
| 3 months | 6 months | |
| Placebo | 15.90 | 15.05 |
| Pregabalin | 12.40 | 15.45 |
summed number of tablets used by each participant over the 72 hour study period (NCT02782169)
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Intervention | tablets (Median) |
|---|---|
| Pregabalin | 1 |
| Placebo | 2 |
reported on an 11-point numerical rating scale (NRS 0-10) where 0 indicates no pain and 10 indicates the most severe pain (NCT02782169)
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Intervention | units on a scale (Mean) |
|---|---|
| Pregabalin | 5.0 |
| Placebo | 5.5 |
A participant was included once if they ever reported a symptom during the 72 hour study period, not reflective of how long the symptom lasted. These were all commonly reported side effects during previous research on medication abortions and commonly reported side effects of pregabalin, so they were not included as adverse events. (NCT02782169)
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Intervention | participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Nausea | Vomiting | Sleepiness | Dizziness | Headache | Blurred Vision | Diarrhea | Constipation | Dry Mouth | |
| Placebo | 42 | 30 | 39 | 26 | 17 | 7 | 29 | 15 | 25 |
| Pregabalin | 43 | 28 | 47 | 45 | 28 | 15 | 28 | 6 | 22 |
summed number of tablets used by each participant over the 72 hour study period (NCT02782169)
Timeframe: Over 72 hours (measured at 0, 2, 6, 12, 24, and 72 hours)
| Intervention | tablets (Median) |
|---|---|
| Pregabalin | 0 |
| Placebo | 0.5 |
Cogstate - Detection Task (DET) is a simple reaction time test of Psychomotor Function. Higher change from baseline means better performance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | msec (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.00 |
| Neurontin® (Gabapentin) | 0.00 |
| Lyrica® (Pregabalin) | -0.01 |
| Placebo (Sugar Pill) | -0.00 |
Miles per Hour (mph) (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | mph (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.831 |
| Lyrica® (Pregabalin) | 1.319 |
| Placebo | 0.851 |
Miles per Hour (mph) (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | mph (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.831 |
| Neurontin® (Gabapentin) | 0.947 |
| Placebo | 0.851 |
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | feet (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.255 |
| Neurontin® (Gabapentin) | 0.395 |
| Placebo | 0.135 |
SDLP (feet): This is a measurement of change from maintaining the normal driving position in the lane over time and / or distance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | feet (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.255 |
| Lyrica® (Pregabalin) | 0.356 |
| Placebo | 0.135 |
"Number of subjects with Treatment-Emergent Adverse Events (TEAE)~Number of subjects with Serious Adverse Event (SAE)~Number of subjects discontinued due to Adverse Event (AE)" (NCT03179345)
Timeframe: Screening to 1 week after Period 4 discharge
| Intervention | participants (Number) | ||
|---|---|---|---|
| Subjects with TEAE | Subjects with SAE | Subjects Discontinued due to AE | |
| Gralise® (Gabapentin) | 6 | 0 | 0 |
| Lyrica® (Pregabalin) | 16 | 0 | 1 |
| Neurontin® (Gabapentin) | 13 | 0 | 1 |
| Placebo (Sugar Pill) | 5 | 0 | 0 |
Portland Neurotoxicity Scale (PNS) comprises 15 questions measured on a 10-point scale. [1=No problem, 2, 3, 4, 5=Often a problem, 6, 7, 8, 9, 10=Severe problem] in 16 categories. Each question was analyzed and is presented in the same way as the primary endpoints. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | scores on a scale (Least Squares Mean) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vision (blurring, double vision) | Energy Level (get up and go) | Memory (ability to remember people, places, or thi | Walking (balance) | Interest (in activities) | Coordination | Tremor (shakiness) | Concentration (ability to concentrate on a task) | Speech (slurring words) | Forgetfulness | Sleepiness (fatigue, sedation, tiredness) | Moodiness | Alertness | Attention Span | Motivation | |
| Gralise® (Gabapentin) | 0.036 | 0.099 | 0.077 | 0.206 | 0.046 | 0.180 | -0.103 | 0.080 | 0.035 | 0.118 | 0.693 | 0.181 | 0.297 | 0.020 | 0.185 |
| Lyrica® (Pregabalin) | 0.249 | 0.315 | 0.125 | 0.405 | 0.096 | 0.350 | -0.031 | 0.137 | 0.065 | 0.175 | 1.176 | 0.098 | 0.607 | 0.146 | 0.368 |
| Neurontin® (Gabapentin) | 0.322 | 0.256 | 0.123 | 0.327 | 0.030 | 0.392 | 0.037 | 0.164 | 0.133 | 0.227 | 0.635 | 0.163 | 0.451 | 0.133 | 0.232 |
| Placebo (Sugar Pill) | 0.115 | 0.331 | -0.041 | 0.107 | 0.070 | 0.218 | 0.068 | 0.182 | 0.103 | 0.079 | 0.541 | 0.100 | 0.353 | 0.015 | 0.271 |
Scale: 1-9, 1=extremely alert, 9 = very sleepy, great effort to keep awake, fighting sleep (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | .774 |
| Neurontin® (Gabapentin) | .264 |
| Lyrica® (Pregabalin) | .868 |
| Placebo (Sugar Pill) | .264 |
Cogstate - The One Card Learning Test (OCLT) is a measure of visual learning and uses a well-validated pattern separation paradigm with playing card stimuli. Higher Score is better performance. Higher change from baseline means better performance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | Score on Scale (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.02 |
| Neurontin® (Gabapentin) | 0.06 |
| Lyrica® (Pregabalin) | 0.00 |
| Placebo (Sugar Pill) | 0.03 |
Cogstate - International Shopping List (ISL) test is a measure of verbal learning and uses a well-validated list-learning paradigm. Total number of correct responses remembering the word list on three consecutive trials at a single assessment. Higher score is better performance. Higher change from baseline means better performance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | Score on Scale (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | 0.36 |
| Neurontin® (Gabapentin) | 0.82 |
| Lyrica® (Pregabalin) | 0.03 |
| Placebo (Sugar Pill) | -0.01 |
Cogstate - Identification Task (IDN) assesses Attention. Score is speed of performance (mean of the log10 transformed reaction times for correct responses). Lower score (quicker speed) is better performance. Higher change from baseline means better performance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | Score on Scale (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | -0.00 |
| Neurontin® (Gabapentin) | 0.00 |
| Lyrica® (Pregabalin) | -0.00 |
| Placebo (Sugar Pill) | 0.01 |
Cogstate - The Groton Maze Learning test is a measure Executive Function. Total number of errors made while attempting to learn the same hidden pathway across the consecutive learning trials performed at a single assessment. Lower score means better performance. Higher change from baseline means better performance. (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3
| Intervention | Number of errors on test (Least Squares Mean) |
|---|---|
| Gralise® (Gabapentin) | -0.40 |
| Neurontin® (Gabapentin) | -0.01 |
| Lyrica® (Pregabalin) | -0.64 |
| Placebo (Sugar Pill) | 3.32 |
Defined as the highest amount of medication per day maintained for a 7 day period. (NCT03256253)
Timeframe: over the course of the 8 week trial or participants' length of participation
| Intervention | milligrams (Mean) |
|---|---|
| Pregabalin | 571.4 |
"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline between pregabalin and placebo across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | proportion (Number) |
|---|---|
| First Intervention = Pregabalin | 0 |
| Second Intervention = Placebo | 0.5 |
| First Intervention = Placebo | 0 |
| Second Intervention = Pregabalin | 0.333 |
"Compare the proportion of patients who have an increase in pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| First Intervention = Pregabalin | 0 |
| First Intervention = Placebo | 0 |
"Compare the number of days of breakthrough analgesic use between pregabalin and placebo within cycle 1 and across the 2 cycles.~The number of days of breakthrough analgesic use (i.e additional pain medication being required) is evaluated based on participant-provided medication logs kept during study treatment. If additional pain medication outside of their normal pain control regimen was reported, this day counts as 1. The total days for each patient are then reported, with a total range from zero to 14 (for patients with breast cancer) or zero to 21 (for patients with a lymphoma)." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | days (Mean) |
|---|---|
| First Intervention = Pregabalin | 1.4 |
| Second Intervention = Placebo | 3.25 |
| First Intervention = Placebo | 0.67 |
| Second Intervention = Pregabalin | 0 |
"Compare the proportion of patients with severe pain between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | proportion (Number) |
|---|---|
| First Intervention = Pregabalin | 0.4 |
| Second Intervention = Placebo | 0.25 |
| First Intervention = Placebo | 0.67 |
| Second Intervention = Pregabalin | 0 |
"Compare the proportion of patients who have an increase in bone/joint pain score of ≥ 3 from baseline through the end of study medication in cycle 1 between Arm A and Arm B.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | proportion (Number) |
|---|---|
| First Intervention = Pregabalin | 0 |
| First Intervention = Placebo | 0 |
"Compare the maximum change in pain score from baseline between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ten-point numerical scale is scored from 0 to 10. They will use this scale to rate their pain (and separately bone/joint pain) with 0 signifying no pain and 10 signifying the worst pain you can imagine. Each patient will be assessed regularly, including: before therapeutic intervention (i.e. at consent/screening), first day of chemotherapy administration (during cycles 1 & 2), 4 days after pegfilgrastim administration (during cycles 1 & 2), and 8 days after pegfilgrastim administration (during cycles 1 & 2)." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| First Intervention = Pregabalin | 0.4 |
| Second Intervention = Placebo | 2 |
| First Intervention = Placebo | 0 |
| Second Intervention = Pregabalin | 1.67 |
"Compare the maximum neuropathic pain score between pregabalin and placebo within cycle 1 and across the 2 cycles.~The ID Pain scale (also know as the Identify Pain scale) is a 6-item, participant-completed screening tool designed to help differentiate nociceptive and neuropathic pain. This pain score also helps to evaluate the presence/absence of neuropathic pain at a given point of time.~Did the pain feel like pins and needles?~Did the pain feel hot/burning?~Did the pain feel numb?~Did the pain feel like electrical shocks?~Is the pain made worse with the touch of clothing or bed sheets?~Is the pain limited to your joints?~A yes response to questions 1-5 are scored as 1; for question 6, a yes is scored as -1. As such, higher scores (approaching 5) signify worse outcomes. The scale's total range for a patient is -1 to 5." (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | units on a scale (Mean) |
|---|---|
| First Intervention = Pregabalin | 0.2 |
| Second Intervention = Placebo | 0.5 |
| First Intervention = Placebo | 0 |
| Second Intervention = Pregabalin | 0.33 |
CTCAE The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. (NCT03407430)
Timeframe: Up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|---|
| First Intervention = Pregabalin | 0 |
| Second Intervention = Pregabalin | 0 |
An average will be calculated of the daily score on the Behavioral Pain Scale (BPS). BPS score ranges from 3-12, with higher scores indicating worse pain. This assessment is used in non-verbal participants. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | score on a scale (Median) |
|---|---|
| Original MMPR - Descending Dose Arm | 2.5 |
| MAST MMPR - Escalating Dose Arm | 2.3 |
An average will be calculated of the daily numeric rating scale (NRS) for pain (0=no pain, 10=worst pain). This assessment is used in verbal participants. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | units on a scale (Median) |
|---|---|
| Original MMPR - Descending Dose Arm | 3.3 |
| MAST MMPR - Escalating Dose Arm | 3.3 |
The costs of the pain medications given during the specified time period. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | dollars (Median) |
|---|---|
| Original MMPR - Descending Dose Arm | 507 |
| MAST MMPR - Escalating Dose Arm | 397 |
"The number of days the patient was in the ICU post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days
| Intervention | ICU days (Mean) |
|---|---|
| Original MMPR - Descending Dose Arm | 0.21 |
| MAST MMPR - Escalating Dose Arm | 0.21 |
Opioid-related complications include ileus, aspiration, unplanned intubation, unplanned admission to an intensive care unit, and use of an opioid-reversal agent. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| Unplanned intubation | Unplanned admission to the intensive care unit | Cardiac arrest with Cardiopulmonary resuscitation (CPR) | Ileus | Naloxone reversal | |
| MAST MMPR - Escalating Dose Arm | 16 | 31 | 13 | 45 | 6 |
| Original MMPR - Descending Dose Arm | 16 | 30 | 18 | 41 | 7 |
"The number of days the patient was hospitalized post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days
| Intervention | hospital days (Mean) |
|---|---|
| Original MMPR - Descending Dose Arm | 4.97 |
| MAST MMPR - Escalating Dose Arm | 5.12 |
(NCT03472469)
Timeframe: Up to 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Original MMPR - Descending Dose Arm | 527 |
| MAST MMPR - Escalating Dose Arm | 476 |
"The number of days the patient on a ventilator post injury or up to 30 days (whichever is sooner). Zero-inflated models are presented as estimated marginal means (95% Credible Interval). The data reported as mean actually refers to marginal mean, and the data reported as 95% Confidence Interval actually refers to a 95% Credible Interval." (NCT03472469)
Timeframe: 30 days
| Intervention | ventilator days (Mean) |
|---|---|
| Original MMPR - Descending Dose Arm | 0.08 |
| MAST MMPR - Escalating Dose Arm | 0.06 |
Opioid use per day is calculated by tallying the dose equivalency of all opioids received and dividing by the number of days hospitalized. Morphine milligram equivalents (MME) per day are reported. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | MME per day (Median) |
|---|---|
| Original MMPR - Descending Dose Arm | 48 |
| MAST MMPR - Escalating Dose Arm | 34 |
the costs associated with the overall hospitalization or the first 30 days (whichever is sooner) related to post trauma care and complications incurred. (NCT03472469)
Timeframe: until discharge from hospital or 30 days post admission (whichever is sooner)
| Intervention | dollars (Median) |
|---|---|
| Original MMPR - Descending Dose Arm | 20093 |
| MAST MMPR - Escalating Dose Arm | 19561 |
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of FPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2. (NCT03652818)
Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Group A/ Placebo Group | 12 |
| Group B/ APAP Group | 23 |
| Group C/ PGB Group | 17 |
| Group D/ Combination Co-dosing Group | 22 |
| Group E/ Combination Split-dosing Group | 10 |
Patient global evaluation was self-reported at time of first rescue or at 12.25 hours post-surgery, whichever was first, using a 0-4 categorical rating scale of: (0) poor, (1) fair, (2) good, (3) very good, and (4) excellent. The number of participants with differing patient global evaluation scores were reported. (NCT03652818)
Timeframe: Upto 12.25 hours
| Intervention | Participants (Count of Participants) | ||||
|---|---|---|---|---|---|
| (0) Poor | (1) Fair | (2) Good | (3) Very good | (4) Excellent | |
| Group A/ Placebo Group | 13 | 3 | 1 | 2 | 0 |
| Group B/ APAP Group | 1 | 2 | 7 | 8 | 5 |
| Group C/ PGB Group | 8 | 2 | 4 | 6 | 1 |
| Group D/ Combination Co-dosing Group | 0 | 3 | 4 | 10 | 5 |
| Group E/ Combination Split-dosing Group | 0 | 1 | 1 | 6 | 2 |
Beginning post-surgery (at initiation of Dose 2), participants were given a stopwatch and asked to press the stopwatch if and when they feel first perceptible relief; a record of the time was noted in the participants record. Cumulative number of participants with onset of MPR confirmed after dose 2 and was recorded from 0.25 hour till 24 hours after administration of dose 2. (NCT03652818)
Timeframe: 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0 and 24 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Group A/ Placebo Group | 3 |
| Group B/ APAP Group | 20 |
| Group C/ PGB Group | 11 |
| Group D/ Combination Co-dosing Group | 17 |
| Group E/ Combination Split-dosing Group | 10 |
Beginning post-surgery (at initiation of Dose 2), Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time weighted sum pain intensity difference scores are reported over 0 to 24 hours. Last observation carried forward method was used. (NCT03652818)
Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Group A/ Placebo Group | -2.4292 |
| Group B/ APAP Group | -68.0778 |
| Group C/ PGB Group | -68.3533 |
| Group D/ Combination Co-dosing Group | -93.3645 |
| Group E/ Combination Split-dosing Group | -82.4099 |
Beginning post-surgery (at initiation of Dose 2), Pain Relief was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = pain as bad as can be). Time-weighted sum pain total pain relief scores over 24 hours is reported Last observation carried forward method was used. (NCT03652818)
Timeframe: 0.5, 0.75, 1, 1.25, 1.75, 2.25 hours (± 5 min) and 3.25, 4.25, 5.25, 6.25, 8.25, 10.25, 12.25, 24 hours (± 10 min)
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Group A/ Placebo Group | 17.1038 |
| Group B/ APAP Group | 88.2775 |
| Group C/ PGB Group | 94.4433 |
| Group D/ Combination Co-dosing Group | 121.9596 |
| Group E/ Combination Split-dosing Group | 91.8373 |
Cumulative narcotic use was defined by cumulative morphine equivalents over the course of a patient's hospital course. The Washington State Agency Medical Director's Group Opioid dose calculator was used to provide a total morphine dose equivalent (MDE) for each patient while in the hospital. (NCT03669081)
Timeframe: 82.25 hours
| Intervention | mg (Median) |
|---|---|
| Toradol and Lyrica | 27 |
| Placebo and Standard of Care | 45 |
Primary outcomes include 30 day mortality post-operatively. (NCT03669081)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Toradol and Lyrica | 0 |
| Placebo and Standard of Care | 0 |
Renal function was evaluated by following serum creatinine levels for up to one year post-operatively. (NCT03669081)
Timeframe: 1 year
| Intervention | mg/dL (Median) |
|---|---|
| Toradol and Lyrica | 0.6 |
| Placebo and Standard of Care | 0.7 |
Primary outcomes include length of hospital stay (LOS). (NCT03669081)
Timeframe: 82.25 hours
| Intervention | hours (Median) |
|---|---|
| Toradol and Lyrica | 51.5 |
| Placebo and Standard of Care | 57.3 |
Patients were evaluated post-operatively during hospital stay for instances of urinary retention. (NCT03669081)
Timeframe: 82.25 hours
| Intervention | Participants (Count of Participants) |
|---|---|
| Toradol and Lyrica | 1 |
| Placebo and Standard of Care | 0 |
Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss. (NCT03669081)
Timeframe: 24 hours
| Intervention | percentage of hematocrit (Mean) |
|---|---|
| Toradol and Lyrica | 6.3 |
| Placebo and Standard of Care | 4.3 |
Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome. (NCT03927781)
Timeframe: Post-op day 3
| Intervention | score on a scale (Mean) |
|---|---|
| Pregabalin 300mg | 88 |
(NCT03927781)
Timeframe: Day of surgery
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 300mg | 10 |
(NCT03927781)
Timeframe: Day of surgery
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 300mg | 6 |
Number of patients stating that they had used opioids on any survey. (NCT03927781)
Timeframe: Up to 1 year post-op
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 300mg | 1 |
Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better. (NCT03927781)
Timeframe: First 30 post-operative days
| Intervention | score on a scale (Mean) |
|---|---|
| Pregabalin 300mg | 3.5 |
Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients. (NCT03927781)
Timeframe: First 30 post-operative days
| Intervention | visits (Number) |
|---|---|
| Pregabalin 300mg | 2 |
Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days. (NCT03927781)
Timeframe: First 30 post-operative days
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 300mg | 1 |
Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients. (NCT03927781)
Timeframe: Up to 1 year post-op
| Intervention | oral morphine equivalents (Number) |
|---|---|
| Pregabalin 300mg | 90 |
Number of patients able to complete 30 day post op questionnaire (NCT03927781)
Timeframe: 30 days post-op
| Intervention | Participants (Count of Participants) |
|---|---|
| Pregabalin 300mg | 5 |
Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals at 0-12, 12-24 and 24-48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time interval (0-12, 12-24 and 24-48 hours). This outcome was compared between a combination of PGB and APAP, APAP alone, and placebo. (NCT04495283)
Timeframe: 0, 12, 24, 48 hours
| Intervention | score on a scale (Least Squares Mean) | ||
|---|---|---|---|
| SPI 0-12 | SPI 12-24 | SPI 24-48 | |
| APAP (Group B) | 49.09 | 69.35 | 184.33 |
| PGB and APAP (Group A) | 33.09 | 50.92 | 126.83 |
| Placebo (Group C). | 58.89 | 88.95 | 221.58 |
Pain Intensity was determined using a pain rating of 0-10 on the NRS, with a score between 0-10 (0= no pain; 10 = worst imaginable pain). SPI were calculated using the trapezoidal method as the AUC of pain intensity as measured using the NRS through various time intervals from 0 hour till each time point at 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours. For specific time interval SPI calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) in the respective time interval, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI at various time intervals were calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at respective time intervals. (NCT04495283)
Timeframe: 0, 1, 2, 4, 6, 8, 10 ,12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, and 48 hours
| Intervention | score on a scale (Mean) | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SPI 0-1 | SPI 0-2 | SPI 0-4 | SPI 0-6 | SPI 0-8 | SPI 0-10 | SPI 0-12 | SPI 0-14 | SPI 0-16 | SPI 0-18 | SPI 0-20 | SPI 0-24 | SPI 0-28 | SPI 0-32 | SPI 0-36 | SPI 0-40 | SPI 0-44 | SPI 0-48 | |
| APAP (Group B) | 0.73 | 2.39 | 8.02 | 17.09 | 28.09 | 38.71 | 49.09 | 58.62 | 67.98 | 78.49 | 86.24 | 108.25 | 128.83 | 148.93 | 169.44 | 186.70 | 199.95 | 223.24 |
| PGB and APAP (Group A) | 0.26 | 1.26 | 5.63 | 12.68 | 20.00 | 26.25 | 33.09 | 41.12 | 49.08 | 55.84 | 61.49 | 77.17 | 88.94 | 100.85 | 114.43 | 126.45 | 139.54 | 153.08 |
| Placebo (Group C). | 0.45 | 2.16 | 9.62 | 20.71 | 33.64 | 45.95 | 58.89 | 72.17 | 84.46 | 97.57 | 108.32 | 134.91 | 158.01 | 180.50 | 203.32 | 224.78 | 246.09 | 267.51 |
The total consumption of opioid rescue analgesia through 24 hours and through 48 hours was reported (NCT04495283)
Timeframe: 24 hours and 48 hours
| Intervention | oral morphine equivalents (Mean) | |
|---|---|---|
| Consumption of Rescue Medication through 24 hours | Consumption of Rescue Medication through 48 hours | |
| APAP (Group B) | 19.24 | 33.39 |
| PGB and APAP (Group A) | 9.86 | 17.36 |
| Placebo (Group C). | 28.88 | 43.88 |
Time to first use of rescue medication from Hour 0 was reported. Hour 0 was defined as the end of surgery (i.e., completion of the last suture). (NCT04495283)
Timeframe: 7 days
| Intervention | hours (Median) |
|---|---|
| PGB and APAP (Group A) | 11.60 |
| APAP (Group B) | 5.78 |
| Placebo (Group C). | 4.31 |
The total consumption of rescue analgesia was reported. (NCT04495283)
Timeframe: 7 days
| Intervention | oral morphine equivalents (Mean) |
|---|---|
| PGB and APAP (Group A) | 17.79 |
| APAP (Group B) | 34.24 |
| Placebo (Group C). | 44.76 |
Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) -was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, were used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: SUM (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and APAP alone (Group B) from Hour 0 to Hour 48 (SPI0-48) (NCT04495283)
Timeframe: 0 to 48 hours
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| PGB and APAP (Group A) | 153.08 |
| APAP (Group B) | 223.24 |
Pain Intensity using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with a score between 0-10 (0= no pain; 10 = worst imaginable pain). Summed Pain Intensity (SPI0-48) was calculated using the trapezoidal method as the area under the curve (AUC) of pain intensity as measured using the NRS through various time intervals up to 48 hours. For SPI0-48 calculation, all available NRS pain intensity scores (scheduled pain intensity, unscheduled pain intensity and pre-rescue pain intensity) from 0 to 48 hours, including any imputed values, was used in the calculation. Hour 0 was defined as the time of the end of surgery. SPI0-48 was calculated using the formula: Sum (1/2 (SPIi + SPIi+1)*Δt), where Δt was the time difference between Time i and Time (i+1). The represented values are sum of pain intensity scores at various time points. This outcome was compared between a combination of PGB and APAP (Group A) and placebo (Group C) from Hour 0 to Hour 48 (SPI0-48) (NCT04495283)
Timeframe: 0 to 48 hours
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| PGB and APAP (Group A) | 153.08 |
| Placebo (Group C). | 267.51 |
Percentage of participants who used rescue medication is reported (NCT04495283)
Timeframe: 7 days
| Intervention | percentage of participants (Number) |
|---|---|
| PGB and APAP (Group A) | 57.1 |
| APAP (Group B) | 80.0 |
| Placebo (Group C). | 82.4 |
The Plasma Concentration (Cmin) is defined as the minimum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion
| Intervention | nanogram per milliliter (ng/ml) (Geometric Mean) |
|---|---|
| PGB and APAP (Group A) | NA |
| APAP (Group B) | NA |
The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion
| Intervention | nanogram per milliliter (ng/ml) (Geometric Mean) |
|---|---|
| Mean Cmax Values of Acetaminophen-First Dose | |
| APAP (Group B) | 16847 |
The Plasma Concentration (Cmax) is defined as the maximum observed concentration. Multiple blood samples were drawn at pre-decided time points. Timing for blood draws was within 3 minutes of the end of every infusion. Three minutes was the maximum allowance as every effort was made to take the sample as close as possible to 1.0 minute after infusion. (NCT04495283)
Timeframe: Pre-infusion (at least 3.0 minutes before the start of the first infusion) and at 0.5, 1.5, 6.0, 8.0, 12.0, 16.0, 18.0, 24.0, 30.0, 32.0, 36.0, 40.0, 42.0, and 48 hours post-infusion
| Intervention | nanogram per milliliter (ng/ml) (Geometric Mean) | ||
|---|---|---|---|
| Mean Cmax Values of Pregabalin- First Dose | Mean Cmax Values of Pregabalin- Last Dose | Mean Cmax Values of Acetaminophen-First Dose | |
| PGB and APAP (Group A) | 10068 | 12960 | 28700 |
Percentages of participants who did not take opioid (rescue medication) over time. (NCT04495283)
Timeframe: 12 to 48 hours
| Intervention | percentage of participants (Number) | |
|---|---|---|
| During 12-24 Hours | During 12-48 Hours | |
| APAP (Group B) | 45.7 | 28.6 |
| PGB and APAP (Group A) | 65.7 | 48.6 |
| Placebo (Group C). | 35.3 | 29.4 |
A TRAE is defined as a treatment-emergent adverse event (TEAE) that was classified by the investigator as related to study drug. The number of participants with TRAE were reported (NCT04495283)
Timeframe: 7 days
| Intervention | participants (Number) |
|---|---|
| PGB and APAP (Group A) | 22 |
| APAP (Group B) | 9 |
| Placebo (Group C). | 7 |
Evaluation of the number of intravenous opioid doses used within 24 hours of postoperative abdominal hysterectomy surgery in patients who used pregabalin 300mg or not as preemptive analgesia (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
| Intervention | number of doses (Median) |
|---|---|
| Group P(0) - Placebo | 4 |
| Group P(1) - Pregabalin 300mg | 2 |
• Evaluation of the time between the end of abdominal hysterectomy surgery and the patient's request for the use of the first dose of intravenous opioid as an analgesic rescue, comparing between patients who used or not pregabalin 300mg as preemptive analgesia (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
| Intervention | Time in minutes (Median) |
|---|---|
| Group P(0) - Placebo | 170 |
| Group P(1) - Pregabalin 300mg | 106 |
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain. (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
| Intervention | score on a scale (Mean) |
|---|---|
| Group P(0) - Placebo | 5 |
| Group P(1) - Pregabalin 300mg | 2 |
• Assess the presence of adverse effects such as nausea and vomiting, itching and dizziness, comparing the intervention group that used pregabalin with the placebo group (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery) and also immediately in the post-anesthetic recovery room
| Intervention | Participants (Count of Participants) |
|---|---|
| Group P(0) - Placebo | 7 |
| Group P(1) - Pregabalin 300mg | 16 |
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain. (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
| Intervention | score on a scale (Mean) |
|---|---|
| Group P(0) - Placebo | 7 |
| Group P(1) - Pregabalin 300mg | 4 |
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single 300mg dose of pregabalin or placebo as preemptive analgesia, using the McGill pain questionnaire, which consists of 20 word groups , and each group can contain from 2 to 6 descriptive words, these descriptors are placed in an increasing order of magnitude in relation to the intensity. The left of each word has a numerical value in an attempt to represent the intensity of the descriptor. For the analysis of the answers, the total number of words chosen in each subgroup by the patient was used to qualify his pain, the minimum value being equal to 0 (zero), if the patient chose not to choose any descriptor, and the maximum value would be 20, as the patient can choose only one descriptor for each subgroup. The quantitative pain index was also evaluated, which represents the sum of the values of each descriptor chosen by the patient, with a minimum value of 0 and a maximum of 78. (NCT04495374)
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
| Intervention | score on a scale (Median) |
|---|---|
| Group P(0) - Placebo | 28.5 |
| Group P(1) - Pregabalin 300mg | 12 |
Total post-operative opioid requirements (opioid dose) were calculated for participants receiving the non-opioid drug regimen, among participants who required post-operative opioid medication. (NCT04766996)
Timeframe: Up to 5 weeks
| Intervention | milligrams (Mean) |
|---|---|
| Prospective Cases Undergoing Non-opioid Drug Regimen | 400 |
The Nebraska Interprofessional Education Attitude Scale (NIPEAS) was developed to measure the attitudes of pre-clinical learners to practicing health professionals. The NIPEAS is a 19-item questionnaire assessing attitudes related to interprofessional collaboration. Responses were given using a 5-point Likert scale where 1 = Strongly Disagree to 5 = Strongly Agree. The total score is the average of the average scores for each item and ranges from 1 to 5. A higher total score indicates increased positive perceptions toward interprofessional collaboration. (NCT04766996)
Timeframe: Prior to protocol implementation (baseline), halfway through the recruitment period (2 months) and after the last participant has been discharged from the hospital (4 months)
| Intervention | score on a scale (Mean) |
|---|---|
| Baseline | |
| Professional Staff | 4.35 |
By using a NRS scale postoperative pain (at rest) at 48hours after cardiac surgery In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10 . Zero usually represents 'no pain at all' whereas 10 represents 'the worst pain ever possible'. (NCT04987372)
Timeframe: At 48 hours after cardiac surgery
| Intervention | units on a scale (Mean) |
|---|---|
| Classical Protocol | 2.28 |
| Multimodal Protocol | 2.17 |
delirium in the direct postoperative phase, by using the ICDSC (Intensive Care Delirium Screening Checklist) score. The ICDSC is score-based (range 0-8) where the ICDSC is positive when any four (or more) symptoms of delirium are present (i.e., altered level of consciousness, inattention, disorientation, hallucinations or delusions, psychomotor activity, inappropriate speech or mood, sleep disturbance or fluctuation of symptoms) (NCT04987372)
Timeframe: At 48 h after surgery
| Intervention | score on a scale (Median) |
|---|---|
| Classical Protocol | 0.0 |
| Multimodal Protocol | 0.0 |
"Maximum effect on the 100 mm visual analog scale for the question I am feeling high where 0 = not at all and 100 = extremely" (NCT05053126)
Timeframe: up to 48 hours after treatment
| Intervention | Score on a 100 mm scale (Mean) |
|---|---|
| Placebo | 10.83 |
| Oxycodone 20 mg | 85.83 |
| Lyrica 300 mg | 55.83 |
| Lyrica 450 mg | 60.43 |
| Lyrica 300mg With Oxycodone 20 mg | 91.36 |
| Lyrica 450 mg With Oxycodone 20 mg | 92.23 |
"100 mm visual analog scale for the question At this moment, I can feel any drug effects where 0 = not at all and 100 = extremely" (NCT05053126)
Timeframe: up to 48 hours after treatment
| Intervention | Score on a 100 mm scale (Least Squares Mean) |
|---|---|
| Placebo | 2.14 |
| Oxycodone 20 mg | 29.97 |
| Lyrica 300 mg | 16.68 |
| Lyrica 450 mg | 20.00 |
| Lyrica 300mg With Oxycodone 20 mg | 36.55 |
| Lyrica 450 mg With Oxycodone 20 mg | 40.98 |
"Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question (at this moment, my liking this drug is) is being asked. It is scored using a 100 mm visual analogue scale (VAS), where 0 mm = Strong Disliking, 50 mm = Neither Like nor Dislike, and 100 mm = Strong Liking" (NCT05053126)
Timeframe: up to 48 hours after treatment
| Intervention | Score on a 100 mm scale (Mean) |
|---|---|
| Placebo | 54.30 |
| Oxycodone 20 mg | 90.85 |
| Lyrica 300 mg | 72.53 |
| Lyrica 450 mg | 76.05 |
| Lyrica 300mg With Oxycodone 20 mg | 96.11 |
| Lyrica 450 mg With Oxycodone 20 mg | 95.06 |
"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question I would take this drug again where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05053126)
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)
| Intervention | Score on a 100 mm scale (Least Squares Mean) |
|---|---|
| Placebo | 53.58 |
| Oxycodone 20 mg | 77.05 |
| Lyrica 300 mg | 63.98 |
| Lyrica 450 mg | 64.87 |
| Lyrica 300mg With Oxycodone 20 mg | 77.91 |
| Lyrica 450 mg With Oxycodone 20 mg | 75.92 |
"100 mm visual analog scale at 24, 36, and 48 hours post-dose for the question Overall, my liking for this drug is where 0 = definitely not, 50 = neutral, and 100 = definitely so. The data from the 24, 36, and 48 hours postdose measurements were combined into a single overall model-adjusted value for 24 to 48 hours post-treatment timeframe by estimation from a mixed model with treatment, period, treatment sequence, time, and treatment*time as fixed effects, subject nested within sequence as a random effect. The compound symmetric covariance matrix was employed. Data from all time points were included" (NCT05053126)
Timeframe: Up to 48 hours after treatment (assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)
| Intervention | Score on a 100 mm scale (Least Squares Mean) |
|---|---|
| Placebo | 53.74 |
| Oxycodone 20 mg | 75.73 |
| Lyrica 300 mg | 60.14 |
| Lyrica 450 mg | 63.54 |
| Lyrica 300mg With Oxycodone 20 mg | 74.86 |
| Lyrica 450 mg With Oxycodone 20 mg | 75.01 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| acetylcarnitine Acetylcarnitine: An acetic acid ester of CARNITINE that facilitates movement of ACETYL COA into the matrices of mammalian MITOCHONDRIA during the oxidation of FATTY ACIDS. | 4.04 | 2 | 1 | O-acylcarnitine | human metabolite |
| gamma-aminobutyric acid gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4. | 28.47 | 1,439 | 375 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid | human metabolite; neurotransmitter; Saccharomyces cerevisiae metabolite; signalling molecule |
| aminolevulinic acid Aminolevulinic Acid: A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS.. 5-aminolevulinic acid : The simplest delta-amino acid in which the hydrogens at the gamma position are replaced by an oxo group. It is metabolised to protoporphyrin IX, a photoactive compound which accumulates in the skin. Used (in the form of the hydrochloride salt)in combination with blue light illumination for the treatment of minimally to moderately thick actinic keratosis of the face or scalp. | 7.6 | 1 | 0 | 4-oxo monocarboxylic acid; amino acid zwitterion; delta-amino acid | antineoplastic agent; dermatologic drug; Escherichia coli metabolite; human metabolite; mouse metabolite; photosensitizing agent; plant metabolite; prodrug; Saccharomyces cerevisiae metabolite |
| 5-hydroxytryptophan 5-Hydroxytryptophan: The immediate precursor in the biosynthesis of SEROTONIN from tryptophan. It is used as an antiepileptic and antidepressant.. 5-hydroxytryptophan : A tryptophan derivative that is tryptophan substituted by a hydroxy group at position 5. | 3.27 | 1 | 0 | hydroxytryptophan | human metabolite; neurotransmitter |
| acetic acid Acetic Acid: Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed). acetic acid : A simple monocarboxylic acid containing two carbons. | 8.21 | 5 | 0 | monocarboxylic acid | antimicrobial food preservative; Daphnia magna metabolite; food acidity regulator; protic solvent |
| acetaldehyde Acetaldehyde: A colorless, flammable liquid used in the manufacture of acetic acid, perfumes, and flavors. It is also an intermediate in the metabolism of alcohol. It has a general narcotic action and also causes irritation of mucous membranes. Large doses may cause death from respiratory paralysis.. acetaldehyde : The aldehyde formed from acetic acid by reduction of the carboxy group. It is the most abundant carcinogen in tobacco smoke.. aldehyde : A compound RC(=O)H, in which a carbonyl group is bonded to one hydrogen atom and to one R group.. acetyl group : A group, formally derived from acetic acid by dehydroxylation, which is fundamental to the biochemistry of all forms of life. When bound to coenzyme A, it is central to the metabolism of carbohydrates and fats. | 2.41 | 1 | 0 | aldehyde | carcinogenic agent; EC 3.5.1.4 (amidase) inhibitor; electron acceptor; Escherichia coli metabolite; human metabolite; mouse metabolite; mutagen; oxidising agent; Saccharomyces cerevisiae metabolite; teratogenic agent |
| acetone methyl ketone : A ketone of formula RC(=O)CH3 (R =/= H). | 2.21 | 1 | 0 | ketone body; methyl ketone; propanones; volatile organic compound | EC 3.5.1.4 (amidase) inhibitor; human metabolite; polar aprotic solvent |
| ammonium hydroxide azane : Saturated acyclic nitrogen hydrides having the general formula NnHn+2. | 3.31 | 1 | 0 | azane; gas molecular entity; mononuclear parent hydride | EC 3.5.1.4 (amidase) inhibitor; metabolite; mouse metabolite; neurotoxin; NMR chemical shift reference compound; nucleophilic reagent; refrigerant |
| quinacrine Quinacrine: An acridine derivative formerly widely used as an antimalarial but superseded by chloroquine in recent years. It has also been used as an anthelmintic and in the treatment of giardiasis and malignant effusions. It is used in cell biological experiments as an inhibitor of phospholipase A2.. quinacrine : A member of the class of acridines that is acridine substituted by a chloro group at position 6, a methoxy group at position 2 and a [5-(diethylamino)pentan-2-yl]nitrilo group at position 9. | 2.05 | 1 | 0 | acridines; aromatic ether; organochlorine compound; tertiary amino compound | antimalarial; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor |
| betaine glycine betaine : The amino acid betaine derived from glycine. | 3.23 | 1 | 0 | amino-acid betaine; glycine derivative | fundamental metabolite |
| bromide Bromides: Salts of hydrobromic acid, HBr, with the bromine atom in the 1- oxidation state. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) | 10.01 | 2 | 1 | halide anion; monoatomic bromine | |
| 1-butanol 1-Butanol: A four carbon linear hydrocarbon that has a hydroxy group at position 1.. butan-1-ol : A primary alcohol that is butane in which a hydrogen of one of the methyl groups is substituted by a hydroxy group. It it produced in small amounts in humans by the gut microbes. | 2.08 | 1 | 0 | alkyl alcohol; primary alcohol; short-chain primary fatty alcohol | human metabolite; mouse metabolite; protic solvent |
| butyric acid Butyric Acid: A four carbon acid, CH3CH2CH2COOH, with an unpleasant odor that occurs in butter and animal fat as the glycerol ester.. butyrate : A short-chain fatty acid anion that is the conjugate base of butyric acid, obtained by deprotonation of the carboxy group.. butyric acid : A straight-chain saturated fatty acid that is butane in which one of the terminal methyl groups has been oxidised to a carboxy group. | 2.6 | 1 | 0 | fatty acid 4:0; straight-chain saturated fatty acid | human urinary metabolite; Mycoplasma genitalium metabolite |
| carbamates [no description available] | 5.9 | 6 | 0 | amino-acid anion | |
| carnitine [no description available] | 3.61 | 2 | 0 | amino-acid betaine | human metabolite; mouse metabolite |
| citric acid, anhydrous Citric Acid: A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.. citric acid : A tricarboxylic acid that is propane-1,2,3-tricarboxylic acid bearing a hydroxy substituent at position 2. It is an important metabolite in the pathway of all aerobic organisms. | 2.31 | 1 | 0 | tricarboxylic acid | antimicrobial agent; chelator; food acidity regulator; fundamental metabolite |
| hydrochloric acid Hydrochloric Acid: A strong corrosive acid that is commonly used as a laboratory reagent. It is formed by dissolving hydrogen chloride in water. GASTRIC ACID is the hydrochloric acid component of GASTRIC JUICE.. hydrogen chloride : A mononuclear parent hydride consisting of covalently bonded hydrogen and chlorine atoms. | 3.46 | 1 | 1 | chlorine molecular entity; gas molecular entity; hydrogen halide; mononuclear parent hydride | mouse metabolite |
| salicylic acid Scalp: The outer covering of the calvaria. It is composed of several layers: SKIN; subcutaneous connective tissue; the occipitofrontal muscle which includes the tendinous galea aponeurotica; loose connective tissue; and the pericranium (the PERIOSTEUM of the SKULL). | 2.55 | 2 | 0 | monohydroxybenzoic acid | algal metabolite; antifungal agent; antiinfective agent; EC 1.11.1.11 (L-ascorbate peroxidase) inhibitor; keratolytic drug; plant hormone; plant metabolite |
| hydrogen sulfide Hydrogen Sulfide: A flammable, poisonous gas with a characteristic odor of rotten eggs. It is used in the manufacture of chemicals, in metallurgy, and as an analytical reagent. (From Merck Index, 11th ed). hydrogen sulfide : A sulfur hydride consisting of a single sulfur atom bonded to two hydrogen atoms. A highly poisonous, flammable gas with a characteristic odour of rotten eggs, it is often produced by bacterial decomposition of organic matter in the absence of oxygen.. thiol : An organosulfur compound in which a thiol group, -SH, is attached to a carbon atom of any aliphatic or aromatic moiety. | 3.31 | 1 | 0 | gas molecular entity; hydracid; mononuclear parent hydride; sulfur hydride | Escherichia coli metabolite; genotoxin; metabolite; signalling molecule; toxin; vasodilator agent |
| 3-hydroxybutyric acid 3-Hydroxybutyric Acid: BUTYRIC ACID substituted in the beta or 3 position. It is one of the ketone bodies produced in the liver.. 3-hydroxybutyric acid : A straight-chain 3-hydroxy monocarboxylic acid comprising a butyric acid core with a single hydroxy substituent in the 3- position; a ketone body whose levels are raised during ketosis, used as an energy source by the brain during fasting in humans. Also used to synthesise biodegradable plastics. | 2.07 | 1 | 0 | (omega-1)-hydroxy fatty acid; 3-hydroxy monocarboxylic acid; hydroxybutyric acid | human metabolite |
| bupropion Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring. | 3.61 | 2 | 0 | aromatic ketone; monochlorobenzenes; secondary amino compound | antidepressant; environmental contaminant; xenobiotic |
| malic acid malic acid : A 2-hydroxydicarboxylic acid that is succinic acid in which one of the hydrogens attached to a carbon is replaced by a hydroxy group.. 2-hydroxydicarboxylic acid : Any dicarboxylic acid carrying a hydroxy group on the carbon atom at position alpha to the carboxy group. | 3.27 | 1 | 0 | 2-hydroxydicarboxylic acid; C4-dicarboxylic acid | food acidity regulator; fundamental metabolite |
| aminocaproic acid Aminocaproic Acid: An antifibrinolytic agent that acts by inhibiting plasminogen activators which have fibrinolytic properties.. 6-aminohexanoic acid : An epsilon-amino acid comprising hexanoic acid carrying an amino substituent at position C-6. Used to control postoperative bleeding, and to treat overdose effects of the thrombolytic agents streptokinase and tissue plasminogen activator. | 3.23 | 1 | 0 | amino acid zwitterion; epsilon-amino acid; omega-amino fatty acid | antifibrinolytic drug; hematologic agent; metabolite |
| formaldehyde paraform: polymerized formaldehyde; RN given refers to parent cpd; used in root canal therapy | 2.71 | 3 | 0 | aldehyde; one-carbon compound | allergen; carcinogenic agent; disinfectant; EC 3.5.1.4 (amidase) inhibitor; environmental contaminant; Escherichia coli metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| glutaric acid glutaric acid: RN given refers to parent cpd. glutaric acid : An alpha,omega-dicarboxylic acid that is a linear five-carbon dicarboxylic acid. | 2.08 | 1 | 0 | alpha,omega-dicarboxylic acid; dicarboxylic fatty acid | Daphnia magna metabolite; human metabolite |
| glycine [no description available] | 2.15 | 1 | 0 | alpha-amino acid; amino acid zwitterion; proteinogenic amino acid; serine family amino acid | EC 2.1.2.1 (glycine hydroxymethyltransferase) inhibitor; fundamental metabolite; hepatoprotective agent; micronutrient; neurotransmitter; NMDA receptor agonist; nutraceutical |
| hydrogen carbonate Bicarbonates: Inorganic salts that contain the -HCO3 radical. They are an important factor in determining the pH of the blood and the concentration of bicarbonate ions is regulated by the kidney. Levels in the blood are an index of the alkali reserve or buffering capacity.. hydrogencarbonate : The carbon oxoanion resulting from the removal of a proton from carbonic acid. | 2.07 | 1 | 0 | carbon oxoanion | cofactor; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| histamine [no description available] | 8.7 | 1 | 1 | aralkylamino compound; imidazoles | human metabolite; mouse metabolite; neurotransmitter |
| hydrogen Hydrogen: The first chemical element in the periodic table with atomic symbol H, and atomic number 1. Protium (atomic weight 1) is by far the most common hydrogen isotope. Hydrogen also exists as the stable isotope DEUTERIUM (atomic weight 2) and the radioactive isotope TRITIUM (atomic weight 3). Hydrogen forms into a diatomic molecule at room temperature and appears as a highly flammable colorless and odorless gas.. dihydrogen : An elemental molecule consisting of two hydrogens joined by a single bond. | 9.15 | 3 | 1 | elemental hydrogen; elemental molecule; gas molecular entity | antioxidant; electron donor; food packaging gas; fuel; human metabolite |
| thioctic acid Thioctic Acid: An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS. | 11.58 | 14 | 3 | dithiolanes; heterocyclic fatty acid; thia fatty acid | fundamental metabolite; geroprotector |
| methanol Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group. | 2.88 | 3 | 0 | alkyl alcohol; one-carbon compound; primary alcohol; volatile organic compound | amphiprotic solvent; Escherichia coli metabolite; fuel; human metabolite; mouse metabolite; Mycoplasma genitalium metabolite |
| melatonin [no description available] | 9.16 | 13 | 2 | acetamides; tryptamines | anticonvulsant; central nervous system depressant; geroprotector; hormone; human metabolite; immunological adjuvant; mouse metabolite; radical scavenger |
| niacinamide nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group. | 2.17 | 1 | 0 | pyridine alkaloid; pyridinecarboxamide; vitamin B3 | anti-inflammatory agent; antioxidant; cofactor; EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor; EC 3.5.1.98 (histone deacetylase) inhibitor; Escherichia coli metabolite; geroprotector; human urinary metabolite; metabolite; mouse metabolite; neuroprotective agent; Saccharomyces cerevisiae metabolite; Sir2 inhibitor |
| niacin Niacin: A water-soluble vitamin of the B complex occurring in various animal and plant tissues. It is required by the body for the formation of coenzymes NAD and NADP. It has PELLAGRA-curative, vasodilating, and antilipemic properties.. vitamin B3 : Any member of a group of vitamers that belong to the chemical structural class called pyridines that exhibit biological activity against vitamin B3 deficiency. Vitamin B3 deficiency causes a condition known as pellagra whose symptoms include depression, dermatitis and diarrhea. The vitamers include nicotinic acid and nicotinamide (and their ionized and salt forms).. nicotinic acid : A pyridinemonocarboxylic acid that is pyridine in which the hydrogen at position 3 is replaced by a carboxy group. | 3.23 | 1 | 0 | pyridine alkaloid; pyridinemonocarboxylic acid; vitamin B3 | antidote; antilipemic drug; EC 3.5.1.19 (nicotinamidase) inhibitor; Escherichia coli metabolite; human urinary metabolite; metabolite; mouse metabolite; plant metabolite; vasodilator agent |
| nitrates Nitrates: Inorganic or organic salts and esters of nitric acid. These compounds contain the NO3- radical. | 2.46 | 2 | 0 | monovalent inorganic anion; nitrogen oxoanion; reactive nitrogen species | |
| 1-propanol 1-Propanol: A colorless liquid made by oxidation of aliphatic hydrocarbons that is used as a solvent and chemical intermediate.. propan-1-ol : The parent member of the class of propan-1-ols that is propane in which a hydrogen of one of the methyl groups is replaced by a hydroxy group. | 2.08 | 1 | 0 | propan-1-ols; short-chain primary fatty alcohol | metabolite; protic solvent |
| pyrazinamide pyrazinecarboxamide : A monocarboxylic acid amide resulting from the formal condensation of the carboxy group of pyrazinoic acid (pyrazine-2-carboxylic acid) with ammonia. A prodrug for pyrazinoic acid, pyrazinecarboxamide is used as part of multidrug regimens for the treatment of tuberculosis. | 3.61 | 2 | 0 | monocarboxylic acid amide; N-acylammonia; pyrazines | antitubercular agent; prodrug |
| pyridoxine 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol: structure in first source. vitamin B6 : Any member of the group of pyridines that exhibit biological activity against vitamin B6 deficiency. Vitamin B6 deficiency is associated with microcytic anemia, electroencephalographic abnormalities, dermatitis with cheilosis (scaling on the lips and cracks at the corners of the mouth) and glossitis (swollen tongue), depression and confusion, and weakened immune function. Vitamin B6 consists of the vitamers pyridoxine, pyridoxal, and pyridoxamine and their respective 5'-phosphate esters (and includes their corresponding ionized and salt forms). | 3.23 | 1 | 0 | hydroxymethylpyridine; methylpyridines; monohydroxypyridine; vitamin B6 | cofactor; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| thiamine thiamine(1+) : A primary alcohol that is 1,3-thiazol-3-ium substituted by (4-amino-2-methylpyrimidin-5-yl)methyl, methyl and 2-hydroxyethyl groups at positions 3, 4 and 5, respectively. | 7.59 | 6 | 1 | primary alcohol; vitamin B1 | Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| 4-iodo-2,5-dimethoxyphenylisopropylamine 4-iodo-2,5-dimethoxyphenylisopropylamine: RN given refers to unlabeled parent cpd without isomeric designation; a serotonin agonist. 2-(4-iodo-2,5-dimethoxyphenyl)-1-methylethylamine : An organoiodine compound that is amphetamine bearing two methoxy substituents at positions 2 and 5 as well as an iodo substituent at position 4. | 2.03 | 1 | 0 | amphetamines; dimethoxybenzene; organoiodine compound | |
| sk&f-38393 2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine: A selective D1 dopamine receptor agonist used primarily as a research tool.. 1-phenyl-2,3,4,5-tetrahydro-1H-3-benzazepine-7,8-diol : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine bearing a phenyl substituent at position 1 and two hydroxy substituents at positions 7 and 8.. SKF 38393 : A racemate comprising equimolar amounts of (R)- and (S)-SKF 38393 | 2.54 | 2 | 0 | benzazepine; catechols; secondary amino compound | |
| 1h-3-benzazepin-7-ol, 8-bromo-2,3,4,5-tetrahydro-3-methyl-5-phenyl- 1H-3-benzazepin-7-ol, 8-bromo-2,3,4,5-tetrahydro-3-methyl-5-phenyl-: stereoselective antagonist of dopamine receptor | 2.31 | 1 | 0 | benzazepine | |
| menthol Menthol: A monoterpene cyclohexanol produced from mint oils. | 8.43 | 1 | 1 | p-menthane monoterpenoid; secondary alcohol | volatile oil component |
| my 5445 MY 5445: potential platelet aggregation inhibitor | 2.21 | 1 | 0 | pyridazines; ring assembly | |
| 1-(3-chlorophenyl)piperazine 1-(3-chlorophenyl)piperazine: supposed metabolite of TRAZODONE; RN given refers to parent cpd; structure. 1-(3-chlorophenyl)piperazine : A N-arylpiperazine that is piperazine carrying a 3-chlorophenyl substituent at position 1. It is a metabolite of the antidepressant drug trazodone. | 2.08 | 1 | 0 | monochlorobenzenes; N-arylpiperazine | drug metabolite; environmental contaminant; serotonergic agonist; xenobiotic |
| 1-anilino-8-naphthalenesulfonate 1-anilino-8-naphthalenesulfonate: RN given refers to parent cpd. 8-anilinonaphthalene-1-sulfonic acid : A naphthalenesulfonic acid that is naphthalene-1-sulfonic acid substituted by a phenylamino group at position 8. | 4.31 | 5 | 0 | aminonaphthalene; naphthalenesulfonic acid | fluorescent probe |
| phenytoin [no description available] | 5.81 | 11 | 0 | imidazolidine-2,4-dione | anticonvulsant; drug allergen; sodium channel blocker; teratogenic agent |
| 7-nitroindazole 7-nitroindazole: an inhibitor of nitric oxide synthase; exhibits anti-nociceptive activity without increasing blood pressure | 7.06 | 1 | 0 | ||
| tacrine Tacrine: A cholinesterase inhibitor that crosses the blood-brain barrier. Tacrine has been used to counter the effects of muscle relaxants, as a respiratory stimulant, and in the treatment of Alzheimer's disease and other central nervous system disorders.. tacrine : A member of the class of acridines that is 1,2,3,4-tetrahydroacridine substituted by an amino group at position 9. It is used in the treatment of Alzheimer's disease. | 2.08 | 1 | 0 | acridines; aromatic amine | EC 3.1.1.7 (acetylcholinesterase) inhibitor |
| acebutolol Acebutolol: A cardioselective beta-1 adrenergic antagonist with little effect on the bronchial receptors. The drug has stabilizing and quinidine-like effects on cardiac rhythm, as well as weak inherent sympathomimetic action.. acebutolol : An ether that is the 2-acetyl-4-(butanoylamino)phenyl ether of the primary hydroxy group of 3-(propan-2-ylamino)propane-1,2-diol. | 3.23 | 1 | 0 | aromatic amide; ethanolamines; ether; monocarboxylic acid amide; propanolamine; secondary amino compound | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympathomimetic agent |
| acetaminophen Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. | 17.35 | 67 | 18 | acetamides; phenols | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; cyclooxygenase 3 inhibitor; environmental contaminant; ferroptosis inducer; geroprotector; hepatotoxic agent; human blood serum metabolite; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| acetazolamide Acetazolamide: One of the CARBONIC ANHYDRASE INHIBITORS that is sometimes effective against absence seizures. It is sometimes useful also as an adjunct in the treatment of tonic-clonic, myoclonic, and atonic seizures, particularly in women whose seizures occur or are exacerbated at specific times in the menstrual cycle. However, its usefulness is transient often because of rapid development of tolerance. Its antiepileptic effect may be due to its inhibitory effect on brain carbonic anhydrase, which leads to an increased transneuronal chloride gradient, increased chloride current, and increased inhibition. (From Smith and Reynard, Textbook of Pharmacology, 1991, p337) | 3.61 | 2 | 0 | monocarboxylic acid amide; sulfonamide; thiadiazoles | anticonvulsant; diuretic; EC 4.2.1.1 (carbonic anhydrase) inhibitor |
| acetohydroxamic acid acetohydroxamic acid: urease inhibitor. oxime : Compounds of structure R2C=NOH derived from condensation of aldehydes or ketones with hydroxylamine. Oximes from aldehydes may be called aldoximes; those from ketones may be called ketoximes.. N-hydroxyacetimidic acid : A carbohydroximic acid consisting of acetimidic acid having a hydroxy group attached to the imide nitrogen.. acetohydroxamic acid : A member of the class of acetohydroxamic acids that is acetamide in which one of the amino hydrogens has been replaced by a hydroxy group. | 3.23 | 1 | 0 | acetohydroxamic acids; carbohydroximic acid | algal metabolite; EC 3.5.1.5 (urease) inhibitor |
| alaproclate alaproclate: specific 5-hydroxytryptamine uptake inhibitors; RN given refers to (DL)-isomer | 3.23 | 1 | 0 | alpha-amino acid ester | |
| albendazole [no description available] | 3.61 | 2 | 0 | aryl sulfide; benzimidazoles; benzimidazolylcarbamate fungicide; carbamate ester | anthelminthic drug; microtubule-destabilising agent; tubulin modulator |
| albuterol Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.. albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). | 3.61 | 2 | 0 | phenols; phenylethanolamines; secondary amino compound | beta-adrenergic agonist; bronchodilator agent; environmental contaminant; xenobiotic |
| alendronate alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups. | 3.69 | 2 | 0 | 1,1-bis(phosphonic acid); primary amino compound | bone density conservation agent; EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor |
| alfuzosin alfuzosin: structure given in first source | 3.23 | 1 | 0 | monocarboxylic acid amide; quinazolines; tetrahydrofuranol | alpha-adrenergic antagonist; antihypertensive agent; antineoplastic agent |
| alosetron alosetron : A pyrido[4,3-b]indole compound having a 5-methyl-1H-imidazol-4-ylmethyl group at the 2-position. | 3.23 | 1 | 0 | imidazoles; pyridoindole | antiemetic; gastrointestinal drug; serotonergic antagonist |
| alprazolam Alprazolam: A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238). alprazolam : A member of the class of triazolobenzodiazepines that is 4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine carrying methyl, phenyl and chloro substituents at positions 1, 6 and 8 respectively. Alprazolam is only found in individuals that have taken this drug. | 9.55 | 16 | 9 | organochlorine compound; triazolobenzodiazepine | anticonvulsant; anxiolytic drug; GABA agonist; muscle relaxant; sedative; xenobiotic |
| alprenolol Alprenolol: One of the ADRENERGIC BETA-ANTAGONISTS used as an antihypertensive, anti-anginal, and anti-arrhythmic agent.. alprenolol : A secondary alcohol that is propan-2-ol substituted by a 2-allylphenoxy group at position 1 and an isopropylamino group at position 3. It is a beta-adrenergic antagonist used as a antihypertensive, anti-arrhythmia and a sympatholytic agent. | 2.08 | 1 | 0 | secondary alcohol; secondary amino compound | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| altretamine Altretamine: A hexamethyl-2,4,6-triamine derivative of 1,3,5-triazine. | 3.23 | 1 | 0 | triamino-1,3,5-triazine | |
| amantadine amant: an antiviral compound consisting of an adamantane derivative chemically linked to a water-solube polyanioic matrix; structure in first source | 3.23 | 1 | 0 | adamantanes; primary aliphatic amine | analgesic; antiparkinson drug; antiviral drug; dopaminergic agent; NMDA receptor antagonist; non-narcotic analgesic |
| ambenonium ambenonium : A symmetrical oxalamide-based bis-quaternary ammonium ion having ethyl and 2-chlorobenzyl groups attached to the nitrogens. | 3.23 | 1 | 0 | quaternary ammonium ion | EC 3.1.1.8 (cholinesterase) inhibitor |
| ambroxol Ambroxol: A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride. | 7.17 | 1 | 0 | aromatic amine | |
| diatrizoic acid Diatrizoate: A commonly used x-ray contrast medium. As DIATRIZOATE MEGLUMINE and as Diatrizoate sodium, it is used for gastrointestinal studies, angiography, and urography.. amidotrizoic acid : A member of the class of benzoic acids that is benzoic acid having iodo substituents at the 2-, 4- and 6-positions and acetamido substituents at the 3- and 5-positions. It is used, mainly as its N-methylglucamine and sodium salts, as an X-ray contrast medium in gastrointestinal studies, angiography, and urography. | 3.61 | 2 | 0 | acetamides; benzoic acids; organoiodine compound | environmental contaminant; radioopaque medium; xenobiotic |
| amifostine anhydrous Amifostine: A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.. amifostine : An organic thiophosphate that is the S-phospho derivative of 2-[(3-aminopropyl)amino]ethanethiol. A prodrug for the free thiol, WR-1065, which is used as a cytoprotectant in cancer chemotherapy and radiotherapy. | 3.23 | 1 | 0 | diamine; organic thiophosphate | antioxidant; prodrug; radiation protective agent |
| aminoglutethimide Aminoglutethimide: An aromatase inhibitor that is used in the treatment of advanced BREAST CANCER.. aminoglutethimide : A dicarboximide that is a six-membered cyclic compound having ethyl and 4-aminophenyl substituents at the 3-position. | 2.08 | 1 | 0 | dicarboximide; piperidones; substituted aniline | adrenergic agent; anticonvulsant; antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| p-aminohippuric acid p-Aminohippuric Acid: The glycine amide of 4-aminobenzoic acid. Its sodium salt is used as a diagnostic aid to measure effective renal plasma flow (ERPF) and excretory capacity.. p-aminohippurate : A hippurate that is the conjugate base of p-aminohippuric acid, arising from deprotonation of the carboxy group.. p-aminohippuric acid : An N-acylglycine that is the 4-amino derivative of hippuric acid; used as a diagnostic agent in the measurement of renal plasma flow. | 3.69 | 2 | 0 | N-acylglycine | Daphnia magna metabolite |
| theophylline [no description available] | 3.61 | 2 | 0 | dimethylxanthine | adenosine receptor antagonist; anti-asthmatic drug; anti-inflammatory agent; bronchodilator agent; drug metabolite; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; fungal metabolite; human blood serum metabolite; immunomodulator; muscle relaxant; vasodilator agent |
| amiodarone Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.. amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. | 8.93 | 3 | 0 | 1-benzofurans; aromatic ketone; organoiodine compound; tertiary amino compound | cardiovascular drug |
| dan 2163 [no description available] | 2.08 | 1 | 0 | aromatic amide; aromatic amine; benzamides; pyrrolidines; sulfone | environmental contaminant; second generation antipsychotic; xenobiotic |
| amitriptyline Amitriptyline: Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.. amitriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5. | 15.33 | 69 | 11 | carbotricyclic compound; tertiary amine | adrenergic uptake inhibitor; antidepressant; environmental contaminant; tropomyosin-related kinase B receptor agonist; xenobiotic |
| amlexanox amlexanox: SRA-A antagonist;structure given in first source. amlexanox : A pyridochromene-derived monocarboxylic acid having an amino substituent at the 2-position, an oxo substituent at the 5-position and an isopropyl substituent at the 7-position. | 2.08 | 1 | 0 | monocarboxylic acid; pyridochromene | anti-allergic agent; anti-ulcer drug; non-steroidal anti-inflammatory drug |
| amlodipine Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. | 8.91 | 3 | 0 | dihydropyridine; ethyl ester; methyl ester; monochlorobenzenes; primary amino compound | antihypertensive agent; calcium channel blocker; vasodilator agent |
| amoxapine Amoxapine: The N-demethylated derivative of the antipsychotic agent LOXAPINE that works by blocking the reuptake of norepinephrine, serotonin, or both; it also blocks dopamine receptors. Amoxapine is used for the treatment of depression.. amoxapine : A dibenzooxazepine compound having a chloro substituent at the 2-position and a piperazin-1-yl group at the 11-position. | 3.61 | 2 | 0 | dibenzooxazepine | adrenergic uptake inhibitor; antidepressant; dopaminergic antagonist; geroprotector; serotonin uptake inhibitor |
| amsacrine Amsacrine: An aminoacridine derivative that intercalates into DNA and is used as an antineoplastic agent.. amsacrine : A sulfonamide that is N-phenylmethanesulfonamide substituted by a methoxy group at position 3 and an acridin-9-ylamino group at position 4. It exhibits antineoplastic activity. | 2.08 | 1 | 0 | acridines; aromatic ether; sulfonamide | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
| anastrozole [no description available] | 3.61 | 2 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| anthralin Anthralin: An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.. anthralin : An anthracene compound derived by the substitution of -OH groups for hydrogen at C-1 and C-8, and with an oxo group at C-9. | 2.08 | 1 | 0 | anthracenes | antipsoriatic |
| antipyrine Antipyrine: An analgesic and antipyretic that has been given by mouth and as ear drops. Antipyrine is often used in testing the effects of other drugs or diseases on drug-metabolizing enzymes in the liver. (From Martindale, The Extra Pharmacopoeia, 30th ed, p29). antipyrine : A pyrazolone derivative that is 1,2-dihydropyrazol-3-one substituted with methyl groups at N-1 and C-5 and with a phenyl group at N-2. | 2.54 | 2 | 0 | pyrazolone | antipyretic; cyclooxygenase 3 inhibitor; environmental contaminant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| acetovanillone apocynin : An aromatic ketone that is 1-phenylethanone substituted by a hydroxy group at position 4 and a methoxy group at position 3. | 2.25 | 1 | 0 | acetophenones; aromatic ketone; methyl ketone | antirheumatic drug; EC 1.6.3.1. [NAD(P)H oxidase (H2O2-forming)] inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; peripheral nervous system drug; plant metabolite |
| aspirin Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity. | 5.42 | 5 | 0 | benzoic acids; phenyl acetates; salicylates | anticoagulant; antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; EC 1.1.1.188 (prostaglandin-F synthase) inhibitor; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; plant activator; platelet aggregation inhibitor; prostaglandin antagonist; teratogenic agent |
| astemizole Astemizole: Antihistamine drug now withdrawn from the market in many countries because of rare but potentially fatal side effects.. astemizole : A piperidine compound having a 2-(4-methoxyphenyl)ethyl group at the 1-position and an N-[(4-fluorobenzyl)benzimidazol-2-yl]amino group at the 4-position. | 2.08 | 1 | 0 | benzimidazoles; piperidines | anti-allergic agent; anticoronaviral agent; H1-receptor antagonist |
| atenolol Atenolol: A cardioselective beta-1 adrenergic blocker possessing properties and potency similar to PROPRANOLOL, but without a negative inotropic effect.. atenolol : An ethanolamine compound having a (4-carbamoylmethylphenoxy)methyl group at the 1-position and an N-isopropyl substituent. | 4.4 | 3 | 0 | ethanolamines; monocarboxylic acid amide; propanolamine | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; sympatholytic agent; xenobiotic |
| azathioprine Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed). azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS. | 3.61 | 2 | 0 | aryl sulfide; C-nitro compound; imidazoles; thiopurine | antimetabolite; antineoplastic agent; carcinogenic agent; DNA synthesis inhibitor; hepatotoxic agent; immunosuppressive agent; prodrug |
| baclofen [no description available] | 7.72 | 18 | 0 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid; monochlorobenzenes; primary amino compound | central nervous system depressant; GABA agonist; muscle relaxant |
| bendazac bendazac : A monocarboxylic acid that is glycolic acid in which the hydrogen attached to the 2-hydroxy group is replaced by a 1-benzyl-1H-indazol-3-yl group. Although it has anti-inflammatory, antinecrotic, choleretic and antilipidaemic properties and has been used for the treatment of various inflammatory skin disorders, its principal effect is to inhibit the denaturation of proteins. Its lysine salt is used in the management of cataracts. | 3.23 | 1 | 0 | indazoles; monocarboxylic acid | non-steroidal anti-inflammatory drug; radical scavenger |
| bendroflumethiazide Bendroflumethiazide: A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. It has been used in the treatment of familial hyperkalemia, hypertension, edema, and urinary tract disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p810). bendroflumethiazide : A sulfonamide consisting of 7-sulfamoyl-3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide in which the hydrogen at position 6 is substituted by a trifluoromethyl group and that at position 3 is substituted by a benzyl group. | 3.23 | 1 | 0 | benzothiadiazine; sulfonamide | antihypertensive agent; diuretic |
| benphothiamine benfotiamine : A thioester that is a synthetic analogue of thiamine obtained by acylative cleavage of the thiazole ring and O-phospohorylation. | 4.37 | 3 | 0 | aminopyrimidine; formamides; organic phosphate; thioester | antioxidant; immunological adjuvant; nutraceutical; protective agent; provitamin B1 |
| benzbromarone Benzbromarone: Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.. benzbromarone : 1-Benzofuran substituted at C-2 and C-3 by an ethyl group and a 3,5-dibromo-4-hydroxybenzoyl group respectively. An inhibitor of CYP2C9, it is used as an anti-gout medication. | 3.61 | 2 | 0 | 1-benzofurans; aromatic ketone | uricosuric drug |
| benzocaine Benzocaine: A surface anesthetic that acts by preventing transmission of impulses along NERVE FIBERS and at NERVE ENDINGS.. dextran sulfate sodium : An organic sodium salt of dextran sulfate. It induces colitis in mice.. benzocaine : A benzoate ester having 4-aminobenzoic acid as the acid component and ethanol as the alcohol component. A surface anaesthetic, it is used to suppress the gag reflex, and as a lubricant and topical anaesthetic on the larynx, mouth, nasal cavity, respiratory tract, oesophagus, rectum, urinary tract, and vagina. | 2.08 | 1 | 0 | benzoate ester; substituted aniline | allergen; antipruritic drug; sensitiser; topical anaesthetic |
| betaxolol [no description available] | 3.23 | 1 | 0 | propanolamine | antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| bethanechol Bethanechol: A slowly hydrolyzing muscarinic agonist with no nicotinic effects. Bethanechol is generally used to increase smooth muscle tone, as in the GI tract following abdominal surgery or in urinary retention in the absence of obstruction. It may cause hypotension, HEART RATE changes, and BRONCHIAL SPASM.. bethanechol : The carbamic acid ester of 2-methylcholine. A slowly hydrolysed muscarinic agonist with no nicotinic effects, it is used as its chloride salt to increase smooth muscle tone, as in the gastrointestinal tract following abdominal surgery, treatment of gastro-oesophageal reflux disease, and as an alternative to catheterisation in the treatment of non-obstructive urinary retention. | 3.23 | 1 | 0 | carbamate ester; quaternary ammonium ion | muscarinic agonist |
| bicalutamide bicalutamide: approved for treatment of advanced prostate cancer. N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide : A member of the class of (trifluoromethyl)benzenes that is 4-amino-2-(trifluoromethyl)benzonitrile in which one of the amino hydrogens is substituted by a 3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoyl group.. bicalutamide : A racemate comprising of equal amounts of (R)-bicalutamide and (S)-bicalutamide. It is an oral non-steroidal antiandrogen used in the treatment of prostate cancer and hirsutism. | 3.61 | 2 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide; monofluorobenzenes; nitrile; sulfone; tertiary alcohol | |
| bay h 4502 bifonazole : A racemate comprising equimolar amounts of R- and S-bifonazole. It is a broad spectrum antifungal drug used for the treatment of fungal skin and nail infections.. 1-[biphenyl-4-yl(phenyl)methyl]imidazole : A member of the class of imidazoles carrying an alpha-(biphenyl-4-yl)benzyl substituent at position 1. | 2.08 | 1 | 0 | biphenyls; imidazoles | |
| biperiden Biperiden: A muscarinic antagonist that has effects in both the central and peripheral nervous systems. It has been used in the treatment of arteriosclerotic, idiopathic, and postencephalitic parkinsonism. It has also been used to alleviate extrapyramidal symptoms induced by phenothiazine derivatives and reserpine.. biperiden : A member of the class of piperidines that is N-propylpiperidine in which the methyl hydrogens have been replaced by hydroxy, phenyl, and 5-norbornen-2-yl groups. A muscarinic antagonist affecting both the central and peripheral nervous systems, it is used in the treatment of all forms of Parkinson's disease. | 3.23 | 1 | 0 | piperidines; tertiary alcohol; tertiary amino compound | antidote to sarin poisoning; antidyskinesia agent; antiparkinson drug; muscarinic antagonist; parasympatholytic |
| bisacodyl Bisacodyl: A diphenylmethane stimulant laxative used for the treatment of CONSTIPATION and for bowel evacuation. (From Martindale, The Extra Pharmacopoeia, 30th ed, p871) | 3.61 | 2 | 0 | diarylmethane | |
| bisoprolol Bisoprolol: A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS. | 3.23 | 1 | 0 | secondary alcohol; secondary amine | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| bromopride bromopride: RN given refers to parent cpd; structure | 2.08 | 1 | 0 | benzamides | |
| bronopol [no description available] | 2.08 | 1 | 0 | nitro compound | |
| bumetanide [no description available] | 3.87 | 3 | 0 | amino acid; benzoic acids; sulfonamide | diuretic; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor |
| bupivacaine Bupivacaine: A widely used local anesthetic agent.. 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide : A piperidinecarboxamide obtained by formal condensation of the carboxy group of N-butylpipecolic acid with the amino group of 2,6-dimethylaniline.. bupivacaine : A racemate composed of equimolar amounts of dextrobupivacaine and levobupivacaine. Used (in the form of its hydrochloride hydrate) as a local anaesthetic. | 7.93 | 9 | 5 | aromatic amide; piperidinecarboxamide; tertiary amino compound | |
| buspirone Buspirone: An anxiolytic agent and serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the BENZODIAZAPINES, but it has an efficacy comparable to DIAZEPAM.. buspirone : An azaspiro compound that is 8-azaspiro[4.5]decane-7,9-dione substituted at the nitrogen atom by a 4-(piperazin-1-yl)butyl group which in turn is substituted by a pyrimidin-2-yl group at the N(4) position. | 7.12 | 5 | 1 | azaspiro compound; N-alkylpiperazine; N-arylpiperazine; organic heteropolycyclic compound; piperidones; pyrimidines | anxiolytic drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; sedative; serotonergic agonist |
| busulfan [no description available] | 3.61 | 2 | 0 | methanesulfonate ester | alkylating agent; antineoplastic agent; carcinogenic agent; insect sterilant; teratogenic agent |
| secbutabarbital secbutabarbital: Butabarbital (a synonym for Secbutabarbital) should be distinguished from Butobarbital | 3.23 | 1 | 0 | barbiturates | |
| caffeine [no description available] | 8.94 | 3 | 0 | purine alkaloid; trimethylxanthine | adenosine A2A receptor antagonist; adenosine receptor antagonist; adjuvant; central nervous system stimulant; diuretic; EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; environmental contaminant; food additive; fungal metabolite; geroprotector; human blood serum metabolite; mouse metabolite; mutagen; plant metabolite; psychotropic drug; ryanodine receptor agonist; xenobiotic |
| verapamil Verapamil: A calcium channel blocker that is a class IV anti-arrhythmia agent.. verapamil : A racemate comprising equimolar amounts of dexverapamil and (S)-verapamil. An L-type calcium channel blocker of the phenylalkylamine class, it is used (particularly as the hydrochloride salt) in the treatment of hypertension, angina pectoris and cardiac arrhythmia, and as a preventive medication for migraine.. 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile : A tertiary amino compound that is 3,4-dimethoxyphenylethylamine in which the hydrogens attached to the nitrogen are replaced by a methyl group and a 4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl group. | 4.43 | 3 | 0 | aromatic ether; nitrile; polyether; tertiary amino compound | |
| candesartan candesartan: a nonpeptide angiotensin II receptor antagonist. candesartan : A benzimidazolecarboxylic acid that is 1H-benzimidazole-7-carboxylic acid substituted by an ethoxy group at position 2 and a ({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl) group at position 1. It is a angiotensin receptor antagonist used for the treatment of hypertension. | 3.23 | 1 | 0 | benzimidazolecarboxylic acid; biphenylyltetrazole | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| carbamazepine Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant. | 13.6 | 44 | 7 | dibenzoazepine; ureas | analgesic; anticonvulsant; antimanic drug; drug allergen; EC 3.5.1.98 (histone deacetylase) inhibitor; environmental contaminant; glutamate transporter activator; mitogen; non-narcotic analgesic; sodium channel blocker; xenobiotic |
| carbinoxamine carbinoxamine: Note: tradenames that start with Histex refer to more than one drug. carbinoxamine : An organochlorine compound that is 2-(4-chlorobenzyl)pyridine in which one of the benzylic hydrogens is substituted by 2-(dimethylamino)ethoxy group. It is an ethanolamine-type antihistamine, used as its maleate salt for treating hay fever, as well as mild cases of Parkinson's disease. | 3.23 | 1 | 0 | monochlorobenzenes; pyridines; tertiary amino compound | anti-allergic agent; antiparkinson drug; H1-receptor antagonist; muscarinic antagonist |
| carisoprodol Carisoprodol: A centrally acting skeletal muscle relaxant whose mechanism of action is not completely understood but may be related to its sedative actions. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1202). carisoprodol : A carbamate ester that is the mono-N-isopropyl derivative of meprobamate (which is a significant metabolite). Carisoprodol interrupts neuronal communication within the reticular formation and spinal cord, resulting in sedation and alteration in pain perception. It is used as a muscle relaxant in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. | 4.16 | 2 | 0 | carbamate ester | muscle relaxant |
| carmustine Carmustine: A cell-cycle phase nonspecific alkylating antineoplastic agent. It is used in the treatment of brain tumors and various other malignant neoplasms. (From Martindale, The Extra Pharmacopoeia, 30th ed, p462) This substance may reasonably be anticipated to be a carcinogen according to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (From Merck Index, 11th ed). carmustine : A member of the class of N-nitrosoureas that is 1,3-bis(2-chloroethyl)urea in which one of the nitrogens is substituted by a nitroso group. | 2.08 | 1 | 0 | N-nitrosoureas; organochlorine compound | alkylating agent; antineoplastic agent |
| carprofen carprofen: RN given refers to cpd without isomeric designation. carprofen : Propanoic acid in which one of the methylene hydrogens is substituted by a 6-chloro-9H-carbazol-2-yl group. A non-steroidal anti-inflammatory drug, it is no longer used in human medicine but is still used for treatment of arthritis in elderly dogs. | 2.48 | 2 | 0 | carbazoles; organochlorine compound | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug; photosensitizing agent |
| carvedilol [no description available] | 3.61 | 2 | 0 | carbazoles; secondary alcohol; secondary amino compound | alpha-adrenergic antagonist; antihypertensive agent; beta-adrenergic antagonist; cardiovascular drug; vasodilator agent |
| celecoxib [no description available] | 13.82 | 34 | 15 | organofluorine compound; pyrazoles; sulfonamide; toluenes | cyclooxygenase 2 inhibitor; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| cetirizine Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively. | 4.99 | 2 | 1 | ether; monocarboxylic acid; monochlorobenzenes; piperazines | anti-allergic agent; environmental contaminant; H1-receptor antagonist; xenobiotic |
| chlorambucil Chlorambucil: A nitrogen mustard alkylating agent used as antineoplastic for chronic lymphocytic leukemia, Hodgkin's disease, and others. Although it is less toxic than most other nitrogen mustards, it has been listed as a known carcinogen in the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (Merck Index, 11th ed). chlorambucil : A monocarboxylic acid that is butanoic acid substituted at position 4 by a 4-[bis(2-chloroethyl)amino]phenyl group. A chemotherapy drug that can be used in combination with the antibody obinutuzumab for the treatment of chronic lymphocytic leukemia. | 3.61 | 2 | 0 | aromatic amine; monocarboxylic acid; nitrogen mustard; organochlorine compound; tertiary amino compound | alkylating agent; antineoplastic agent; carcinogenic agent; drug allergen; immunosuppressive agent |
| chlorcyclizine chlorcyclizine: was heading 1964-94 (Prov 1964-73); CHLOROCYCLIZINE & HISTACHLORAZINE were see CHLORCYCLIZINE 1977-94; use PIPERAZINES to search CHLORCYCLIZINE 1966-94; histamine H1-blocker used both orally and topically in allergies and also for the prevention of motion sickness | 3.23 | 1 | 0 | diarylmethane | |
| chlordiazepoxide Chlordiazepoxide: An anxiolytic benzodiazepine derivative with anticonvulsant, sedative, and amnesic properties. It has also been used in the symptomatic treatment of alcohol withdrawal.. chlordiazepoxide : A benzodiazepine that is 3H-1,4-benzodiazepine 4-oxide substituted by a chloro group at position 7, a phenyl group at position 5 and a methylamino group at position 2. | 4.27 | 5 | 0 | benzodiazepine | |
| chlormezanone Chlormezanone: A non-benzodiazepine that is used in the management of anxiety. It has been suggested for use in the treatment of muscle spasm.. chlormezanone : A 1,3-thiazine that is 1,3-thiazinan-4-one S,S-dioxide in which a hydrogen at position 2 is substituted by a 4-chlorophenyl group and the hydrogen attached to the nitrogen is substituted by methyl. A non-benzodiazepine muscle relaxant, it was used in the management of anxiety and in the treatment of muscle spasms until being discontinued worldwide by its manufacturer in 1996, due to rare but serious cutaneous reactions. | 3.23 | 1 | 0 | 1,3-thiazine; lactam; monochlorobenzenes; sulfone | antipsychotic agent; anxiolytic drug; muscle relaxant |
| chloroquine Chloroquine: The prototypical antimalarial agent with a mechanism that is not well understood. It has also been used to treat rheumatoid arthritis, systemic lupus erythematosus, and in the systemic therapy of amebic liver abscesses.. chloroquine : An aminoquinoline that is quinoline which is substituted at position 4 by a [5-(diethylamino)pentan-2-yl]amino group at at position 7 by chlorine. It is used for the treatment of malaria, hepatic amoebiasis, lupus erythematosus, light-sensitive skin eruptions, and rheumatoid arthritis. | 3.61 | 2 | 0 | aminoquinoline; organochlorine compound; secondary amino compound; tertiary amino compound | anticoronaviral agent; antimalarial; antirheumatic drug; autophagy inhibitor; dermatologic drug |
| chlorothiazide Chlorothiazide: A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p812). thiazide : Heterocyclic compound with sulfur and nitrogen in the ring.. chlorothiazide : 4H-1,2,4-benzothiadiazine 1,1-dioxide in which the hydrogen at position is substituted by chlorine and that at position 7 is substituted by a sulfonamide group. A diuretic, it is used for treatment of oedema and hypertension. | 3.23 | 1 | 0 | benzothiadiazine | antihypertensive agent; diuretic |
| chlorpheniramine Chlorpheniramine: A histamine H1 antagonist used in allergic reactions, hay fever, rhinitis, urticaria, and asthma. It has also been used in veterinary applications. One of the most widely used of the classical antihistaminics, it generally causes less drowsiness and sedation than PROMETHAZINE.. chlorphenamine : A tertiary amino compound that is propylamine which is substituted at position 3 by a pyridin-2-yl group and a p-chlorophenyl group and in which the hydrogens attached to the nitrogen are replaced by methyl groups. A histamine H1 antagonist, it is used to relieve the symptoms of hay fever, rhinitis, urticaria, and asthma. | 4.45 | 3 | 0 | monochlorobenzenes; pyridines; tertiary amino compound | anti-allergic agent; antidepressant; antipruritic drug; H1-receptor antagonist; histamine antagonist; serotonin uptake inhibitor |
| chlorpromazine Chlorpromazine: The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking DOPAMINE RECEPTORS. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.. chlorpromazine : A substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropanamine moiety. | 3.61 | 2 | 0 | organochlorine compound; phenothiazines; tertiary amine | anticoronaviral agent; antiemetic; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; phenothiazine antipsychotic drug |
| chlorpropamide Chlorpropamide: A sulfonylurea hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. (From Martindale, The Extra Pharmacopoeia, 30th ed, p277). chlorpropamide : An N-sulfonylurea that is urea in which a hydrogen attached to one of the nitrogens is substituted by 4-chlorobenzenesulfonyl group and a hydrogen attached to the other nitrogen is substituted by propyl group. Chlorpropamide is a hypoglycaemic agent used in the treatment of type 2 (non-insulin-dependent) diabetes mellitus not responding to dietary modification. | 3.61 | 2 | 0 | monochlorobenzenes; N-sulfonylurea | hypoglycemic agent; insulin secretagogue |
| chlorthalidone Chlorthalidone: A benzenesulfonamide-phthalimidine that tautomerizes to a BENZOPHENONES form. It is considered a thiazide-like diuretic. | 3.61 | 2 | 0 | isoindoles; monochlorobenzenes; sulfonamide | |
| chlorzoxazone Chlorzoxazone: A centrally acting central muscle relaxant with sedative properties. It is claimed to inhibit muscle spasm by exerting an effect primarily at the level of the spinal cord and subcortical areas of the brain. (From Martindale, The Extra Pharmacopoea, 30th ed, p1202). chlorzoxazone : A member of the class of 1,3-benzoxazoles that is 1,3-benzoxazol-2-ol in which the hydrogen atom at position 5 is substituted by chlorine. A centrally acting muscle relaxant with sedative properties, it is used for the symptomatic treatment of painful muscle spasm. | 3.61 | 2 | 0 | 1,3-benzoxazoles; heteroaryl hydroxy compound; organochlorine compound | muscle relaxant; sedative |
| cifenline [no description available] | 2.08 | 1 | 0 | diarylmethane | |
| ciclopirox [no description available] | 2.08 | 1 | 0 | cyclic hydroxamic acid; hydroxypyridone antifungal drug; pyridone | antibacterial agent; antiseborrheic |
| ciglitazone ciglitazone: structure given in second source; PPAR agonist used for type II diabetes. ciglitazone : An aromatic ether that consists of 1,3-thiazolidine-2,4-dione with position 5 substituted by a 4-[(1-methylcyclohexyl)methoxy]benzyl group. A selective PPARgamma agonist. | 2.08 | 1 | 0 | aromatic ether; thiazolidinone | antineoplastic agent; insulin-sensitizing drug |
| cilostazol [no description available] | 3.61 | 2 | 0 | lactam; tetrazoles | anticoagulant; bronchodilator agent; EC 3.1.4.17 (3',5'-cyclic-nucleotide phosphodiesterase) inhibitor; fibrin modulating drug; neuroprotective agent; platelet aggregation inhibitor; vasodilator agent |
| cimetidine Cimetidine: A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.. cimetidine : A member of the class of guanidines that consists of guanidine carrying a methyl substituent at position 1, a cyano group at position 2 and a 2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl group at position 3. It is a H2-receptor antagonist that inhibits the production of acid in stomach. | 3.61 | 2 | 0 | aliphatic sulfide; guanidines; imidazoles; nitrile | adjuvant; analgesic; anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
| ciprofibrate [no description available] | 2.08 | 1 | 0 | cyclopropanes; monocarboxylic acid; organochlorine compound | antilipemic drug |
| ciprofloxacin Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.. ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively. | 3.61 | 2 | 0 | aminoquinoline; cyclopropanes; fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone; zwitterion | antibacterial drug; antiinfective agent; antimicrobial agent; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; environmental contaminant; topoisomerase IV inhibitor; xenobiotic |
| citalopram Citalopram: A furancarbonitrile that is one of the serotonin uptake inhibitors used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from TARDIVE DYSKINESIA in preference to tricyclic antidepressants, which aggravate dyskinesia.. citalopram : A racemate comprising equimolar amounts of (R)-citalopram and its enantiomer, escitalopram. It is used as an antidepressant, although only escitalopram is active.. 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile : A nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group. | 8.07 | 8 | 2 | 2-benzofurans; cyclic ether; nitrile; organofluorine compound; tertiary amino compound | |
| clioquinol Clioquinol: A potentially neurotoxic 8-hydroxyquinoline derivative long used as a topical anti-infective, intestinal antiamebic, and vaginal trichomonacide. The oral preparation has been shown to cause subacute myelo-optic neuropathy and has been banned worldwide.. 5-chloro-7-iodoquinolin-8-ol : A monohydroxyquinoline that is quinolin-8-ol in which the hydrogens at positions 5 and 7 are replaced by chlorine and iodine, respectively. It has antibacterial and atifungal properties, and is used in creams for the treatment of skin infections. It has also been investigated as a chelator of copper and zinc ions for the possible treatment of Alzheimer's disease. | 2.08 | 1 | 0 | monohydroxyquinoline; organochlorine compound; organoiodine compound | antibacterial agent; antifungal agent; antimicrobial agent; antineoplastic agent; antiprotozoal drug; chelator; copper chelator |
| clobazam Clobazam: A benzodiazepine derivative that is a long-acting GABA-A RECEPTOR agonist. It is used as an antiepileptic in the treatment of SEIZURES, including seizures associated with LENNOX-GASTAUT SYNDROME. It is also used as an anxiolytic, for the short-term treatment of acute ANXIETY.. clobazam : 7-Chloro-1H-1,5-benzodiazepine-2,4(3H,5H)-dione in which the hydrogen attached to the nitrogen at position 1 is substituted by a methyl group, whilst that attached to the other nitrogen is substituted by a phenyl group. It is used for the short-term management of acute anxiety and as an adjunct in the treatment of epilepsy in association with other antiepileptics. | 10.87 | 6 | 1 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; GABA modulator |
| clofazimine Clofazimine: A fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619). clofazimine : 3-Isopropylimino-3,5-dihydro-phenazine in which the hydrogen at position 5 is substituted substituted by a 4-chlorophenyl group, and that at position 2 is substituted by a (4-chlorophenyl)amino group. A dark red crystalline solid, clofazimine is an antimycobacterial and is one of the main drugs used for the treatment of multi-bacillary leprosy. However, it can cause red/brown discolouration of the skin, so other treatments are often preferred in light-skinned patients. | 2.08 | 1 | 0 | monochlorobenzenes; phenazines | dye; leprostatic drug; non-steroidal anti-inflammatory drug |
| clofibrate angiokapsul: contains clofibrate & insoitolnicotinate | 3.61 | 2 | 0 | aromatic ether; ethyl ester; monochlorobenzenes | anticholesteremic drug; antilipemic drug; geroprotector; PPARalpha agonist |
| clomiphene [no description available] | 3.61 | 2 | 0 | tertiary amine | estrogen antagonist; estrogen receptor modulator |
| clomipramine Clomipramine: A tricyclic antidepressant similar to IMIPRAMINE that selectively inhibits the uptake of serotonin in the brain. It is readily absorbed from the gastrointestinal tract and demethylated in the liver to form its primary active metabolite, desmethylclomipramine.. clomipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine which is substituted by chlorine at position 3 and in which the hydrogen attached to the nitrogen is replaced by a 3-(dimethylamino)propyl group. One of the more sedating tricyclic antidepressants, it is used as the hydrochloride salt for the treatment of depression as well as obsessive-compulsive disorder and phobias. | 4.67 | 4 | 0 | dibenzoazepine | anticoronaviral agent; antidepressant; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; serotonergic antagonist; serotonergic drug; serotonin uptake inhibitor |
| clonazepam Clonazepam: An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.. clonazepam : 1,3-Dihydro-2H-1,4-benzodiazepin-2-one in which the hydrogens at positions 5 and 7 are substituted by 2-chlorophenyl and nitro groups, respectively. It is used in the treatment of all types of epilepsy and seizures, as well as myoclonus and associated abnormal movements, and panic disorders. However, its use can be limited by the development of tolerance and by sedation. | 9.7 | 8 | 0 | 1,4-benzodiazepinone; monochlorobenzenes | anticonvulsant; anxiolytic drug; GABA modulator |
| clonidine Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group. | 14.02 | 10 | 1 | clonidine; imidazoline | |
| 4-chloro-N-(2,6-dimethyl-1-piperidinyl)-3-sulfamoylbenzamide [no description available] | 2.08 | 1 | 0 | sulfonamide | |
| chlorazepate clorazepic acid : A 1,4-benzodiazepinone in which the oxo group is at position 2, and which is substituted at positions 3, 5, and 7 by carboxy, phenyl and chloro groups, respectively. | 3.23 | 1 | 0 | 1,4-benzodiazepinone | anticonvulsant; anxiolytic drug; GABA modulator; prodrug |
| clotrimazole [no description available] | 3.23 | 1 | 0 | conazole antifungal drug; imidazole antifungal drug; imidazoles; monochlorobenzenes | antiinfective agent; environmental contaminant; xenobiotic |
| cyclobenzaprine cyclobenzaprine: RN given refers to parent cpd; Lisseril is synonymous for HCl; structure. cyclobenzaprine : 5-Methylidene-5H-dibenzo[a,d]cycloheptene in which one of the hydrogens of the methylidene group is substituted by a 2-(dimethylamino)ethyl group. A centrally acting skeletal muscle relaxant, it is used as its hydrochloride salt in the symptomatic treatment of painful muscle spasm. | 3.98 | 3 | 0 | carbotricyclic compound | antidepressant; muscle relaxant; tranquilizing drug |
| cyclofenil Cyclofenil: A gonadal stimulant and inducer of ovulation. It is used in the treatment of infertility and amenorrhea, but is thought to be less effective than CLOMIPHENE. | 3.23 | 1 | 0 | organic molecular entity | |
| cyproheptadine Cyproheptadine: A serotonin antagonist and a histamine H1 blocker used as antipruritic, appetite stimulant, antiallergic, and for the post-gastrectomy dumping syndrome, etc.. cyproheptadine : The product resulting from the formal oxidative coupling of position 5 of 5H-dibenzo[a,d]cycloheptene with position 4 of 1-methylpiperidine resulting in the formation of a double bond between the two fragments. It is a sedating antihistamine with antimuscarinic and calcium-channel blocking actions. It is used (particularly as the hydrochloride sesquihydrate) for the relief of allergic conditions including rhinitis, conjunctivitis due to inhalant allergens and foods, urticaria and angioedema, and in pruritic skin disorders. Unlike other antihistamines, it is also a seratonin receptor antagonist, making it useful in conditions such as vascular headache and anorexia. | 3.62 | 2 | 0 | piperidines; tertiary amine | anti-allergic agent; antipruritic drug; gastrointestinal drug; H1-receptor antagonist; serotonergic antagonist |
| dapsone [no description available] | 3.61 | 2 | 0 | substituted aniline; sulfone | anti-inflammatory drug; antiinfective agent; antimalarial; leprostatic drug |
| deferoxamine Deferoxamine: Natural product isolated from Streptomyces pilosus. It forms iron complexes and is used as a chelating agent, particularly in the mesylate form.. desferrioxamine B : An acyclic desferrioxamine that is butanedioic acid in which one of the carboxy groups undergoes formal condensation with the primary amino group of N-(5-aminopentyl)-N-hydroxyacetamide and the second carboxy group undergoes formal condensation with the hydroxyamino group of N(1)-(5-aminopentyl)-N(1)-hydroxy-N(4)-[5-(hydroxyamino)pentyl]butanediamide. It is a siderophore native to Streptomyces pilosus biosynthesised by the DesABCD enzyme cluster as a high affinity Fe(III) chelator. | 3.23 | 1 | 0 | acyclic desferrioxamine | bacterial metabolite; ferroptosis inhibitor; iron chelator; siderophore |
| desipramine Desipramine: A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.. desipramine : A dibenzoazepine consisting of 10,11-dihydro-5H-dibenzo[b,f]azepine substituted on nitrogen with a 3-(methylamino)propyl group. | 4.94 | 6 | 0 | dibenzoazepine; secondary amino compound | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; cholinergic antagonist; drug allergen; EC 3.1.4.12 (sphingomyelin phosphodiesterase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; serotonin uptake inhibitor |
| amphetamine Amphetamine: A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.. 1-phenylpropan-2-amine : A primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.. amphetamine : A racemate comprising equimolar amounts of (R)-amphetamine (also known as levamphetamine or levoamphetamine) and (S)-amphetamine (also known as dexamfetamine or dextroamphetamine. | 3.63 | 2 | 0 | primary amine | |
| diazepam Diazepam: A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.. diazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5. | 12.2 | 10 | 3 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; environmental contaminant; sedative; xenobiotic |
| diazoxide Diazoxide: A benzothiadiazine derivative that is a peripheral vasodilator used for hypertensive emergencies. It lacks diuretic effect, apparently because it lacks a sulfonamide group.. diazoxide : A benzothiadiazine that is the S,S-dioxide of 2H-1,2,4-benzothiadiazine which is substituted at position 3 by a methyl group and at position 7 by chlorine. A peripheral vasodilator, it increases the concentration of glucose in the plasma and inhibits the secretion of insulin by the beta- cells of the pancreas. It is used orally in the management of intractable hypoglycaemia and intravenously in the management of hypertensive emergencies. | 3.61 | 2 | 0 | benzothiadiazine; organochlorine compound; sulfone | antihypertensive agent; beta-adrenergic agonist; bronchodilator agent; cardiotonic drug; diuretic; K-ATP channel agonist; sodium channel blocker; sympathomimetic agent; vasodilator agent |
| diclofenac Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. | 7.92 | 12 | 3 | amino acid; aromatic amine; dichlorobenzene; monocarboxylic acid; secondary amino compound | antipyretic; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| dichlorphenamide Dichlorphenamide: A carbonic anhydrase inhibitor that is used in the treatment of glaucoma.. diclofenamide : A sulfonamide that is benzene-1,3-disulfonamide in which the hydrogens at positions 4 and 5 are substituted by chlorine. An oral carbonic anhydrase inhibitor, it partially suppresses the secretion (inflow) of aqueous humor in the eye and so reduces intraocular pressure. It is used for the treatment of glaucoma. | 3.23 | 1 | 0 | dichlorobenzene; sulfonamide | antiglaucoma drug; EC 4.2.1.1 (carbonic anhydrase) inhibitor; ophthalmology drug |
| dicyclomine Dicyclomine: A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms.. dicyclomine : The ester resulting from the formal condensation of 1-cyclohexylcyclohexanecarboxylic acid with 2-(diethylamino)ethanol. An anticholinergic, it is used as the hydrochloride to treat or prevent spasm in the muscles of the gastrointestinal tract, particularly that associated with irritable bowel syndrome. | 3.23 | 1 | 0 | carboxylic ester; tertiary amine | antispasmodic drug; muscarinic antagonist; parasympatholytic |
| pentetic acid Pentetic Acid: An iron chelating agent with properties like EDETIC ACID. DTPA has also been used as a chelator for other metals, such as plutonium. | 3.23 | 1 | 0 | pentacarboxylic acid | copper chelator |
| diflunisal Diflunisal: A salicylate derivative and anti-inflammatory analgesic with actions and side effects similar to those of ASPIRIN.. diflunisal : An organofluorine compound comprising salicylic acid having a 2,4-difluorophenyl group at the 5-position. | 3.69 | 2 | 0 | monohydroxybenzoic acid; organofluorine compound | non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| dimercaprol Dimercaprol: An anti-gas warfare agent that is effective against Lewisite (dichloro(2-chlorovinyl)arsine) and formerly known as British Anti-Lewisite or BAL. It acts as a chelating agent and is used in the treatment of arsenic, gold, and other heavy metal poisoning.. dimercaprol : A dithiol that is propane-1,2-dithiol in which one of the methyl hydrogens is replaced by a hydroxy group. a chelating agent originally developed during World War II as an experimental antidote against the arsenic-based poison gas Lewisite, it has been used clinically since 1949 for the treatment of poisoning by arsenic, mercury and gold. It can also be used for treatment of poisoning by antimony, bismuth and possibly thallium, and (with sodium calcium edetate) in cases of acute leaad poisoning. Administration is by (painful) intramuscular injection of a suspension of dimercaprol in peanut oil, typically every 4 hours for 2-10 days depending on the toxicity. In the past, dimercaprol was also used for the treatment of Wilson's disease, a severely debilitating genetic disorder in which the body tends to retain copper, with resultant liver and brain injury. | 3.23 | 1 | 0 | dithiol; primary alcohol | chelator |
| diphenhydramine Diphenhydramine: A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.. diphenhydramine : An ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug.. antitussive : An agent that suppresses cough. Antitussives have a central or a peripheral action on the cough reflex, or a combination of both. Compare with expectorants, which are considered to increase the volume of secretions in the respiratory tract, so facilitating their removal by ciliary action and coughing, and mucolytics, which decrease the viscosity of mucus, facilitating its removal by ciliary action and expectoration. | 7.35 | 9 | 4 | ether; tertiary amino compound | anti-allergic agent; antidyskinesia agent; antiemetic; antiparkinson drug; antipruritic drug; antitussive; H1-receptor antagonist; local anaesthetic; muscarinic antagonist; oneirogen; sedative |
| dipyridamole Dipyridamole: A phosphodiesterase inhibitor that blocks uptake and metabolism of adenosine by erythrocytes and vascular endothelial cells. Dipyridamole also potentiates the antiaggregating action of prostacyclin. (From AMA Drug Evaluations Annual, 1994, p752). dipyridamole : A pyrimidopyrimidine that is 2,2',2'',2'''-(pyrimido[5,4-d]pyrimidine-2,6-diyldinitrilo)tetraethanol substituted by piperidin-1-yl groups at positions 4 and 8 respectively. A vasodilator agent, it inhibits the formation of blood clots. | 3.61 | 2 | 0 | piperidines; pyrimidopyrimidine; tertiary amino compound; tetrol | adenosine phosphodiesterase inhibitor; EC 3.5.4.4 (adenosine deaminase) inhibitor; platelet aggregation inhibitor; vasodilator agent |
| disopyramide Disopyramide: A class I anti-arrhythmic agent (one that interferes directly with the depolarization of the cardiac membrane and thus serves as a membrane-stabilizing agent) with a depressant action on the heart similar to that of guanidine. It also possesses some anticholinergic and local anesthetic properties.. disopyramide : A monocarboxylic acid amide that is butanamide substituted by a diisopropylamino group at position 4, a phenyl group at position 2 and a pyridin-2-yl group at position 2. It is used as a anti-arrhythmia drug. | 3.61 | 2 | 0 | monocarboxylic acid amide; pyridines; tertiary amino compound | anti-arrhythmia drug |
| disulfiram [no description available] | 3.61 | 2 | 0 | organic disulfide; organosulfur acaricide | angiogenesis inhibitor; antineoplastic agent; apoptosis inducer; EC 1.2.1.3 [aldehyde dehydrogenase (NAD(+))] inhibitor; EC 3.1.1.1 (carboxylesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; EC 5.99.1.2 (DNA topoisomerase) inhibitor; ferroptosis inducer; fungicide; NF-kappaB inhibitor |
| valproic acid Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem. | 10.85 | 25 | 4 | branched-chain fatty acid; branched-chain saturated fatty acid | anticonvulsant; antimanic drug; EC 3.5.1.98 (histone deacetylase) inhibitor; GABA agent; neuroprotective agent; psychotropic drug; teratogenic agent |
| domperidone Domperidone: A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.. domperidone : 1-[3-(Piperidin-1-yl)propyl]-1,3-dihydro-2H-benzimidazol-2-one in which the 4-position of the piperidine ring is substituted by a 5-chloro-1,3-dihydro-2H-benzimidazol-2-on-1-yl group. A dopamine antagonist, it is used as an antiemetic for the short-term treatment of nausea and vomiting, and to control gastrointestinal effects of dopaminergic drugs given in the management of parkinsonism. The free base is used in oral suspensions, while the maleate salt is used in tablet preparations. | 2.08 | 1 | 0 | benzimidazoles; heteroarylpiperidine | antiemetic; dopaminergic antagonist |
| donepezil Donepezil: An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.. donepezil : A racemate comprising equimolar amounts of (R)- and (S)-donepezil. A centrally acting reversible acetylcholinesterase inhibitor, its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine.. 2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindan-1-one : A member of the class of indanones that is 5,6-dimethoxyindan-1-one which is substituted at position 2 by an (N-benzylpiperidin-4-yl)methyl group. | 3.91 | 3 | 0 | aromatic ether; indanones; piperidines; racemate | EC 3.1.1.7 (acetylcholinesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; nootropic agent |
| doxapram Doxapram: A central respiratory stimulant with a brief duration of action. (From Martindale, The Extra Pharmocopoeia, 30th ed, p1225). doxapram : A member of the class of pyrrolidin-2-ones that is N-ethylpyrrolidin-2-one in which both of the hydrogens at the 3 position (adjacent to the carbonyl group) are substituted by phenyl groups, and one of the hydrogens at the 4 position is substituted by a 2-(morpholin-4-yl)ethyl group. A central and respiratory stimulant with a brief duration of action, it is used (generally as the hydrochloride or the hydrochloride hydrate) as a temporary treatment of acute respiratory failure, particularly when superimposed on chronic obstructive pulmonary disease, and of postoperative respiratory depression. It has also been used for treatment of postoperative shivering. | 3.23 | 1 | 0 | morpholines; pyrrolidin-2-ones | central nervous system stimulant |
| doxazosin Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.. doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure. | 3.23 | 1 | 0 | aromatic amine; benzodioxine; monocarboxylic acid amide; N-acylpiperazine; N-arylpiperazine; quinazolines | alpha-adrenergic antagonist; antihyperplasia drug; antihypertensive agent; antineoplastic agent; vasodilator agent |
| doxepin Doxepin: A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.. doxepin : A dibenzooxepine that is 6,11-dihydrodibenzo[b,e]oxepine substituted by a 3-(dimethylamino)propylidene group at position 11. It is used as an antidepressant drug. | 11.03 | 4 | 1 | dibenzooxepine; tertiary amino compound | antidepressant |
| doxylamine Doxylamine: Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM. | 3.23 | 1 | 0 | pyridines; tertiary amine | anti-allergic agent; antiemetic; antitussive; cholinergic antagonist; H1-receptor antagonist; histamine antagonist; sedative |
| droperidol Droperidol: A butyrophenone with general properties similar to those of HALOPERIDOL. It is used in conjunction with an opioid analgesic such as FENTANYL to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593). droperidol : An organofluorine compound that is haloperidol in which the hydroxy group has been eliminated with the introduction of a double bond in the piperidine ring, and the 4-chlorophenyl group has been replaced by a benzimidazol-2-on-1-yl group. It is used in the management of chemotherapy-induced nausea and vomiting, and in conjunction with an opioid analgesic such as fentanyl to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. | 3.71 | 2 | 0 | aromatic ketone; benzimidazoles; organofluorine compound | anaesthesia adjuvant; antiemetic; dopaminergic antagonist; first generation antipsychotic |
| dyphylline Dyphylline: A THEOPHYLLINE derivative with broncho- and vasodilator properties. It is used in the treatment of asthma, cardiac dyspnea, and bronchitis.. dyphylline : An oxopurine that is theophylline bearing a 2,3-dihydroxypropyl group at the 7 position. It has broncho- and vasodilator properties, and is used in the treatment of asthma, cardiac dyspnea, and bronchitis. It is also an ingredient in preparations that have been promoted for coughs. | 3.23 | 1 | 0 | oxopurine; propane-1,2-diols | bronchodilator agent; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; muscle relaxant; vasodilator agent |
| ebastine [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
| edrophonium Edrophonium: A rapid-onset, short-acting cholinesterase inhibitor used in cardiac arrhythmias and in the diagnosis of myasthenia gravis. It has also been used as an antidote to curare principles.. edrophonium : A quaternary ammonium ion that is N-ethyl-N,N-dimethylanilinium in which one of the meta positions is substituted by a hydroxy group. It is a reversible inhibitor of cholinesterase, with a rapid onset (30-60 seconds after injection) but a short duration of action (5-15 minutes). The chloride salt is used in myasthenia gravis both diagnostically and to distinguish between under- or over-treatment with other anticholinesterases. It has also been used for the reversal of neuromuscular blockade in anaesthesia, and for the management of poisoning due to tetrodotoxin, a neuromuscular blocking toxin found in puffer fish and other marine animals. | 3.23 | 1 | 0 | phenols; quaternary ammonium ion | antidote; diagnostic agent; EC 3.1.1.8 (cholinesterase) inhibitor |
| enoxacin Enoxacin: A broad-spectrum 6-fluoronaphthyridinone antibacterial agent that is structurally related to NALIDIXIC ACID.. enoxacin : A 1,8-naphthyridine derivative that is 1,4-dihydro-1,8-naphthyridine with an ethyl group at the 1 position, a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a piperazin-1-yl group at the 7 position. An antibacterial, it is used in the treatment of urinary-tract infections and gonorrhoea. | 2.08 | 1 | 0 | 1,8-naphthyridine derivative; amino acid; fluoroquinolone antibiotic; monocarboxylic acid; N-arylpiperazine; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor |
| estazolam Estazolam: A benzodiazepine with anticonvulsant, hypnotic, and muscle relaxant properties. It has been shown in some cases to be more potent than DIAZEPAM or NITRAZEPAM.. estazolam : A triazolo[4,3-a][1,4]benzodiazepine having a phenyl group at position 6 and a chloro substituent at position 8. A short-acting benzodiazepine with general properties similar to diazepam, it is given by mouth as a hypnotic in the short-term management of insomnia. | 3.23 | 1 | 0 | triazoles; triazolobenzodiazepine | anticonvulsant; anxiolytic drug; GABA modulator |
| ethacrynic acid Ethacrynic Acid: A compound that inhibits symport of sodium, potassium, and chloride primarily in the ascending limb of Henle, but also in the proximal and distal tubules. This pharmacological action results in excretion of these ions, increased urinary output, and reduction in extracellular fluid. This compound has been classified as a loop or high ceiling diuretic.. etacrynic acid : An aromatic ether that is phenoxyacetic acid in which the phenyl ring is substituted by chlorines at positions 2 and 3, and by a 2-methylidenebutanoyl group at position 4. It is a loop diuretic used to treat high blood pressure resulting from diseases such as congestive heart failure, liver failure, and kidney failure. It is also a glutathione S-transferase (EC 2.5.1.18) inhibitor. | 3.61 | 2 | 0 | aromatic ether; aromatic ketone; dichlorobenzene; monocarboxylic acid | EC 2.5.1.18 (glutathione transferase) inhibitor; ion transport inhibitor; loop diuretic |
| ethosuximide Ethosuximide: An anticonvulsant especially useful in the treatment of absence seizures unaccompanied by other types of seizures.. ethosuximide : A dicarboximide that is pyrrolidine-2,5-dione in which the hydrogens at position 3 are substituted by one methyl and one ethyl group. An antiepileptic, it is used in the treatment of absence seizures and may be used for myoclonic seizures, but is ineffective against tonic-clonic seizures. | 4.72 | 4 | 0 | dicarboximide; pyrrolidinone | anticonvulsant; geroprotector; T-type calcium channel blocker |
| ethotoin ethotoin: was heading 1966-94 (see under HYDANTOINS 1966-90); use HYDANTOINS to search ETHOTOIN 1966-94. ethotoin : An imidazolidine-2,4-dione that is hydantoin substituted by ethyl and phenyl at positions 3 and 5, respectively. An antiepileptic, it is less toxic than phenytoin but also less effective. | 3.23 | 1 | 0 | imidazolidine-2,4-dione | anticonvulsant |
| etidronate Etidronic Acid: A diphosphonate which affects calcium metabolism. It inhibits ectopic calcification and slows down bone resorption and bone turnover.. etidronic acid : A 1,1-bis(phosphonic acid) that is (ethane-1,1-diyl)bis(phosphonic acid) having a hydroxy substituent at the 1-position. It inhibits the formation, growth, and dissolution of hydroxyapatite crystals by chemisorption to calcium phosphate surfaces. | 3.23 | 1 | 0 | 1,1-bis(phosphonic acid) | antineoplastic agent; bone density conservation agent; chelator |
| etodolac Etodolac: A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).. etodolac : A monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is substituted by a 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl moiety. A preferential inhibitor of cyclo-oxygenase 2 and non-steroidal anti-inflammatory, it is used for the treatment of rheumatoid arthritis and osteoarthritis, and for the alleviation of postoperative pain. Administered as the racemate, only the (S)-enantiomer is active. | 3.87 | 3 | 0 | monocarboxylic acid; organic heterotricyclic compound | antipyretic; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| brl 42810 [no description available] | 3.92 | 3 | 0 | 2-aminopurines; acetate ester | antiviral drug; prodrug |
| felbamate Felbamate: A PEGylated phenylcarbamate derivative that acts as an antagonist of NMDA RECEPTORS. It is used as an anticonvulsant, primarily for the treatment of SEIZURES in severe refractory EPILEPSY.. felbamate : The bis(carbamate ester) of 2-phenylpropane-1,3-diol. An anticonvulsant, it is used in the treatment of epilepsy. | 4.74 | 3 | 0 | carbamate ester | anticonvulsant; neuroprotective agent |
| 4-biphenylylacetic acid biphenyl-4-ylacetic acid : A monocarboxylic acid in which one of the alpha-hydrogens is substituted by a biphenyl-4-yl group. An active metabolite of fenbufen, it is used as a topical medicine to treat muscle inflammation and arthritis. | 2.08 | 1 | 0 | biphenyls; monocarboxylic acid | non-steroidal anti-inflammatory drug |
| felodipine Felodipine: A dihydropyridine calcium antagonist with positive inotropic effects. It lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels.. felodipine : The mixed (methyl, ethyl) diester of 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid. A calcium-channel blocker, it lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels. It is used in the management of hypertension and angina pectoris. | 3.61 | 2 | 0 | dichlorobenzene; dihydropyridine; ethyl ester; methyl ester | anti-arrhythmia drug; antihypertensive agent; calcium channel blocker; vasodilator agent |
| fenbufen fenbufen: structure; RN given refers to parent cpd | 2.31 | 1 | 0 | 4-oxo monocarboxylic acid; biphenyls | non-steroidal anti-inflammatory drug |
| fenfluramine Fenfluramine: A centrally active drug that apparently both blocks serotonin uptake and provokes transport-mediated serotonin release.. fenfluramine : A secondary amino compound that is 1-phenyl-propan-2-amine in which one of the meta-hydrogens is substituted by trifluoromethyl, and one of the hydrogens attached to the nitrogen is substituted by an ethyl group. It binds to the serotonin reuptake pump, causing inhbition of serotonin uptake and release of serotonin. The resulting increased levels of serotonin lead to greater serotonin receptor activation which in turn lead to enhancement of serotoninergic transmission in the centres of feeding behavior located in the hypothalamus. This suppresses the appetite for carbohydrates. Fenfluramine was used as the hydrochloride for treatment of diabetes and obesity. It was withdrawn worldwide after reports of heart valve disease and pulmonary hypertension. | 3.51 | 1 | 0 | (trifluoromethyl)benzenes; secondary amino compound | appetite depressant; serotonergic agonist; serotonin uptake inhibitor |
| fenofibrate Pharmavit: a polyvitamin product, comprising vitamins A, D2, B1, B2, B6, C, E, nicotinamide, & calcium pantothene; may be a promising agent for application to human populations exposed to carcinogenic and genetic hazards of ionizing radiation; RN from CHEMLINE | 3.61 | 2 | 0 | aromatic ether; chlorobenzophenone; isopropyl ester; monochlorobenzenes | antilipemic drug; environmental contaminant; geroprotector; xenobiotic |
| fenoldopam Fenoldopam: A dopamine D1 receptor agonist that is used as an antihypertensive agent. It lowers blood pressure through arteriolar vasodilation. | 3.23 | 1 | 0 | benzazepine | alpha-adrenergic agonist; antihypertensive agent; dopamine agonist; dopaminergic antagonist; vasodilator agent |
| fenoprofen Fenoprofen: A propionic acid derivative that is used as a non-steroidal anti-inflammatory agent.. fenoprofen : A monocarboxylic acid that is propanoic acid in which one of the hydrogens at position 2 is substituted by a 3-phenoxyphenyl group. A non-steroidal anti-inflammatory drug, the dihydrate form of the calcium salt is used for the management of mild to moderate pain and for the relief of pain and inflammation associated with disorders such as arthritis. It is pharmacologically similar to aspirin, but causes less gastrointestinal bleeding. | 3.69 | 2 | 0 | monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| fentanyl Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078). fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid. | 16.39 | 22 | 18 | anilide; monocarboxylic acid amide; piperidines | adjuvant; anaesthesia adjuvant; anaesthetic; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic |
| fexofenadine fexofenadine: a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; structure in first source; RN refers to HCl. fexofenadine : A piperidine-based anti-histamine compound. | 3.23 | 1 | 0 | piperidines; tertiary amine | anti-allergic agent; H1-receptor antagonist |
| fipexide fipexide: regulates dopaminergic systems at macromolecular level | 3.23 | 1 | 0 | benzodioxoles | |
| flavoxate Flavoxate: A drug that has been used in various urinary syndromes and as an antispasmodic. Its therapeutic usefulness and its mechanism of action are not clear. It may have local anesthetic activity and direct relaxing effects on smooth muscle as well as some activity as a muscarinic antagonist.. flavoxate : A carboxylic ester resulting from the formal condensation of 3-methylflavone-8-carboxylic acid with 2-(1-piperidinyl)ethanol. | 3.23 | 1 | 0 | carboxylic ester; flavones; piperidines; tertiary amino compound | antispasmodic drug; muscarinic antagonist; parasympatholytic |
| flecainide Flecainide: A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.. flecainide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2,5-bis(2,2,2-trifluoroethoxy)benzoic acid with the primary amino group of piperidin-2-ylmethylamine. An antiarrhythmic agent used (in the form of its acetate salt) to prevent and treat tachyarrhythmia (abnormal fast rhythm of the heart). | 3.23 | 1 | 0 | aromatic ether; monocarboxylic acid amide; organofluorine compound; piperidines | anti-arrhythmia drug |
| fleroxacin Fleroxacin: A broad-spectrum antimicrobial fluoroquinolone. The drug strongly inhibits the DNA-supercoiling activity of DNA GYRASE.. fleroxacin : A fluoroquinolone antibiotic that is 4-oxo-1,4-dihydroquinoline which is substituted at positions 1, 3, 6, 7 and 8 by 2-fluoroethyl, carboxy, fluoro, 4-methylpiperazin-1-yl and fluoro groups, respectively. It is active against many Gram-positive and Gram-negative bacteria. | 2.08 | 1 | 0 | difluorobenzene; fluoroquinolone antibiotic; monocarboxylic acid; N-alkylpiperazine; quinolines | antibacterial drug; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; topoisomerase IV inhibitor |
| fluconazole Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis. | 3.61 | 2 | 0 | conazole antifungal drug; difluorobenzene; tertiary alcohol; triazole antifungal drug | environmental contaminant; P450 inhibitor; xenobiotic |
| flucytosine Flucytosine: A fluorinated cytosine analog that is used as an antifungal agent.. flucytosine : An organofluorine compound that is cytosine that is substituted at position 5 by a fluorine. A prodrug for the antifungal 5-fluorouracil, it is used for the treatment of systemic fungal infections. | 3.61 | 2 | 0 | aminopyrimidine; nucleoside analogue; organofluorine compound; pyrimidine antifungal drug; pyrimidone | prodrug |
| fluphenazine [no description available] | 3.23 | 1 | 0 | N-alkylpiperazine; organofluorine compound; phenothiazines | anticoronaviral agent; dopaminergic antagonist; phenothiazine antipsychotic drug |
| flumazenil Flumazenil: A potent benzodiazepine receptor antagonist. Since it reverses the sedative and other actions of benzodiazepines, it has been suggested as an antidote to benzodiazepine overdoses.. flumazenil : An organic heterotricyclic compound that is 5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted at positions 3, 5, 6, and 8 by ethoxycarbonyl, methyl, oxo, and fluoro groups, respectively. It is used as an antidote to benzodiazepine overdose. | 5.34 | 3 | 0 | ethyl ester; imidazobenzodiazepine; organofluorine compound | antidote to benzodiazepine poisoning; GABA antagonist |
| fluorescite fluorescein (acid form) : A xanthene dye that is highly fluorescent and commonly used as a fluorescent tracer. | 3.61 | 2 | 0 | benzoic acids; cyclic ketone; hydroxy monocarboxylic acid; organic heterotricyclic compound; phenols; xanthene dye | fluorescent dye; radioopaque medium |
| fluorouracil Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.. 5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth. | 4.31 | 5 | 0 | nucleobase analogue; organofluorine compound | antimetabolite; antineoplastic agent; environmental contaminant; immunosuppressive agent; radiosensitizing agent; xenobiotic |
| fluoxetine Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.. fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. | 5.41 | 6 | 0 | (trifluoromethyl)benzenes; aromatic ether; secondary amino compound | |
| flurazepam Flurazepam: A benzodiazepine derivative used mainly as a hypnotic.. flurazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a 2-(diethylamino)ethyl group, 2-fluorophenyl group and chloro group at positions 1, 5 and 7, respectively. It is a partial agonist of GABAA receptors and used for the treatment of insomnia. | 3.23 | 1 | 0 | 1,4-benzodiazepinone; monofluorobenzenes; organochlorine compound; tertiary amino compound | anticonvulsant; anxiolytic drug; GABAA receptor agonist; sedative |
| flurbiprofen Flurbiprofen: An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.. flurbiprofen : A monocarboxylic acid that is a 2-fluoro-[1,1'-biphenyl-4-yl] moiety linked to C-2 of propionic acid. A non-steroidal anti-inflammatory, analgesic and antipyretic, it is used as a pre-operative anti-miotic as well as orally for arthritis or dental pain. | 3.23 | 1 | 0 | fluorobiphenyl; monocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| flutamide Flutamide: An antiandrogen with about the same potency as cyproterone in rodent and canine species. | 3.61 | 2 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide | androgen antagonist; antineoplastic agent |
| fomepizole Fomepizole: A pyrazole and competitive inhibitor of ALCOHOL DEHYDROGENASE that is used for the treatment of poisoning by ETHYLENE GLYCOL or METHANOL.. fomepizole : A member of the class of pyrazoles that is 1H-pyrazole substituted by a methyl group at position 4. | 3.23 | 1 | 0 | pyrazoles | antidote; EC 1.1.1.1 (alcohol dehydrogenase) inhibitor; protective agent |
| foscarnet Foscarnet: An antiviral agent used in the treatment of cytomegalovirus retinitis. Foscarnet also shows activity against human herpesviruses and HIV.. phosphonoformic acid : Phosphoric acid in which one of the hydroxy groups is replaced by a carboxylic acid group. It is used as the trisodium salt as an antiviral agent in the treatment of cytomegalovirus retinitis (CMV retinitis, an inflamation of the retina that can lead to blindness) and as an alternative to ganciclovir for AIDS patients who require concurrent antiretroviral therapy but are unable to tolerate ganciclovir due to haematological toxicity. | 3.23 | 1 | 0 | carboxylic acid; one-carbon compound; phosphonic acids | antiviral drug; geroprotector; HIV-1 reverse transcriptase inhibitor; sodium-dependent Pi-transporter inhibitor |
| furosemide Furosemide: A benzoic-sulfonamide-furan. It is a diuretic with fast onset and short duration that is used for EDEMA and chronic RENAL INSUFFICIENCY.. furosemide : A chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively. It is a diuretic used in the treatment of congestive heart failure. | 3.61 | 2 | 0 | chlorobenzoic acid; furans; sulfonamide | environmental contaminant; loop diuretic; xenobiotic |
| gabapentin Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.. gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. | 23.71 | 566 | 31 | gamma-amino acid | anticonvulsant; calcium channel blocker; environmental contaminant; xenobiotic |
| vanoxerine vanoxerine: structure given in first source. vanoxerine : An N-alkylpiperazine that consists of piperazine bearing 2-bis(4-fluorophenyl)methoxy]ethyl and 3-phenylpropyl groups at positions 1 and 4 respectively. Potent, competitive inhibitor of dopamine uptake (Ki = 1 nM for inhibition of striatal dopamine uptake). Has > 100-fold lower affinity for the noradrenalin and 5-HT uptake carriers. Also a potent sigma ligand (IC50 = 48 nM). Centrally active following systemic administration. | 2.13 | 1 | 0 | ether; N-alkylpiperazine; organofluorine compound; tertiary amino compound | dopamine uptake inhibitor |
| gemfibrozil [no description available] | 3.61 | 2 | 0 | aromatic ether | antilipemic drug |
| glafenine Glafenine: An anthranilic acid derivative with analgesic properties used for the relief of all types of pain.. glafenine : A carboxylic ester that is 2,3-dihydroxypropyl anthranilate in which the amino group is substituted by a 7-chloroquinolin-4-yl group. A non-steroidal anti-inflammatory drug, glafenine and its hydrochloride salt were used for the relief of all types of pain, but high incidence of anaphylactic reactions resulted in their withdrawal from the market. | 3.23 | 1 | 0 | aminoquinoline; carboxylic ester; glycol; organochlorine compound; secondary amino compound | inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| gliclazide Gliclazide: An oral sulfonylurea hypoglycemic agent which stimulates insulin secretion. | 2.08 | 1 | 0 | N-sulfonylurea | hypoglycemic agent; insulin secretagogue; radical scavenger |
| glimepiride glimepiride: structure given in first source | 3.61 | 2 | 0 | sulfonamide | |
| glipizide Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.. glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus. | 3.61 | 2 | 0 | aromatic amide; monocarboxylic acid amide; N-sulfonylurea; pyrazines | EC 2.7.1.33 (pantothenate kinase) inhibitor; hypoglycemic agent; insulin secretagogue |
| glyburide Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide. glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group. | 4.09 | 4 | 0 | monochlorobenzenes; N-sulfonylurea | anti-arrhythmia drug; EC 2.7.1.33 (pantothenate kinase) inhibitor; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor; hypoglycemic agent |
| 2-cyclopentyl-2-hydroxy-2-phenylacetic acid (1,1-dimethyl-3-pyrrolidin-1-iumyl) ester [no description available] | 3.23 | 1 | 0 | benzenes | |
| granisetron [no description available] | 3.23 | 1 | 0 | aromatic amide; indazoles | |
| guaifenesin Guaifenesin: An expectorant that also has some muscle relaxing action. It is used in many cough preparations. | 3.23 | 1 | 0 | methoxybenzenes | |
| guanethidine Guanethidine: An antihypertensive agent that acts by inhibiting selectively transmission in post-ganglionic adrenergic nerves. It is believed to act mainly by preventing the release of norepinephrine at nerve endings and causes depletion of norepinephrine in peripheral sympathetic nerve terminals as well as in tissues.. guanethidine : A member of the class of guanidines in which one of the hydrogens of the amino group has been replaced by a 2-azocan-1-ylethyl group.. guanethidine sulfate : A organic sulfate salt composed of two molecules of guanethidine and one of sulfuric acid. | 3.23 | 1 | 0 | azocanes; guanidines | adrenergic antagonist; antihypertensive agent; sympatholytic agent |
| guanfacine Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS. | 3.61 | 2 | 0 | acetamides | |
| guanidine Guanidine: A strong organic base existing primarily as guanidium ions at physiological pH. It is found in the urine as a normal product of protein metabolism. It is also used in laboratory research as a protein denaturant. (From Martindale, the Extra Pharmacopoeia, 30th ed and Merck Index, 12th ed) It is also used in the treatment of myasthenia and as a fluorescent probe in HPLC.. guanidine : An aminocarboxamidine, the parent compound of the guanidines. | 3.71 | 2 | 0 | carboxamidine; guanidines; one-carbon compound | |
| haloperidol Haloperidol: A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279). haloperidol : A compound composed of a central piperidine structure with hydroxy and p-chlorophenyl substituents at position 4 and an N-linked p-fluorobutyrophenone moiety. | 4.95 | 6 | 0 | aromatic ketone; hydroxypiperidine; monochlorobenzenes; organofluorine compound; tertiary alcohol | antidyskinesia agent; antiemetic; dopaminergic antagonist; first generation antipsychotic; serotonergic antagonist |
| hydralazine Hydralazine: A direct-acting vasodilator that is used as an antihypertensive agent.. hydralazine : The 1-hydrazino derivative of phthalazine; a direct-acting vasodilator that is used as an antihypertensive agent. | 3.57 | 2 | 0 | azaarene; hydrazines; ortho-fused heteroarene; phthalazines | antihypertensive agent; vasodilator agent |
| hydrochlorothiazide Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.. hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure. | 3.61 | 2 | 0 | benzothiadiazine; organochlorine compound; sulfonamide | antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
| hydroflumethiazide Hydroflumethiazide: A thiazide diuretic with actions and uses similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p822). hydroflumethiazide : A benzothiadiazine consisting of a 3,4-dihydro-HH-1,2,4-benzothiadiazine bicyclic system dioxygenated on sulfur and carrying trifluoromethyl and aminosulfonyl groups at positions 6 and 7 respectively. A diuretic with actions and uses similar to those of hydrochlorothiazide. | 3.61 | 2 | 0 | benzothiadiazine; thiazide | antihypertensive agent; diuretic |
| hydroxychloroquine Hydroxychloroquine: A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970). hydroxychloroquine : An aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions. | 3.59 | 2 | 0 | aminoquinoline; organochlorine compound; primary alcohol; secondary amino compound; tertiary amino compound | anticoronaviral agent; antimalarial; antirheumatic drug; dermatologic drug |
| hydroxyurea [no description available] | 3.61 | 2 | 0 | one-carbon compound; ureas | antimetabolite; antimitotic; antineoplastic agent; DNA synthesis inhibitor; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; genotoxin; immunomodulator; radical scavenger; teratogenic agent |
| hydroxyzine Hydroxyzine: A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.. hydroxyzine : A N-alkylpiperazine that is piperzine in which the nitrogens atoms are substituted by 2-(2-hydroxyethoxy)ethyl and (4-chlorophenyl)(phenyl)methyl groups respectively. | 4.12 | 2 | 0 | hydroxyether; monochlorobenzenes; N-alkylpiperazine | anticoronaviral agent; antipruritic drug; anxiolytic drug; dermatologic drug; H1-receptor antagonist |
| ibuprofen Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine | 13.52 | 27 | 13 | monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; radical scavenger; xenobiotic |
| phenelzine Phenelzine: One of the MONOAMINE OXIDASE INHIBITORS used to treat DEPRESSION; PHOBIC DISORDERS; and PANIC. | 3.23 | 1 | 0 | primary amine | |
| lidocaine Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline. | 16.33 | 53 | 9 | benzenes; monocarboxylic acid amide; tertiary amino compound | anti-arrhythmia drug; drug allergen; environmental contaminant; local anaesthetic; xenobiotic |
| ifosfamide [no description available] | 3.61 | 2 | 0 | ifosfamides | alkylating agent; antineoplastic agent; environmental contaminant; immunosuppressive agent; xenobiotic |
| imipramine Imipramine: The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.. imipramine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)propyl group at the nitrogen atom. | 6.79 | 6 | 3 | dibenzoazepine | adrenergic uptake inhibitor; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| amrinone Amrinone: A positive inotropic cardiotonic (CARDIOTONIC AGENTS) with vasodilator properties, phosphodiesterase 3 inhibitory activity, and the ability to stimulate calcium ion influx into the cardiac cell.. amrinone : A 3,4'-bipyridine substituted at positions 5 and 6 by an amino group and a keto function respectively. A pyridine phosphodiesterase 3 inhibitor, it is a drug that may improve the prognosis in patients with congestive heart failure. | 3.61 | 2 | 0 | bipyridines | EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
| indapamide Indapamide: A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. indapamide : A sulfonamide formed by condensation of the carboxylic group of 4-chloro-3-sulfamoylbenzoic acid with the amino group of 2-methyl-2,3-dihydro-1H-indol-1-amine. | 4.38 | 3 | 0 | indoles; organochlorine compound; sulfonamide | antihypertensive agent; diuretic |
| indomethacin Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis. | 4.59 | 7 | 0 | aromatic ether; indole-3-acetic acids; monochlorobenzenes; N-acylindole | analgesic; drug metabolite; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; gout suppressant; non-steroidal anti-inflammatory drug; xenobiotic metabolite; xenobiotic |
| iohexol Iohexol: An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.. iohexol : A benzenedicarboxamide compound having N-(2,3-dihydroxypropyl)carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and an N-(2,3-dihydroxypropyl)acetamido group at the 5-position. | 2.08 | 1 | 0 | benzenedicarboxamide; organoiodine compound | environmental contaminant; radioopaque medium; xenobiotic |
| ioversol [no description available] | 3.23 | 1 | 0 | amidobenzoic acid | |
| iproniazid [no description available] | 3.61 | 2 | 0 | carbohydrazide; pyridines | |
| avapro Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.. irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension. | 3.61 | 2 | 0 | azaspiro compound; biphenylyltetrazole | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| 1-methyl-3-isobutylxanthine 1-Methyl-3-isobutylxanthine: A potent cyclic nucleotide phosphodiesterase inhibitor; due to this action, the compound increases cyclic AMP and cyclic GMP in tissue and thereby activates CYCLIC NUCLEOTIDE-REGULATED PROTEIN KINASES. 3-isobutyl-1-methylxanthine : An oxopurine that is xanthine which is substituted at positions 1 and 3 by methyl and isobutyl groups, respectively. | 2.17 | 1 | 0 | 3-isobutyl-1-methylxanthine | |
| isocarboxazid Isocarboxazid: An MAO inhibitor that is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in the treatment of panic disorder and the phobic disorders. (From AMA, Drug Evaluations Annual, 1994, p311) | 3.23 | 1 | 0 | benzenes | |
| isoflurane Isoflurane: A stable, non-explosive inhalation anesthetic, relatively free from significant side effects. | 5.14 | 2 | 1 | organofluorine compound | inhalation anaesthetic |
| isoniazid Hydra: A genus of freshwater polyps in the family Hydridae, order Hydroida, class HYDROZOA. They are of special interest because of their complex organization and because their adult organization corresponds roughly to the gastrula of higher animals.. hydrazide : Compounds derived from oxoacids RkE(=O)l(OH)m (l =/= 0) by replacing -OH by -NRNR2 (R groups are commonly H). (IUPAC). | 3.61 | 2 | 0 | carbohydrazide | antitubercular agent; drug allergen |
| propyphenazone propyphenazone: structure. propyphenazone : A pyrazolone derivative that is antipyrine substituted at C-4 by an isopropyl group. | 2.25 | 1 | 0 | pyrazolone | non-narcotic analgesic; non-steroidal anti-inflammatory drug; peripheral nervous system drug |
| isoproterenol Isoproterenol: Isopropyl analog of EPINEPHRINE; beta-sympathomimetic that acts on the heart, bronchi, skeletal muscle, alimentary tract, etc. It is used mainly as bronchodilator and heart stimulant.. isoprenaline : A secondary amino compound that is noradrenaline in which one of the hydrogens attached to the nitrogen is replaced by an isopropyl group. A sympathomimetic acting almost exclusively on beta-adrenergic receptors, it is used (mainly as the hydrochloride salt) as a bronghodilator and heart stimulant for the management of a variety of cardiac disorders. | 3.23 | 1 | 0 | catechols; secondary alcohol; secondary amino compound | beta-adrenergic agonist; bronchodilator agent; cardiotonic drug; sympathomimetic agent |
| isoxsuprine Isoxsuprine: A beta-adrenergic agonist that causes direct relaxation of uterine and vascular smooth muscle. Its vasodilating actions are greater on the arteries supplying skeletal muscle than on those supplying skin. It is used in the treatment of peripheral vascular disease and in premature labor. | 3.23 | 1 | 0 | alkylbenzene | |
| isradipine Isradipine: A potent antagonist of CALCIUM CHANNELS that is highly selective for VASCULAR SMOOTH MUSCLE. It is effective in the treatment of chronic stable angina pectoris, hypertension, and congestive cardiac failure. | 3.61 | 2 | 0 | benzoxadiazole; dihydropyridine; isopropyl ester; methyl ester | |
| itraconazole [no description available] | 3.61 | 2 | 0 | piperazines | |
| ketamine Ketamine: A cyclohexanone derivative used for induction of anesthesia. Its mechanism of action is not well understood, but ketamine can block NMDA receptors (RECEPTORS, N-METHYL-D-ASPARTATE) and may interact with sigma receptors.. ketamine : A member of the class of cyclohexanones in which one of the hydrogens at position 2 is substituted by a 2-chlorophenyl group, while the other is substituted by a methylamino group. | 11.74 | 30 | 2 | cyclohexanones; monochlorobenzenes; secondary amino compound | analgesic; environmental contaminant; intravenous anaesthetic; neurotoxin; NMDA receptor antagonist; xenobiotic |
| ketanserin Ketanserin: A selective serotonin receptor antagonist with weak adrenergic receptor blocking properties. The drug is effective in lowering blood pressure in essential hypertension. It also inhibits platelet aggregation. It is well tolerated and is particularly effective in older patients.. ketanserin : A member of the class of quinazolines that is quinazoline-2,4(1H,3H)-dione which is substituted at position 3 by a 2-[4-(p-fluorobenzoyl)piperidin-1-yl]ethyl group. | 2.08 | 1 | 0 | aromatic ketone; organofluorine compound; piperidines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; cardiovascular drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; serotonergic antagonist |
| ketoconazole 1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively. | 3.61 | 2 | 0 | dichlorobenzene; dioxolane; ether; imidazoles; N-acylpiperazine; N-arylpiperazine | |
| ketoprofen Ketoprofen: An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.. ketoprofen : An oxo monocarboxylic acid that consists of propionic acid substituted by a 3-benzoylphenyl group at position 2. | 5.57 | 4 | 1 | benzophenones; oxo monocarboxylic acid | antipyretic; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-steroidal anti-inflammatory drug; xenobiotic |
| ketorolac Ketorolac: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is an NSAID and is used principally for its analgesic activity. (From Martindale The Extra Pharmacopoeia, 31st ed). ketorolac : A racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure.. 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : A member of the class of pyrrolizines that is 2,3-dihydro-1H-pyrrolizine which is substituted at positions 1 and 5 by carboxy and benzoyl groups, respectively. | 10.31 | 14 | 5 | amino acid; aromatic ketone; monocarboxylic acid; pyrrolizines; racemate | analgesic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| ketotifen Ketotifen: A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.. ketotifen : An organic heterotricyclic compound that is 4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one which is substituted at position 4 by a 1-methylpiperidin-4-ylidene group. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is used (usually as its hydrogen fumarate salt) for the treatment of asthma, where it may take several weeks to exert its full effect. | 8.8 | 1 | 1 | cyclic ketone; olefinic compound; organic heterotricyclic compound; organosulfur heterocyclic compound; piperidines; tertiary amino compound | anti-asthmatic drug; H1-receptor antagonist |
| labetalol Labetalol: A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS.. labetalol : A diastereoisomeric mixture of approximately equal amounts of all four possible stereoisomers ((R,S)-labetolol, (S,R)-labetolol, (S,S)-labetalol and (R,R)-labetalol). It is an adrenergic antagonist used to treat high blood pressure.. 2-hydroxy-5-{1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl}benzamide : A member of the class of benzamides that is benzamide substituted by a hydroxy group at position 2 and by a 1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl group at position 5. | 3.23 | 1 | 0 | benzamides; benzenes; phenols; primary carboxamide; salicylamides; secondary alcohol; secondary amino compound | |
| lamotrigine [no description available] | 11.78 | 41 | 3 | 1,2,4-triazines; dichlorobenzene; primary arylamine | anticonvulsant; antidepressant; antimanic drug; calcium channel blocker; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; excitatory amino acid antagonist; geroprotector; non-narcotic analgesic; xenobiotic |
| lansoprazole Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers. | 3.61 | 2 | 0 | benzimidazoles; pyridines; sulfoxide | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor |
| leflunomide Leflunomide: An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.. leflunomide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-methyl-1,2-oxazole-4-carboxylic acid with the anilino group of 4-(trifluoromethyl)aniline. The prodrug of teriflunomide. | 3.61 | 2 | 0 | (trifluoromethyl)benzenes; isoxazoles; monocarboxylic acid amide | antineoplastic agent; antiparasitic agent; EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor; EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor; hepatotoxic agent; immunosuppressive agent; non-steroidal anti-inflammatory drug; prodrug; pyrimidine synthesis inhibitor; tyrosine kinase inhibitor |
| letrozole [no description available] | 3.61 | 2 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| linopirdine linopirdine: acetylcholine releasing drug | 2.06 | 1 | 0 | indoles | |
| lofepramine Lofepramine: A psychotropic IMIPRAMINE derivative that acts as a tricyclic antidepressant and possesses few anticholinergic properties. It is metabolized to DESIPRAMINE. | 2.08 | 1 | 0 | aromatic ketone; dibenzoazepine; monochlorobenzenes; tertiary amino compound | antidepressant |
| lomefloxacin lomefloxacin: structure given in first source. lomefloxacin : A fluoroquinolone antibiotic, used (generally as the hydrochloride salt) to treat bacterial infections including bronchitis and urinary tract infections. It is also used to prevent urinary tract infections prior to surgery. | 3.23 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antimicrobial agent; antitubercular agent; photosensitizing agent |
| lomustine [no description available] | 3.61 | 2 | 0 | N-nitrosoureas; organochlorine compound | alkylating agent; antineoplastic agent |
| loperamide Loperamide: One of the long-acting synthetic ANTIDIARRHEALS; it is not significantly absorbed from the gut, and has no effect on the adrenergic system or central nervous system, but may antagonize histamine and interfere with acetylcholine release locally.. loperamide : A synthetic piperidine derivative, effective against diarrhoea resulting from gastroenteritis or inflammatory bowel disease. | 3.64 | 2 | 0 | monocarboxylic acid amide; monochlorobenzenes; piperidines; tertiary alcohol | anticoronaviral agent; antidiarrhoeal drug; mu-opioid receptor agonist |
| loratadine Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.. loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders. | 8.95 | 3 | 0 | benzocycloheptapyridine; ethyl ester; N-acylpiperidine; organochlorine compound; tertiary carboxamide | anti-allergic agent; cholinergic antagonist; geroprotector; H1-receptor antagonist |
| lorazepam Lorazepam: A benzodiazepine used as an anti-anxiety agent with few side effects. It also has hypnotic, anticonvulsant, and considerable sedative properties and has been proposed as a preanesthetic agent. | 7.8 | 7 | 3 | benzodiazepine | |
| losartan Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position | 4.19 | 2 | 0 | biphenylyltetrazole; imidazoles | angiotensin receptor antagonist; anti-arrhythmia drug; antihypertensive agent; endothelin receptor antagonist |
| loxapine Loxapine: An antipsychotic agent used in SCHIZOPHRENIA. | 3.23 | 1 | 0 | dibenzooxazepine | antipsychotic agent; dopaminergic antagonist |
| loxoprofen loxoprofen: RN given refers to parent cpd without isomeric designation; structure in first source. loxoprofen : A monocarboxylic acid that is propionic acid in which one of the hydrogens at position 2 is substituted by a 4-[(2-oxocyclopentyl)methyl]phenyl group. A prodrug that is rapidly converted into its active trans-alcohol metabolite following oral administration. | 3.5 | 1 | 1 | cyclopentanones; monocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| maprotiline Maprotiline: A bridged-ring tetracyclic antidepressant that is both mechanistically and functionally similar to the tricyclic antidepressants, including side effects associated with its use. | 3.61 | 2 | 0 | anthracenes | |
| mebendazole Mebendazole: A benzimidazole that acts by interfering with CARBOHYDRATE METABOLISM and inhibiting polymerization of MICROTUBULES.. mebendazole : A carbamate ester that is methyl 1H-benzimidazol-2-ylcarbamate substituted by a benzoyl group at position 5. | 3.61 | 2 | 0 | aromatic ketone; benzimidazoles; carbamate ester | antinematodal drug; microtubule-destabilising agent; tubulin modulator |
| mecamylamine Mecamylamine: A nicotinic antagonist that is well absorbed from the gastrointestinal tract and crosses the blood-brain barrier. Mecamylamine has been used as a ganglionic blocker in treating hypertension, but, like most ganglionic blockers, is more often used now as a research tool. | 3.23 | 1 | 0 | primary aliphatic amine | |
| mechlorethamine nitrogen mustard : Compounds having two beta-haloalkyl groups bound to a nitrogen atom, as in (X-CH2-CH2)2NR. | 3.23 | 1 | 0 | nitrogen mustard; organochlorine compound | alkylating agent |
| meclizine Meclizine: A histamine H1 antagonist used in the treatment of motion sickness, vertigo, and nausea during pregnancy and radiation sickness. | 3.23 | 1 | 0 | diarylmethane | |
| meclofenamic acid Meclofenamic Acid: A non-steroidal anti-inflammatory agent with antipyretic and antigranulation activities. It also inhibits prostaglandin biosynthesis.. meclofenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,6-dichloro-3-methylphenyl group. A non-steroidal anti-inflammatory drug, it is used as the sodium salt for the treatment of dysmenorrhoea (painful periods), osteoarthritis and rheumatoid arthritis. | 3.23 | 1 | 0 | aminobenzoic acid; organochlorine compound; secondary amino compound | analgesic; anticonvulsant; antineoplastic agent; antipyretic; antirheumatic drug; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
| mefenamic acid Mefenamic Acid: A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.. mefenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,3-dimethylphenyl group. Although classed as a non-steroidal anti-inflammatory drug, its anti-inflammatory properties are considered to be minor. It is used to relieve mild to moderate pain, including headaches, dental pain, osteoarthritis and rheumatoid arthritis. | 3.61 | 2 | 0 | aminobenzoic acid; secondary amino compound | analgesic; antipyretic; antirheumatic drug; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-steroidal anti-inflammatory drug; xenobiotic |
| memantine [no description available] | 8.84 | 3 | 0 | adamantanes; primary aliphatic amine | antidepressant; antiparkinson drug; dopaminergic agent; neuroprotective agent; NMDA receptor antagonist |
| mepenzolate mepenzolic acid: anticholinergic, antispasmodic agent; RN given refers to parent cpd; structure | 3.23 | 1 | 0 | diarylmethane | |
| meperidine Meperidine: A narcotic analgesic that can be used for the relief of most types of moderate to severe pain, including postoperative pain and the pain of labor. Prolonged use may lead to dependence of the morphine type; withdrawal symptoms appear more rapidly than with morphine and are of shorter duration.. pethidine : A piperidinecarboxylate ester that is piperidine which is substituted by a methyl group at position 1 and by phenyl and ethoxycarbonyl groups at position 4. It is an analgesic which is used for the treatment of moderate to severe pain, including postoperative pain and labour pain. | 6.65 | 4 | 2 | ethyl ester; piperidinecarboxylate ester; tertiary amino compound | antispasmodic drug; kappa-opioid receptor agonist; mu-opioid receptor agonist; opioid analgesic |
| mephenytoin Mephenytoin: An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.. mephenytoin : An imidazolidine-2,4-dione (hydantoin) in which the imidazolidine nucleus carries a methyl group at N-3 and has ethyl and phenyl substituents at C-5. An anticonvulsant, it is no longer available in the USA or the UK but is still studied largely because of its interesting hydroxylation polymorphism. | 3.23 | 1 | 0 | imidazolidine-2,4-dione | anticonvulsant |
| mepivacaine Mepivacaine: A local anesthetic that is chemically related to BUPIVACAINE but pharmacologically related to LIDOCAINE. It is indicated for infiltration, nerve block, and epidural anesthesia. Mepivacaine is effective topically only in large doses and therefore should not be used by this route. (From AMA Drug Evaluations, 1994, p168). mepivacaine : A piperidinecarboxamide in which N-methylpipecolic acid and 2,6-dimethylaniline have combined to form the amide bond. It is used as a local amide-type anaesthetic. | 3.23 | 1 | 0 | piperidinecarboxamide | drug allergen; local anaesthetic |
| meprobamate Meprobamate: A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Meprobamate has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of ANXIETY DISORDERS, and also for the short-term management of INSOMNIA but has largely been superseded by the BENZODIAZEPINES. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) | 3.23 | 1 | 0 | organic molecular entity | |
| mesalamine Mesalamine: An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed). mesalamine : A monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position. | 3.23 | 1 | 0 | amino acid; aromatic amine; monocarboxylic acid; monohydroxybenzoic acid; phenols | non-steroidal anti-inflammatory drug |
| mesoridazine Mesoridazine: A phenothiazine antipsychotic with effects similar to CHLORPROMAZINE.. mesoridazine : A phenothiazine substituted at position 2 (para to the S atom) by a methylsulfinyl group, and on the nitrogen by a 2-(1-methylpiperidin-2-yl)ethyl group. | 3.23 | 1 | 0 | phenothiazines; sulfoxide; tertiary amino compound | dopaminergic antagonist; first generation antipsychotic |
| metaproterenol Metaproterenol: A beta-2 adrenergic agonist used in the treatment of ASTHMA and BRONCHIAL SPASM.. orciprenaline : A racemate composed of equimolar amounts of (R)- and (S)-orciprenaline. Used (as its sulfate salt) to relax the airway muscles and improve breathing for patients suffering from asthma or bronchitis.. 5-[1-hydroxy-2-(isopropanylamino)ethyl]benzene-1,3-diol : A member of the class of resorcinols bearing an additional 1-hydroxy-2-(isopropanylamino)ethyl substituent at position 5 of resorcinol itself. | 3.23 | 1 | 0 | aralkylamino compound; phenylethanolamines; resorcinols; secondary alcohol; secondary amino compound | |
| metformin Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289). metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1. | 4.61 | 4 | 0 | guanidines | environmental contaminant; geroprotector; hypoglycemic agent; xenobiotic |
| methadone Methadone: A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3). methadone : A racemate comprising equimolar amounts of dextromethadone and levomethadone. It is a opioid analgesic which is used as a painkiller and as a substitute for heroin in the treatment of heroin addiction.. 6-(dimethylamino)-4,4-diphenylheptan-3-one : A ketone that is heptan-3-one substituted by a dimethylamino group at position 6 and two phenyl groups at position 4. | 10.15 | 7 | 0 | benzenes; diarylmethane; ketone; tertiary amino compound | |
| methazolamide Methazolamide: A carbonic anhydrase inhibitor that is used as a diuretic and in the treatment of glaucoma. | 3.23 | 1 | 0 | sulfonamide; thiadiazoles | |
| methocarbamol Methocarbamol: A centrally acting muscle relaxant whose mode of action has not been established. It is used as an adjunct in the symptomatic treatment of musculoskeletal conditions associated with painful muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1206). methocarbamol : A racemate comprising equimolar amounts of (R)- and (S)-methocarbamol. A centrally acting skeletal muscle relaxant, it is used as an adjunct in the short-term symptomatic treatment of painful muscle spasm. The (R)-enantiomer is more active than the (S)-enantiomer.. 2-hydroxy-3-(2-methoxyphenoxy)propyl carbamate : A carbamate ester that is glycerol in which one of the primary alcohol groups has been converted to its 2-methoxyphenyl ether while the other has been converted to the corresponding carbamate ester. | 3.23 | 1 | 0 | aromatic ether; carbamate ester; secondary alcohol | |
| methoxsalen Methoxsalen: A naturally occurring furocoumarin compound found in several species of plants, including Psoralea corylifolia. It is a photoactive substance that forms DNA ADDUCTS in the presence of ultraviolet A irradiation.. methoxsalen : A member of the class of psoralens that is 7H-furo[3,2-g]chromen-7-one in which the 9 position is substituted by a methoxy group. It is a constituent of the fruits of Ammi majus. Like other psoralens, trioxsalen causes photosensitization of the skin. It is administered topically or orally in conjunction with UV-A for phototherapy treatment of vitiligo and severe psoriasis. | 3.63 | 2 | 0 | aromatic ether; psoralens | antineoplastic agent; cross-linking reagent; dermatologic drug; photosensitizing agent; plant metabolite |
| methyclothiazide Methyclothiazide: A thiazide diuretic with properties similar to those of HYDROCHLOROTHIAZIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p825) | 3.23 | 1 | 0 | benzothiadiazine | |
| methylphenidate Methylphenidate: A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.. methylphenidate : A racemate comprising equimolar amounts of the two threo isomers of methyl phenyl(piperidin-2-yl)acetate. A central stimulant and indirect-acting sympathomimetic, is used (generally as the hydrochloride salt) in the treatment of hyperactivity disorders in children and for the treatment of narcolepsy.. methyl phenyl(piperidin-2-yl)acetate : A amino acid ester that is methyl phenylacetate in which one of the hydrogens alpha to the carbonyl group is replaced by a piperidin-2-yl group. | 3.61 | 2 | 0 | beta-amino acid ester; methyl ester; piperidines | |
| metoclopramide Metoclopramide: A dopamine D2 antagonist that is used as an antiemetic.. metoclopramide : A member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine. | 3.61 | 2 | 0 | benzamides; monochlorobenzenes; substituted aniline; tertiary amino compound | antiemetic; dopaminergic antagonist; environmental contaminant; gastrointestinal drug; xenobiotic |
| metolazone Metolazone: A quinazoline-sulfonamide derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. metolazone : A quinazoline that consists of 1,2,3,4-tetrahydroquinazolin-4-one bearing additional methyl, 2-tolyl, sulfamyl and chloro substituents at positions 2, 3, 6 and 7 respectively. A quinazoline diuretic, with properties similar to thiazide diuretics. | 3.23 | 1 | 0 | organochlorine compound; quinazolines; sulfonamide | antihypertensive agent; diuretic; ion transport inhibitor |
| metoprolol Metoprolol: A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.. metoprolol : A propanolamine that is 1-(propan-2-ylamino)propan-2-ol substituted by a 4-(2-methoxyethyl)phenoxy group at position 1. | 3.61 | 2 | 0 | aromatic ether; propanolamine; secondary alcohol; secondary amino compound | antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; geroprotector; xenobiotic |
| metronidazole Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death. | 3.61 | 2 | 0 | C-nitro compound; imidazoles; primary alcohol | antiamoebic agent; antibacterial drug; antimicrobial agent; antiparasitic agent; antitrichomonal drug; environmental contaminant; prodrug; radiosensitizing agent; xenobiotic |
| metyrapone Metyrapone: An inhibitor of the enzyme STEROID 11-BETA-MONOOXYGENASE. It is used as a test of the feedback hypothalamic-pituitary mechanism in the diagnosis of CUSHING SYNDROME.. metyrapone : An aromatic ketone that is 3,3-dimethylbutan-2-one in which the methyl groups at positions 1 and 4 are replaced by pyridin-3-yl groups. A steroid 11beta-monooxygenase (EC 1.14.15.4) inhibitor, it is used in the diagnosis of adrenal insufficiency. | 3.23 | 1 | 0 | aromatic ketone | antimetabolite; diagnostic agent; EC 1.14.15.4 (steroid 11beta-monooxygenase) inhibitor |
| mexiletine Mexiletine: Antiarrhythmic agent pharmacologically similar to LIDOCAINE. It may have some anticonvulsant properties.. mexiletine : An aromatic ether which is 2,6-dimethylphenyl ether of 2-aminopropan-1-ol. | 8.7 | 11 | 2 | aromatic ether; primary amino compound | anti-arrhythmia drug |
| mianserin Mianserin: A tetracyclic compound with antidepressant effects. It may cause drowsiness and hematological problems. Its mechanism of therapeutic action is not well understood, although it apparently blocks alpha-adrenergic, histamine H1, and some types of serotonin receptors.. mianserin : A dibenzoazepine (specifically 1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine) methyl-substituted on N-2. Closely related to (and now mostly superseded by) the tetracyclic antidepressant mirtazapinean, it is an atypical antidepressant used in the treatment of depression throughout Europe and elsewhere. | 2.59 | 2 | 0 | dibenzoazepine | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; geroprotector; H1-receptor antagonist; histamine agonist; sedative; serotonergic antagonist |
| midazolam Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. | 3.93 | 3 | 0 | imidazobenzodiazepine; monofluorobenzenes; organochlorine compound | anticonvulsant; antineoplastic agent; anxiolytic drug; apoptosis inducer; central nervous system depressant; GABAA receptor agonist; general anaesthetic; muscle relaxant; sedative |
| midodrine Midodrine: An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION.. midodrine : An aromatic ether that is 1,4-dimethoxybenzene which is substituted at position 2 by a 2-(glycylamino)-1-hydroxyethyl group. A direct-acting sympathomimetic with selective alpha-adrenergic agonist activity, it is used (generally as its hydrochloride salt) as a peripheral vasoconstrictor in the treatment of certain hypotensive states. The main active moiety is its major metabolite, deglymidodrine. | 3.65 | 2 | 0 | amino acid amide; aromatic ether; secondary alcohol | alpha-adrenergic agonist; prodrug; sympathomimetic agent; vasoconstrictor agent |
| milrinone [no description available] | 3.23 | 1 | 0 | bipyridines; nitrile; pyridone | cardiotonic drug; EC 3.1.4.17 (3',5'-cyclic-nucleotide phosphodiesterase) inhibitor; platelet aggregation inhibitor; vasodilator agent |
| minoxidil Minoxidil: A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371). minoxidil : A pyrimidine N-oxide that is pyrimidine-2,4-diamine 3-oxide substituted by a piperidin-1-yl group at position 6. | 3.61 | 2 | 0 | dialkylarylamine; tertiary amino compound | |
| mirtazapine Mirtazapine: A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders. | 9.15 | 4 | 0 | benzazepine; tetracyclic antidepressant | alpha-adrenergic antagonist; anxiolytic drug; H1-receptor antagonist; histamine antagonist; oneirogen; serotonergic antagonist |
| mitotane Mitotane: A derivative of the insecticide DICHLORODIPHENYLDICHLOROETHANE that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression. | 3.23 | 1 | 0 | diarylmethane | |
| mitoxantrone Mitoxantrone: An anthracenedione-derived antineoplastic agent.. mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8. | 4.1 | 2 | 0 | dihydroxyanthraquinone | analgesic; antineoplastic agent |
| moclobemide Moclobemide: A reversible inhibitor of monoamine oxidase type A; (RIMA); (see MONOAMINE OXIDASE INHIBITORS) that has antidepressive properties.. moclobemide : A member of the class of benzamides that is benzamide substituted by a chloro group at position 4 and a 2-(morpholin-4-yl)ethyl group at the nitrogen atom. It acts as a reversible monoamine oxidase inhibitor and is used in the treatment of depression. | 2.49 | 2 | 0 | benzamides; monochlorobenzenes; morpholines | antidepressant; environmental contaminant; xenobiotic |
| modafinil Modafinil: A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.. modafinil : A racemate comprising equimolar amounts of armodafinil and (S)-modafinil. A central nervous system stimulant, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. The optical enantiomers of modafinil have similar pharmacological actions in animals.. 2-[(diphenylmethyl)sulfinyl]acetamide : A sulfoxide that is dimethylsulfoxide in which two hydrogens attached to one of the methyl groups are replaced by phenyl groups, while one hydrogen attached to the other methyl group is replaced by a carbamoyl (aminocarbonyl) group. | 3.63 | 2 | 0 | monocarboxylic acid amide; sulfoxide | |
| moxisylyte Moxisylyte: An alpha-adrenergic blocking agent that is used in Raynaud's disease. It is also used locally in the eye to reverse the mydriasis caused by phenylephrine and other sympathomimetic agents. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1312) | 3.23 | 1 | 0 | monoterpenoid | |
| acecainide Acecainide: A major metabolite of PROCAINAMIDE. Its anti-arrhythmic action may cause cardiac toxicity in kidney failure.. N-acetylprocainamide : A benzamide obtained via formal condensation of 4-acetamidobenzoic acid and 2-(diethylamino)ethylamine. | 2.08 | 1 | 0 | acetamides; benzamides | anti-arrhythmia drug |
| nabumetone Nabumetone: A butanone non-steroidal anti-inflammatory drug and cyclooxygenase-2 (COX2) inhibitor that is used in the management of pain associated with OSTEOARTHRITIS and RHEUMATOID ARTHRITIS.. nabumetone : A methyl ketone that is 2-butanone in which one of the methyl hydrogens at position 4 is replaced by a 6-methoxy-2-naphthyl group. A prodrug that is converted to the active metabolite, 6-methoxy-2-naphthylacetic acid, following oral administration. It is shown to have a slightly lower risk of gastrointestinal side effects than most other non-steroidal anti-inflammatory drugs. | 3.23 | 1 | 0 | methoxynaphthalene; methyl ketone | cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| nadolol [no description available] | 3.61 | 2 | 0 | tetralins | |
| nalidixic acid [no description available] | 3.61 | 2 | 0 | 1,8-naphthyridine derivative; monocarboxylic acid; quinolone antibiotic | antibacterial drug; antimicrobial agent; DNA synthesis inhibitor |
| naratriptan naratriptan: structure given in first source | 3.23 | 1 | 0 | heteroarylpiperidine; sulfonamide; tryptamines | serotonergic agonist; vasoconstrictor agent |
| nefazodone nefazodone: may be useful as an opiate adjunct | 3.61 | 2 | 0 | aromatic ether; monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazoles | alpha-adrenergic antagonist; analgesic; antidepressant; serotonergic antagonist; serotonin uptake inhibitor |
| nefopam Nefopam: Non-narcotic analgesic chemically similar to ORPHENADRINE. Its mechanism of action is unclear. It is used for the relief of acute and chronic pain. (From Martindale, The Extra Pharmacopoeia, 30th ed, p26). nefopam : A racemate comprising equal amounts of (R)- and (S)-nefopam. The hydrochloride is a centrally acting non-opiate analgesic commonly used for the treatment of moderate to severe pain.. 5-methyl-1-phenyl-3,4,5,6-tetrahydro-1H-2,5-benzoxazocine : A member of the class of benzoxazocines that is 3,4,5,6-tetrahydro-1H-2,5-benzoxazocine substituted by phenyl and methyl groups at positions 1 and 5 respectively. | 3.66 | 2 | 0 | benzoxazocine; tertiary amino compound | |
| neostigmine Neostigmine: A cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine. Neostigmine, unlike PHYSOSTIGMINE, does not cross the blood-brain barrier.. neostigmine : A quaternary ammonium ion comprising an anilinium ion core having three methyl substituents on the aniline nitrogen, and a 3-[(dimethylcarbamoyl)oxy] substituent at position 3. It is a parasympathomimetic which acts as a reversible acetylcholinesterase inhibitor. | 2.08 | 1 | 0 | quaternary ammonium ion | antidote to curare poisoning; EC 3.1.1.7 (acetylcholinesterase) inhibitor |
| nevirapine Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection. | 3.61 | 2 | 0 | cyclopropanes; dipyridodiazepine | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| nialamide Nialamide: An MAO inhibitor that is used as an antidepressive agent. | 3.23 | 1 | 0 | organonitrogen compound; organooxygen compound | |
| nicardipine Nicardipine: A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents.. nicardipine : A racemate comprising equimolar amounts of (R)- and (S)-nicardipine. It is a calcium channel blocker which is used to treat hypertension.. 2-[benzyl(methyl)amino]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine substituted by a methyl, {2-[benzyl(methyl)amino]ethoxy}carbonyl, 3-nitrophenyl, methoxycarbonyl and methyl groups at positions 2, 3, 4, 5 and 6, respectively. | 3.61 | 2 | 0 | benzenes; C-nitro compound; diester; dihydropyridine; methyl ester; tertiary amino compound | |
| niclosamide Niclosamide: An antihelmintic that is active against most tapeworms. (From Martindale, The Extra Pharmacopoeia, 30th ed, p48). niclosamide : A secondary carboxamide resulting from the formal condensation of the carboxy group of 5-chlorosalicylic acid with the amino group of 2-chloro-4-nitroaniline. It is an oral anthelmintic drug approved for use against tapeworm infections. | 2.41 | 1 | 0 | benzamides; C-nitro compound; monochlorobenzenes; salicylanilides; secondary carboxamide | anthelminthic drug; anticoronaviral agent; antiparasitic agent; apoptosis inducer; molluscicide; piscicide; STAT3 inhibitor |
| nifedipine Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. | 3.61 | 2 | 0 | C-nitro compound; dihydropyridine; methyl ester | calcium channel blocker; human metabolite; tocolytic agent; vasodilator agent |
| nilutamide [no description available] | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; C-nitro compound; imidazolidinone | androgen antagonist; antineoplastic agent |
| nimesulide nimesulide: structure. nimesulide : An aromatic ether having phenyl and 2-methylsulfonamido-5-nitrophenyl as the two aryl groups. | 3.61 | 2 | 0 | aromatic ether; C-nitro compound; sulfonamide | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| nimodipine Nimodipine: A calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.. nimodipine : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a (2-methoxyethoxy)carbonyl group at position 3, a m-nitrophenyl group at position 4, and an isopropoxycarbonyl group at position 5. An L-type calcium channel blocker, it acts particularly on cerebral circulation, and is used both orally and intravenously for the prevention and treatment of subarachnoid hemorrhage from ruptured intracranial aneurysm. | 3.84 | 3 | 0 | 2-methoxyethyl ester; C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; isopropyl ester | antihypertensive agent; calcium channel blocker; cardiovascular drug; vasodilator agent |
| nisoldipine Nisoldipine: A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.. nisoldipine : A racemate consisting of equimolar amounts of (R)- and (S)-nisoldipine. A calcium channel blocker, it is used in the treatment of hypertension and angina pectoris.. methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a methoxycarbonyl group at position 3, an o-nitrophenyl group at position 4, and an isobutoxycarbonyl group at position 5. The racemate, a calcium channel blocker, is used in the treatment of hypertension and angina pectoris. | 3.61 | 2 | 0 | C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; methyl ester | |
| nitrazepam Nitrazepam: A benzodiazepine derivative used as an anticonvulsant and hypnotic.. nitrazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one which is substituted at positions 5 and 7 by phenyl and nitro groups, respectively. It is used as a hypnotic for the short-term management of insomnia and for the treatment of epileptic spasms in infants (West's syndrome). | 2.08 | 1 | 0 | 1,4-benzodiazepinone; C-nitro compound | anticonvulsant; antispasmodic drug; drug metabolite; GABA modulator; sedative |
| nitrendipine Nitrendipine: A calcium channel blocker with marked vasodilator action. It is an effective antihypertensive agent and differs from other calcium channel blockers in that it does not reduce glomerular filtration rate and is mildly natriuretic, rather than sodium retentive.. nitrendipine : A dihydropyridine that is 1,4-dihydropyridine substituted by methyl groups at positions 2 and 6, a 3-nitrophenyl group at position 4, a ethoxycarbonyl group at position 3 and a methoxycarbonyl group at position 5. It is a calcium-channel blocker used in the treatment of hypertension. | 2.08 | 1 | 0 | C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; ethyl ester; methyl ester | antihypertensive agent; calcium channel blocker; geroprotector; vasodilator agent |
| nitroglycerin Nitroglycerin: A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.. nitroglycerol : A nitrate ester that is glycerol in which nitro group(s) replace the hydrogen(s) attached to one or more of the hydroxy groups.. nitroglycerin : A nitroglycerol that is glycerol in which the hydrogen atoms of all three hydroxy groups are replaced by nitro groups. It acts as a prodrug, releasing nitric oxide to open blood vessels and so alleviate heart pain. | 8.62 | 2 | 0 | nitroglycerol | explosive; muscle relaxant; nitric oxide donor; prodrug; tocolytic agent; vasodilator agent; xenobiotic |
| nizatidine [no description available] | 3.23 | 1 | 0 | 1,3-thiazoles; C-nitro compound; carboxamidine; organic sulfide; tertiary amino compound | anti-ulcer drug; cholinergic drug; H2-receptor antagonist |
| nomifensine Nomifensine: An isoquinoline derivative that prevents dopamine reuptake into synaptosomes. The maleate was formerly used in the treatment of depression. It was withdrawn worldwide in 1986 due to the risk of acute hemolytic anemia with intravascular hemolysis resulting from its use. In some cases, renal failure also developed. (From Martindale, The Extra Pharmacopoeia, 30th ed, p266). nomifensine : An N-methylated tetrahydroisoquinoline carrying phenyl and amino substituents at positions C-4 and C-8, respectively. | 3.23 | 1 | 0 | isoquinolines | dopamine uptake inhibitor |
| norfloxacin Norfloxacin: A synthetic fluoroquinolone (FLUOROQUINOLONES) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA GYRASE.. norfloxacin : A quinolinemonocarboxylic acid with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase. | 3.61 | 2 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antibacterial drug; DNA synthesis inhibitor; environmental contaminant; xenobiotic |
| nortriptyline Nortriptyline: A metabolite of AMITRIPTYLINE that is also used as an antidepressive agent. Nortriptyline is used in major depression, dysthymia, and atypical depressions.. nortriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(methylamino)propylidene group at position 5. It is an active metabolite of amitriptyline. | 11.08 | 12 | 2 | organic tricyclic compound; secondary amine | adrenergic uptake inhibitor; analgesic; antidepressant; antineoplastic agent; apoptosis inducer; drug metabolite |
| ofloxacin Ofloxacin: A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.. 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid : An oxazinoquinoline that is 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinolin-7-one substituted by methyl, carboxy, fluoro, and 4-methylpiperazin-1-yl groups at positions 3, 6, 9, and 10, respectively.. ofloxacin : A racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. | 3.61 | 2 | 0 | 3-oxo monocarboxylic acid; N-arylpiperazine; N-methylpiperazine; organofluorine compound; oxazinoquinoline | |
| omeprazole Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5. | 4.28 | 5 | 0 | aromatic ether; benzimidazoles; pyridines; sulfoxide | |
| ondansetron Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. | 14.21 | 8 | 3 | carbazoles | |
| orphenadrine Orphenadrine: A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.. orphenadrine : A tertiary amino compound which is the phenyl-o-tolylmethyl ether of 2-(dimethylamino)ethanol. | 3.23 | 1 | 0 | ether; tertiary amino compound | antidyskinesia agent; antiparkinson drug; H1-receptor antagonist; muscarinic antagonist; muscle relaxant; NMDA receptor antagonist; parasympatholytic |
| oxonic acid Oxonic Acid: Antagonist of urate oxidase. | 3.25 | 1 | 0 | 1,3,5-triazines; monocarboxylic acid | |
| oxaprozin Oxaprozin: An oxazole-propionic acid derivative, cyclooxygenase inhibitor, and non-steroidal anti-inflammatory drug that is used in the treatment of pain and inflammation associated with of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; and ARTHRITIS, JUVENILE.. oxaprozin : A monocarboxylic acid that is a propionic acid derivative having a 4,5-diphenyl-1,3-oxazol-2-yl substituent at position 3. It is non-steroidal anti-inflammatory drug commonly used to relieve the pain and inflammatory responses associated with osteoarthritis and rheumatoid arthritis. | 3.61 | 2 | 0 | 1,3-oxazoles; monocarboxylic acid | analgesic; non-steroidal anti-inflammatory drug |
| oxazepam Oxazepam: A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.. oxazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a hydroxy group at position 3 and phenyl group at position 5. | 3.23 | 1 | 0 | 1,4-benzodiazepinone; organochlorine compound | anxiolytic drug; environmental contaminant; xenobiotic |
| oxidopamine Oxidopamine: A neurotransmitter analogue that depletes noradrenergic stores in nerve endings and induces a reduction of dopamine levels in the brain. Its mechanism of action is related to the production of cytolytic free-radicals.. oxidopamine : A benzenetriol that is phenethylamine in which the hydrogens at positions 2, 4, and 5 on the phenyl ring are replaced by hydroxy groups. It occurs naturally in human urine, but is also produced as a metabolite of the drug DOPA (used for the treatment of Parkinson's disease). | 2.03 | 1 | 0 | benzenetriol; catecholamine; primary amino compound | drug metabolite; human metabolite; neurotoxin |
| oxybutynin oxybutynin: RN given refers to parent cpd. oxybutynin : A racemate comprising equimolar amounts of (R)-oxybutynin and esoxybutynin. An antispasmodic used for the treatment of overactive bladder. | 10.22 | 12 | 3 | acetylenic compound; carboxylic ester; racemate; tertiary alcohol; tertiary amino compound | antispasmodic drug; calcium channel blocker; local anaesthetic; muscarinic antagonist; muscle relaxant; parasympatholytic |
| aminosalicylic acid Aminosalicylic Acid: An antitubercular agent often administered in association with ISONIAZID. The sodium salt of the drug is better tolerated than the free acid.. 4-aminosalicylic acid : An aminobenzoic acid that is salicylic acid substituted by an amino group at position 4. | 3.23 | 1 | 0 | aminobenzoic acid; phenols | antitubercular agent |
| palmidrol palmidrol: a cannabinoid receptor-inactive eCB-related molecule used as prophylactic in helping to prevent respiratory viral infection. palmitoyl ethanolamide : An N-(long-chain-acyl)ethanolamine that is the ethanolamide of palmitic (hexadecanoic) acid. | 3.99 | 1 | 1 | endocannabinoid; N-(long-chain-acyl)ethanolamine; N-(saturated fatty acyl)ethanolamine | anti-inflammatory drug; anticonvulsant; antihypertensive agent; neuroprotective agent |
| pamidronate [no description available] | 4.22 | 2 | 0 | phosphonoacetic acid | |
| pantoprazole Pantoprazole: 2-pyridinylmethylsulfinylbenzimidazole proton pump inhibitor that is used in the treatment of GASTROESOPHAGEAL REFLUX and PEPTIC ULCER.. pantoprazole : A member of the class of benzimidazoles that is 1H-benzimidazole substituted by a difluoromethoxy group at position 5 and a [(3,4-dimethoxypyridin-2-yl)methyl]sulfinyl group at position 2. | 3.23 | 1 | 0 | aromatic ether; benzimidazoles; organofluorine compound; pyridines; sulfoxide | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor; environmental contaminant; xenobiotic |
| papaverine Papaverine: An alkaloid found in opium but not closely related to the other opium alkaloids in its structure or pharmacological actions. It is a direct-acting smooth muscle relaxant used in the treatment of impotence and as a vasodilator, especially for cerebral vasodilation. The mechanism of its pharmacological actions is not clear, but it apparently can inhibit phosphodiesterases and it may have direct actions on calcium channels.. papaverine : A benzylisoquinoline alkaloid that is isoquinoline substituted by methoxy groups at positions 6 and 7 and a 3,4-dimethoxybenzyl group at position 1. It has been isolated from Papaver somniferum. | 3.61 | 2 | 0 | benzylisoquinoline alkaloid; dimethoxybenzene; isoquinolines | antispasmodic drug; vasodilator agent |
| pemoline Pemoline: A central nervous system stimulant used in fatigue and depressive states and to treat hyperkinetic disorders in children.. pemoline : A member of the class of 1,3-oxazoles that is 1,3-oxazol-4(5H)-one which is substituted by an amino group at position 2 and by a phenyl group at position 5. A central nervous system stimulant, it was used to treat hyperactivity disorders in children, but withdrawn from use following reports of serious hepatotoxicity. | 3.61 | 2 | 0 | 1,3-oxazoles | central nervous system stimulant |
| pentamidine Pentamidine: Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of PNEUMOCYSTIS pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.. pentamidine : A diether consisting of pentane-1,5-diol in which both hydroxyl hydrogens have been replaced by 4-amidinophenyl groups. A trypanocidal drug that is used for treatment of cutaneous leishmaniasis and Chagas disease. | 3.61 | 2 | 0 | aromatic ether; carboxamidine; diether | anti-inflammatory agent; antifungal agent; calmodulin antagonist; chemokine receptor 5 antagonist; EC 2.3.1.48 (histone acetyltransferase) inhibitor; NMDA receptor antagonist; S100 calcium-binding protein B inhibitor; trypanocidal drug; xenobiotic |
| pentobarbital Pentobarbital: A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236). pentobarbital : A member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and sec-pentyl groups. | 3.23 | 1 | 0 | barbiturates | GABAA receptor agonist |
| pentoxifylline [no description available] | 4.41 | 3 | 0 | oxopurine | |
| perhexiline Perhexiline: 2-(2,2-Dicyclohexylethyl)piperidine. Coronary vasodilator used especially for angina of effort. It may cause neuropathy and hepatitis. | 3.23 | 1 | 0 | piperidines | cardiovascular drug |
| perphenazine Perphenazine: An antipsychotic phenothiazine derivative with actions and uses similar to those of CHLORPROMAZINE.. perphenazine : A phenothiazine derivative in which the phenothiazine tricycle carries a chloro substituent at the 2-position and a 3-[4-(2-hydroxyethyl)piperazin-1-yl]propyl group at N-10. | 3.61 | 2 | 0 | N-(2-hydroxyethyl)piperazine; N-alkylpiperazine; organochlorine compound; phenothiazines | antiemetic; dopaminergic antagonist; phenothiazine antipsychotic drug |
| phenacetin Saridon: contains phenacetin, caffeine, propyphenazone & pyrithyldione | 2.08 | 1 | 0 | acetamides; aromatic ether | cyclooxygenase 3 inhibitor; non-narcotic analgesic; peripheral nervous system drug |
| pheniramine Pheniramine: One of the HISTAMINE H1 ANTAGONISTS with little sedative action. It is used in treatment of hay fever, rhinitis, allergic dermatoses, and pruritus. | 3.47 | 1 | 1 | pyridines; tertiary amino compound | |
| phenobarbital Phenobarbital: A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.. phenobarbital : A member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and phenyl groups. | 6.2 | 5 | 1 | barbiturates | anticonvulsant; drug allergen; excitatory amino acid antagonist; sedative |
| phenoxybenzamine Phenoxybenzamine: An alpha-adrenergic antagonist with long duration of action. It has been used to treat hypertension and as a peripheral vasodilator. | 3.23 | 1 | 0 | aromatic amine | |
| phentermine Phentermine: A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity. | 3.23 | 1 | 0 | primary amine | adrenergic agent; appetite depressant; central nervous system drug; central nervous system stimulant; dopaminergic agent; sympathomimetic agent |
| 4-phenylbutyric acid 4-phenylbutyric acid: RN refers to the parent cpd. 4-phenylbutyric acid : A monocarboxylic acid the structure of which is that of butyric acid substituted with a phenyl group at C-4. It is a histone deacetylase inhibitor that displays anticancer activity. It inhibits cell proliferation, invasion and migration and induces apoptosis in glioma cells. It also inhibits protein isoprenylation, depletes plasma glutamine, increases production of foetal haemoglobin through transcriptional activation of the gamma-globin gene and affects hPPARgamma activation. | 3.23 | 1 | 0 | monocarboxylic acid | antineoplastic agent; apoptosis inducer; EC 3.5.1.98 (histone deacetylase) inhibitor; prodrug |
| o-phthalaldehyde o-Phthalaldehyde: A reagent that forms fluorescent conjugation products with primary amines. It is used for the detection of many biogenic amines, peptides, and proteins in nanogram quantities in body fluids.. phthalaldehyde : A dialdehyde in which two formyl groups are attached to adjacent carbon centres on a benzene ring. | 2.44 | 2 | 0 | benzaldehydes; dialdehyde | epitope |
| pindolol Pindolol: A moderately lipophilic beta blocker (ADRENERGIC BETA-ANTAGONISTS). It is non-cardioselective and has intrinsic sympathomimetic actions, but little membrane-stabilizing activity. (From Martindale, The Extra Pharmocopoeia, 30th ed, p638). pindolol : A member of the class of indols which is the 2-hydroxy-3-(isopropylamino)propyl ether derivative of 1H-indol-4-ol. | 3.61 | 2 | 0 | indoles; secondary amine | antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist; serotonergic antagonist; vasodilator agent |
| pioglitazone Pioglitazone: A thiazolidinedione and PPAR GAMMA agonist that is used in the treatment of TYPE 2 DIABETES MELLITUS.. pioglitazone : A member of the class of thiazolidenediones that is 1,3-thiazolidine-2,4-dione substituted by a benzyl group at position 5 which in turn is substituted by a 2-(5-ethylpyridin-2-yl)ethoxy group at position 4 of the phenyl ring. It exhibits hypoglycemic activity. | 3.86 | 3 | 0 | aromatic ether; pyridines; thiazolidinediones | antidepressant; cardioprotective agent; EC 2.7.1.33 (pantothenate kinase) inhibitor; EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; geroprotector; hypoglycemic agent; insulin-sensitizing drug; PPARgamma agonist; xenobiotic |
| piracetam Piracetam: A compound suggested to be both a nootropic and a neuroprotective agent. | 10.76 | 24 | 2 | organonitrogen compound; organooxygen compound | |
| piribedil Piribedil: A dopamine D2 agonist. It is used in the treatment of parkinson disease, particularly for alleviation of tremor. It has also been used for circulatory disorders and in other applications as a D2 agonist. | 2.08 | 1 | 0 | N-arylpiperazine | |
| polythiazide [no description available] | 3.23 | 1 | 0 | benzothiadiazine | |
| pyridoxal phosphate-6-azophenyl-2',4'-disulfonic acid pyridoxal phosphate-6-azophenyl-2',4'-disulfonic acid: a novel antagonist that selectively blocks P2 purinoceptor receptors; a useful tool to study co-transmission in tissues when ATP and coexisting neurotransmitters act in concert. 5'-phosphopyridoxal-6-azobenzene-2,4-disulfonic acid : An arenesulfonic acid that is pyridoxal 5'-phosphate carrying an additional 2,4-disulfophenylazo substituent at position 6. | 2.08 | 1 | 0 | arenesulfonic acid; azobenzenes; methylpyridines; monohydroxypyridine; organic phosphate; pyridinecarbaldehyde | purinergic receptor P2X antagonist |
| duodote duodote: consists of atropine and pralidoxime chloride; for treating those exposed to organophosphorus-containing nerve agents | 3.23 | 1 | 0 | pyridinium ion | antidote to organophosphate poisoning; antidote to sarin poisoning; cholinergic drug; cholinesterase reactivator |
| ono 1078 pranlukast: SRS-A antagonist; leukotriene D4 receptor antagonist | 2.08 | 1 | 0 | chromones | |
| pyranoprofen pyranoprofen: RN given refers to unlabled parent cpd; structure given in first source | 2.08 | 1 | 0 | pyridochromene | |
| praziquantel azinox: Russian drug | 3.61 | 2 | 0 | isoquinolines | |
| prazosin Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively. | 3.61 | 2 | 0 | aromatic ether; furans; monocarboxylic acid amide; piperazines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| prilocaine Prilocaine: A local anesthetic that is similar pharmacologically to LIDOCAINE. Currently, it is used most often for infiltration anesthesia in dentistry.. prilocaine : An amino acid amide in which N-propyl-DL-alanine and 2-methylaniline have combined to form the amide bond; used as a local anaesthetic. | 4.35 | 1 | 1 | amino acid amide; monocarboxylic acid amide | anticonvulsant; local anaesthetic |
| primaquine Primaquine: An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404). primaquine : An N-substituted diamine that is pentane-1,4-diamine substituted by a 6-methoxyquinolin-8-yl group at the N(4) position. It is a drug used in the treatment of malaria and Pneumocystis pneumonia. | 3.61 | 2 | 0 | aminoquinoline; aromatic ether; N-substituted diamine | antimalarial |
| primidone Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.. primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures. | 3.61 | 2 | 0 | pyrimidone | anticonvulsant; environmental contaminant; xenobiotic |
| probenecid Probenecid: The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.. probenecid : A sulfonamide in which the nitrogen of 4-sulfamoylbenzoic acid is substituted with two propyl groups. | 3.61 | 2 | 0 | benzoic acids; sulfonamide | uricosuric drug |
| procainamide Procainamide: A class Ia antiarrhythmic drug that is structurally-related to PROCAINE.. procainamide : A benzamide that is 4-aminobenzamide substituted on the amide N by a 2-(diethylamino)ethyl group. It is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias. | 3.61 | 2 | 0 | benzamides | anti-arrhythmia drug; platelet aggregation inhibitor; sodium channel blocker |
| procarbazine Procarbazine: An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.. procarbazine : A benzamide obtained by formal condensation of the carboxy group of 4-[(2-methylhydrazino)methyl]benzoic acid with the amino group of isopropylamine. An antineoplastic chemotherapy drug used for treatment of Hodgkin's lymphoma. Metabolism yields azo-procarbazine and hydrogen peroxide, which results in the breaking of DNA strands. | 3.23 | 1 | 0 | benzamides; hydrazines | antineoplastic agent |
| prochlorperazine Prochlorperazine: A phenothiazine antipsychotic used principally in the treatment of NAUSEA; VOMITING; and VERTIGO. It is more likely than CHLORPROMAZINE to cause EXTRAPYRAMIDAL DISORDERS. (From Martindale, The Extra Pharmacopoeia, 30th ed, p612). prochlorperazine : A member of the class of phenothiazines that is 10H-phenothiazine having a chloro substituent at the 2-position and a 3-(4-methylpiperazin-1-yl)propyl group at the N-10 position. | 3.61 | 2 | 0 | N-alkylpiperazine; N-methylpiperazine; organochlorine compound; phenothiazines | alpha-adrenergic antagonist; antiemetic; cholinergic antagonist; dopamine receptor D2 antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; first generation antipsychotic |
| procyclidine Procyclidine: A muscarinic antagonist that crosses the blood-brain barrier and is used in the treatment of drug-induced extrapyramidal disorders and in parkinsonism.. procyclidine : A tertiary alcohol that consists of propan-1-ol substituted by a cyclohexyl and a phenyl group at position 1 and a pyrrolidin-1-yl group at position 3. | 3.61 | 2 | 0 | pyrrolidines; tertiary alcohol | antidyskinesia agent; antiparkinson drug; muscarinic antagonist |
| promethazine Promethazine: A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals.. promethazine : A tertiary amine that is a substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropan-2-amine moiety. | 3.95 | 3 | 0 | phenothiazines; tertiary amine | anti-allergic agent; anticoronaviral agent; antiemetic; antipruritic drug; H1-receptor antagonist; local anaesthetic; sedative |
| propafenone Propafenone: An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity.. propafenone : An aromatic ketone that is 3-(propylamino)propane-1,2-diol in which the hydrogen of the primary hydroxy group is replaced by a 2-(3-phenylpropanoyl)phenyl group. It is a class 1C antiarrhythmic drug with local anesthetic effects, and is used as the hydrochloride salt in the management of supraventricular and ventricular arrhythmias. | 3.61 | 2 | 0 | aromatic ketone; secondary alcohol; secondary amino compound | anti-arrhythmia drug |
| propantheline Propantheline: A muscarinic antagonist used as an antispasmodic, in rhinitis, in urinary incontinence, and in the treatment of ulcers. At high doses it has nicotinic effects resulting in neuromuscular blocking. | 3.23 | 1 | 0 | xanthenes | |
| propofol Propofol: An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.. propofol : A phenol resulting from the formal substitution of the hydrogen at the 2 position of 1,3-diisopropylbenzene by a hydroxy group. | 7.8 | 5 | 4 | phenols | anticonvulsant; antiemetic; intravenous anaesthetic; radical scavenger; sedative |
| propranolol Propranolol: A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.. propranolol : A propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3. | 11.01 | 4 | 1 | naphthalenes; propanolamine; secondary amine | anti-arrhythmia drug; antihypertensive agent; anxiolytic drug; beta-adrenergic antagonist; environmental contaminant; human blood serum metabolite; vasodilator agent; xenobiotic |
| protriptyline Protriptyline: Tricyclic antidepressant similar in action and side effects to IMIPRAMINE. It may produce excitation. | 3.23 | 1 | 0 | carbotricyclic compound | antidepressant |
| pyridostigmine [no description available] | 3.23 | 1 | 0 | pyridinium ion | |
| pyrimethamine Maloprim: contains above 2 cpds | 3.23 | 1 | 0 | aminopyrimidine; monochlorobenzenes | antimalarial; antiprotozoal drug; EC 1.5.1.3 (dihydrofolate reductase) inhibitor |
| sch 16134 quazepam: structure given in first source | 3.23 | 1 | 0 | benzodiazepine | |
| quetiapine [no description available] | 3.23 | 1 | 0 | dibenzothiazepine; N-alkylpiperazine; N-arylpiperazine | adrenergic antagonist; dopaminergic antagonist; histamine antagonist; second generation antipsychotic; serotonergic antagonist |
| 1,2,5,8-tetrahydroxy anthraquinone 1,2,5,8-tetrahydroxy anthraquinone: structure in first source. quinalizarin : A tetrahydroxyanthraquinone having the four hydroxy groups at the 1-, 2-, 5- and 8-positions. | 2.08 | 1 | 0 | tetrahydroxyanthraquinone | EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor |
| rabeprazole Rabeprazole: A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. | 3.23 | 1 | 0 | benzimidazoles; pyridines; sulfoxide | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor |
| raloxifene raloxifene : A member of the class of 1-benzothiophenes that is 1-benzothiophene in which the hydrogens at positions 2, 3, and 6 have been replaced by p-hydroxyphenyl, p-[2-(piperidin-1-yl)ethoxy]benzoyl, and hydroxy groups, respectively. | 3.23 | 1 | 0 | 1-benzothiophenes; aromatic ketone; N-oxyethylpiperidine; phenols | bone density conservation agent; estrogen antagonist; estrogen receptor modulator |
| ranitidine [no description available] | 2.08 | 1 | 0 | aralkylamine | |
| riluzole Riluzole: A glutamate antagonist (RECEPTORS, GLUTAMATE) used as an anticonvulsant (ANTICONVULSANTS) and to prolong the survival of patients with AMYOTROPHIC LATERAL SCLEROSIS. | 3.61 | 2 | 0 | benzothiazoles | |
| rimantadine Rimantadine: An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza. | 3.23 | 1 | 0 | alkylamine | |
| risperidone Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2. | 3.94 | 3 | 0 | 1,2-benzoxazoles; heteroarylpiperidine; organofluorine compound; pyridopyrimidine | alpha-adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; psychotropic drug; second generation antipsychotic; serotonergic antagonist |
| rizatriptan rizatriptan: structure given in first source; RN given refers to benzoate | 3.23 | 1 | 0 | tryptamines | anti-inflammatory drug; serotonergic agonist; vasoconstrictor agent |
| rofecoxib [no description available] | 2.08 | 1 | 0 | butenolide; sulfone | analgesic; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| rolipram [no description available] | 2.17 | 1 | 0 | pyrrolidin-2-ones | antidepressant; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
| ropinirole [no description available] | 4.6 | 4 | 0 | indolones; tertiary amine | antidyskinesia agent; antiparkinson drug; central nervous system drug; dopamine agonist |
| salicylsalicylic acid salicylsalicylic acid: structure. salsalate : A dimeric benzoate ester obtained by intermolecular condensation between the carboxy of one molecule of salicylic acid with the phenol group of a second. It is a prodrug for salycylic acid that is used for treatment of rheumatoid arthritis and osteoarthritis and also shows activity against type II diabetes. | 3.23 | 1 | 0 | benzoate ester; benzoic acids; phenols; salicylates | antineoplastic agent; antirheumatic drug; EC 3.5.2.6 (beta-lactamase) inhibitor; hypoglycemic agent; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| secobarbital Secobarbital: A barbiturate that is used as a sedative. Secobarbital is reported to have no anti-anxiety activity.. secobarbital : A member of the class of barbiturates that is barbituric acid in which the hydrogens at position 5 are substituted by prop-2-en-1-yl and pentan-2-yl groups. | 3.23 | 1 | 0 | barbiturates | anaesthesia adjuvant; GABA modulator; sedative |
| sibutramine sibutramine: serotonin and norepinephrine transporter inhibitor; Meridia is tradename for sibutramine hydrochloride | 3.23 | 1 | 0 | organochlorine compound; tertiary amino compound | anti-obesity agent; serotonin uptake inhibitor |
| sulfadiazine Sulfadiazine: One of the short-acting SULFONAMIDES used in combination with PYRIMETHAMINE to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.. sulfadiazine : A sulfonamide consisting of pyrimidine with a 4-aminobenzenesulfonamido group at the 2-position.. diazine : The parent structure of the diazines. | 3.61 | 2 | 0 | pyrimidines; substituted aniline; sulfonamide antibiotic; sulfonamide | antiinfective agent; antimicrobial agent; antiprotozoal drug; coccidiostat; drug allergen; EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; xenobiotic |
| sodium fluoride [no description available] | 3.31 | 1 | 0 | fluoride salt | mutagen |
| risedronic acid Risedronic Acid: A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION. | 3.69 | 2 | 0 | pyridines | |
| sotalol Sotalol: An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.. sotalol : A sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias. | 3.61 | 2 | 0 | ethanolamines; secondary alcohol; secondary amino compound; sulfonamide | anti-arrhythmia drug; beta-adrenergic antagonist; environmental contaminant; xenobiotic |
| imatinib [no description available] | 3.61 | 2 | 0 | aromatic amine; benzamides; N-methylpiperazine; pyridines; pyrimidines | antineoplastic agent; apoptosis inducer; tyrosine kinase inhibitor |
| vorinostat Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.. vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL). | 3.61 | 2 | 0 | dicarboxylic acid diamide; hydroxamic acid | antineoplastic agent; apoptosis inducer; EC 3.5.1.98 (histone deacetylase) inhibitor |
| succinylcholine Succinylcholine: A quaternary skeletal muscle relaxant usually used in the form of its bromide, chloride, or iodide. It is a depolarizing relaxant, acting in about 30 seconds and with a duration of effect averaging three to five minutes. Succinylcholine is used in surgical, anesthetic, and other procedures in which a brief period of muscle relaxation is called for.. succinylcholine : A quaternary ammonium ion that is the bis-choline ester of succinic acid. | 5.63 | 4 | 1 | quaternary ammonium ion; succinate ester | drug allergen; muscle relaxant; neuromuscular agent |
| sulfamethizole Sulfamethizole: A sulfathiazole antibacterial agent.. sulfamethizole : A sulfonamide consisting of a 1,3,4-thiadiazole nucleus with a methyl substituent at C-5 and a 4-aminobenzenesulfonamido group at C-2. | 3.23 | 1 | 0 | sulfonamide antibiotic; sulfonamide; thiadiazoles | antiinfective agent; antimicrobial agent; drug allergen; EC 2.5.1.15 (dihydropteroate synthase) inhibitor |
| sulfamethoxazole Sulfamethoxazole: A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208). sulfamethoxazole : An isoxazole (1,2-oxazole) compound having a methyl substituent at the 5-position and a 4-aminobenzenesulfonamido group at the 3-position. | 2.08 | 1 | 0 | isoxazoles; substituted aniline; sulfonamide antibiotic; sulfonamide | antibacterial agent; antiinfective agent; antimicrobial agent; drug allergen; EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; epitope; P450 inhibitor; xenobiotic |
| sulfanitran [no description available] | 2.08 | 1 | 0 | sulfonamide | |
| sulfasalazine Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907). sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position. | 3.61 | 2 | 0 | ||
| sulfathiazole Sulfathiazole: A sulfathiazole compound that is used as a short-acting anti-infective agent. It is no longer commonly used systemically due to its toxicity, but may still be applied topically in combination with other drugs for the treatment of vaginal and skin infections, and is still used in veterinary medicine.. sulfathiazole : A 1,3-thiazole compound having a 4-aminobenzenesulfonamido group at the 2-position. | 3.23 | 1 | 0 | 1,3-thiazoles; substituted aniline; sulfonamide antibiotic; sulfonamide | antiinfective agent; drug allergen; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; xenobiotic |
| sulfisoxazole Sulfisoxazole: A short-acting sulfonamide antibacterial with activity against a wide range of gram- negative and gram-positive organisms.. sulfisoxazole : A sulfonamide antibacterial with an oxazole substituent. It has antibiotic activity against a wide range of gram-negative and gram-positive organisms. | 2.08 | 1 | 0 | isoxazoles; sulfonamide antibiotic; sulfonamide | antibacterial drug; drug allergen |
| 2-(octylamino)-1-[4-(propan-2-ylthio)phenyl]-1-propanol [no description available] | 3.23 | 1 | 0 | alkylbenzene | |
| sumatriptan Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.. sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults. | 3.61 | 2 | 0 | sulfonamide; tryptamines | serotonergic agonist; vasoconstrictor agent |
| gatifloxacin Gatifloxacin: A fluoroquinolone antibacterial agent and DNA TOPOISOMERASE II inhibitor that is used as an ophthalmic solution for the treatment of BACTERIAL CONJUNCTIVITIS.. gatifloxacin : A monocarboxylic acid that is 4-oxo-1,4-dihydroquinoline-3-carboxylic acid which is substituted on the nitrogen by a cyclopropyl group and at positions 6, 7, and 8 by fluoro, 3-methylpiperazin-1-yl, and methoxy groups, respectively. Gatifloxacin is an antibiotic of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacterial topoisomerase type-II enzymes. | 2.08 | 1 | 0 | N-arylpiperazine; organofluorine compound; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antiinfective agent; antimicrobial agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
| tazarotene tazarotene: a topical acetylenic retinoid; a topical kerytolytic. tazarotene : The ethyl ester of tazarotenic acid. A prodrug for tazarotenic acid, it is used for the treatment of psoriasis, acne, and sun-damaged skin. | 2.08 | 1 | 0 | acetylenic compound; ethyl ester; pyridines; retinoid; thiochromane | keratolytic drug; prodrug; teratogenic agent |
| tegafur [no description available] | 3.25 | 1 | 0 | organohalogen compound; pyrimidines | |
| temazepam Temazepam: A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent. | 3.23 | 1 | 0 | benzodiazepine | |
| temozolomide [no description available] | 3.61 | 2 | 0 | imidazotetrazine; monocarboxylic acid amide; triazene derivative | alkylating agent; antineoplastic agent; prodrug |
| terazosin Terazosin: induces decreased blood pressure; used in the treatment of benign prostatic hyperplasia | 3.61 | 2 | 0 | furans; piperazines; primary amino compound; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; antineoplastic agent |
| terbutaline Terbutaline: A selective beta-2 adrenergic agonist used as a bronchodilator and tocolytic.. terbutaline : A member of the class of phenylethanolamines that is catechol substituted at position 5 by a 2-(tert-butylamino)-1-hydroxyethyl group. | 3.61 | 2 | 0 | phenylethanolamines; resorcinols | anti-asthmatic drug; beta-adrenergic agonist; bronchodilator agent; EC 3.1.1.7 (acetylcholinesterase) inhibitor; hypoglycemic agent; sympathomimetic agent; tocolytic agent |
| terfenadine Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME. | 2.49 | 2 | 0 | diarylmethane | |
| thalidomide Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.. thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.. 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group. | 4.96 | 4 | 0 | phthalimides; piperidones | |
| thiabendazole Tresaderm: dermatologic soln containing dexamethasone, thiabendazole & neomycin sulfate | 3.23 | 1 | 0 | 1,3-thiazoles; benzimidazole fungicide; benzimidazoles | antifungal agrochemical; antinematodal drug |
| thioridazine Thioridazine: A phenothiazine antipsychotic used in the management of PHYCOSES, including SCHIZOPHRENIA.. thioridazine : A phenothiazine derivative having a methylsulfanyl subsitituent at the 2-position and a (1-methylpiperidin-2-yl)ethyl] group at the N-10 position. | 3.23 | 1 | 0 | phenothiazines; piperidines | alpha-adrenergic antagonist; dopaminergic antagonist; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; first generation antipsychotic; H1-receptor antagonist; serotonergic antagonist |
| thiotepa Thiotepa: A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed). | 3.61 | 2 | 0 | aziridines | |
| tiapride [no description available] | 2.08 | 1 | 0 | benzamides | |
| ticlopidine Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.. ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group. | 3.23 | 1 | 0 | monochlorobenzenes; thienopyridine | anticoagulant; fibrin modulating drug; hematologic agent; P2Y12 receptor antagonist; platelet aggregation inhibitor |
| tilorone Tilorone: An antiviral agent used as its hydrochloride. It is the first recognized synthetic, low-molecular-weight compound that is an orally active interferon inducer, and is also reported to have antineoplastic and anti-inflammatory actions.. tilorone : A member of the class of fluoren-9-ones that is 9H-fluoren-9-one which is substituted by a 2-(diethylamino)ethoxy group at positions 2 and 7. It is an interferon inducer and a selective alpha7 nicotinic acetylcholine receptor (alpha7 nAChR) agonist. Its hydrochloride salt is used as an antiviral drug. | 2.08 | 1 | 0 | aromatic ether; diether; fluoren-9-ones; tertiary amino compound | anti-inflammatory agent; antineoplastic agent; antiviral agent; interferon inducer; nicotinic acetylcholine receptor agonist |
| tinidazole Tinidazole: A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.. tinidazole : 1H-imidazole substituted at C-1 by a (2-ethylsulfonyl)ethyl group, at C-2 by a methyl group and at C-5 by a nitro group. It is used as an antiprotozoal, antibacterial agent. | 4.43 | 3 | 0 | imidazoles | antiamoebic agent; antibacterial drug; antiparasitic agent; antiprotozoal drug |
| tiopronin Tiopronin: Sulfhydryl acylated derivative of GLYCINE. | 3.23 | 1 | 0 | N-acyl-amino acid | |
| tizanidine tizanidine: RN given refers to parent cpd; structure. tizanidine : 2,1,3-Benzothiadiazole substituted at C-4 by a Delta(1)-imidazolin-2-ylamino group and at C-4 by a chloro group. It is an agonist at alpha2-adrenergic receptor sites. | 3.9 | 3 | 0 | benzothiadiazole; imidazoles | alpha-adrenergic agonist; muscle relaxant |
| nikethamide Nikethamide: A central nervous system stimulant. It was formerly used in the treatment of barbiturate overdose but is now considered to be of no value for such purposes and may be dangerous. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1229) | 2.08 | 1 | 0 | pyridinecarboxamide | |
| tolazamide Tolazamide: A sulphonylurea hypoglycemic agent with actions and uses similar to those of CHLORPROPAMIDE.. tolazamide : An N-sulfonylurea that is 1-tosylurea in which a hydrogen attached to the nitrogen at position 3 is replaced by an azepan-1-yl group. A hypoglycemic agent, it is used for the treatment of type 2 diabetes mellitus. | 3.23 | 1 | 0 | N-sulfonylurea | hypoglycemic agent; potassium channel blocker |
| tolbutamide Tolbutamide: A sulphonylurea hypoglycemic agent with actions and uses similar to those of CHLORPROPAMIDE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290). tolbutamide : An N-sulfonylurea that consists of 1-butylurea having a tosyl group attached at the 3-position. | 3.61 | 2 | 0 | N-sulfonylurea | human metabolite; hypoglycemic agent; insulin secretagogue; potassium channel blocker |
| tolmetin Tolmetin: A non-steroidal anti-inflammatory agent (ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL) similar in mode of action to INDOMETHACIN.. tolmetin : A monocarboxylic acid that is (1-methylpyrrol-2-yl)acetic acid substituted at position 5 on the pyrrole ring by a 4-methylbenzoyl group. Used in the form of its sodium salt dihydrate as a nonselective nonsteroidal anti-inflammatory drug. | 3.69 | 2 | 0 | aromatic ketone; monocarboxylic acid; pyrroles | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
| tolnaftate [no description available] | 2.08 | 1 | 0 | monothiocarbamic ester | antifungal drug |
| tolperisone Tolperisone: A centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1211) | 2.41 | 1 | 0 | aromatic ketone | |
| ultram 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol : A tertiary alcohol that is cyclohexanol substituted at positions 1 and 2 by 3-methoxyphenyl and dimethylaminomethyl groups respectively. | 3.23 | 1 | 0 | aromatic ether; tertiary alcohol; tertiary amino compound | |
| tranexamic acid Tranexamic Acid: Antifibrinolytic hemostatic used in severe hemorrhage. | 3.23 | 1 | 0 | amino acid | |
| trazodone Trazodone: A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309). trazodone : An N-arylpiperazine in which one nitrogen is substituted by a 3-chlorophenyl group, while the other is substituted by a 3-(3-oxo[1,2,4]triazolo[4,3-a]pyridin-2(3H)-yl)propyl group. | 11.18 | 3 | 1 | monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazolopyridine | adrenergic antagonist; antidepressant; anxiolytic drug; H1-receptor antagonist; sedative; serotonin uptake inhibitor |
| triamterene Triamterene: A pteridinetriamine compound that inhibits SODIUM reabsorption through SODIUM CHANNELS in renal EPITHELIAL CELLS.. triamterene : Pteridine substituted at positions 2, 4 and 7 with amino groups and at position 6 with a phenyl group. A sodium channel blocker, it is used as a diuretic in the treatment of hypertension and oedema. | 3.61 | 2 | 0 | pteridines | diuretic; sodium channel blocker |
| triazolam Triazolam: A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries. | 5.48 | 4 | 1 | triazolobenzodiazepine | sedative |
| trifluoperazine [no description available] | 3.23 | 1 | 0 | N-alkylpiperazine; N-methylpiperazine; organofluorine compound; phenothiazines | antiemetic; calmodulin antagonist; dopaminergic antagonist; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor; phenothiazine antipsychotic drug |
| trihexyphenidyl Trihexyphenidyl: One of the centrally acting MUSCARINIC ANTAGONISTS used for treatment of PARKINSONIAN DISORDERS and drug-induced extrapyramidal movement disorders and as an antispasmodic. | 3.23 | 1 | 0 | amine | |
| trimethadione Trimethadione: An anticonvulsant effective in absence seizures, but generally reserved for refractory cases because of its toxicity. (From AMA Drug Evaluations Annual, 1994, p378). trimethadione : An oxazolidinone that is 1,3-oxazolidine-2,4-dione substituted by methyl groups at positions 3, 5 and 5. It is an antiepileptic agent. | 3.23 | 1 | 0 | oxazolidinone | anticonvulsant; geroprotector |
| trimethobenzamide trimethobenzamide: major descriptor (64-84); on-line search BENZAMIDES (64-84); Index Medicus search TRIMETHOBENZAMIDE (64-84); RN given refers to parent cpd. trimethobenzamide : The amide obtained by formal condensation of 3,4,5-trihydroxybenzoic acid with 4-[2-(N,N-dimethylamino)ethoxy]benzylamine. It is used to prevent nausea and vomitting in humans. | 3.23 | 1 | 0 | benzamides; tertiary amino compound | antiemetic |
| trimethoprim Trimethoprim: A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM, SULFAMETHOXAZOLE DRUG COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.. trimethoprim : An aminopyrimidine antibiotic whose structure consists of pyrimidine 2,4-diamine and 1,2,3-trimethoxybenzene moieties linked by a methylene bridge. | 3.61 | 2 | 0 | aminopyrimidine; methoxybenzenes | antibacterial drug; diuretic; drug allergen; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; environmental contaminant; xenobiotic |
| trimetrexate Trimetrexate: A nonclassical folic acid inhibitor through its inhibition of the enzyme dihydrofolate reductase. It is being tested for efficacy as an antineoplastic agent and as an antiparasitic agent against PNEUMOCYSTIS PNEUMONIA in AIDS patients. Myelosuppression is its dose-limiting toxic effect. | 3.23 | 1 | 0 | ||
| trimipramine Trimipramine: Tricyclic antidepressant similar to IMIPRAMINE, but with more antihistaminic and sedative properties.. trimipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)-2-methylpropyl group at the nitrogen atom. It is used as an antidepressant. | 3.23 | 1 | 0 | dibenzoazepine; tertiary amino compound | antidepressant; environmental contaminant; xenobiotic |
| troglitazone Troglitazone: A chroman and thiazolidinedione derivative that acts as a PEROXISOME PROLIFERATOR-ACTIVATED RECEPTORS (PPAR) agonist. It was formerly used in the treatment of TYPE 2 DIABETES MELLITUS, but has been withdrawn due to hepatotoxicity. | 3.61 | 2 | 0 | chromanes; thiazolidinone | anticoagulant; anticonvulsant; antineoplastic agent; antioxidant; EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; hypoglycemic agent; platelet aggregation inhibitor; vasodilator agent |
| thenoyltrifluoroacetone Thenoyltrifluoroacetone: Chelating agent and inhibitor of cellular respiration. | 2.08 | 1 | 0 | ||
| tyramine [no description available] | 3.23 | 1 | 0 | monoamine molecular messenger; primary amino compound; tyramines | EC 3.1.1.8 (cholinesterase) inhibitor; Escherichia coli metabolite; human metabolite; mouse metabolite; neurotransmitter |
| delavirdine Delavirdine: A potent, non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1.. delavirdine : The amide resulting from the formal condensation of 5-[(methylsulfonyl)amino]-1H-indole-2-carboxylic acid and 4-amino group of 1-[3-(isopropylamino)pyridin-2-yl]piperazine, delavirdine is a non-nucleoside reverse transcriptase inhibitor with activity specific for HIV-1. Viral resistance emerges rapidly when delavirdine is used alone, so it is therefore used (as the methanesulfonic acid salt) with other antiretrovirals for combination therapy of HIV infection. | 3.23 | 1 | 0 | aminopyridine; indolecarboxamide; N-acylpiperazine; sulfonamide | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| undecylenic acid undecylenic acid: a fatty acid with a terminal double bond. 10-undecenoic acid : An undecenoic acid having its double bond in the 10-position. It is derived from castor oil and is used for the treatment of skin problems.. undecenoic acid : A C11, straight-chain fatty acid carrying a C=C double bond at any position. | 2.08 | 1 | 0 | undecenoic acid | antifungal drug; plant metabolite |
| urapidil [no description available] | 2.08 | 1 | 0 | piperazines | |
| venlafaxine venlafaxine : A tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-methoxyphenyl group. | 3.85 | 3 | 0 | cyclohexanols; monomethoxybenzene; tertiary alcohol; tertiary amino compound | adrenergic uptake inhibitor; analgesic; antidepressant; dopamine uptake inhibitor; environmental contaminant; serotonin uptake inhibitor; xenobiotic |
| vigabatrin [no description available] | 7.38 | 22 | 0 | gamma-amino acid | anticonvulsant; EC 2.6.1.19 (4-aminobutyrate--2-oxoglutarate transaminase) inhibitor |
| pirinixic acid pirinixic acid: structure | 2.08 | 1 | 0 | aryl sulfide; organochlorine compound; pyrimidines | |
| ici 204,219 zafirlukast: a leukotriene D4 receptor antagonist | 3.61 | 2 | 0 | carbamate ester; indoles; N-sulfonylcarboxamide | anti-asthmatic agent; leukotriene antagonist |
| zaleplon zaleplon: an azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; a hypnotic with less marked effect on psychomotor functions compared to lorazepam. zaleplon : A pyrazolo[1,5-a]pyrimidine having a nitrile group at position 3 and a 3-(N-ethylacetamido)phenyl substituent at the 7-position. | 4.43 | 3 | 0 | nitrile; pyrazolopyrimidine | anticonvulsant; anxiolytic drug; central nervous system depressant; sedative |
| zolpidem Zolpidem: An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.. zolpidem : An imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position. | 4.87 | 5 | 0 | imidazopyridine | central nervous system depressant; GABA agonist; sedative |
| zonisamide Zonisamide: A benzisoxazole and sulfonamide derivative that acts as a CALCIUM CHANNEL blocker. It is used primarily as an adjunctive antiepileptic agent for the treatment of PARTIAL SEIZURES, with or without secondary generalization.. zonisamide : A 1,2-benzoxazole compound having a sulfamoylmethyl substituent at the 3-position. | 11.48 | 10 | 0 | 1,2-benzoxazoles; sulfonamide | anticonvulsant; antioxidant; central nervous system drug; protective agent; T-type calcium channel blocker |
| zopiclone zopiclone: S(+)-enantiomer of racemic zopiclone; azabicyclo(4.3.0)nonane; a nonbenzodiazepine; one of the so-called of Z drugs (zopiclone, eszopiclone, zolpidem, and zaleplon) for which there is some correlation with tumors; was term of zopiclone 2004-2007. zopiclone : A pyrrolo[3,4-b]pyrazine compound having a 4-methylpiperazine-1-carboxyl group at the 5-position, a 5-chloropyridin-2-yl group at the 6-position and an oxo-substituent at the 7-position. | 4.45 | 6 | 0 | monochloropyridine; pyrrolopyrazine | central nervous system depressant; sedative |
| cortisone acetate Cortisone Acetate: The acetate ester of cortisone that is used mainly for replacement therapy in adrenocortical insufficiency and in the treatment of many allergic and inflammatory disorders. | 3.23 | 1 | 0 | corticosteroid hormone | |
| mitomycin Mitomycin: An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.. mitomycin : A family of aziridine-containing natural products isolated from Streptomyces caespitosus or Streptomyces lavendulae. | 3.23 | 1 | 0 | mitomycin | alkylating agent; antineoplastic agent |
| corticosterone [no description available] | 3.31 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| prednisolone Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. | 4.14 | 4 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; drug metabolite; environmental contaminant; immunosuppressive agent; xenobiotic |
| reserpine Reserpine: An alkaloid found in the roots of Rauwolfia serpentina and R. vomitoria. Reserpine inhibits the uptake of norepinephrine into storage vesicles resulting in depletion of catecholamines and serotonin from central and peripheral axon terminals. It has been used as an antihypertensive and an antipsychotic as well as a research tool, but its adverse effects limit its clinical use.. reserpine : An alkaloid found in the roots of Rauwolfia serpentina and R. vomitoria. | 9.52 | 6 | 0 | alkaloid ester; methyl ester; yohimban alkaloid | adrenergic uptake inhibitor; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; first generation antipsychotic; plant metabolite; xenobiotic |
| phentolamine Phentolamine: A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.. phentolamine : A substituted aniline that is 3-aminophenol in which the hydrogens of the amino group are replaced by 4-methylphenyl and 4,5-dihydro-1H-imidazol-2-ylmethyl groups respectively. An alpha-adrenergic antagonist, it is used for the treatment of hypertension. | 3.23 | 1 | 0 | imidazoles; phenols; substituted aniline; tertiary amino compound | alpha-adrenergic antagonist; vasodilator agent |
| sorbitol D-glucitol : The D-enantiomer of glucitol (also known as D-sorbitol). | 3.23 | 1 | 0 | glucitol | cathartic; Escherichia coli metabolite; food humectant; human metabolite; laxative; metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite; sweetening agent |
| thyroxine Thyroxine: The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.. thyroxine : An iodothyronine compound having iodo substituents at the 3-, 3'-, 5- and 5'-positions. | 3.23 | 1 | 0 | 2-halophenol; iodophenol; L-phenylalanine derivative; non-proteinogenic L-alpha-amino acid; thyroxine zwitterion; thyroxine | antithyroid drug; human metabolite; mouse metabolite; thyroid hormone |
| dextroamphetamine Dextroamphetamine: The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.. (S)-amphetamine : A 1-phenylpropan-2-amine that has S configuration. | 3.57 | 2 | 0 | 1-phenylpropan-2-amine | adrenergic agent; adrenergic uptake inhibitor; dopamine uptake inhibitor; dopaminergic agent; neurotoxin; sympathomimetic agent |
| spironolactone Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. | 3.23 | 1 | 0 | 3-oxo-Delta(4) steroid; oxaspiro compound; steroid lactone; thioester | aldosterone antagonist; antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
| aldosterone [no description available] | 3.31 | 1 | 0 | 11beta-hydroxy steroid; 18-oxo steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid hormone; mineralocorticoid; primary alpha-hydroxy ketone; steroid aldehyde | human metabolite; mouse metabolite |
| penicillamine Penicillamine: 3-Mercapto-D-valine. The most characteristic degradation product of the penicillin antibiotics. It is used as an antirheumatic and as a chelating agent in Wilson's disease.. penicillamine : An alpha-amino acid having the structure of valine substituted at the beta position with a sulfanyl group. | 3.61 | 2 | 0 | non-proteinogenic alpha-amino acid; penicillamine | antirheumatic drug; chelator; copper chelator; drug allergen |
| cysteine [no description available] | 3.23 | 1 | 0 | cysteine zwitterion; cysteine; L-alpha-amino acid; proteinogenic amino acid; serine family amino acid | EC 4.3.1.3 (histidine ammonia-lyase) inhibitor; flour treatment agent; human metabolite |
| prednisone Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid. | 6.36 | 10 | 0 | 11-oxo steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; immunosuppressive agent; prodrug |
| estrone Hydroxyestrones: Estrone derivatives substituted with one or more hydroxyl groups in any position. They are important metabolites of estrone and other estrogens. | 3.23 | 1 | 0 | 17-oxo steroid; 3-hydroxy steroid; phenolic steroid; phenols | antineoplastic agent; bone density conservation agent; estrogen; human metabolite; mouse metabolite |
| methylprednisolone acetate Methylprednisolone Acetate: Methylprednisolone derivative that is used as an anti-inflammatory agent for the treatment of ALLERGY and ALLERGIC RHINITIS; ASTHMA; and BURSITIS; and for the treatment of ADRENAL INSUFFICIENCY.. methylprednisolone acetate : An acetate ester resulting from the formal condensation of the 21-hydroxy function of 6alpha-methylprednisolone compound with acetic acid. | 3.17 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; acetate ester; glucocorticoid; steroid ester; tertiary alpha-hydroxy ketone | anti-inflammatory drug |
| oxandrolone Oxandrolone: A synthetic hormone with anabolic and androgenic properties. | 3.23 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo steroid; anabolic androgenic steroid; oxa-steroid | anabolic agent; androgen |
| penicillin g Penicillin G: A penicillin derivative commonly used in the form of its sodium or potassium salts in the treatment of a variety of infections. It is effective against most gram-positive bacteria and against gram-negative cocci. It has also been used as an experimental convulsant because of its actions on GAMMA-AMINOBUTYRIC ACID mediated synaptic transmission.. benzylpenicillin : A penicillin in which the substituent at position 6 of the penam ring is a phenylacetamido group. | 3.23 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug; drug allergen; epitope |
| pilocarpine Pilocarpine: A slowly hydrolyzed muscarinic agonist with no nicotinic effects. Pilocarpine is used as a miotic and in the treatment of glaucoma.. (+)-pilocarpine : The (+)-enantiomer of pilocarpine. | 8.85 | 3 | 0 | pilocarpine | antiglaucoma drug |
| pentylenetetrazole Pentylenetetrazole: A pharmaceutical agent that displays activity as a central nervous system and respiratory stimulant. It is considered a non-competitive GAMMA-AMINOBUTYRIC ACID antagonist. Pentylenetetrazole has been used experimentally to study seizure phenomenon and to identify pharmaceuticals that may control seizure susceptibility.. pentetrazol : An organic heterobicyclic compound that is 1H-tetrazole in which the hydrogens at positions 1 and 5 are replaced by a pentane-1,5-diyl group. A central and respiratory stimulant, it was formerly used for the treatment of cough and other respiratory tract disorders, cardiovascular disorders including hypotension, and pruritis. | 3.04 | 4 | 0 | organic heterobicyclic compound; organonitrogen heterocyclic compound | |
| triiodothyronine Triiodothyronine: A T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3.. 3,3',5-triiodo-L-thyronine : An iodothyronine compound having iodo substituents at the 3-, 3'- and 5-positions. Although some is produced in the thyroid, most of the 3,3',5-triiodo-L-thyronine in the body is generated by mono-deiodination of L-thyroxine in the peripheral tissues. Its metabolic activity is about 3 to 5 times that of L-thyroxine. The sodium salt is used in the treatment of hypothyroidism. | 3.23 | 1 | 0 | 2-halophenol; amino acid zwitterion; iodophenol; iodothyronine | human metabolite; mouse metabolite; thyroid hormone |
| carbon tetrachloride Carbon Tetrachloride: A solvent for oils, fats, lacquers, varnishes, rubber waxes, and resins, and a starting material in the manufacturing of organic compounds. Poisoning by inhalation, ingestion or skin absorption is possible and may be fatal. (Merck Index, 11th ed). tetrachloromethane : A chlorocarbon that is methane in which all the hydrogens have been replaced by chloro groups. | 2.08 | 1 | 0 | chlorocarbon; chloromethanes | hepatotoxic agent; refrigerant |
| alanine Alanine: A non-essential amino acid that occurs in high levels in its free state in plasma. It is produced from pyruvate by transamination. It is involved in sugar and acid metabolism, increases IMMUNITY, and provides energy for muscle tissue, BRAIN, and the CENTRAL NERVOUS SYSTEM.. alanine : An alpha-amino acid that consists of propionic acid bearing an amino substituent at position 2. | 2.06 | 1 | 0 | alanine zwitterion; alanine; L-alpha-amino acid; proteinogenic amino acid; pyruvate family amino acid | EC 4.3.1.15 (diaminopropionate ammonia-lyase) inhibitor; fundamental metabolite |
| serine Serine: A non-essential amino acid occurring in natural form as the L-isomer. It is synthesized from GLYCINE or THREONINE. It is involved in the biosynthesis of PURINES; PYRIMIDINES; and other amino acids.. serine : An alpha-amino acid that is alanine substituted at position 3 by a hydroxy group. | 2.95 | 4 | 0 | L-alpha-amino acid; proteinogenic amino acid; serine family amino acid; serine zwitterion; serine | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| chloramphenicol Amphenicol: Chloramphenicol and its derivatives. | 3.61 | 2 | 0 | C-nitro compound; carboxamide; diol; organochlorine compound | antibacterial drug; antimicrobial agent; Escherichia coli metabolite; geroprotector; Mycoplasma genitalium metabolite; protein synthesis inhibitor |
| aspartic acid Aspartic Acid: One of the non-essential amino acids commonly occurring in the L-form. It is found in animals and plants, especially in sugar cane and sugar beets. It may be a neurotransmitter.. aspartic acid : An alpha-amino acid that consists of succinic acid bearing a single alpha-amino substituent. L-aspartic acid : The L-enantiomer of aspartic acid. | 4.51 | 2 | 0 | aspartate family amino acid; aspartic acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; mouse metabolite; neurotransmitter |
| glutamine Glutamine: A non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from GLUTAMIC ACID and AMMONIA. It is the principal carrier of NITROGEN in the body and is an important energy source for many cells.. L-glutamine : An optically active form of glutamine having L-configuration.. glutamine : An alpha-amino acid that consists of butyric acid bearing an amino substituent at position 2 and a carbamoyl substituent at position 4. | 8.55 | 2 | 0 | amino acid zwitterion; glutamine family amino acid; glutamine; L-alpha-amino acid; polar amino acid zwitterion; proteinogenic amino acid | EC 1.14.13.39 (nitric oxide synthase) inhibitor; Escherichia coli metabolite; human metabolite; metabolite; micronutrient; mouse metabolite; nutraceutical; Saccharomyces cerevisiae metabolite |
| cyanides Cyanides: Inorganic salts of HYDROGEN CYANIDE containing the -CN radical. The concept also includes isocyanides. It is distinguished from NITRILES, which denotes organic compounds containing the -CN radical.. cyanides : Salts and C-organyl derivatives of hydrogen cyanide, HC#N.. isocyanide : The isomer HN(+)#C(-) of hydrocyanic acid, HC#N, and its hydrocarbyl derivatives RNC (RN(+)#C(-)).. cyanide : A pseudohalide anion that is the conjugate base of hydrogen cyanide. | 2.42 | 2 | 0 | pseudohalide anion | EC 1.9.3.1 (cytochrome c oxidase) inhibitor |
| vincristine [no description available] | 3.23 | 1 | 0 | acetate ester; formamides; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; tertiary alcohol; tertiary amino compound; vinca alkaloid | antineoplastic agent; drug; microtubule-destabilising agent; plant metabolite; tubulin modulator |
| physostigmine Physostigmine: A cholinesterase inhibitor that is rapidly absorbed through membranes. It can be applied topically to the conjunctiva. It also can cross the blood-brain barrier and is used when central nervous system effects are desired, as in the treatment of severe anticholinergic toxicity. | 3.23 | 1 | 0 | carbamate ester; indole alkaloid | antidote to curare poisoning; EC 3.1.1.8 (cholinesterase) inhibitor; miotic |
| sucrose Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar. | 2.58 | 2 | 0 | glycosyl glycoside | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; osmolyte; Saccharomyces cerevisiae metabolite; sweetening agent |
| ethinyl estradiol Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration. | 2.08 | 1 | 0 | 17-hydroxy steroid; 3-hydroxy steroid; terminal acetylenic compound | xenoestrogen |
| tubocurarine Tubocurarine: A neuromuscular blocker and active ingredient in CURARE; plant based alkaloid of Menispermaceae.. tubocurarine : A benzylisoquinoline alkaloid muscle relaxant which constitutes the active component of curare.. isoquinoline alkaloid : Any alkaloid that has a structure based on an isoquinoline nucleus. They are derived from the amino acids like tyrosine and phenylalanine. | 2.08 | 1 | 0 | bisbenzylisoquinoline alkaloid | drug allergen; muscle relaxant; nicotinic antagonist |
| apomorphine Apomorphine: A derivative of morphine that is a dopamine D2 agonist. It is a powerful emetic and has been used for that effect in acute poisoning. It has also been used in the diagnosis and treatment of parkinsonism, but its adverse effects limit its use. | 3.89 | 3 | 0 | aporphine alkaloid | alpha-adrenergic drug; antidyskinesia agent; antiparkinson drug; dopamine agonist; emetic; serotonergic drug |
| methyltestosterone Methyltestosterone: A synthetic hormone used for androgen replacement therapy and as an hormonal antineoplastic agent (ANTINEOPLASTIC AGENTS, HORMONAL).. methyltestosterone : A 17beta-hydroxy steroid that is testosterone bearing a methyl group at the 17alpha position. | 3.23 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; enone | anabolic agent; androgen; antineoplastic agent |
| tetrabenazine 9,10-dimethoxy-3-isobutyl-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-one : A benzoquinolizine that is 1,2,3,4,4a,9,10,10a-octahydrophenanthrene in which the carbon at position 10a is replaced by a nitrogen and which is substituted by an isobutyl group at position 2, an oxo group at position 3, and methoxy groups at positions 6 and 7. | 3.23 | 1 | 0 | benzoquinolizine; cyclic ketone; tertiary amino compound | |
| kanamycin a Kanamycin: Antibiotic complex produced by Streptomyces kanamyceticus from Japanese soil. Comprises 3 components: kanamycin A, the major component, and kanamycins B and C, the minor components.. kanamycin : Kanamycin is a naturally occurring antibiotic complex from Streptomyces kanamyceticus that consists of several components: kanamycin A, the major component (also usually designated as kanamycin), and kanamycins B, C, D and X the minor components. | 3.61 | 2 | 0 | kanamycins | bacterial metabolite |
| carbostyril Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2. | 2.08 | 1 | 0 | monohydroxyquinoline; quinolone | bacterial xenobiotic metabolite |
| levodopa Levodopa: The naturally occurring form of DIHYDROXYPHENYLALANINE and the immediate precursor of DOPAMINE. Unlike dopamine itself, it can be taken orally and crosses the blood-brain barrier. It is rapidly taken up by dopaminergic neurons and converted to DOPAMINE. It is used for the treatment of PARKINSONIAN DISORDERS and is usually given with agents that inhibit its conversion to dopamine outside of the central nervous system.. L-dopa : An optically active form of dopa having L-configuration. Used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease | 3.58 | 2 | 0 | amino acid zwitterion; dopa; L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | allelochemical; antidyskinesia agent; antiparkinson drug; dopaminergic agent; hapten; human metabolite; mouse metabolite; neurotoxin; plant growth retardant; plant metabolite; prodrug |
| edetic acid Edetic Acid: A chelating agent that sequesters a variety of polyvalent cations such as CALCIUM. It is used in pharmaceutical manufacturing and as a food additive. | 3.23 | 1 | 0 | ethylenediamine derivative; polyamino carboxylic acid; tetracarboxylic acid | anticoagulant; antidote; chelator; copper chelator; geroprotector |
| cysteamine Cysteamine: A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.. cysteamine : An amine that consists of an ethane skeleton substituted with a thiol group at C-1 and an amino group at C-2. | 3.23 | 1 | 0 | amine; thiol | geroprotector; human metabolite; mouse metabolite; radiation protective agent |
| acetylcholine chloride acetylcholine chloride : The chloride salt of acetylcholine, and a parasympatomimetic drug. | 3.23 | 1 | 0 | quaternary ammonium salt | |
| mepazine mepazine: major descriptor (66-85); on-line search PHENOTHIAZINES (66-85); Index Medicus search MEPAZINE (66-85); RN given refers to parent cpd. pacatal : A phenothiazine derivative in which 10H-phenothiazine has an N-methylpiperidin-4-ylmethyl substituent at the N-10 position. | 3.23 | 1 | 0 | phenothiazines | |
| cloxacillin Cloxacillin: A semi-synthetic antibiotic that is a chlorinated derivative of OXACILLIN.. cloxacillin : A semisynthetic penicillin antibiotic carrying a 3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido group at position 6. | 3.23 | 1 | 0 | penicillin allergen; penicillin; semisynthetic derivative | antibacterial agent; antibacterial drug |
| leucine Leucine: An essential branched-chain amino acid important for hemoglobin formation.. leucine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isobutyl group. | 2.02 | 1 | 0 | amino acid zwitterion; L-alpha-amino acid; leucine; proteinogenic amino acid; pyruvate family amino acid | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| berlition berlition: antioxidant preparation containing alpha-lipoic acid, used in the neuroprotective therapy of chronic brain ischemia for correction of free-radical processes. (R)-lipoic acid : The (R)-enantiomer of lipoic acid. A vitamin-like, C8 thia fatty acid with anti-oxidant properties.. lipoic acid : A heterocyclic thia fatty acid comprising pentanoic acid with a 1,2-dithiolan-3-yl group at the 5-position. | 2.06 | 1 | 0 | dithiolanes; heterocyclic fatty acid; lipoic acid; thia fatty acid | cofactor; nutraceutical; prosthetic group |
| calcium acetate calcium acetate: a principal compound used as phosphate binders in patients with chronic renal failure; used like sevelamer. calcium acetate : The calcium salt of acetic acid. It is used, commonly as a hydrate, to treat hyperphosphataemia (excess phosphate in the blood) in patients with kidney disease: the calcium ion combines with dietary phosphate to form (insoluble) calcium phosphate, which is excreted in the faeces. | 3.23 | 1 | 0 | calcium salt | chelator |
| lactose Lactose: A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.. lactose : A glycosylglucose disaccharide, found most notably in milk, that consists of D-galactose and D-glucose fragments bonded through a beta-1->4 glycosidic linkage. The glucose fragment can be in either the alpha- or beta-pyranose form, whereas the galactose fragment can only have the beta-pyranose form.. beta-lactose : The beta-anomer of lactose. | 7.01 | 1 | 0 | lactose | |
| methionine Methionine: A sulfur-containing essential L-amino acid that is important in many body functions.. methionine : A sulfur-containing amino acid that is butyric acid bearing an amino substituent at position 2 and a methylthio substituent at position 4. | 3.23 | 1 | 0 | aspartate family amino acid; L-alpha-amino acid; methionine zwitterion; methionine; proteinogenic amino acid | antidote to paracetamol poisoning; human metabolite; micronutrient; mouse metabolite; nutraceutical |
| phenylalanine Phenylalanine: An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.. L-phenylalanine : The L-enantiomer of phenylalanine.. phenylalanine : An aromatic amino acid that is alanine in which one of the methyl hydrogens is substituted by a phenyl group. | 2 | 1 | 0 | amino acid zwitterion; erythrose 4-phosphate/phosphoenolpyruvate family amino acid; L-alpha-amino acid; phenylalanine; proteinogenic amino acid | algal metabolite; EC 3.1.3.1 (alkaline phosphatase) inhibitor; Escherichia coli metabolite; human xenobiotic metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
| colchicine (S)-colchicine : A colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions. | 3.61 | 2 | 0 | alkaloid; colchicine | anti-inflammatory agent; gout suppressant; mutagen |
| mebanazine mebanazine: RN given refers to parent cpd without isomeric designation; structure | 3.23 | 1 | 0 | benzenes | |
| oxacillin Oxacillin: An antibiotic similar to FLUCLOXACILLIN used in resistant staphylococci infections.. oxacillin : A penicillin antibiotic carrying a 5-methyl-3-phenylisoxazole-4-carboxamide group at position 6beta. | 3.23 | 1 | 0 | penicillin | antibacterial agent; antibacterial drug |
| triamcinolone diacetate triamcinolone diacetate: lysyl oxidase antagonist; Polcortolon may also refers to triamcinolone | 2.08 | 1 | 0 | corticosteroid hormone | |
| cycloserine Cycloserine: Antibiotic substance produced by Streptomyces garyphalus.. D-cycloserine : A 4-amino-1,2-oxazolidin-3-one that has R configuration. It is an antibiotic produced by Streptomyces garyphalus or S. orchidaceus and is used as part of a multi-drug regimen for the treatment of tuberculosis when resistance to, or toxicity from, primary drugs has developed. An analogue of D-alanine, it interferes with bacterial cell wall synthesis in the cytoplasm by competitive inhibition of L-alanine racemase (which forms D-alanine from L-alanine) and D-alanine--D-alanine ligase (which incorporates D-alanine into the pentapeptide required for peptidoglycan formation and bacterial cell wall synthesis). | 3.23 | 1 | 0 | 4-amino-1,2-oxazolidin-3-one; organonitrogen heterocyclic antibiotic; organooxygen heterocyclic antibiotic; zwitterion | antiinfective agent; antimetabolite; antitubercular agent; metabolite; NMDA receptor agonist |
| benziodarone benziodarone: minor descriptor (75-89); on-line & INDEX MEDICUS search BENZOFURANS (68-89) & IODOBENZOATES (74) | 3.23 | 1 | 0 | aromatic ketone | |
| ampicillin Ampicillin: Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.. ampicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-phenylacetamido group. | 3.23 | 1 | 0 | beta-lactam antibiotic; penicillin allergen; penicillin | antibacterial drug |
| mannitol [no description available] | 3.54 | 2 | 0 | mannitol | allergen; antiglaucoma drug; compatible osmolytes; Escherichia coli metabolite; food anticaking agent; food bulking agent; food humectant; food stabiliser; food thickening agent; hapten; metabolite; osmotic diuretic; sweetening agent |
| cytarabine [no description available] | 3.61 | 2 | 0 | beta-D-arabinoside; monosaccharide derivative; pyrimidine nucleoside | antimetabolite; antineoplastic agent; antiviral agent; immunosuppressive agent |
| medroxyprogesterone acetate [no description available] | 2.08 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; corticosteroid; steroid ester | adjuvant; androgen; antineoplastic agent; antioxidant; female contraceptive drug; inhibitor; progestin; synthetic oral contraceptive |
| valine Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine. | 2.13 | 1 | 0 | L-alpha-amino acid zwitterion; L-alpha-amino acid; proteinogenic amino acid; pyruvate family amino acid; valine | algal metabolite; Escherichia coli metabolite; human metabolite; micronutrient; mouse metabolite; nutraceutical; Saccharomyces cerevisiae metabolite |
| isoleucine Isoleucine: An essential branched-chain aliphatic amino acid found in many proteins. It is an isomer of LEUCINE. It is important in hemoglobin synthesis and regulation of blood sugar and energy levels.. isoleucine : A 2-amino-3-methylpentanoic acid having either (2R,3R)- or (2S,3S)-configuration.. L-isoleucine : The L-enantiomer of isoleucine. | 3.14 | 5 | 0 | aspartate family amino acid; isoleucine; L-alpha-amino acid zwitterion; L-alpha-amino acid; proteinogenic amino acid | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| arginine Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group. | 3.85 | 3 | 0 | arginine; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | biomarker; Escherichia coli metabolite; micronutrient; mouse metabolite; nutraceutical |
| ethane Ethane: A two carbon alkane with the formula H3C-CH3.. ethane : An alkane comprising of two carbon atoms. | 7.01 | 1 | 0 | alkane; gas molecular entity | plant metabolite; refrigerant |
| acetonitrile acetonitrile: RN given refers to unlabeled cpd. acetonitrile : A nitrile that is hydrogen cyanide in which the hydrogen has been replaced by a methyl group. | 7.21 | 1 | 0 | aliphatic nitrile; volatile organic compound | EC 3.5.1.4 (amidase) inhibitor; NMR chemical shift reference compound; polar aprotic solvent |
| perflutren Definity: a fluorocarbon-filled ultrasonic contrast agent; Definity is tradename. octafluoropropane : A fluorocarbon that is propane in which all of the hydrogens have been replaced by fluorines. | 3.23 | 1 | 0 | fluoroalkane; fluorocarbon | |
| triamcinolone acetonide Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; cyclic ketal; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone | anti-allergic agent; anti-inflammatory drug |
| fluoxymesterone Fluoxymesterone: An anabolic steroid that has been used in the treatment of male HYPOGONADISM, delayed puberty in males, and in the treatment of breast neoplasms in women. | 3.23 | 1 | 0 | 11beta-hydroxy steroid; 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; anabolic androgenic steroid; fluorinated steroid | anabolic agent; antineoplastic agent |
| methsuximide methsuximide: anticonvulsant effective in petit mal & psychomotor epilepsy; has a number of unpleasant & toxic side effects; minor descriptor (75-86); on-line & INDEX MEDICUS search SUCCINIMIDES (75-86); RN given refers to parent cpd without isomeric designation | 3.23 | 1 | 0 | organic molecular entity | |
| tromethamine Tromethamine: An organic amine proton acceptor. It is used in the synthesis of surface-active agents and pharmaceuticals; as an emulsifying agent for cosmetic creams and lotions, mineral oil and paraffin wax emulsions, as a biological buffer, and used as an alkalizer. (From Merck, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p1424) | 5.02 | 2 | 1 | primary amino compound; triol | buffer |
| acrylic acid acrylic acid: RN given refers to parent cpd. acrylic acid : A alpha,beta-unsaturated monocarboxylic acid that is ethene substituted by a carboxy group. | 2.01 | 1 | 0 | alpha,beta-unsaturated monocarboxylic acid | metabolite |
| methylprednisolone Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone. | 4.57 | 7 | 0 | 6-methylprednisolone; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antiemetic; environmental contaminant; neuroprotective agent; xenobiotic |
| rotenone Derris: A plant genus of the family FABACEAE. The root is a source of rotenoids (ROTENONE) and flavonoids. Some species of Pongamia have been reclassified to this genus and some to MILLETTIA. Some species of Deguelia have been reclassified to this genus.. rotenoid : Members of the class of tetrahydrochromenochromene that consists of a cis-fused tetrahydrochromeno[3,4-b]chromene skeleton and its substituted derivatives. The term was originally restricted to natural products, but is now also used to describe semi-synthetic and fully synthetic compounds. | 2.08 | 1 | 0 | organic heteropentacyclic compound; rotenones | antineoplastic agent; metabolite; mitochondrial NADH:ubiquinone reductase inhibitor; phytogenic insecticide; piscicide; toxin |
| brompheniramine Brompheniramine: Histamine H1 antagonist used in treatment of allergies, rhinitis, and urticaria.. brompheniramine : Pheniramine in which the hydrogen at position 4 of the phenyl substituent is substituted by bromine. A histamine H1 receptor antagonist, brompheniramine is used (commonly as its maleate salt) for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 3.23 | 1 | 0 | organobromine compound; pyridines | anti-allergic agent; H1-receptor antagonist |
| penicillin v Penicillin V: A broad-spectrum penicillin antibiotic used orally in the treatment of mild to moderate infections by susceptible gram-positive organisms.. phenoxymethylpenicillin : A penicillin compound having a 6beta-(phenoxyacetyl)amino side-chain. | 3.23 | 1 | 0 | penicillin allergen; penicillin | |
| isosorbide dinitrate Isosorbide Dinitrate: A vasodilator used in the treatment of ANGINA PECTORIS. Its actions are similar to NITROGLYCERIN but with a slower onset of action. | 6.53 | 5 | 0 | glucitol derivative; nitrate ester | nitric oxide donor; vasodilator agent |
| n-vinyl-2-pyrrolidinone N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source | 2.61 | 2 | 0 | pyrrolidin-2-ones | |
| salicylaldehyde o-hydroxybenzaldehyde: structure in first source | 7.15 | 1 | 0 | hydroxybenzaldehyde | nematicide; plant metabolite |
| pseudoephedrine Pseudoephedrine: A phenethylamine that is an isomer of EPHEDRINE which has less central nervous system effects and usage is mainly for respiratory tract decongestion.. pseudoephedrine : A member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group. | 3.23 | 1 | 0 | phenylethanolamines; secondary alcohol; secondary amino compound | anti-asthmatic drug; bronchodilator agent; central nervous system drug; nasal decongestant; plant metabolite; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
| diethylpropion Diethylpropion: A appetite depressant considered to produce less central nervous system disturbance than most drugs in this therapeutic category. It is also considered to be among the safest for patients with hypertension. (From AMA Drug Evaluations Annual, 1994, p2290). diethylpropion : An aromatic ketone that is propiophenone in which one of the hydrogens alpha- to the carbonyl is substituted by a diethylamino group. A central stimulant and indirect-acting sympathomimetic, it is an appetite depressant and is used as the hydrochloride as an anoretic in the short term management of obesity. | 3.23 | 1 | 0 | aromatic ketone; tertiary amine | appetite depressant |
| quinoxalines quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4. | 2.01 | 1 | 0 | mancude organic heterobicyclic parent; naphthyridine; ortho-fused heteroarene | |
| 4-butyrolactone 4-Butyrolactone: One of the FURANS with a carbonyl thereby forming a cyclic lactone. It is an endogenous compound made from gamma-aminobutyrate and is the precursor of gamma-hydroxybutyrate. It is also used as a pharmacological agent and solvent.. tetrahydrofuranone : Any oxolane having an oxo- substituent at any position on the tetrahydrofuran ring.. gamma-butyrolactone : A butan-4-olide that is tetrahydrofuran substituted by an oxo group at position 2. | 3.17 | 5 | 0 | butan-4-olide | metabolite; neurotoxin |
| 1,3-ditolylguanidine 1,3-ditolylguanidine: structure given in first source; a selective ligand for the sigma binding sites in the brain | 2.13 | 1 | 0 | toluenes | |
| nitrobenzene nitrobenzene : A nitroarene consisting of benzene carrying a single nitro substituent. An industrial chemical used widely in the production of aniline. | 2.15 | 1 | 0 | nitroarene; nitrobenzenes | |
| 4-bromophenyl phenyl ether 4-bromodiphenyl ether: induces apoptosis. 4-bromophenyl phenyl ether : An aromatic ether that is diphenyl ether substituted at position 4 by a bromo group. | 3.31 | 1 | 0 | aromatic ether; organobromine compound | |
| benzonatate benzonatate: structure in Merck Index, 9th ed, #1107. benzonatate : The ester obtained by formal condensation of 4-butylaminobenzoic acid with nonaethylene glycol monomethyl ether. Structurally related to procaine and benzocaine, it has an anaesthetic effect on the stretch sensors in the lungs, and is used as a non-narcotic cough suppressant. | 3.23 | 1 | 0 | benzoate ester; secondary amino compound; substituted aniline | anaesthetic; antitussive |
| 2-cyanoacetamide 2-cyanoacetamide: used in fluorimetric labeling of monosaccharides; structure | 2.13 | 1 | 0 | ||
| cyclohexanol Cyclohexanols: Monohydroxy derivatives of cyclohexanes that contain the general formula R-C6H11O. They have a camphorlike odor and are used in making soaps, insecticides, germicides, dry cleaning, and plasticizers.. cyclohexanols : An alcohol in which one or more hydroxy groups are attached to a cyclohexane skeleton. | 10.75 | 13 | 7 | cyclohexanols; secondary alcohol | solvent |
| pyrroles 1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen. | 4.28 | 5 | 0 | pyrrole; secondary amine | |
| thiophenes Thiophenes: A monocyclic heteroarene furan in which the oxygen atom is replaced by a sulfur.. thiophenes : Compounds containing at least one thiophene ring. | 16.01 | 77 | 8 | mancude organic heteromonocyclic parent; monocyclic heteroarene; thiophenes; volatile organic compound | non-polar solvent |
| 1,4-butanediol butane-1,4-diol : A butanediol that is butane in which one hydrogen of each of the methyl groups is substituted by a hydroxy group. A colourless, water-miscible, viscous liquid at room temperature (m.p. 16degreeC) with a high boiling point (230degreeC), it is mainly used for the production of other organic chemicals, particularly the solvent oxolane (also known as tetrahydrofuran or THF). | 7.07 | 1 | 0 | butanediol; glycol | neurotoxin; prodrug; protic solvent |
| methylergonovine Methylergonovine: A homolog of ERGONOVINE containing one more CH2 group. (Merck Index, 11th ed) | 3.23 | 1 | 0 | ergoline alkaloid | |
| phenformin Phenformin: A biguanide hypoglycemic agent with actions and uses similar to those of METFORMIN. Although it is generally considered to be associated with an unacceptably high incidence of lactic acidosis, often fatal, it is still available in some countries. (From Martindale, The Extra Pharmacopoeia, 30th ed, p290). phenformin : A member of the class of biguanides that is biguanide in which one of the terminal nitrogen atoms is substituted by a 2-phenylethyl group. It was used as an anti-diabetic drug but was later withdrawn from the market due to potential risk of lactic acidosis. | 2.08 | 1 | 0 | biguanides | antineoplastic agent; geroprotector; hypoglycemic agent |
| 2'-hydroxyacetophenone 2-acetylphenol : A monohydroxyacetophenone that is acetophenone in which one of the hydrogens ortho to the acetyl group has been replaced by a hydroxy group. | 2.13 | 1 | 0 | monohydroxyacetophenone; phenols | flavouring agent |
| cinchophen cinchophen: was heading 1963-94; ACIPHENOCHINOLIUM was see CHINOPHEN 1978-94; use QUINOLINES to search CINCHOPHEN 1966-94 | 3.23 | 1 | 0 | quinolines | |
| yohimbine Yohimbine: A plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of ERECTILE DYSFUNCTION.. yohimbine : An indole alkaloid with alpha2-adrenoceptor antagonist activity. It is produced by Corynanthe johimbe and Rauwolfia serpentina. | 2.97 | 4 | 0 | methyl 17-hydroxy-20xi-yohimban-16-carboxylate | alpha-adrenergic antagonist; dopamine receptor D2 antagonist; serotonergic antagonist |
| diphenhydramine hydrochloride Antitussive Agents: Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally.. diphenhydramine hydrochloride : The hydrochloride salt of diphenhydramine. | 3.88 | 3 | 0 | hydrochloride; organoammonium salt | anti-allergic agent; antiemetic; antiparkinson drug; antipruritic drug; H1-receptor antagonist; local anaesthetic; muscarinic antagonist; sedative |
| nafcillin Nafcillin: A semi-synthetic antibiotic related to penicillin.. nafcillin : A penicillin in which the substituent at position 6 of the penam ring is a (2-ethoxy-1-naphthoyl)amino group. | 3.23 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| methohexital Methohexital: An intravenous anesthetic with a short duration of action that may be used for induction of anesthesia.. methohexital : A barbiturate, the structure of which is that of barbituric acid substituted at N-1 by a methyl group and at C-5 by allyl and 1-methylpent-2-ynyl groups. | 3.23 | 1 | 0 | acetylenic compound; barbiturates | drug allergen; intravenous anaesthetic |
| quinazolines Quinazolines: A group of aromatic heterocyclic compounds that contain a bicyclic structure with two fused six-membered aromatic rings, a benzene ring and a pyrimidine ring.. quinazoline : A mancude organic heterobicyclic parent that is naphthalene in which the carbon atoms at positions 1 and 3 have been replaced by nitrogen atoms.. quinazolines : Any organic heterobicyclic compound based on a quinazoline skeleton and its substituted derivatives. | 3.14 | 1 | 0 | azaarene; mancude organic heterobicyclic parent; ortho-fused heteroarene; quinazolines | |
| indazoles Indazoles: A group of heterocyclic aromatic organic compounds consisting of the fusion of BENZENE and PYRAZOLES. | 2.06 | 1 | 0 | indazole | |
| isoxazoles Isoxazoles: Azoles with an OXYGEN and a NITROGEN next to each other at the 1,2 positions, in contrast to OXAZOLES that have nitrogens at the 1,3 positions.. isoxazole : A monocyclic heteroarene with a structure consisting of a 5-membered ring containing three carbon atoms and an oxygen and nitrogen atom adjacent to each other. It is the parent of the class of isoxazoles.. isoxazoles : Oxazoles in which the N and O atoms are adjacent. | 8.04 | 8 | 1 | isoxazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| thiazoles [no description available] | 4.37 | 4 | 1 | 1,3-thiazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| pyrazines Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms. | 3.85 | 3 | 0 | diazine; pyrazines | Daphnia magna metabolite |
| calcium gluconate [no description available] | 2.04 | 1 | 0 | calcium salt | nutraceutical |
| ephedrine Ephedrine: A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.. (-)-ephedrine : A phenethylamine alkaloid that is 2-phenylethanamine substituted by a methyl group at the amino nitrogen and a methyl and a hydroxy group at position 2 and 1 respectively. | 3.23 | 1 | 0 | phenethylamine alkaloid; phenylethanolamines | bacterial metabolite; environmental contaminant; nasal decongestant; plant metabolite; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
| pirinitramide Pirinitramide: A diphenylpropylamine with intense narcotic analgesic activity of long duration. It is a derivative of MEPERIDINE with similar activity and usage. | 3.45 | 1 | 1 | nitrile | |
| aminophylline Aminophylline: A drug combination that contains THEOPHYLLINE and ethylenediamine. It is more soluble in water than theophylline but has similar pharmacologic actions. It's most common use is in bronchial asthma, but it has been investigated for several other applications.. aminophylline : A mixture comprising of theophylline and ethylenediamine in a 2:1 ratio. | 3.61 | 2 | 0 | mixture | bronchodilator agent; cardiotonic drug |
| azacitidine Azacitidine: A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.. 5-azacytidine : An N-glycosyl-1,3,5-triazine that is 4-amino-1,3,5-triazin-2(1H)-one substituted by a beta-D-ribofuranosyl residue via an N-glycosidic linkage. An antineoplastic agent, it is used in the treatment of myeloid leukaemia. | 3.23 | 1 | 0 | N-glycosyl-1,3,5-triazine; nucleoside analogue | antineoplastic agent |
| galantamine Galantamine: A benzazepine derived from norbelladine. It is found in GALANTHUS and other AMARYLLIDACEAE. It is a cholinesterase inhibitor that has been used to reverse the muscular effects of GALLAMINE TRIETHIODIDE and TUBOCURARINE and has been studied as a treatment for ALZHEIMER DISEASE and other central nervous system disorders.. galanthamine : A benzazepine alkaloid isolated from certain species of daffodils. | 3.61 | 2 | 0 | benzazepine alkaloid fundamental parent; benzazepine alkaloid; organic heterotetracyclic compound; tertiary amino compound | antidote to curare poisoning; cholinergic drug; EC 3.1.1.7 (acetylcholinesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; plant metabolite |
| nandrolone decanoate Nandrolone Decanoate: Decanoic acid ester of nandrolone that is used as an anabolic agent to prevent or treat WASTING SYNDROME associated with severe chronic illness or HIV infection (HIV WASTING SYNDROME). It may also be used in the treatment of POSTMENOPAUSAL OSTEOPOROSIS. | 3.23 | 1 | 0 | steroid ester | |
| procarbazine hydrochloride procarbazine hydrochloride : A hydrochloride obtained by combining procarbazine with one equivalent of hydrochloric acid. An antineoplastic chemotherapy drug used for treatment of Hodgkin's lymphoma. Metabolism yields azo-procarbazine and hydrogen peroxide, which results in the breaking of DNA strands. | 2.08 | 1 | 0 | hydrochloride | antineoplastic agent |
| betamethasone Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) | 9.23 | 3 | 1 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | anti-asthmatic agent; anti-inflammatory drug; immunosuppressive agent |
| fluorobenzenes Fluorobenzenes: Derivatives of BENZENE that contain FLUORINE.. monofluorobenzene : The simplest member of the class of monofluorobenzenes that is benzene carrying a single fluoro substituent.. fluorobenzenes : Any fluoroarene that is a benzene or a substituted benzene carrying at least one fluoro group. | 3.17 | 1 | 0 | monofluorobenzenes | NMR chemical shift reference compound |
| normethadone normethadone: RN given refers to parent cpd | 2.13 | 1 | 0 | diarylmethane | |
| dextropropoxyphene Dextropropoxyphene: A narcotic analgesic structurally related to METHADONE. Only the dextro-isomer has an analgesic effect; the levo-isomer appears to exert an antitussive effect.. propoxyphene : A racemate of the (1R,2R)- and (1S,2R)- diastereoisomers.. dextropropoxyphene : The (1S,2R)-(+)-diastereoisomer of propoxyphene. | 5.26 | 3 | 1 | 1-benzyl-3-(dimethylamino)-2-methyl-1-phenylpropyl propanoate | mu-opioid receptor agonist; opioid analgesic |
| chenodeoxycholic acid Chenodeoxycholic Acid: A bile acid, usually conjugated with either glycine or taurine. It acts as a detergent to solubilize fats for intestinal absorption and is reabsorbed by the small intestine. It is used as cholagogue, a choleretic laxative, and to prevent or dissolve gallstones.. chenodeoxycholic acid : A dihydroxy-5beta-cholanic acid that is (5beta)-cholan-24-oic acid substituted by hydroxy groups at positions 3 and 7 respectively.. chenodeoxycholate : Conjugate base of chenodeoxycholic acid; major species at pH 7.3. | 3.23 | 1 | 0 | bile acid; C24-steroid; dihydroxy-5beta-cholanic acid | human metabolite; mouse metabolite |
| emetine Emetine: The principal alkaloid of ipecac, from the ground roots of Uragoga (or Cephaelis) ipecacuanha or U. acuminata, of the Rubiaceae. It is used as an amebicide in many different preparations and may cause serious cardiac, hepatic, or renal damage and violent diarrhea and vomiting. Emetine inhibits protein synthesis in EUKARYOTIC CELLS but not PROKARYOTIC CELLS.. emetine : A pyridoisoquinoline comprising emetam having methoxy substituents at the 6'-, 7'-, 10- and 11-positions. It is an antiprotozoal agent and emetic. It inhibits SARS-CoV2, Zika and Ebola virus replication and displays antimalarial, antineoplastic and antiamoebic properties. | 2.08 | 1 | 0 | isoquinoline alkaloid; pyridoisoquinoline | antiamoebic agent; anticoronaviral agent; antiinfective agent; antimalarial; antineoplastic agent; antiprotozoal drug; antiviral agent; autophagy inhibitor; emetic; expectorant; plant metabolite; protein synthesis inhibitor |
| bicuculline Bicuculline: An isoquinoline alkaloid obtained from Dicentra cucullaria and other plants. It is a competitive antagonist for GABA-A receptors.. bicuculline : A benzylisoquinoline alkaloid that is 6-methyl-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinoline which is substituted at the 5-pro-S position by a (6R)-8-oxo-6,8-dihydrofuro[3,4-e][1,3]benzodioxol-6-yl group. A light-sensitive competitive antagonist of GABAA receptors. It was originally identified in 1932 in plant alkaloid extracts and has been isolated from Dicentra cucullaria, Adlumia fungosa, Fumariaceae, and several Corydalis species. | 2.02 | 1 | 0 | benzylisoquinoline alkaloid; isoquinoline alkaloid; isoquinolines | agrochemical; central nervous system stimulant; GABA-gated chloride channel antagonist; GABAA receptor antagonist; neurotoxin |
| captodiamine captodiamine: Captodiamine represents an interesting strategy for achieving benzodiazepine substitution with a low risk of dependence or impairment of cognitive function | 4.19 | 1 | 0 | diarylmethane | |
| kainic acid Kainic Acid: (2S-(2 alpha,3 beta,4 beta))-2-Carboxy-4-(1-methylethenyl)-3-pyrrolidineacetic acid. Ascaricide obtained from the red alga Digenea simplex. It is a potent excitatory amino acid agonist at some types of excitatory amino acid receptors and has been used to discriminate among receptor types. Like many excitatory amino acid agonists it can cause neurotoxicity and has been used experimentally for that purpose. | 7.07 | 1 | 0 | dicarboxylic acid; L-proline derivative; non-proteinogenic L-alpha-amino acid; pyrrolidinecarboxylic acid | antinematodal drug; excitatory amino acid agonist |
| phenylpropanolamine Phenylpropanolamine: A sympathomimetic that acts mainly by causing release of NOREPINEPHRINE but also has direct agonist activity at some adrenergic receptors. It is most commonly used as a nasal vasoconstrictor and an appetite depressant.. phenylpropanolamine : An amphetamine in which the parent 1-phenylpropan-2-amine skeleton is substituted at position 1 with an hydroxy group. A decongestant and appetite suppressant, it is commonly used in prescription and over-the-counter cough and cold preparations.. (-)-norephedrine : An amphetamine that is propylbenzene substituted by a hydroxy group at position 1 and by an amino group at position 2 (the 1R,2S-stereoisomer). It is a plant alkaloid. | 3.45 | 1 | 1 | amphetamines; phenethylamine alkaloid | plant metabolite |
| dipicolinic acid dipicolinic acid : A pyridinedicarboxylic acid carrying two carboxy groups at positions 2 and 6. | 2.31 | 1 | 0 | pyridinedicarboxylic acid | bacterial metabolite |
| 4-hydroxybutyric acid 4-hydroxybutyric acid: was an entry term to Sodium Oxybate (74-98). 4-hydroxybutyric acid : A 4-hydroxy monocarboxylic acid that is butyric acid in which one of the hydrogens at position 4 is replaced by a hydroxy group. | 3.23 | 1 | 0 | 4-hydroxy monocarboxylic acid; hydroxybutyric acid | general anaesthetic; GHB receptor agonist; neurotoxin; sedative |
| dihydroergotamine Dihydroergotamine: A 9,10alpha-dihydro derivative of ERGOTAMINE. It is used as a vasoconstrictor, specifically for the therapy of MIGRAINE DISORDERS.. dihydroergotamine : Ergotamine in which a single bond replaces the double bond between positions 9 and 10. A semisynthetic ergot alkaloid with weaker oxytocic and vasoconstrictor properties than ergotamine, it is used (as the methanesulfonic or tartaric acid salts) for the treatment of migraine and orthostatic hypotension. | 3.23 | 1 | 0 | ergot alkaloid; semisynthetic derivative | dopamine agonist; non-narcotic analgesic; serotonergic agonist; sympatholytic agent; vasoconstrictor agent |
| medroxyprogesterone [no description available] | 3.23 | 1 | 0 | 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(4) steroid; tertiary alpha-hydroxy ketone | contraceptive drug; progestin; synthetic oral contraceptive |
| dimenhydrinate gravinol: has antioxidant and ant-inflammatory activities; structure in first source | 3.61 | 2 | 0 | diarylmethane | |
| chlormethiazole Chlormethiazole: A sedative and anticonvulsant often used in the treatment of alcohol withdrawal. Chlormethiazole has also been proposed as a neuroprotective agent. The mechanism of its therapeutic activity is not entirely clear, but it does potentiate GAMMA-AMINOBUTYRIC ACID receptors response and it may also affect glycine receptors. | 2.05 | 1 | 0 | thiazoles | |
| methoxyhydroxyphenylglycol Methoxyhydroxyphenylglycol: Synthesized from endogenous epinephrine and norepinephrine in vivo. It is found in brain, blood, CSF, and urine, where its concentrations are used to measure catecholamine turnover. | 2.03 | 1 | 0 | methoxybenzenes; phenols | |
| methamphetamine Methamphetamine: A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.. methamphetamine : A member of the class of amphetamines in which the amino group of (S)-amphetamine carries a methyl substituent. | 3.23 | 1 | 0 | amphetamines; secondary amine | central nervous system stimulant; environmental contaminant; neurotoxin; psychotropic drug; xenobiotic |
| levocarnitine (R)-carnitine : The (R)-enantiomer of carnitine. | 3.23 | 1 | 0 | carnitine | antilipemic drug; nootropic agent; nutraceutical; Saccharomyces cerevisiae metabolite; water-soluble vitamin (role) |
| ethyl chloroformate [no description available] | 7.07 | 1 | 0 | ||
| malondialdehyde Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form. | 2.57 | 2 | 0 | dialdehyde | biomarker |
| sulfanilylurea sulfanilylurea: antimicrobial agent; structure | 3.23 | 1 | 0 | benzenes; sulfonamide | |
| trinitrobenzenesulfonic acid Trinitrobenzenesulfonic Acid: A reagent that is used to neutralize peptide terminal amino groups.. 2,4,6-trinitrobenzenesulfonic acid : The arenesulfonic acid that is benzenesulfonic acid with three nitro substituents in the 2-, 4- and 6-positions. | 4.31 | 4 | 1 | arenesulfonic acid; C-nitro compound | epitope; explosive; reagent |
| 1-naphthylisothiocyanate 1-Naphthylisothiocyanate: A tool for the study of liver damage which causes bile stasis and hyperbilirubinemia acutely and bile duct hyperplasia and biliary cirrhosis chronically, with changes in hepatocyte function. It may cause skin and kidney damage. | 2.08 | 1 | 0 | isothiocyanate | insecticide |
| lactulose [no description available] | 3.23 | 1 | 0 | glycosylfructose | gastrointestinal drug; laxative |
| megestrol acetate [no description available] | 2.08 | 1 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; steroid ester | antineoplastic agent; appetite enhancer; contraceptive drug; progestin; synthetic oral contraceptive |
| pamabrom [no description available] | 3.23 | 1 | 0 | ||
| acetylcysteine N-acetyl-L-cysteine : An N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine. | 4.54 | 3 | 0 | acetylcysteine; L-cysteine derivative; N-acetyl-L-amino acid | antidote to paracetamol poisoning; antiinfective agent; antioxidant; antiviral drug; ferroptosis inhibitor; geroprotector; human metabolite; mucolytic; radical scavenger; vulnerary |
| 5-methylhexanoic acid [no description available] | 2.17 | 1 | 0 | medium-chain fatty acid | |
| erythromycin Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively. | 10.28 | 3 | 1 | cyclic ketone; erythromycin | |
| hydroxychloroquine sulfate [no description available] | 2.08 | 1 | 0 | ||
| levonorgestrel Levonorgestrel: A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. | 3.61 | 2 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin; synthetic oral contraceptive |
| diphenoxylate Diphenoxylate: A MEPERIDINE congener used as an antidiarrheal, usually in combination with ATROPINE. At high doses, it acts like morphine. Its unesterified metabolite difenoxin has similar properties and is used similarly. It has little or no analgesic activity.. diphenoxylate : A piperidinecarboxylate ester that is the ethyl ester of difenoxin. | 3.23 | 1 | 0 | ethyl ester; nitrile; piperidinecarboxylate ester; tertiary amine | antidiarrhoeal drug |
| deoxycytidine [no description available] | 2.45 | 2 | 0 | pyrimidine 2'-deoxyribonucleoside | Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| ethambutol hydrochloride ethambutol dihydrochloride : The dihydrchloride salt of ethambutol. A bacteriostatic antimycobacterial drug, it is effective against Mycobacterium tuberculosis and some other mycobacteria. It is used in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol dihydrochloride is used alone. | 2.08 | 1 | 0 | hydrochloride | antitubercular agent |
| ethambutol Ethambutol: An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863). ethambutol : An ethylenediamine derivative that is ethane-1,2-diamine in which one hydrogen attached to each of the nitrogens is sutstituted by a 1-hydroxybutan-2-yl group (S,S-configuration). It is a bacteriostatic antimycobacterial drug, effective against Mycobacterium tuberculosis and some other mycobacteria. It is used (as the dihydrochloride salt) in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol is used alone. | 3.23 | 1 | 0 | ethanolamines; ethylenediamine derivative | antitubercular agent; environmental contaminant; xenobiotic |
| antimycin a [no description available] | 2.08 | 1 | 0 | benzamides; formamides; macrodiolide; phenols | antifungal agent; mitochondrial respiratory-chain inhibitor; piscicide |
| vancomycin Vancomycin: Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to RISTOCETIN that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear.. vancomycin : A complex glycopeptide from Streptomyces orientalis. It inhibits a specific step in the synthesis of the peptidoglycan layer in the Gram-positive bacteria Staphylococcus aureus and Clostridium difficile. | 4.2 | 2 | 0 | glycopeptide | antibacterial drug; antimicrobial agent; bacterial metabolite |
| d-alpha tocopherol Vitamin E: A generic descriptor for all TOCOPHEROLS and TOCOTRIENOLS that exhibit ALPHA-TOCOPHEROL activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of ISOPRENOIDS.. tocopherol : A collective name for a group of closely related lipids that contain a chroman-6-ol nucleus substituted at position 2 by a methyl group and by a saturated hydrocarbon chain consisting of three isoprenoid units. They are designated as alpha-, beta-, gamma-, and delta-tocopherol depending on the number and position of additional methyl substituents on the aromatic ring. Tocopherols occur in vegetable oils and vegetable oil products, almost exclusively with R,R,R configuration. Tocotrienols differ from tocopherols only in having three double bonds in the hydrocarbon chain.. vitamin E : Any member of a group of fat-soluble chromanols that exhibit biological activity against vitamin E deficiency. The vitamers in this class consists of a chroman-6-ol core which is substituted at position 2 by a methyl group and (also at position 2) either a saturated or a triply-unsaturated hydrocarbon chain consisting of three isoprenoid units. The major function of vitamin E is to act as a natural antioxidant by scavenging free radicals and molecular oxygen.. (R,R,R)-alpha-tocopherol : An alpha-tocopherol that has R,R,R configuration. The naturally occurring stereoisomer of alpha-tocopherol, it is found particularly in sunflower and olive oils. | 4.34 | 5 | 0 | alpha-tocopherol | algal metabolite; antiatherogenic agent; anticoagulant; antioxidant; antiviral agent; EC 2.7.11.13 (protein kinase C) inhibitor; immunomodulator; micronutrient; nutraceutical; plant metabolite |
| pregnenolone carbonitrile Pregnenolone Carbonitrile: A catatoxic steroid and microsomal enzyme inducer having significant effects on the induction of cytochrome P450. It has also demonstrated the potential for protective capability against acetaminophen-induced liver damage. | 2.08 | 1 | 0 | aliphatic nitrile | |
| ibufenac ibufenac: used in the treatment of rheumatism; also possesses antipyretic properties; minor descriptor (75-84); on-line & Index Medicus search PHENYLACETATES (75-84); RN given refers to parent cpd. ibufenac : A monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is replaced by a 4-isobutylphenyl group. Although it was shown to be effective in treatment of rheumatoid arthritis, the clinical use of ibufenac was discontinued due to hepatotoxic side-effects. | 3.23 | 1 | 0 | monocarboxylic acid | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; hepatotoxic agent; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| metylperon metylperon: RN given refers to parent cpd | 2.08 | 1 | 0 | aromatic ketone | |
| metaxalone [no description available] | 3.23 | 1 | 0 | aromatic ether | |
| spectinomycin Spectinomycin: An antibiotic produced by Streptomyces spectabilis. It is active against gram-negative bacteria and used for the treatment of GONORRHEA.. spectinomycin dihydrochloride : A hydrochloride obtained by combining spectinomycin with two molar equivalents of hydrochloric acid. An antibiotic that is active against gram-negative bacteria and used (as its pentahydrate) to treat gonorrhea.. spectinomycin : A pyranobenzodioxin and antibiotic that is active against gram-negative bacteria and used (as its dihydrochloride pentahydrate) to treat gonorrhea. It is produced by the bacterium Streptomyces spectabilis. | 3.23 | 1 | 0 | cyclic acetal; cyclic hemiketal; cyclic ketone; pyranobenzodioxin; secondary alcohol; secondary amino compound | antibacterial drug; antimicrobial agent; bacterial metabolite |
| s,n,n'-tripropylthiocarbamate Reward: An object or a situation that can serve to reinforce a response, to satisfy a motive, or to afford pleasure.. vernolate : A monounsaturated fatty acid anion that is the conjugate base of vernolic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 4.38 | 5 | 0 | tertiary amine | |
| dronabinol Dronabinol: A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.. Delta(9)-tetrahydrocannabinol : A diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy. | 6.03 | 4 | 1 | benzochromene; diterpenoid; phytocannabinoid; polyketide | cannabinoid receptor agonist; epitope; hallucinogen; metabolite; non-narcotic analgesic |
| amiloride Amiloride: A pyrazine compound inhibiting SODIUM reabsorption through SODIUM CHANNELS in renal EPITHELIAL CELLS. This inhibition creates a negative potential in the luminal membranes of principal cells, located in the distal convoluted tubule and collecting duct. Negative potential reduces secretion of potassium and hydrogen ions. Amiloride is used in conjunction with DIURETICS to spare POTASSIUM loss. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p705). amiloride : A member of the class of pyrazines resulting from the formal monoacylation of guanidine with the carboxy group of 3,5-diamino-6-chloropyrazine-2-carboxylic acid. | 3.23 | 1 | 0 | aromatic amine; guanidines; organochlorine compound; pyrazines | diuretic; sodium channel blocker |
| pimozide Pimozide: A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403). pimozide : A member of the class of benzimidazoles that is 1,3-dihydro-2H-benzimidazol-2-one in which one of the nitrogens is substituted by a piperidin-4-yl group, which in turn is substituted on the nitrogen by a 4,4-bis(p-fluorophenyl)butyl group. | 3.23 | 1 | 0 | benzimidazoles; heteroarylpiperidine; organofluorine compound | antidyskinesia agent; dopaminergic antagonist; first generation antipsychotic; H1-receptor antagonist; serotonergic antagonist |
| dexbrompheniramine dexbrompheniramine : The (pharmacologically active) (S)-(+)-enantiomer of brompheniramine. A histamine H1 receptor antagonist, it is used (commonly as its maleate salt) for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 3.23 | 1 | 0 | brompheniramine | anti-allergic agent; H1-receptor antagonist |
| stavudine Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase | 3.61 | 2 | 0 | dihydrofuran; nucleoside analogue; organic molecular entity | antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| dicloxacillin Dicloxacillin: One of the PENICILLINS which is resistant to PENICILLINASE.. dicloxacillin : A penicillin that is 6-aminopenicillanic acid in which one of the amino hydrogens is replaced by a 3-(2,6-dichlorophenyl)-5-methyl-1,2-oxazol-4-yl]formyl group. | 3.61 | 2 | 0 | dichlorobenzene; penicillin | antibacterial drug |
| megestrol Megestrol: A progestational hormone used most commonly as the acetate ester. As the acetate, it is more potent than progesterone both as a progestagen and as an ovulation inhibitor. It has also been used in the palliative treatment of breast cancer.. megestrol : A 3-oxo Delta(4)-steroid that is pregna-4,6-diene-3,20-dione substituted by a methyl group at position 6 and a hydroxy group at position 17. | 3.23 | 1 | 0 | 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(4) steroid; tertiary alpha-hydroxy ketone | antineoplastic agent; appetite enhancer; contraceptive drug; progestin; synthetic oral contraceptive |
| streptomycin [no description available] | 3.23 | 1 | 0 | antibiotic antifungal drug; antibiotic fungicide; streptomycins | antibacterial drug; antifungal agrochemical; antimicrobial agent; antimicrobial drug; bacterial metabolite; protein synthesis inhibitor |
| cladribine [no description available] | 3.61 | 2 | 0 | organochlorine compound; purine 2'-deoxyribonucleoside | antineoplastic agent; immunosuppressive agent |
| carbenicillin Carbenicillin: Broad-spectrum semisynthetic penicillin derivative used parenterally. It is susceptible to gastric juice and penicillinase and may damage platelet function.. carbenicillin : A penicillin antibiotic having a 6beta-2-carboxy-2-phenylacetamido side-chain. | 3.23 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| metocurine metocurine: from Chinese herb Cyclea hainanensis Mrr | 2.08 | 1 | 0 | isoquinolines | |
| clomacran clomacran: RN given refers to parent cpd; structure | 3.23 | 1 | 0 | acridines | |
| methenamine hippurate methenamine hippurate: both parts of molecule contribute to its antibacterial action | 3.23 | 1 | 0 | N-acylglycine | |
| olsalazine olsalazine: cpd with 2 salicylate molecules linked together by an azo bond. olsalazine : An azobenzene that consists of two molecules of 4-aminosalicylic acid joined by an azo linkage. A prodrug for mesalazine, an anti-inflammatory drug, it is used (as the disodium salt) in the treatment of inflammatory bowel disease. | 3.23 | 1 | 0 | azobenzenes; dicarboxylic acid | non-steroidal anti-inflammatory drug; prodrug |
| n-methylaspartate N-Methylaspartate: An amino acid that, as the D-isomer, is the defining agonist for the NMDA receptor subtype of glutamate receptors (RECEPTORS, NMDA).. N-methyl-D-aspartic acid : An aspartic acid derivative having an N-methyl substituent and D-configuration. | 9.9 | 11 | 0 | amino dicarboxylic acid; D-alpha-amino acid; D-aspartic acid derivative; secondary amino compound | neurotransmitter agent |
| etidronate disodium etidronate disodium : An organic sodium salt resulting from the replacement of two protons from etidronic acid (one from from each of the phosphonic acid groups) by sodium ions. | 2.08 | 1 | 0 | organic sodium salt | antineoplastic agent; bone density conservation agent; chelator |
| palladium Palladium: A chemical element having an atomic weight of 106.4, atomic number of 46, and the symbol Pd. It is a white, ductile metal resembling platinum, and following it in abundance and importance of applications. It is used in dentistry in the form of gold, silver, and copper alloys.. palladium : Chemical element (nickel group element atom) with atomic number 46. | 3.65 | 2 | 0 | metal allergen; nickel group element atom; platinum group metal atom | |
| rhenium Rhenium: A metal, atomic number 75, atomic weight 186.207, symbol Re. | 3.31 | 1 | 0 | manganese group element atom | |
| rhodium Rhodium: A hard and rare metal of the platinum group, atomic number 45, atomic weight 102.905, symbol Rh.. rhodium atom : A cobalt group element atom of atomic number 45. | 2.44 | 2 | 0 | cobalt group element atom | |
| gadolinium Gadolinium: An element of the rare earth family of metals. It has the atomic symbol Gd, atomic number 64, and atomic weight 157.25. Its oxide is used in the control rods of some nuclear reactors. | 2.02 | 1 | 0 | f-block element atom; lanthanoid atom | |
| gold Gold: A yellow metallic element with the atomic symbol Au, atomic number 79, and atomic weight 197. It is used in jewelry, goldplating of other metals, as currency, and in dental restoration. Many of its clinical applications, such as ANTIRHEUMATIC AGENTS, are in the form of its salts. | 7.41 | 1 | 0 | copper group element atom; elemental gold | |
| zirconium Zirconium: A rather rare metallic element with atomic number 40, atomic weight 91.224, and symbol Zr. | 3.31 | 1 | 0 | titanium group element atom | |
| zalcitabine Zalcitabine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication at low concentrations, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal toxic side effect is axonal degeneration resulting in peripheral neuropathy.. zalcitabine : A pyrimidine 2',3'-dideoxyribonucleoside compound having cytosine as the nucleobase. | 2.08 | 1 | 0 | pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| magnesium sulfate Magnesium Sulfate: A small colorless crystal used as an anticonvulsant, a cathartic, and an electrolyte replenisher in the treatment of pre-eclampsia and eclampsia. It causes direct inhibition of action potentials in myometrial muscle cells. Excitation and contraction are uncoupled, which decreases the frequency and force of contractions. (From AMA Drug Evaluations Annual, 1992, p1083). magnesium sulfate : A magnesium salt having sulfate as the counterion. | 13.14 | 6 | 2 | magnesium salt; metal sulfate; organic magnesium salt | anaesthetic; analgesic; anti-arrhythmia drug; anticonvulsant; calcium channel blocker; cardiovascular drug; fertilizer; tocolytic agent |
| camptothecin NSC 100880: carboxylate (opened lactone) form of camptothecin; RN refers to (S)-isomer; structure given in first source | 2.08 | 1 | 0 | delta-lactone; pyranoindolizinoquinoline; quinoline alkaloid; tertiary alcohol | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor; genotoxin; plant metabolite |
| zinc sulfate Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995). zinc sulfate : A metal sulfate compound having zinc(2+) as the counterion. | 2.17 | 1 | 0 | metal sulfate; zinc molecular entity | fertilizer |
| sodium thiosulfate sodium thiosulfate: do not confuse synonym sodium hyposulfite with sodium hyposulfite, synonym for di-Na salt of dithionous acid. sodium thiosulfate : An inorganic sodium salt composed of sodium and thiosulfate ions in a 2:1 ratio. | 3.23 | 1 | 0 | inorganic sodium salt | antidote to cyanide poisoning; antifungal drug; nephroprotective agent |
| fluorine Fluorine: A nonmetallic, diatomic gas that is a trace element and member of the halogen family. It is used in dentistry as fluoride (FLUORIDES) to prevent dental caries. | 2.11 | 1 | 0 | diatomic fluorine; gas molecular entity | NMR chemical shift reference compound |
| radon Radon: A naturally radioactive element with atomic symbol Rn, and atomic number 86. It is a member of the noble gas family found in soil, and is released during the decay of RADIUM.. radon(0) : A monoatomic radon that has an oxidation state of zero. | 7.13 | 1 | 0 | monoatomic radon; noble gas atom; p-block element atom | |
| 4-chloro-7-nitrobenzofurazan 4-Chloro-7-nitrobenzofurazan: A benzofuran derivative used as a protein reagent since the terminal N-NBD-protein conjugate possesses interesting fluorescence and spectral properties. It has also been used as a covalent inhibitor of both beef heart mitochondrial ATPase and bacterial ATPase.. 4-chloro-7-nitrobenzofurazan : A benzoxadiazole that is 2,1,3-benzoxadiazole which is substituted at position 4 by chlorine and at position 7 by a nitro group. | 2.05 | 1 | 0 | benzoxadiazole; C-nitro compound; organochlorine compound | EC 1.4.3.4 (monoamine oxidase) inhibitor; EC 3.6.1.3 (adenosinetriphosphatase) inhibitor; fluorescent probe; fluorochrome |
| trolamine salicylate Arthritis: Acute or chronic inflammation of JOINTS. | 3.51 | 2 | 0 | ||
| mafenide acetate [no description available] | 2.08 | 1 | 0 | carboxylic acid | |
| diacerein diacerein: chelates with bivalent metals; a quinone which possesses redox properties; metabolized to active rhein; proposed mechanisms include inhibiting IL1 and metalloproteinases; called a slow acting symptomatic drug in osteoarthritis; no effect of cyclooxygenase; | 2.08 | 1 | 0 | anthraquinone | |
| selegiline Selegiline: A selective, irreversible inhibitor of Type B monoamine oxidase that is used for the treatment of newly diagnosed patients with PARKINSON DISEASE, and for the treatment of depressive disorders. The compound without isomeric designation is Deprenyl. | 3.23 | 1 | 0 | selegiline; terminal acetylenic compound | geroprotector |
| selegiline hydrochloride, (r)-isomer [no description available] | 2.08 | 1 | 0 | hydrochloride; terminal acetylenic compound | antiparkinson drug; dopaminergic agent; EC 1.4.3.4 (monoamine oxidase) inhibitor |
| clemastine Clemastine: A histamine H1 antagonist used as the hydrogen fumarate in hay fever, rhinitis, allergic skin conditions, and pruritus. It causes drowsiness.. clemastine : 2-[(2R)-1-Methylpyrrolidin-2-yl]ethanol in which the hydrogen of the hydroxy group is substituted by a 1-(4-chlorophenyl)-1-phenylethyl group (R configuration). An antihistamine with antimuscarinic and moderate sedative properties, it is used as its fumarate salt for the symptomatic relief of allergic conditions such as rhinitis, urticaria, conjunctivitis and in pruritic (severe itching) skin conditions. | 3.23 | 1 | 0 | monochlorobenzenes; N-alkylpyrrolidine | anti-allergic agent; antipruritic drug; H1-receptor antagonist; muscarinic antagonist |
| thiamphenicol [no description available] | 2.08 | 1 | 0 | monocarboxylic acid amide; sulfone | antimicrobial agent; immunosuppressive agent |
| pancuronium bromide pancuronium bromide : A bromide salt consisting of two bromide ions and one pancuronium dication. | 2.08 | 1 | 0 | bromide salt | cholinergic antagonist; muscle relaxant; nicotinic antagonist |
| cephalexin Cephalexin: A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.. cephalexin : A semisynthetic first-generation cephalosporin antibiotic having methyl and beta-(2R)-2-amino-2-phenylacetamido groups at the 3- and 7- of the cephem skeleton, respectively. It is effective against both Gram-negative and Gram-positive organisms, and is used for treatment of infections of the skin, respiratory tract and urinary tract. | 3.23 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; semisynthetic derivative | antibacterial drug |
| cromolyn sodium Cromolyn Sodium: A chromone complex that acts by inhibiting the release of chemical mediators from sensitized MAST CELLS. It is used in the prophylactic treatment of both allergic and exercise-induced asthma, but does not affect an established asthmatic attack.. disodium cromoglycate : An organic sodium salt that is the disodium salt of cromoglycic acid. | 5.55 | 2 | 0 | organic sodium salt | anti-asthmatic drug; drug allergen |
| tetradecanoylphorbol acetate Tetradecanoylphorbol Acetate: A phorbol ester found in CROTON OIL with very effective tumor promoting activity. It stimulates the synthesis of both DNA and RNA.. phorbol ester : Esters of phorbol, originally found in croton oil (from Croton tiglium, of the family Euphorbiaceae). A number of phorbol esters possess activity as tumour promoters and activate the mechanisms associated with cell growth. Some of these are used in experiments as activators of protein kinase C.. phorbol 13-acetate 12-myristate : A phorbol ester that is phorbol in which the hydroxy groups at the cyclopropane ring juction (position 13) and the adjacent carbon (position 12) have been converted into the corresponding acetate and myristate esters. It is a major active constituent of the seed oil of Croton tiglium. It has been used as a tumour promoting agent for skin carcinogenesis in rodents and is associated with increased cell proliferation of malignant cells. However its function is controversial since a decrease in cell proliferation has also been observed in several cancer cell types. | 2.07 | 1 | 0 | acetate ester; diester; phorbol ester; tertiary alpha-hydroxy ketone; tetradecanoate ester | antineoplastic agent; apoptosis inducer; carcinogenic agent; mitogen; plant metabolite; protein kinase C agonist; reactive oxygen species generator |
| ornidazole Ornidazole: A nitroimidazole antiprotozoal agent used in ameba and trichomonas infections. It is partially plasma-bound and also has radiation-sensitizing action.. ornidazole : A C-nitro compound that is 5-nitroimidazole in which the hydrogens at positions 1 and 2 are replaced by 3-chloro-2-hydroxypropyl and methyl groups, respectively. It is used in the treatment of susceptible protozoal infections and for the treatment of anaerobic bacterial infections. | 2.08 | 1 | 0 | C-nitro compound; imidazoles; organochlorine compound; secondary alcohol | antiamoebic agent; antibacterial drug; antiinfective agent; antiprotozoal drug; antitrichomonal drug; epitope |
| danazol Danazol: A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders. | 3.61 | 2 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | anti-estrogen; estrogen antagonist; geroprotector |
| fenclozic acid fenclozic acid: an analgesic & antipyretic with anti-inflammatory properties; minor descriptor (75-86); on-line & INDEX MEDICUS search THIAZOLES (75-86); RN given refers to parent cpd | 3.23 | 1 | 0 | ||
| laxagetten 4,4'-diacetoxydiphenylpyridylemethane [no description available] | 3.23 | 1 | 0 | ||
| daunorubicin Daunorubicin: A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of LEUKEMIA and other NEOPLASMS.. anthracycline : Anthracyclines are polyketides that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine.. daunorubicin : A natural product found in Actinomadura roseola. | 3.23 | 1 | 0 | aminoglycoside antibiotic; anthracycline; p-quinones; tetracenequinones | antineoplastic agent; bacterial metabolite |
| fludarabine phosphate fludarabine phosphate: structure given in first source. fludarabine phosphate : A purine arabinonucleoside monophosphate having 2-fluoroadenine as the nucleobase. A prodrug, it is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. Once incorporated into DNA, 2-fluoro-ara-ATP functions as a DNA chain terminator. It is used for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to, or whose disease has progressed during, treatment with at least one standard alkylating-agent containing regimenas. | 3.61 | 2 | 0 | nucleoside analogue; organofluorine compound; purine arabinonucleoside monophosphate | antimetabolite; antineoplastic agent; antiviral agent; DNA synthesis inhibitor; immunosuppressive agent; prodrug |
| alclofenac alclofenac: was heading 1975-94 (was see under PHENYLACETATES 1975-90); use PHENYLACETATES to search ALCLOFENAC 1975-94; an anti-inflammatory agent used in the treatment of rheumatoid arthritis; acts also as an analgesic and an antipyretic. alclofenac : An aromatic ether in which the ether oxygen links an allyl group to the 4-position of (3-chlorophenyl)acetic acid.A non-steroidal anti-inflammatory drug, it was withdrawn from the UK market in 1979 due to concerns with its association with vasculitis and rash. | 3.23 | 1 | 0 | aromatic ether; monocarboxylic acid; monochlorobenzenes | drug allergen; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| bromocriptine Bromocriptine: A semisynthetic ergotamine alkaloid that is a dopamine D2 agonist. It suppresses prolactin secretion. | 3.23 | 1 | 0 | indole alkaloid | antidyskinesia agent; antiparkinson drug; dopamine agonist; hormone antagonist |
| phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid. | 8.11 | 29 | 1 | benzenes; phenyl acetates | |
| oxyphenisatin [no description available] | 3.23 | 1 | 0 | indoles | |
| fludrocortisone Fludrocortisone: A synthetic mineralocorticoid with anti-inflammatory activity. | 3.23 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; fluorinated steroid; mineralocorticoid | adrenergic agent; anti-inflammatory drug |
| ursodeoxycholic acid Ursodeoxycholic Acid: An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.. ursodeoxycholic acid : A bile acid found in the bile of bears (Ursidae) as a conjugate with taurine. Used therapeutically, it prevents the synthesis and absorption of cholesterol and can lead to the dissolution of gallstones.. ursodeoxycholate : A bile acid anion that is the conjugate base of ursodeoxycholic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 4.14 | 2 | 0 | bile acid; C24-steroid; dihydroxy-5beta-cholanic acid | human metabolite; mouse metabolite |
| pregnanolone Pregnanolone: A pregnane found in the urine of pregnant women and sows. It has anesthetic, hypnotic, and sedative properties.. 3alpha-hydroxy-5beta-pregnan-20-one : The 3alpha-stereoisomer of 3-hydroxy-5beta-pregnan-20-one. | 3.13 | 1 | 0 | 3-hydroxy-5beta-pregnan-20-one; 3alpha-hydroxy steroid | human metabolite; intravenous anaesthetic; sedative |
| benzonidazole benzonidazole: used in treatment of Chagas' disease. benznidazole : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of (2-nitroimidazol-1-yl)acetic acid with the aromatic amino group of benzylamine. Used for treatment of Chagas disease. | 2.08 | 1 | 0 | C-nitro compound; imidazoles; monocarboxylic acid amide | antiprotozoal drug |
| transferrin Transferrin: An iron-binding beta1-globulin that is synthesized in the LIVER and secreted into the blood. It plays a central role in the transport of IRON throughout the circulation. A variety of transferrin isoforms exist in humans, including some that are considered markers for specific disease states. | 3.31 | 1 | 0 | ||
| alkenes [no description available] | 2.99 | 4 | 0 | ||
| glutamic acid Glutamic Acid: A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.. glutamic acid : An alpha-amino acid that is glutaric acid bearing a single amino substituent at position 2. | 10.99 | 23 | 2 | glutamic acid; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; ferroptosis inducer; micronutrient; mouse metabolite; neurotransmitter; nutraceutical |
| dexchlorpheniramine dexchlorpheniramine: RN given refers to parent cpd(S)-isomer | 3.23 | 1 | 0 | chlorphenamine | |
| glucaric acid Glucaric Acid: A sugar acid derived from D-glucose in which both the aldehydic carbon atom and the carbon atom bearing the primary hydroxyl group are oxidized to carboxylic acid groups.. D-glucaric acid : The D-enantiomer of glucaric acid.. glucaric acid : A hexaric acid derived by oxidation of sugar such as glucose with nitric acid. | 3.31 | 1 | 0 | glucaric acid | antineoplastic agent |
| clometacin clometacin: structure | 3.23 | 1 | 0 | N-acylindole | |
| cefazolin Cefazolin: A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.. cefazolin : A first-generation cephalosporin compound having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups at positions 3 and 7 respectively. | 3.23 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; tetrazoles; thiadiazoles | antibacterial drug |
| adenosine diphosphate ribose Adenosine Diphosphate Ribose: An ester formed between the aldehydic carbon of RIBOSE and the terminal phosphate of ADENOSINE DIPHOSPHATE. It is produced by the hydrolysis of nicotinamide-adenine dinucleotide (NAD) by a variety of enzymes, some of which transfer an ADP-ribosyl group to target proteins. | 2.41 | 1 | 0 | ADP-sugar | Escherichia coli metabolite; mouse metabolite |
| amoxicillin Amoxicillin: A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.. amoxicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. | 4.43 | 3 | 0 | penicillin allergen; penicillin | antibacterial drug |
| timolol (S)-timolol (anhydrous) : The (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine. | 3.61 | 2 | 0 | timolol | anti-arrhythmia drug; antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist |
| indoramin Indoramin: An alpha-1 adrenergic antagonist that is commonly used as an antihypertensive agent. | 2.08 | 1 | 0 | tryptamines | |
| tramadol Tramadol: A narcotic analgesic proposed for severe pain. It may be habituating.. tramadol : A racemate consisting of equal amounts of (R,R)- and (S,S)-tramadol. A centrally acting synthetic opioid analgesic, used (as the hydrochloride salt) to treat moderately severe pain. The (R,R)-enantiomer exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. Originally developed by Gruenenthal GmbH and launched in 1977, it was subsequently isolated from the root bark of the South African tree Nauclea latifolia.. (R,R)-tramadol : A 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol in which both stereocentres have R-configuration; the (R,R)-enantiomer of the racemic opioid analgesic tramadol, it exhibits ten-fold higher analgesic potency than the (S,S)-enantiomer. | 15.6 | 58 | 4 | 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol | adrenergic uptake inhibitor; antitussive; capsaicin receptor antagonist; delta-opioid receptor agonist; kappa-opioid receptor agonist; metabolite; mu-opioid receptor agonist; muscarinic antagonist; nicotinic antagonist; NMDA receptor antagonist; opioid analgesic; serotonergic antagonist; serotonin uptake inhibitor |
| oxcarbazepine Oxcarbazepine: A carbamazepine derivative that acts as a voltage-gated sodium channel blocker. It is used for the treatment of PARTIAL SEIZURES with or without secondary generalization. It is also an inducer of CYTOCHROME P-450 CYP3A4.. oxcarbazepine : A dibenzoazepine derivative, having a carbamoyl group at the ring nitrogen, substituted with an oxo group at C-4 of the azepeine ring which is also hydrogenated at C-4 and C-5. It is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. | 10.35 | 25 | 2 | cyclic ketone; dibenzoazepine | anticonvulsant; drug allergen |
| carbidopa carbidopa (anhydrous) : 3-(3,4-Dihydroxyphenyl)propanoic acid in which the hydrogens alpha- to the carboxyl group are substituted by hydrazinyl and methyl groups (S-configuration). Carbidopa is a dopa decarboxylase inhibitor, so prevents conversion of levodopa to dopamine. It has no antiparkinson activity by itself, but is used (commonly as its hydrate) in the management of Parkinson's disease to reduce peripheral adverse effects of levodopa. | 3.61 | 2 | 0 | catechols; hydrazines; monocarboxylic acid | antiparkinson drug; dopaminergic agent; EC 4.1.1.28 (aromatic-L-amino-acid decarboxylase) inhibitor |
| moricizine Moricizine: An antiarrhythmia agent used primarily for ventricular rhythm disturbances.. moricizine : A phenothiazine substituted on the nitrogen by a 3-(morpholin-4-yl)propanoyl group, and at position 2 by an (ethoxycarbonyl)amino group. | 3.23 | 1 | 0 | carbamate ester; morpholines; phenothiazines | anti-arrhythmia drug |
| amineptin amineptin: used in treatment of neuroses with psychoasthenic, anxio-phobic & depressive manifestations; synonym S 1694 refers to HCl; structure. amineptine : A carbocyclic fatty acid that is 5-aminoheptanoic acid in which one of the hydrogens attached to the nitrogen is replaced by a 10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-yl group. A tricyclic antidepressant, it was never approved in the US and was withdrawn from the French market in 1999 due to concerns over abuse, dependence and severe acne. | 3.23 | 1 | 0 | amino acid; carbocyclic fatty acid; carbotricyclic compound; secondary amino compound | antidepressant; dopamine uptake inhibitor |
| zidovudine Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase. | 4.41 | 3 | 0 | azide; pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| feprazone Feprazone: A pyrazole that has analgesic, anti-inflammatory, and antipyretic properties. It has been used in mild to moderate pain, fever, and inflammation associated with musculoskeletal and joint disorders. (From Martindale, The Extra Pharmacopoeia, 30th ed, p15) | 2.08 | 1 | 0 | organic molecular entity | |
| pirprofen pirprofen: anti-inflammatory agent used in therapy of rheumatoid arthritis; prostaglandin synthetase inhibitor; more potent than indomethacin; structure | 3.23 | 1 | 0 | pyrroline | |
| tobramycin Tobramycin: An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.. tobramycin : A amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. | 2.08 | 1 | 0 | amino cyclitol glycoside | antibacterial agent; antimicrobial agent; toxin |
| paclitaxel Taxus: Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL). | 7.7 | 14 | 2 | taxane diterpenoid; tetracyclic diterpenoid | antineoplastic agent; human metabolite; metabolite; microtubule-stabilising agent |
| etoposide [no description available] | 3.61 | 2 | 0 | beta-D-glucoside; furonaphthodioxole; organic heterotetracyclic compound | antineoplastic agent; DNA synthesis inhibitor |
| substance p [no description available] | 5.44 | 5 | 1 | peptide | neurokinin-1 receptor agonist; neurotransmitter; vasodilator agent |
| dobutamine Dobutamine: A catecholamine derivative with specificity for BETA-1 ADRENERGIC RECEPTORS. It is commonly used as a cardiotonic agent after CARDIAC SURGERY and during DOBUTAMINE STRESS ECHOCARDIOGRAPHY.. dobutamine : A catecholamine that is 4-(3-aminobutyl)phenol in which one of the hydrogens attached to the nitrogen is substituted by a 2-(3,4-dihydroxyphenyl)ethyl group. A beta1-adrenergic receptor agonist that has cardiac stimulant action without evoking vasoconstriction or tachycardia, it is used as the hydrochloride to increase the contractility of the heart in the management of acute heart failure. | 3.23 | 1 | 0 | catecholamine; secondary amine | beta-adrenergic agonist; cardiotonic drug; sympathomimetic agent |
| penbutolol Penbutolol: A nonselective beta-blocker used as an antihypertensive and an antianginal agent. | 3.23 | 1 | 0 | ethanolamines | |
| ribavirin Rebetron: Rebetron is tradename | 3.61 | 2 | 0 | 1-ribosyltriazole; aromatic amide; monocarboxylic acid amide; primary carboxamide | anticoronaviral agent; antiinfective agent; antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| amikacin Amikacin: A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.. amikacin : An amino cyclitol glycoside that is kanamycin A acylated at the N-1 position by a 4-amino-2-hydroxybutyryl group. | 3.61 | 2 | 0 | alpha-D-glucoside; amino cyclitol glycoside; aminoglycoside; carboxamide | antibacterial drug; antimicrobial agent; nephrotoxin |
| phorbol 12,13-dibutyrate Phorbol 12,13-Dibutyrate: A phorbol ester found in CROTON OIL which, in addition to being a potent skin tumor promoter, is also an effective activator of calcium-activated, phospholipid-dependent protein kinase (protein kinase C). Due to its activation of this enzyme, phorbol 12,13-dibutyrate profoundly affects many different biological systems. | 2.01 | 1 | 0 | butyrate ester; phorbol ester; tertiary alpha-hydroxy ketone | |
| fluorescamine Fluorescamine: A nonfluorescent reagent for the detection of primary amines, peptides and proteins. The reaction products are highly fluorescent. | 2.08 | 1 | 0 | ||
| cephradine Cephradine: A semi-synthetic cephalosporin antibiotic.. cephradine : A first-generation cephalosporin antibiotic with a methyl substituent at position 3, and a (2R)-2-amino-2-cyclohexa-1,4-dien-1-ylacetamido substituent at position 7, of the cephem skeleton. | 3.23 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin | antibacterial drug |
| ticrynafen Ticrynafen: A novel diuretic with uricosuric action. It has been proposed as an antihypertensive agent.. tienilic acid : An aromatic ketone that is 2,3-dichlorophenoxyacetic acid in which the hydrogen at position 4 on the benzene ring is replaced by a thiophenecarbonyl group. A loop diuretic used to treat hypertension, it was withdrawn from the market in 1982 due to links with hepatitis. | 3.23 | 1 | 0 | aromatic ether; aromatic ketone; dichlorobenzene; monocarboxylic acid; thiophenes | antihypertensive agent; hepatotoxic agent; loop diuretic |
| methyldopa Methyldopa: An alpha-2 adrenergic agonist that has both central and peripheral nervous system effects. Its primary clinical use is as an antihypertensive agent.. alpha-methyl-L-dopa : A derivative of L-tyrosine having a methyl group at the alpha-position and an additional hydroxy group at the 3-position on the phenyl ring. | 3.23 | 1 | 0 | L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | alpha-adrenergic agonist; antihypertensive agent; hapten; peripheral nervous system drug; sympatholytic agent |
| diltiazem Diltiazem: A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.. diltiazem : A 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate in which both stereocentres have S configuration. A calcium-channel blocker and vasodilator, it is used as the hydrochloride in the management of angina pectoris and hypertension. | 3.61 | 2 | 0 | 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate | antihypertensive agent; calcium channel blocker; vasodilator agent |
| vecuronium bromide Vecuronium Bromide: Monoquaternary homolog of PANCURONIUM. A non-depolarizing neuromuscular blocking agent with shorter duration of action than pancuronium. Its lack of significant cardiovascular effects and lack of dependence on good kidney function for elimination as well as its short duration of action and easy reversibility provide advantages over, or alternatives to, other established neuromuscular blocking agents.. vecuronium bromide : The organic bromide salt of a 5alpha-androstane compound having 3alpha-acetoxy-, 17beta-acetoxy-, 2beta-piperidinino- and 16beta-N-methylpiperidinium substituents. | 2.08 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent; nicotinic antagonist |
| vecuronium vecuronium : A 5alpha-androstane compound having 3alpha-acetoxy-, 17beta-acetoxy-, 2beta-piperidino- and 16beta-N-methylpiperidinium substituents. | 3.23 | 1 | 0 | acetate ester; androstane; quaternary ammonium ion | drug allergen; muscle relaxant; neuromuscular agent; nicotinic antagonist |
| ng-nitroarginine methyl ester NG-Nitroarginine Methyl Ester: A non-selective inhibitor of nitric oxide synthase. It has been used experimentally to induce hypertension. | 2.11 | 1 | 0 | alpha-amino acid ester; L-arginine derivative; methyl ester; N-nitro compound | EC 1.14.13.39 (nitric oxide synthase) inhibitor |
| benoxaprofen benoxaprofen: RN given refers to parent cpd; structure. benoxaprofen : A monocarboxylic acid that is propionic acid substituted at position 2 by a 2-(4-chlorophenyl)-1,3-benzoxazol-5-yl group. It was used as a non-steroidal anti-inflammatory drug until 1982 when it was withdrawn from the market due to adverse side-effects including liver necrosis, photosensitivity, and carcinogenicity in animals. | 3.23 | 1 | 0 | 1,3-benzoxazoles; monocarboxylic acid; monochlorobenzenes | antipsoriatic; antipyretic; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; hepatotoxic agent; nephrotoxin; non-narcotic analgesic; non-steroidal anti-inflammatory drug; protein kinase C agonist |
| exifone [no description available] | 3.23 | 1 | 0 | benzophenones | |
| mefloquine (-)-(11S,2'R)-erythro-mefloquine : An optically active form of [2,8-bis(trifluoromethyl)quinolin-4-yl]-(2-piperidyl)methanol having (-)-(11S,2'R)-erythro-configuration. An antimalarial agent, used in racemic form, which acts as a blood schizonticide; its mechanism of action is unknown. | 3.23 | 1 | 0 | [2,8-bis(trifluoromethyl)quinolin-4-yl]-(2-piperidyl)methanol | antimalarial |
| nitazoxanide nitazoxanide: a 5-nitrothiazolyl derivative used for a broad range of intestinal parasitic infections including CRYPTOSPORIDIUM and GIARDIA; it is a redox-active nitrothiazolyl-salicylamide prodrug | 3.94 | 3 | 0 | benzamides; carboxylic ester | |
| sufentanil Sufentanil: An opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent.. sufentanil : An anilide resulting from the formal condensation of the aryl amino group of 4-(methoxymethyl)-N-phenyl-1-[2-(2-thienyl)ethyl]piperidin-4-amine with propanoic acid. | 11.52 | 4 | 3 | anilide; ether; piperidines; thiophenes | anaesthesia adjuvant; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic |
| acarbose [no description available] | 3.61 | 2 | 0 | tetrasaccharide derivative | EC 3.2.1.1 (alpha-amylase) inhibitor; EC 3.2.1.20 (alpha-glucosidase) inhibitor; geroprotector; hypoglycemic agent |
| torsemide Torsemide: A pyridine and sulfonamide derivative that acts as a sodium-potassium chloride symporter inhibitor (loop diuretic). It is used for the treatment of EDEMA associated with CONGESTIVE HEART FAILURE; CHRONIC RENAL INSUFFICIENCY; and LIVER DISEASES. It is also used for the management of HYPERTENSION.. torasemide : An N-sulfonylurea obtained by formal condensation of [(3-methylphenyl)amino]pyridine-3-sulfonic acid with the free amino group of N-isopropylurea. It is a potent loop diuretic used for the treatment of hypertension and edema in patients with congestive heart failure. | 3.23 | 1 | 0 | aminopyridine; N-sulfonylurea; secondary amino compound | antihypertensive agent; loop diuretic |
| epirubicin Epirubicin: An anthracycline which is the 4'-epi-isomer of doxorubicin. The compound exerts its antitumor effects by interference with the synthesis and function of DNA. | 3.59 | 2 | 0 | aminoglycoside; anthracycline antibiotic; anthracycline; deoxy hexoside; monosaccharide derivative; p-quinones; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | antimicrobial agent; antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
| lorcainide [no description available] | 2.08 | 1 | 0 | acetamides | |
| idarubicin Idarubicin: An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA. | 3.23 | 1 | 0 | anthracycline antibiotic; deoxy hexoside; monosaccharide derivative | |
| propiconazole Orbit: Bony cavity that holds the eyeball and its associated tissues and appendages. | 2.5 | 2 | 0 | conazole fungicide; cyclic ketal; dichlorobenzene; triazole fungicide; triazoles | antifungal agrochemical; EC 1.14.13.70 (sterol 14alpha-demethylase) inhibitor; environmental contaminant; xenobiotic |
| piperacillin Piperacillin: Semisynthetic, broad-spectrum, AMPICILLIN derived ureidopenicillin antibiotic proposed for PSEUDOMONAS infections. It is also used in combination with other antibiotics.. piperacillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-[(4-ethyl-2,3-dioxopiperazin-1-yl)carboxamido]-2-phenylacetamido group. | 3.23 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| paroxetine Paroxetine: A serotonin uptake inhibitor that is effective in the treatment of depression.. paroxetine : A benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo. | 8.9 | 8 | 2 | aromatic ether; benzodioxoles; organofluorine compound; piperidines | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
| captopril Captopril: A potent and specific inhibitor of PEPTIDYL-DIPEPTIDASE A. It blocks the conversion of ANGIOTENSIN I to ANGIOTENSIN II, a vasoconstrictor and important regulator of arterial blood pressure. Captopril acts to suppress the RENIN-ANGIOTENSIN SYSTEM and inhibits pressure responses to exogenous angiotensin.. captopril : A L-proline derivative in which L-proline is substituted on nitrogen with a (2S)-2-methyl-3-sulfanylpropanoyl group. It is used as an anti-hypertensive ACE inhibitor drug. | 8.92 | 3 | 0 | alkanethiol; L-proline derivative; N-acylpyrrolidine; pyrrolidinemonocarboxylic acid | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| cefoperazone Cefoperazone: Semisynthetic broad-spectrum cephalosporin with a tetrazolyl moiety that is resistant to beta-lactamase. It may be used to treat Pseudomonas infections.. cefoperazone : A semi-synthetic parenteral cephalosporin with a tetrazolyl moiety that confers beta-lactamase resistance. | 3.23 | 1 | 0 | cephalosporin | antibacterial drug |
| staurosporine [no description available] | 2.08 | 1 | 0 | indolocarbazole alkaloid; organic heterooctacyclic compound | apoptosis inducer; bacterial metabolite; EC 2.7.11.13 (protein kinase C) inhibitor; geroprotector |
| foscarnet sodium trisodium phosphonoformate : The trisodium salt of phosphonoformic acid. It is used as an antiviral agent in the treatment of cytomegalovirus retinitis (CMV retinitis, an inflamation of the retina that can lead to blindness) and as an alternative to ganciclovir for AIDS patients who require concurrent antiretroviral therapy but are unable to tolerate ganciclovir due to haematological toxicity. | 2.08 | 1 | 0 | one-carbon compound; organic sodium salt | antiviral drug |
| atracurium Atracurium: A non-depolarizing neuromuscular blocking agent with short duration of action. Its lack of significant cardiovascular effects and its lack of dependence on good kidney function for elimination provide clinical advantage over alternate non-depolarizing neuromuscular blocking agents.. atracurium : A diester compound consisting of pentane-1,5-diol with both hydroxyls bearing 3-[1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-3,4-dihydroisoquinolinium-2(1H)-yl]propanoyl groups. | 3.23 | 1 | 0 | diester; quaternary ammonium ion | muscle relaxant; nicotinic antagonist |
| atracurium besylate atracurium besylate : The bisbenzenesulfonate salt of atracurium. | 2.08 | 1 | 0 | organosulfonate salt; quaternary ammonium salt | muscle relaxant; nicotinic antagonist |
| nicorandil Nicorandil: A derivative of the NIACINAMIDE that is structurally combined with an organic nitrate. It is a potassium-channel opener that causes vasodilatation of arterioles and large coronary arteries. Its nitrate-like properties produce venous vasodilation through stimulation of guanylate cyclase.. nicorandil : A pyrimidinecarboxamide that is nicotinamide in which one of the hydrogens attached to the carboxamide nitrogen is replaced by a 2-(nitrooxy)ethyl group. It has both nitrate-like and ATP-sensitive potassium channel activator properties, and is used for the prevention and treatment of angina pectoris. | 2.08 | 1 | 0 | nitrate ester; pyridinecarboxamide | potassium channel opener; vasodilator agent |
| pergolide Pergolide: A long-acting dopamine agonist which has been used to treat PARKINSON DISEASE and HYPERPROLACTINEMIA but withdrawn from some markets due to potential for HEART VALVE DISEASES.. pergolide : A diamine that is ergoline in which the beta-hydrogen at position 8 is replaced by a (methylthio)methyl group and the hydrogen attached to the piperidine nitrogen (position 6) is replaced by a propyl group. A dopamine D2 receptor agonist which also has D1 and D2 agonist properties, it is used as the mesylate salt in the management of Parkinson's disease, although it was withdrawn from the U.S. and Canadian markets in 2007 due to an increased risk of cardiac valve dysfunction. | 3.23 | 1 | 0 | diamine; methyl sulfide; organic heterotetracyclic compound | antiparkinson drug; dopamine agonist |
| pergolide mesylate pergolide mesylate : A methanesulfonate salt obtained from pergolide by mixing eqimolar amount of pergolide and methanesulfonic acid. A dopamine D2 receptor agonist which also has D1 and D2 agonist properties, it is used in the management of Parkinson's disease, although it was withdrawn from the U.S. and Canadian markets in 2007 due to an increased risk of cardiac valve dysfunction. | 2.08 | 1 | 0 | methanesulfonate salt | antiparkinson drug; dopamine agonist; geroprotector |
| cefadroxil anhydrous Cefadroxil: Long-acting, broad-spectrum, water-soluble, CEPHALEXIN derivative.. cefadroxil : A cephalosporin bearing methyl and (2R)-2-amino-2-(4-hydroxyphenyl)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 3.61 | 2 | 0 | cephalosporin | antibacterial drug |
| talniflumate talniflumate: an anti-inflammatory molecule for the treatment of cystic fibrosis, chronic obstructive pulmonary disease and asthma | 2.08 | 1 | 0 | benzofurans | |
| fenoldopam mesylate [no description available] | 2.08 | 1 | 0 | benzazepine | |
| fialuridine [no description available] | 3.23 | 1 | 0 | ||
| cefaclor anhydrous Cefaclor: Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.. cefaclor : A cephalosporin bearing chloro and (R)-2-amino-2-phenylacetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 3.61 | 2 | 0 | cephalosporin | antibacterial drug; drug allergen |
| pefloxacin Pefloxacin: A synthetic broad-spectrum fluoroquinolone antibacterial agent active against most gram-negative and gram-positive bacteria.. pefloxacin : A quinolone that is 4-oxo-1,4-dihydroquinoline which is substituted at positions 1, 3, 6 and 7 by ethyl, carboxy, fluorine, and 4-methylpiperazin-1-yl groups, respectively. | 2.08 | 1 | 0 | fluoroquinolone antibiotic; monocarboxylic acid; N-alkylpiperazine; N-arylpiperazine; quinolone antibiotic; quinolone | antibacterial drug; antiinfective agent; DNA synthesis inhibitor |
| alfentanil Alfentanil: A short-acting opioid anesthetic and analgesic derivative of FENTANYL. It produces an early peak analgesic effect and fast recovery of consciousness. Alfentanil is effective as an anesthetic during surgery, for supplementation of analgesia during surgical procedures, and as an analgesic for critically ill patients.. alfentanil : A member of the class of piperidines that is piperidine having a 2-(4-ethyl-5-oxo-4,5-dihydro-1H-tetrazol-1-yl)ethyl group at the 1-position as well as N-phenylpropanamido- and methoxymethyl groups at the 4-position. | 10.08 | 2 | 1 | monocarboxylic acid amide; piperidines | central nervous system depressant; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic; peripheral nervous system drug |
| fomesafen fomesafen: a protoporphyrinogen oxidase-inhibiting herbicide. fomesafen : An N-sulfonylcarboxamide that is N-(methylsulfonyl)benzamide in which the phenyl ring is substituted by a nitro group at position 2 and a 2-chloro-4-(trifluoromethyl)phenoxy group at position 5. A protoporphyrinogen oxidase inhibitor, it was specially developed for use (generally as the corresponding sodium salt, fomesafen-sodium) for post-emergence control of broad-leaf weeds in soya. | 2.43 | 2 | 0 | aromatic ether; C-nitro compound; monochlorobenzenes; N-sulfonylcarboxamide; organofluorine compound; phenols | agrochemical; EC 1.3.3.4 (protoporphyrinogen oxidase) inhibitor; herbicide |
| miglustat miglustat: a glucosylceramide synthase inhibitor. miglustat : A hydroxypiperidine that is deoxynojirimycin in which the amino hydrogen is replaced by a butyl group. | 3.23 | 1 | 0 | piperidines; tertiary amino compound | anti-HIV agent; EC 2.4.1.80 (ceramide glucosyltransferase) inhibitor |
| haloperidol decanoate [no description available] | 3.23 | 1 | 0 | organic molecular entity | |
| cefotetan Cefotetan: A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.. cefotetan : A semi-synthetic second-generation cephamycin antibiotic with [(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl, methoxy and {[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl}amino groups at the 3, 7alpha, and 7beta positions, respectively, of the cephem skeleton. It is resistant to a wide range of beta-lactamases and is active against a broad spectrum of aerobic and anaerobic Gram-positive and Gram-negative microorganisms. | 3.61 | 2 | 0 | ||
| lovastatin Lovastatin: A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.. lovastatin : A fatty acid ester that is mevastatin carrying an additional methyl group on the carbobicyclic skeleton. It is used in as an anticholesteremic drug and has been found in fungal species such as Aspergillus terreus and Pleurotus ostreatus (oyster mushroom). | 3.61 | 2 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; polyketide; statin (naturally occurring) | anticholesteremic drug; antineoplastic agent; Aspergillus metabolite; prodrug |
| flupirtine flupirtine: RN given refers to parent cpd without isomeric designation | 2.58 | 2 | 0 | aminopyridine | |
| tolrestat tolrestat: RN & structure given in first source | 3.23 | 1 | 0 | naphthalenes | EC 1.1.1.21 (aldehyde reductase) inhibitor |
| enoximone Enoximone: A selective phosphodiesterase inhibitor with vasodilating and positive inotropic activity that does not cause changes in myocardial oxygen consumption. It is used in patients with CONGESTIVE HEART FAILURE. | 2.08 | 1 | 0 | aromatic ketone | |
| stepronin [no description available] | 2.08 | 1 | 0 | N-acyl-amino acid | |
| simvastatin Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug. | 3.93 | 3 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; statin (semi-synthetic) | EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; ferroptosis inducer; geroprotector; prodrug |
| idazoxan Idazoxan: A benzodioxane-linked imidazole that has alpha-2 adrenoceptor antagonist activity.. idazoxan : A benzodioxine that is 2,3-dihydro-1,4-benzodioxine in which one of the hydrogens at position 2 has been replaced by a 4,5-dihydro-1H-imidazol-2-yl group. | 2.08 | 1 | 0 | benzodioxine; imidazolines | alpha-adrenergic antagonist |
| remoxipride Remoxipride: An antipsychotic agent that is specific for dopamine D2 receptors. It has been shown to be effective in the treatment of schizophrenia. | 2.08 | 1 | 0 | dimethoxybenzene | |
| balsalazide balsalazide: a mesalamine 5-aminosalicylate prodrug; 99% of ingested drug remains intact through the stomach and is delivered to and activated in the colon; used for inflammatory bowel disease, ulcerative colitis and radiation-induced proctosigmoiditis but avoided in patients with known hypersensitivity reaction to salicylates or mesalamine; structure in first source. balsalazide : A monohydroxybenzoic acid consisting of 5-aminosalicylic acid (mesalazine) linked to 4-aminobenzoyl-beta-alanine via an azo bond. | 3.23 | 1 | 0 | ||
| pravastatin Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin. | 3.23 | 1 | 0 | 3-hydroxy carboxylic acid; carbobicyclic compound; carboxylic ester; hydroxy monocarboxylic acid; secondary alcohol; statin (semi-synthetic) | anticholesteremic drug; environmental contaminant; metabolite; xenobiotic |
| cabergoline Cabergoline: An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE.. cabergoline : An N-acylurea that is (8R)-ergoline-8-carboxamide in which the hydrogen attached to the piperidine nitrogen (position 6) is substituted by an allyl group and the hydrogens attached to the carboxamide nitrogen are substituted by a 3-(dimethylamino)propyl group and an N-ethylcarbamoyl group. A dopamine D2 receptor agonist, cabergoline is used in the management of Parkinson's disease and of disorders associated with hyperprolactinaemia. | 3.61 | 2 | 0 | N-acylurea | antineoplastic agent; antiparkinson drug; dopamine agonist |
| atomoxetine hydrochloride Atomoxetine Hydrochloride: A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.. atomoxetine hydrochloride : The hydrochloride salt of atomoxetine. | 2.08 | 1 | 0 | hydrochloride | adrenergic uptake inhibitor; antidepressant |
| atomoxetine atomoxetine : A secondary amino compound having methyl and 3-(2-methylphenoxy)-3-phenylpropan-1-yl substituents. | 3.23 | 1 | 0 | aromatic ether; secondary amino compound; toluenes | adrenergic uptake inhibitor; antidepressant; environmental contaminant; xenobiotic |
| quinapril Quinapril: A tetrahydroisoquinoline derivative and ANGIOTENSIN CONVERTING ENZYME inhibitor that is used in the treatment of HYPERTENSION and HEART FAILURE.. quinapril : A member of the class of isoquinolines that is (3S)-2-L-alanyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid in which the alpha-amino group of the alanyl residue has been substituted by a 1-ethoxycarbonyl-4-phenylbutan-2-yl group (the all-S isomer). A prodrug for quinaprilat (by hydrolysis of the ethyl ester to the corresponding carboxylic acid), it is used as an angiotensin-converting enzyme inhibitor (ACE inhibitor) used (generally as the hydrochloride salt) for the treatment of hypertension and congestive heart failure. | 3.61 | 2 | 0 | dicarboxylic acid monoester; ethyl ester; isoquinolines; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| alpidem [no description available] | 5.08 | 2 | 0 | imidazoles | |
| mifepristone Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME. | 7.21 | 5 | 0 | 3-oxo-Delta(4) steroid; acetylenic compound; tertiary amino compound | abortifacient; contraceptive drug; hormone antagonist; synthetic oral contraceptive |
| itraconazole Itraconazole: A triazole antifungal agent that inhibits cytochrome P-450-dependent enzymes required for ERGOSTEROL synthesis.. itraconazole : An N-arylpiperazine that is cis-ketoconazole in which the imidazol-1-yl group is replaced by a 1,2,4-triazol-1-yl group and in which the actyl group attached to the piperazine moiety is replaced by a p-[(+-)1-sec-butyl-5-oxo-1,5-dihydro-4H-1,2,4-triazol-4-yl]phenyl group. A potent P-glycoprotein and CYP3A4 inhibitor, it is used as an antifungal drug for the treatment of various fungal infections, including aspergillosis, blastomycosis, candidiasis, chromoblastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, and sporotrichosis. | 2.21 | 1 | 0 | aromatic ether; conazole antifungal drug; cyclic ketal; dichlorobenzene; dioxolane; N-arylpiperazine; triazole antifungal drug; triazoles | EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor; Hedgehog signaling pathway inhibitor; P450 inhibitor |
| fosphenytoin fosphenytoin: structure given in first & second source | 3.23 | 1 | 0 | imidazolidine-2,4-dione | |
| salmeterol xinafoate Salmeterol Xinafoate: A selective ADRENERGIC BETA-2 RECEPTOR agonist that functions as a BRONCHODILATOR when administered by inhalation. It is used to manage the symptoms of ASTHMA and CHRONIC OBSTRUCTIVE PULMONARY DISEASE. | 2.08 | 1 | 0 | naphthoic acid | |
| ranolazine Ranolazine: An acetanilide and piperazine derivative that functions as a SODIUM CHANNEL BLOCKER and prevents the release of enzymes during MYOCARDIAL ISCHEMIA. It is used in the treatment of ANGINA PECTORIS.. N-(2,6-dimethylphenyl)-2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetamide : An aromatic amide obtained by formal condensation of the carboxy group of 2-{4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl}acetic acid with the amino group of 2,6-dimethylaniline.. ranolazine : A racemate comprising equal amounts of (R)- and (S)-ranolazine. Used for treatment of chronic angina. | 3.23 | 1 | 0 | aromatic amide; monocarboxylic acid amide; monomethoxybenzene; N-alkylpiperazine; secondary alcohol | |
| fura-2 Fura-2: A fluorescent calcium chelating agent which is used to study intracellular calcium in tissues. | 2.02 | 1 | 0 | ||
| finasteride Finasteride: An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.. finasteride : An aza-steroid that is a synthetic drug for the treatment of benign prostatic hyperplasia. | 3.61 | 2 | 0 | 3-oxo steroid; aza-steroid; delta-lactam | androgen antagonist; antihyperplasia drug; EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor |
| imiquimod Imiquimod: A topically-applied aminoquinoline immune modulator that induces interferon production. It is used in the treatment of external genital and perianal warts, superficial CARCINOMA, BASAL CELL; and ACTINIC KERATOSIS.. imiquimod : An imidazoquinoline fused [4,5-c] carrying isobutyl and amino substituents at N-1 and C-4 respectively. A prescription medication, it acts as an immune response modifier and is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis. | 2.08 | 1 | 0 | imidazoquinoline | antineoplastic agent; interferon inducer |
| n 0437, (-)-isomer rotigotine: Antiparkinson Agent and dopamine receptor agonist; structure given in first source; RN given refers to cpd without isomeric designation | 4.77 | 3 | 0 | tetralins | |
| esmolol methyl 3-{4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl}propanoate : A methyl ester that is methyl 3-(4-hydroxyphenyl)propanoate in which the hydrogen attached to the phenolic hydroxy group is substituted by a 2-hydroxy-3-(isopropylamino)propyl group.. esmolol : A racemate comprising equimolar amounts of (R)- and (S)-esmolol. A cardioselective and short-acting beta1 receptor blocker with rapid onset but lacking intrinsic sympathomimetic and membrane-stabilising properties, it is used as the hydrochloride salt in the management of supraventricular arrhythmias, and for the control of hypertension and tachycardia during surgery. While the S enantiomer possesses all of the heart rate control, both enantiomers contribute to lowering blood pressure. | 3.23 | 1 | 0 | aromatic ether; ethanolamines; methyl ester; secondary alcohol; secondary amino compound | |
| sertindole sertindole : A phenylindole that is 1H-indole which is substituted on the nitrogen by a p-chlorophenyl group, at position 5 by chlorine, and at position 3 by a piperidin-4-yl group, which is itself substituted on the nitrogen by a 2-(2-oxoimidazolidin-1-yl)ethyl group. | 2.08 | 1 | 0 | heteroarylpiperidine; imidazolidinone; organochlorine compound; organofluorine compound; phenylindole | alpha-adrenergic antagonist; H1-receptor antagonist; second generation antipsychotic; serotonergic antagonist |
| adapalene Adapalene: A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.. adapalene : A naphthoic acid that is CD437 in which the phenolic hydroxy group has been converted to its methyl ether. | 2.08 | 1 | 0 | adamantanes; monocarboxylic acid; naphthoic acid | dermatologic drug; EC 2.7.11.22 (cyclin-dependent kinase) inhibitor; non-steroidal anti-inflammatory drug |
| adefovir adefovir: inhibitor of African swine fever virus. adefovir(1-) : A organophosphonate oxoanion obtained by removal of a proton from the phosphonate group of adefovir, a nucleoside reverse transcriptase inhibitor. It is the major microspecies at pH 7.3 (according to Marvin v 6.2.0.).. adefovir : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens has been replaced by a 2-(6-amino-9H-purin-9-yl)ethoxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(t-butoxycarbonyloxymethyl) ester (dipivoxil ester) prodrug is used to treat chronic hepatitis B viral infection. | 3.23 | 1 | 0 | 6-aminopurines; ether; phosphonic acids | antiviral drug; DNA synthesis inhibitor; drug metabolite; HIV-1 reverse transcriptase inhibitor; nephrotoxic agent |
| aromasil [no description available] | 3.61 | 2 | 0 | 17-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor; environmental contaminant; xenobiotic |
| sparfloxacin [no description available] | 2.08 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | |
| zileuton [no description available] | 3.61 | 2 | 0 | 1-benzothiophenes; ureas | anti-asthmatic drug; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; ferroptosis inhibitor; leukotriene antagonist; non-steroidal anti-inflammatory drug |
| remacemide remacemide: structure given in first source | 2.13 | 1 | 0 | stilbenoid | |
| clopidogrel Clopidogrel: A ticlopidine analog and platelet purinergic P2Y receptor antagonist that inhibits adenosine diphosphate-mediated PLATELET AGGREGATION. It is used to prevent THROMBOEMBOLISM in patients with ARTERIAL OCCLUSIVE DISEASES; MYOCARDIAL INFARCTION; STROKE; or ATRIAL FIBRILLATION.. clopidogrel : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group, the methylene hydrogen of which is replaced by a methoxycarbonyl group (the S enantiomer). A P2Y12 receptor antagonist, it is used to inhibit blood clots and prevent heart attacks. | 3.23 | 1 | 0 | methyl ester; monochlorobenzenes; thienopyridine | anticoagulant; P2Y12 receptor antagonist; platelet aggregation inhibitor |
| cidofovir anhydrous Cidofovir: An acyclic nucleoside phosphonate that acts as a competitive inhibitor of viral DNA polymerases. It is used in the treatment of RETINITIS caused by CYTOMEGALOVIRUS INFECTIONS and may also be useful for treating HERPESVIRUS INFECTIONS.. cidofovir anhydrous : Cytosine substituted at the 1 position by a 3-hydroxy-2-(phosphonomethoxy)propyl group (S configuration). A nucleoside analogue, it is an injectable antiviral used for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. | 3.61 | 2 | 0 | phosphonic acids; pyrimidone | anti-HIV agent; antineoplastic agent; antiviral drug; photosensitizing agent |
| tiagabine Tiagabine: A nipecotic acid derivative that acts as a GABA uptake inhibitor and anticonvulsant agent. It is used in the treatment of EPILEPSY, for refractory PARTIAL SEIZURES.. tiagabine : A piperidinemonocarboxylic acid that is (R)-nipecotic acid in which the hydrogen attached to the nitrogen has been replaced by a 1,1-bis(3-methyl-2-thienyl)but-1-en-4-yl group. A GABA reuptake inhibitor, it is used (generally as the hydrochloride salt) for the treatment of epilepsy. | 7.24 | 9 | 1 | beta-amino acid; piperidinemonocarboxylic acid; tertiary amino compound; thiophenes | anticonvulsant; GABA reuptake inhibitor |
| topotecan Topotecan: An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.. topotecan : A pyranoindolizinoquinoline used as an antineoplastic agent. It is a derivative of camptothecin and works by binding to the topoisomerase I-DNA complex and preventing religation of these 328 single strand breaks. | 3.23 | 1 | 0 | pyranoindolizinoquinoline | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor |
| bromfenac bromfenac: bromfenac sodium is the active cpd; structure in first source. bromfenac : Amfenac in which the the hydrogen at the 4 position of the benzoyl group is substituted by bromine. It is used for the management of ocular pain and treatment of postoperative inflammation in patients who have undergone cataract extraction. It was withdrawn from the US market in 1998, following concerns over off-label abuse and hepatic failure. | 3.61 | 2 | 0 | aromatic amino acid; benzophenones; organobromine compound; substituted aniline | non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| gemcitabine hydrochloride [no description available] | 2.08 | 1 | 0 | hydrochloride; organofluorine compound | anticoronaviral agent; antimetabolite; antineoplastic agent; antiviral drug; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; immunosuppressive agent; radiosensitizing agent |
| gemcitabine gemcitabine : A 2'-deoxycytidine having geminal fluoro substituents in the 2'-position. An inhibitor of ribonucleotide reductase, gemcitabine is used in the treatment of various carcinomas, particularly non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer. | 3.86 | 3 | 0 | organofluorine compound; pyrimidine 2'-deoxyribonucleoside | antimetabolite; antineoplastic agent; antiviral drug; DNA synthesis inhibitor; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; environmental contaminant; immunosuppressive agent; photosensitizing agent; prodrug; radiosensitizing agent; xenobiotic |
| ibutilide ibutilide: RN & structure in first source; RN refers to the fumarate salt | 3.23 | 1 | 0 | benzenes; organic amino compound | |
| aripiprazole Aripiprazole: A piperazine and quinolone derivative that is used primarily as an antipsychotic agent. It is a partial agonist of SEROTONIN RECEPTOR, 5-HT1A and DOPAMINE D2 RECEPTORS, where it also functions as a post-synaptic antagonist, and an antagonist of SEROTONIN RECEPTOR, 5-HT2A. It is used for the treatment of SCHIZOPHRENIA and BIPOLAR DISORDER, and as an adjunct therapy for the treatment of depression.. aripiprazole : An N-arylpiperazine that is piperazine substituted by a 4-[(2-oxo-1,2,3,4-tetrahydroquinolin-7-yl)oxy]butyl group at position 1 and by a 2,3-dichlorophenyl group at position 4. It is an antipsychotic drug used for the treatment of Schizophrenia, and other mood disorders. | 4.49 | 6 | 0 | aromatic ether; delta-lactam; dichlorobenzene; N-alkylpiperazine; N-arylpiperazine; quinolone | drug metabolite; H1-receptor antagonist; second generation antipsychotic; serotonergic agonist |
| remifentanil Remifentanil: A piperidine-propionate derivative and opioid analgesic structurally related to FENTANYL. It functions as a short-acting MU OPIOID RECEPTOR agonist, and is used as an analgesic during induction or maintenance of general anesthesia, following surgery, during childbirth, and in mechanically ventilated patients under intensive care.. remifentanil : A piperidinecarboxylate ester that is methyl piperidine-4-carboxylate in which the hydrogen attached to the nitrogen is substituted by a 3-methoxy-3-oxopropyl group and the hydrogen at position 4 is substituted the nitrogen of N-propanoylaniline. | 11.11 | 4 | 2 | alpha-amino acid ester; anilide; monocarboxylic acid amide; piperidinecarboxylate ester | intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic; sedative |
| atorvastatin calcium anhydrous [no description available] | 2.08 | 1 | 0 | organic calcium salt | |
| atorvastatin [no description available] | 4.75 | 3 | 0 | aromatic amide; dihydroxy monocarboxylic acid; monofluorobenzenes; pyrroles; statin (synthetic) | environmental contaminant; xenobiotic |
| lamivudine [no description available] | 3.61 | 2 | 0 | monothioacetal; nucleoside analogue; oxacycle; primary alcohol | allergen; anti-HBV agent; antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor; prodrug |
| duloxetine hydrochloride Duloxetine Hydrochloride: A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.. (S)-duloxetine hydrochloride : A duloxetine hydrochloride in which the duloxetine moiety has S configuration. | 19.08 | 162 | 31 | duloxetine hydrochloride | antidepressant |
| duloxetine [no description available] | 3.23 | 1 | 0 | duloxetine | |
| irinotecan [no description available] | 3.69 | 2 | 0 | carbamate ester; delta-lactone; N-acylpiperidine; pyranoindolizinoquinoline; ring assembly; tertiary alcohol; tertiary amino compound | antineoplastic agent; apoptosis inducer; EC 5.99.1.2 (DNA topoisomerase) inhibitor; prodrug |
| valsartan Valsartan: A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.. valsartan : A monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity. | 3.61 | 2 | 0 | biphenylyltetrazole; monocarboxylic acid amide; monocarboxylic acid | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| ibandronic acid Ibandronic Acid: Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS. | 3.89 | 3 | 0 | ||
| ziprasidone ziprasidone: a benzisothiazoylpiperazine derivative; has combined dopamine and serotonin receptor antagonist activity; structurally related to tiospirone. ziprasidone : A piperazine compound having 1,2-benzothiazol-3-yl- and 2-(6-chloro-1,3-dihydro-2-oxindol-5-yl)ethyl substituents attached to the nitrogen atoms. | 3.59 | 2 | 0 | 1,2-benzisothiazole; indolones; organochlorine compound; piperazines | antipsychotic agent; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; psychotropic drug; serotonergic antagonist |
| zolmitriptan zolmitriptan: an antimigraine compound; a serotonin (5HT)-1D receptor agonist. zolmitriptan : A member of the class of tryptamines that is N,N-dimethyltryptamine in which the hydrogen at position 5 of the indole ring has been replaced by a [(4S)-2-oxo-1,3-oxazolidin-4-yl]methyl group. A serotonin 5-HT1 B and D receptor agonist, it is used for the treatment of migraine. | 3.61 | 2 | 0 | oxazolidinone; tryptamines | anti-inflammatory drug; serotonergic agonist; vasoconstrictor agent |
| adefovir dipivoxil bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine: structure given in first source. adefovir pivoxil : An organic phosphonate that is the dipivoxil ester of adefovir. A prodrug for adefovir, an HIV-1 reverse transcriptase inhibitor, adefovir pivoxil is used to treat chronic hepatitis B viral infection. | 2.08 | 1 | 0 | 6-aminopurines; carbonate ester; ether; organic phosphonate | antiviral drug; DNA synthesis inhibitor; HIV-1 reverse transcriptase inhibitor; nephrotoxic agent; prodrug |
| emtricitabine Emtricitabine: A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.. emtricitabine : An organofluorine compound that is 5-fluorocytosine substituted at the 1 position by a 2-(hydroxymethyl)-1,3-oxathiolan-5-yl group (2R,5S configuration). It is used in combination therapy for the treatment of HIV-1 infection. | 3.61 | 2 | 0 | monothioacetal; nucleoside analogue; organofluorine compound; pyrimidone | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| tasosartan tasosartan: angiotensin II antagonist; structure given in first source | 3.23 | 1 | 0 | biphenyls | |
| tiludronic acid tiludronic acid: a bone resorption inhibitor; an antihypercalcemic agent; used in the tratment of Paget's disease; used in the treatment and prevention of osteoporosis; structure given in first source | 3.23 | 1 | 0 | organochlorine compound | |
| tirofiban Tirofiban: Tyrosine analog and PLATELET GLYCOPROTEIN GPIIB-IIIA COMPLEX antagonist that inhibits PLATELET AGGREGATION and is used in the treatment of ACUTE CORONARY SYNDROME.. tirofiban : A member of the class of piperidines that is L-tyrosine in which a hydrogen attached to the amino group is replaced by a butylsulfonyl group and in which the hydrogen attached to the phenolic hydroxy group is replaced by a 4-(piperidin-4-yl)butyl group. | 3.23 | 1 | 0 | L-tyrosine derivative; piperidines; sulfonamide | anticoagulant; fibrin modulating drug; platelet glycoprotein-IIb/IIIa receptor antagonist |
| capecitabine Capecitabine: A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.. capecitabine : A carbamate ester that is cytidine in which the hydrogen at position 5 is replaced by fluorine and in which the amino group attached to position 4 is converted into its N-(penyloxy)carbonyl derivative. Capecitabine is a antineoplastic agent used in the treatment of cancers. | 3.59 | 2 | 0 | carbamate ester; cytidines; organofluorine compound | antimetabolite; antineoplastic agent; prodrug |
| adenosine quinquefolan B: isolated from roots of Panax quinquefolium L.; RN not in Chemline 10/87; RN from Toxlit | 3.23 | 1 | 0 | adenosines; purines D-ribonucleoside | analgesic; anti-arrhythmia drug; fundamental metabolite; human metabolite; vasodilator agent |
| cathinone cathinone: alkaloid from khat shrub, Catha edulis; RN given refers to parent cpd without isomeric designation. cathinone : The S stereoisomer of 2-aminopropiophenone. | 2.13 | 1 | 0 | 2-aminopropiophenone; monoamine alkaloid | central nervous system stimulant; psychotropic drug |
| paroxetine hydrochloride paroxetine hydrochloride : The hydrochloride salt of paroxetine. It is an antidepressant drug. | 2.08 | 1 | 0 | hydrochloride | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
| bupropion hydrochloride [no description available] | 2.08 | 1 | 0 | aromatic ketone | |
| venlafaxine hydrochloride Venlafaxine Hydrochloride: A cyclohexanol and phenylethylamine derivative that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. | 12.2 | 18 | 9 | hydrochloride | |
| trazodone hydrochloride Triticum: A plant genus of the family POACEAE that is the source of EDIBLE GRAIN. A hybrid with rye (SECALE CEREALE) is called TRITICALE. The seed is ground into FLOUR and used to make BREAD, and is the source of WHEAT GERM AGGLUTININS.. trazodone hydrochloride : A hydrochloride salt prepared from equimolar amounts of trazodone and hydrogen chloride. | 2.08 | 1 | 0 | hydrochloride | adrenergic antagonist; antidepressant; H1-receptor antagonist; sedative; serotonin uptake inhibitor |
| trovafloxacin trovafloxacin: a trifluoronaphthyridone derivative of 7-(3-azabicyclo(3.1.0)hexyl)naphthyridone; has antineoplastic activity. trovafloxacin : A 1,8-naphthyridine derivative that is 4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid bearing additional 2,4-difluorophenyl, fluoro and 6-amino-3-azabicyclo[3.1.0]hex-3-yl substituents at positions 1, 6 and 7 respectively. A broad-spectrum antibiotic that was withdrawn from the market due to risk of liver failure. | 3.23 | 1 | 0 | ||
| cefprozil [no description available] | 3.23 | 1 | 0 | cephalosporin; semisynthetic derivative | antibacterial drug |
| doxazosin mesylate Cardura: Trade name in United States. | 2.08 | 1 | 0 | methanesulfonate salt | geroprotector |
| efavirenz efavirenz: HIV-1 reverse transcriptase inhibitor. efavirenz : 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection. | 3.61 | 2 | 0 | acetylenic compound; benzoxazine; cyclopropanes; organochlorine compound; organofluorine compound | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| nelfinavir Nelfinavir: A potent HIV protease inhibitor. It is used in combination with other antiviral drugs in the treatment of HIV in both adults and children.. nelfinavir : An aryl sulfide that is used (as its mesylate salt) for treatment of HIV and also exhibits some anticancer properties. | 3.61 | 2 | 0 | aryl sulfide; benzamides; organic heterobicyclic compound; phenols; secondary alcohol; tertiary amino compound | antineoplastic agent; HIV protease inhibitor |
| glucose, (beta-d)-isomer beta-D-glucose : D-Glucopyranose with beta configuration at the anomeric centre.. (1->4)-beta-D-glucan : A beta-D-glucan in which the glucose units are connected by (1->4) linkages.. (1->3)-beta-D-glucan : A beta-D-glucan in which the glucose units are connected by (1->3) linkages. | 2.5 | 2 | 0 | D-glucopyranose | epitope; mouse metabolite |
| mevastatin mevastatin: antifungal metabolite from Penicillium brevicopactum; potent inhibitory activity to sterol synthesis; structure. mevastatin : A carboxylic ester that is pravastatin that is lacking the allylic hydroxy group. A hydroxymethylglutaryl-CoA reductase inhibitor (statin) isolated from Penicillium citrinum and from Penicillium brevicompactum, its clinical use as a lipid-regulating drug ceased following reports of toxicity in animals. | 2.08 | 1 | 0 | 2-pyranones; carboxylic ester; hexahydronaphthalenes; polyketide; statin (naturally occurring) | antifungal agent; apoptosis inducer; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; fungal metabolite; Penicillium metabolite |
| bupivacaine hydrochloride bupivacaine hydrochloride (anhydrous) : A racemate composed of equimolar amounts of dextrobupivacaine hydrochloride and levobupivacaine hydrochloride. The monohydrate form is commonly used as a local anaesthetic.. 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide hydrochloride : A hydrochloride obtained by combining 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide with one molar equivalent of hydrochloric acid. | 2.08 | 1 | 0 | hydrochloride; racemate | adrenergic antagonist; amphiphile; EC 3.1.1.8 (cholinesterase) inhibitor; EC 3.6.3.8 (Ca(2+)-transporting ATPase) inhibitor; local anaesthetic |
| fenofibric acid fenofibric acid: RN given refers to parent cpd without isomeric designation; structure. fenofibric acid : A monocarboxylic acid that is 2-methylpropanoic acid substituted by a 4-(4-chlorobenzoyl)phenoxy group at position 2. It is a metabolite of the drug fenofibrate. | 3.23 | 1 | 0 | aromatic ketone; chlorobenzophenone; monocarboxylic acid | drug metabolite; marine xenobiotic metabolite |
| plerixafor plerixafor: a bicyclam derivate, highly potent & selective inhibitor of HIV-1 & HIV-2. plerixafor : An azamacrocycle consisting of two cyclam rings connected by a 1,4-phenylenebis(methylene) linker. It is a CXCR4 chemokine receptor antagonist and a hematopoietic stem cell mobilizer. It is used in combination with grulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the perpheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma. | 3.61 | 2 | 0 | azacycloalkane; azamacrocycle; benzenes; crown amine; secondary amino compound; tertiary amino compound | anti-HIV agent; antineoplastic agent; C-X-C chemokine receptor type 4 antagonist; immunological adjuvant |
| amprenavir [no description available] | 3.61 | 2 | 0 | carbamate ester; sulfonamide; tetrahydrofuryl ester | antiviral drug; HIV protease inhibitor |
| oseltamivir Oseltamivir: An acetamido cyclohexene that is a structural homolog of SIALIC ACID and inhibits NEURAMINIDASE.. oseltamivir : A cyclohexenecarboxylate ester that is the ethyl ester of oseltamivir acid. An antiviral prodrug (it is hydrolysed to the active free carboxylic acid in the liver), it is used to slow the spread of influenza. | 3.23 | 1 | 0 | acetamides; amino acid ester; cyclohexenecarboxylate ester; primary amino compound | antiviral drug; EC 3.2.1.18 (exo-alpha-sialidase) inhibitor; environmental contaminant; prodrug; xenobiotic |
| ticlopidine hydrochloride [no description available] | 2.08 | 1 | 0 | hydrochloride | |
| epirubicin hydrochloride [no description available] | 2.08 | 1 | 0 | ||
| histamine phosphate histamine phosphate : A phosphate salt that is the diphosphate salt of histamine. | 3.23 | 1 | 0 | phosphate salt | histamine agonist |
| tilbroquinol [no description available] | 3.23 | 1 | 0 | organohalogen compound; quinolines | |
| bendamustine [no description available] | 3.23 | 1 | 0 | benzimidazoles | |
| droxicam droxicam: structure given in first source. droxicam : An organic heterotricyclic compound that is 2H,5H-[1,3]oxazino[5,6-c][1,2]benzothiazine-2,4(3H)-dione 6,6-dioxide substituted at positions 3 and 5 by pyridin-2-yl and methyl groups respectively. A prodrug of piroxicam, it is used for the relief of pain and inflammation in musculoskeletal disorders such as rheumatoid arthritis and osteoarthritis. | 3.23 | 1 | 0 | organic heterotricyclic compound; pyridines | cyclooxygenase 1 inhibitor; hepatotoxic agent; non-narcotic analgesic; non-steroidal anti-inflammatory drug; platelet aggregation inhibitor; prodrug |
| milnacipran Milnacipran: A cyclopropanecarboxamide serotonin and norepinephrine reuptake inhibitor (SNRI) that is used in the treatment of FIBROMYALGIA. | 11.46 | 19 | 3 | acetamides | |
| ebrotidine ebrotidine: an H2-receptor antagonist and gastric mucosa protector | 3.23 | 1 | 0 | sulfonamide | |
| dimiracetam dimiracetam: structure given in first source; an antiamnestic agent | 7.15 | 1 | 0 | ||
| pazufloxacin [no description available] | 2.08 | 1 | 0 | quinolines | |
| repaglinide [no description available] | 3.61 | 2 | 0 | piperidines | |
| telmisartan Telmisartan: A biphenyl compound and benzimidazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION.. telmisartan : A member of the class of benzimidazoles used widely in the treatment of hypertension. | 8.92 | 3 | 0 | benzimidazoles; biphenyls; carboxybiphenyl | angiotensin receptor antagonist; antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; environmental contaminant; xenobiotic |
| triazoles Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms. | 4.58 | 4 | 0 | 1,2,3-triazole | |
| miconazole nitrate miconazole nitrate : A racemate composed of equimolar amounts of (R)- and (S)-miconazole nitrate. An antifungal used for the treatment of athlete's foot, jock itch, ringworm and other fungal skin infections. It inhibits the synthesis of ergosterol, a critical component of fungal cell membranes. | 2.08 | 1 | 0 | ||
| sertraline Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression.. sertraline : A member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. | 5.72 | 5 | 1 | dichlorobenzene; secondary amino compound; tetralins | antidepressant; serotonin uptake inhibitor |
| zoledronic acid Zoledronic Acid: An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.. zoledronic acid : An imidazole compound having a 2,2-bis(phosphono)-2-hydroxyethane-1-yl substituent at the 1-position. | 3.89 | 3 | 0 | 1,1-bis(phosphonic acid); imidazoles | bone density conservation agent |
| artemisinin (+)-artemisinin : A sesquiterpene lactone obtained from sweet wormwood, Artemisia annua, which is used as an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. | 2.08 | 1 | 0 | organic peroxide; sesquiterpene lactone | antimalarial; plant metabolite |
| brinzolamide brinzolamide: an antiglaucoma agent | 2.08 | 1 | 0 | sulfonamide; thienothiazine | antiglaucoma drug; EC 4.2.1.1 (carbonic anhydrase) inhibitor |
| drospirenone drospirenone: a progestational compound with antimineralocorticoid and antiandrogenic activity; structure given in first source | 2.08 | 1 | 0 | 3-oxo-Delta(4) steroid; steroid lactone | aldosterone antagonist; contraceptive drug; progestin |
| artemether Artemether: An artemisinin derivative that is used in the treatment of MALARIA.. artemether : An artemisinin derivative that is artemisinin in which the lactone has been converted to the corresponding lactol methyl ether. It is used in combination with lumefantrine as an antimalarial for the treatment of multi-drug resistant strains of falciparum malaria. | 2.08 | 1 | 0 | artemisinin derivative; cyclic acetal; organic peroxide; semisynthetic derivative; sesquiterpenoid | antimalarial |
| acamprosate Acamprosate: Structural analog of taurine that is used for the prevention of relapse in individuals with ALCOHOLISM.. acamprosate : An organosulfonic acid that is propane-1-sulfonic acid substituted by an acetylamino group at position 3. | 3.23 | 1 | 0 | acetamides; organosulfonic acid | environmental contaminant; neurotransmitter agent; xenobiotic |
| isaxonine isaxonine: promotes nerve growth | 3.23 | 1 | 0 | aminopyrimidine | |
| nebivolol 2,2'-iminobis[1-(6-fluoro-3,4-dihydro-2H-chromen-2-yl)ethanol] : A member of the class of chromanes that is 2,2'-iminodiethanol in which one hydrogen attached to each hydroxy-bearing carbon is replaced by a 6-fluorochroman-2-yl group. | 3.23 | 1 | 0 | chromanes; diol; organofluorine compound; secondary alcohol; secondary amino compound | |
| uk 68798 [no description available] | 3.61 | 2 | 0 | aromatic ether; sulfonamide; tertiary amino compound | anti-arrhythmia drug; potassium channel blocker |
| hp 873 iloperidone: an atypical, negative symptom antipsychotic agent. iloperidone : A member of the class of piperidines that is the 4-acetyl-2-methoxyphenyl ether of 3-(piperidin-1-yl)propan-1-ol which is substituted at position 4 of the piperidine ring by a 6-fluoro-1,2-benzoxazol-3-yl group. A member of the group of second generation antipsychotics (also known as an atypical antipsychotics), it is used for the treatment of schizophrenia. | 3.61 | 2 | 0 | 1,2-benzoxazoles; aromatic ether; aromatic ketone; methyl ketone; monoamine; organofluorine compound; piperidines; tertiary amino compound | dopaminergic antagonist; second generation antipsychotic; serotonergic antagonist |
| dexrazoxane Dexrazoxane: The (+)-enantiomorph of razoxane. | 3.23 | 1 | 0 | razoxane | antineoplastic agent; cardiovascular drug; chelator; immunosuppressive agent |
| loxapine succinate [no description available] | 2.08 | 1 | 0 | succinate salt | geroprotector |
| fenoxypropazine [no description available] | 3.23 | 1 | 0 | aromatic ether | |
| voriconazole Voriconazole: A triazole antifungal agent that specifically inhibits STEROL 14-ALPHA-DEMETHYLASE and CYTOCHROME P-450 CYP3A.. voriconazole : A triazole-based antifungal agent used for the treatment of esophageal candidiasis, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp. It is an inhibitor of cytochrome P450 2C9 (CYP2C9) and CYP3A4. | 3.61 | 2 | 0 | conazole antifungal drug; difluorobenzene; pyrimidines; tertiary alcohol; triazole antifungal drug | P450 inhibitor |
| betamipron [no description available] | 2.08 | 1 | 0 | organonitrogen compound; organooxygen compound | |
| uroxatral [no description available] | 2.08 | 1 | 0 | hydrochloride | |
| aceclofenac [no description available] | 3.61 | 2 | 0 | amino acid; carboxylic ester; dichlorobenzene; monocarboxylic acid; secondary amino compound | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| nitrefazole [no description available] | 3.23 | 1 | 0 | imidazoles | |
| thiocolchicoside [no description available] | 2.08 | 1 | 0 | glycoside | |
| leupeptin [no description available] | 2.17 | 1 | 0 | aldehyde; tripeptide | bacterial metabolite; calpain inhibitor; cathepsin B inhibitor; EC 3.4.21.4 (trypsin) inhibitor; serine protease inhibitor |
| doripenem Doripenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of infections such as HOSPITAL-ACQUIRED PNEUMONIA, and complicated intra-abdominal or urinary-tract infections, including PYELONEPHRITIS. | 3.61 | 2 | 0 | carbapenems | |
| maslinic acid (2Alpha,3beta)-2,3-dihydroxyolean-12-en-28-oic acid: from Luehea divaricata and Agrimonia eupatoria | 2.08 | 1 | 0 | dihydroxy monocarboxylic acid; pentacyclic triterpenoid | anti-inflammatory agent; antineoplastic agent; antioxidant; plant metabolite |
| oxazolidin-2-one Oxazolidinones: Derivatives of oxazolidin-2-one. They represent an important class of synthetic antibiotic agents.. oxazolidin-2-one : An oxazolidinone that is 1,3-oxazolidine with an oxo substituent at position 2.. oxazolidinone : An oxazolidine containing one or more oxo groups. | 2.05 | 1 | 0 | carbamate ester; oxazolidinone | metabolite |
| atovaquone Atovaquone: A hydroxynaphthoquinone that has antimicrobial activity and is being used in antimalarial protocols.. atovaquone : A naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position. | 3.23 | 1 | 0 | hydroxy-1,2-naphthoquinone | |
| bendamustine hydrochloride [no description available] | 3.14 | 1 | 0 | ||
| rivastigmine [no description available] | 3.23 | 1 | 0 | carbamate ester; tertiary amino compound | cholinergic drug; EC 3.1.1.8 (cholinesterase) inhibitor; neuroprotective agent |
| frovatriptan [no description available] | 3.23 | 1 | 0 | carbazoles | |
| eletriptan eletriptan: 5-HT(1B/1D) receptor agonist; structure in first source. eletriptan : An N-alkylpyrrolidine, that is N-methylpyrrolidine in which the pro-R hydrogen at position 2 is replaced by a {5-[2-(phenylsulfonyl)ethyl]-1H-indol-3-yl}methyl group. | 3.23 | 1 | 0 | indoles; N-alkylpyrrolidine; sulfone | non-steroidal anti-inflammatory drug; serotonergic agonist; vasoconstrictor agent |
| rosiglitazone [no description available] | 3.89 | 3 | 0 | aminopyridine; thiazolidinediones | EC 6.2.1.3 (long-chain-fatty-acid--CoA ligase) inhibitor; ferroptosis inhibitor; insulin-sensitizing drug |
| tamiflu [no description available] | 2.08 | 1 | 0 | phosphate salt | |
| bexarotene [no description available] | 3.61 | 2 | 0 | benzoic acids; naphthalenes; retinoid | antineoplastic agent |
| s20098 [no description available] | 3.95 | 2 | 1 | acetamides | |
| flunisolide flunisolide: flunisolide HFA is a formulation of flunisolide using hydrofluoroalkane (HFA) as propellant in place of chlorofluorocarbon (CFC) ones | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic ketal; fluorinated steroid; primary alpha-hydroxy ketone | anti-asthmatic drug; anti-inflammatory drug; immunosuppressive agent |
| ketorolac tromethamine Ketorolac Tromethamine: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is a non-steroidal anti-inflammatory agent used for analgesia for postoperative pain and inhibits cyclooxygenase activity.. ketorolac tromethamine : An organoammonium salt resulting from the mixture of equimolar amounts of ketorolac and tromethamine (tris). It has potent non-sedating analgesic and moderate anti-inflammatory effects. It is used in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. | 3.87 | 2 | 1 | organoammonium salt | analgesic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor |
| clarithromycin Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. | 4.67 | 4 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; protein synthesis inhibitor; xenobiotic |
| nicotine (S)-nicotine : A 3-(1-methylpyrrolidin-2-yl)pyridine in which the chiral centre has S-configuration. The naturally occurring and most active enantiomer of nicotine, isolated from Nicotiana tabacum. | 3.87 | 2 | 1 | 3-(1-methylpyrrolidin-2-yl)pyridine | anxiolytic drug; biomarker; immunomodulator; mitogen; neurotoxin; nicotinic acetylcholine receptor agonist; peripheral nervous system drug; phytogenic insecticide; plant metabolite; psychotropic drug; teratogenic agent; xenobiotic |
| moexipril [no description available] | 3.23 | 1 | 0 | peptide | |
| gliquidone gliquidone: structure; RN given refers to parent cpd | 2.08 | 1 | 0 | isoquinolines | |
| 1-methyl-1,2,3,4-tetrahydroisoquinoline 1-methyl-1,2,3,4-tetrahydroisoquinoline: endogenous amine from rat brain | 7.05 | 1 | 0 | isoquinolines | |
| melanotan-ii melanotan-II: synthetic cyclic heptapeptide, an analog of alpha-melanotropin (4,10); capable of stimulating melanin synthesis & promoting rapid tanning of skin; currently in trials for use in the prevention of sunlight-induced skin cancer | 2.1 | 1 | 0 | organic molecular entity | |
| mci 9038 [no description available] | 3.23 | 1 | 0 | peptide | |
| lopinavir [no description available] | 2.08 | 1 | 0 | amphetamines; dicarboxylic acid diamide | anticoronaviral agent; antiviral drug; HIV protease inhibitor |
| phorbolol myristate acetate [no description available] | 2.07 | 1 | 0 | ||
| moxifloxacin hydrochloride moxifloxacin hydrochloride : A hydrochloride comprising equimolar amounts of moxifloxacin and hydrogen chloride. | 2.08 | 1 | 0 | hydrochloride | antibacterial drug |
| fulvestrant Fulvestrant: An estradiol derivative and estrogen receptor antagonist that is used for the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer.. fulvestrant : A 3-hydroxy steroid that is 17beta-estradiol in which the 7alpha hydrogen has been replaced by a nonyl group in which one of the hydrogens of the terminal methyl has been replaced by a (4,4,5,5,5-pentafluoropentyl)sulfinyl group. An estrogen receptor antagonist, it is used in the treatment of breast cancer. | 3.61 | 2 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; organofluorine compound; sulfoxide | antineoplastic agent; estrogen antagonist; estrogen receptor antagonist |
| mizoribine [no description available] | 2.08 | 1 | 0 | imidazoles | anticoronaviral agent |
| sr141716 [no description available] | 2.08 | 1 | 0 | amidopiperidine; carbohydrazide; dichlorobenzene; monochlorobenzenes; pyrazoles | anti-obesity agent; appetite depressant; CB1 receptor antagonist |
| bosentan anhydrous Bosentan: A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS. | 3.61 | 2 | 0 | primary alcohol; pyrimidines; sulfonamide | antihypertensive agent; endothelin receptor antagonist |
| 7,7-diphenyl-2-(1-imino-2-(2-methoxyphenyl)ethyl)perhydroisoindol-4-one 7,7-diphenyl-2-(1-imino-2-(2-methoxyphenyl)ethyl)perhydroisoindol-4-one: structure given in first source; RP 68651 is the inactive (3aS,7aS)-isomer; substance P antagonist | 2.13 | 1 | 0 | ||
| sivelestat sivelestat: inhibitor of neutrophil elastase; structure given in first source | 2.15 | 1 | 0 | N-acylglycine; pivalate ester | |
| racecadotril racecadotril: parenterally active enkephalinase inhibitor | 2.08 | 1 | 0 | N-acyl-amino acid | |
| perindopril Perindopril: An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.. perindopril : An alpha-amino acid ester that is the ethyl ester of N-{(2S)-1-[(2S,3aS,7aS)-2-carboxyoctahydro-1H-indol-1-yl]-1-oxopropan-2-yl}-L-norvaline | 4.09 | 2 | 0 | alpha-amino acid ester; dicarboxylic acid monoester; ethyl ester; organic heterobicyclic compound | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| fingolimod hydrochloride Fingolimod Hydrochloride: A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.. fingolimod hydrochloride : The hydrochloride salt of 2-amino-2-[2-(4-octylphenyl) ethyl]-1,3-propanediol (fingolimod). | 3.35 | 1 | 0 | hydrochloride | immunosuppressive agent; prodrug; sphingosine-1-phosphate receptor agonist |
| tadalafil [no description available] | 3.91 | 3 | 0 | benzodioxoles; pyrazinopyridoindole | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
| norbuprenorphine norbuprenorphine: metabolite of buprenorphine found in urine & feces; RN given refers to (5alpha,7alpha)-isomer; structure given in first source | 2.31 | 1 | 0 | phenanthrenes | |
| paliperidone 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one : A member of the class of pyridopyrimidines that is 9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2.. paliperidone : A racemate comprising equimolar amounts of (R)- and (S)-paliperidone. Paliperidone is the primary active metabolite of the older antipsychotic risperidone and is used for treatment of schizophrenia. | 3.23 | 1 | 0 | 1,2-benzoxazoles; heteroarylpiperidine; organofluorine compound; pyridopyrimidine; secondary alcohol | |
| 2-aminobicyclo(2,2,1)heptane-2-carboxylic acid 2-aminobicyclo(2,2,1)heptane-2-carboxylic acid: amino acid analog; releases insulin; RN given refers to unlabeled cpd without isomeric designation | 2.05 | 1 | 0 | monoterpenoid | |
| nitisinone [no description available] | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; C-nitro compound; cyclohexanones; mesotrione | EC 1.13.11.27 (4-hydroxyphenylpyruvate dioxygenase) inhibitor |
| plavix [no description available] | 2.08 | 1 | 0 | azaheterocycle sulfate salt; organoammonium sulfate salt | anticoagulant; P2Y12 receptor antagonist; platelet aggregation inhibitor |
| clofarabine [no description available] | 3.61 | 2 | 0 | adenosines; organofluorine compound | antimetabolite; antineoplastic agent |
| pramipexole Pramipexole: A benzothiazole derivative and dopamine agonist with antioxidant properties that is used in the treatment of PARKINSON DISEASE and RESTLESS LEGS SYNDROME.. pramipexole : A member of the class of benzothiazoles that is 4,5,6,7-tetrahydro-1,3-benzothiazole in which the hydrogens at the 2 and 6-pro-S-positions are substituted by amino and propylamino groups, respectively. | 9.77 | 11 | 3 | benzothiazoles; diamine | antidyskinesia agent; antiparkinson drug; dopamine agonist; radical scavenger |
| valdecoxib [no description available] | 3.87 | 3 | 0 | isoxazoles; sulfonamide | antipyretic; antirheumatic drug; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| parecoxib parecoxib: structure in first source. parecoxib : An N-acylsulfonamide resulting from the formal condensation of valdecoxib with propionic acid. It is a prodrug for valdecoxib. | 4.34 | 1 | 1 | isoxazoles; N-sulfonylcarboxamide | cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| mitiglinide mitiglinide: a rapid and short-acting hypoglycemic agent; acts on sulfonylurea receptor closing KATP channels; considered one of the glinides-an imprecise grouping; structure given in first source | 2.31 | 1 | 0 | benzenes; monocarboxylic acid | |
| ezogabine ezogabine: structure in first source. ezogabine : A substituted aniline that is benzene-1,2,4-triamine bearing ethoxycarbonyl and 4-fluorobenzyl substituents at positions N-1 and N-4 respectively. An anticonvulsant used to treat seizures associated with epilepsy in adults. | 3.95 | 3 | 0 | carbamate ester; organofluorine compound; secondary amino compound; substituted aniline | anticonvulsant; potassium channel modulator |
| saccharolactone saccharolactone: used as index for assessing induction of hepatic enzymes by anticonvulsants; RN given refers to cpd without isomeric designation. D-glucaro-1,4-lactone : A delta-lactone that is D-glucono-1,4-lactone in which the hydroxy group at position 6 has been oxidised to the corresponding carboxylic acid. | 3.31 | 1 | 0 | aldarolactone; delta-lactone | |
| almotriptan almotriptan : An indole compound having a 2-(dimethylamino)ethyl group at the 3-position and a (pyrrolidin-1-ylsulfonyl)methyl group at the 5-position. | 3.23 | 1 | 0 | indoles; sulfonamide; tertiary amine | non-steroidal anti-inflammatory drug; serotonergic agonist; vasoconstrictor agent |
| mk 0663 [no description available] | 4.16 | 4 | 0 | bipyridines; organochlorine compound; sulfone | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| gefitinib [no description available] | 3.61 | 2 | 0 | aromatic ether; monochlorobenzenes; monofluorobenzenes; morpholines; quinazolines; secondary amino compound; tertiary amino compound | antineoplastic agent; epidermal growth factor receptor antagonist |
| nnc 711 NNC 711: structure in first source | 2.46 | 2 | 0 | ||
| angiotensin ii, des-phe(8)- Ile(5)-angiotensin II (1-7) : An angiotensin compound consisting of the linear heptapeptide sequence L-Asp-L-Arg-L-Val-L-Tyr-L-Ile-L-His-L-Pro. | 2.25 | 1 | 0 | amino acid zwitterion; angiotensin | vasodilator agent |
| desloratadine desloratadine: major metabolite of loratadine. desloratadine : Loratadine in which the ethoxycarbonyl group attached to the piperidine ring is replaced by hydrogen. The major metabolite of loratidine, desloratadine is an antihistamine which is used for the symptomatic relief of allergic conditions including rhinitis and chronic urticaria. It does not readily enter the central nervous system, so does not cause drowsiness. | 3.61 | 2 | 0 | benzocycloheptapyridine | anti-allergic agent; cholinergic antagonist; drug metabolite; H1-receptor antagonist |
| desvenlafaxine O-desmethylvenlafaxine : A tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-hydroxyphenyl group. It is a metabolite of the drug venlafaxine. | 3.23 | 1 | 0 | cyclohexanols; phenols; tertiary amino compound | antidepressant; drug metabolite; marine xenobiotic metabolite |
| methotrexate [no description available] | 3.61 | 2 | 0 | dicarboxylic acid; monocarboxylic acid amide; pteridines | abortifacient; antimetabolite; antineoplastic agent; antirheumatic drug; dermatologic drug; DNA synthesis inhibitor; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; immunosuppressive agent |
| reboxetine Reboxetine: A morpholine derivative that is a selective and potent noradrenaline reuptake inhibitor; it is used in the treatment of DEPRESSIVE DISORDER. | 2.31 | 1 | 0 | aromatic ether | |
| tamsulosin [no description available] | 3.23 | 1 | 0 | 5-(2-{[2-(2-ethoxyphenoxy)ethyl]amino}propyl)-2-methoxybenzenesulfonamide | alpha-adrenergic antagonist; antineoplastic agent |
| rufinamide rufinamide: for treatment of Lennox-Gastaut syndrome; structure in first source | 4.64 | 4 | 0 | aromatic amide; heteroarene | |
| sulbactam [no description available] | 2.08 | 1 | 0 | penicillanic acids | |
| olmesartan medoxomil Olmesartan Medoxomil: An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION. | 3.61 | 2 | 0 | biphenyls | |
| dexpanthenol dexpanthenol: The alcohol of pantothenic acid | 3.23 | 1 | 0 | amino alcohol; monocarboxylic acid amide | cholinergic drug; provitamin |
| fosamprenavir fosamprenavir: a prodrug of the protease inhibitor amprenavir. fosamprenavir : A sulfonamide with a structure based on that of sulfanilamide substituted on the sulfonamide nitrogen by a (2R,3S)-4-phenyl-2-(phosphonooxy)-3-({[(3S)-tetrahydrofuran-3-yloxy]carbonyl}amino)butyl group. It is a pro-drug of the HIV protease inhibitor and antiretroviral drug amprenavir. | 3.23 | 1 | 0 | sulfonamide | prodrug |
| abiraterone [no description available] | 2.08 | 1 | 0 | 3beta-hydroxy-Delta(5)-steroid; 3beta-sterol; pyridines | antineoplastic agent; EC 1.14.99.9 (steroid 17alpha-monooxygenase) inhibitor |
| ivabradine Ivabradine: A benzazepine derivative and selective HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNELS inhibitor that lowers the heart rate. It is used in the treatment of CHRONIC STABLE ANGINA in patients unable to take BETA-ADRENERGIC BLOCKERS, and in the treatment of HEART FAILURE.. ivabradine : A member of the class of benzazepines that is 7,8-dimethoxy-1,3,4,5-tetrahydro-3-benzazepin-2-one in which the amide hydrogen is replaced by a [{[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl}(methyl)amino]propyl} group. Used (as its hydrochloride salt) to treat patients with angina who have intolerance to beta blockers and/or heart failure. | 7.15 | 1 | 0 | aromatic ether; benzazepine; carbobicyclic compound; tertiary amino compound | cardiotonic drug |
| febuxostat Febuxostat: A thiazole derivative and inhibitor of XANTHINE OXIDASE that is used for the treatment of HYPERURICEMIA in patients with chronic GOUT.. febuxostat : A 1,3-thiazolemonocarboxylic acid that is 4-methyl-1,3-thiazole-5-carboxylic acid which is substituted by a 3-cyano-4-(2-methylpropoxy)phenyl group at position 2. It is an orally-active, potent, and selective xanthine oxidase inhibitor used for the treatment of chronic hyperuricaemia in patients with gout. | 3.61 | 2 | 0 | 1,3-thiazolemonocarboxylic acid; aromatic ether; nitrile | EC 1.17.3.2 (xanthine oxidase) inhibitor |
| beta-lactams 2-azetidinone: structure in first source. azetidin-2-one : An unsubstituted beta-lactam compound.. beta-lactam : A lactam in which the amide bond is contained within a four-membered ring, which includes the amide nitrogen and the carbonyl carbon. | 2.6 | 1 | 0 | beta-lactam antibiotic allergen; beta-lactam | |
| perrhenate perrhenate: RN given refers to cpd with MF of O4-Re | 3.31 | 1 | 0 | monovalent inorganic anion; rhenium oxoanion | |
| proline Proline: A non-essential amino acid that is synthesized from GLUTAMIC ACID. It is an essential component of COLLAGEN and is important for proper functioning of joints and tendons.. proline : An alpha-amino acid that is pyrrolidine bearing a carboxy substituent at position 2. | 2.61 | 2 | 0 | amino acid zwitterion; glutamine family amino acid; L-alpha-amino acid; proline; proteinogenic amino acid | algal metabolite; compatible osmolytes; Escherichia coli metabolite; micronutrient; mouse metabolite; nutraceutical; Saccharomyces cerevisiae metabolite |
| escitalopram Escitalopram: S-enantiomer of CITALOPRAM. Belongs to a class of drugs known as SELECTIVE SEROTONIN REUPTAKE INHIBITORS, used to treat depression and generalized anxiety disorder.. escitalopram : A 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile that has S-configuration at the chiral centre. It is the active enantiomer of citalopram. | 3.23 | 1 | 0 | 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile | antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| lexapro Lexapro: Trade name of escitalopram, the active S-enantiomer of the racemic citalopram. | 2.08 | 1 | 0 | ||
| 10-propargyl-10-deazaaminopterin 10-propargyl-10-deazaaminopterin: structure in first source. pralatrexate : A pteridine that is the N-4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl derivative of L-glutamic acid. Used for treatment of Peripheral T-Cell Lymphoma, an aggressive form of non-Hodgkins lymphoma. | 3.23 | 1 | 0 | N-acyl-L-glutamic acid; pteridines; terminal acetylenic compound | antimetabolite; antineoplastic agent; EC 1.5.1.3 (dihydrofolate reductase) inhibitor |
| docetaxel anhydrous Docetaxel: A semisynthetic analog of PACLITAXEL used in the treatment of locally advanced or metastatic BREAST NEOPLASMS and NON-SMALL CELL LUNG CANCER.. docetaxel anhydrous : A tetracyclic diterpenoid that is paclitaxel with the N-benzyloxycarbonyl group replaced by N-tert-butoxycarbonyl, and the acetoxy group at position 10 replaced by a hydroxy group. | 5.71 | 5 | 1 | secondary alpha-hydroxy ketone; tetracyclic diterpenoid | antimalarial; antineoplastic agent; photosensitizing agent |
| atazanavir atazanavir : A heavily substituted carbohydrazide that is an antiretroviral drug of the protease inhibitor (PI) class used to treat infection of human immunodeficiency virus (HIV). | 3.23 | 1 | 0 | carbohydrazide | antiviral drug; HIV protease inhibitor |
| levofloxacin Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase. | 3.61 | 2 | 0 | 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid; fluoroquinolone antibiotic; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; topoisomerase IV inhibitor |
| ezetimibe Ezetimibe: An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.. ezetimibe : A beta-lactam that is azetidin-2-one which is substituted at 1, 3, and 4 by p-fluorophenyl, 3-(p-fluorophenyl)-3-hydroxypropyl, and 4-hydroxyphenyl groups, respectively (the 3R,3'S,4S enantiomer). | 3.93 | 3 | 0 | azetidines; beta-lactam; organofluorine compound | anticholesteremic drug; antilipemic drug; antimetabolite |
| ertapenem Ertapenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.. ertapenem : Meropenem in which the one of the two methyl groups attached to the amide nitrogen is replaced by hydrogen while the other is replaced by a 3-carboxyphenyl group. The sodium salt is used for the treatment of moderate to severe susceptible infections including intra-abdominal and acute gynaecological infections, pneumonia, and infections of the skin and of the urinary tract. | 3.23 | 1 | 0 | carbapenemcarboxylic acid; pyrrolidinecarboxamide | antibacterial drug |
| nepafenac nepafenac: amide analog of amfenac; structure in first source. nepafenac : A monocarboxylic acid amide that is amfenac in which the carboxylic acid group has been converted into the corresponding carboxamide. It is a prodrug for amfenac, used in eye drops to treat pain and inflammation following cataract surgery. | 2.03 | 1 | 0 | monocarboxylic acid amide | cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| cox 189 lumiracoxib: a COX-2 inhibitor. lumiracoxib : An amino acid that is phenylacetic acid which is substituted at position 2 by the nitrogen of 2-chloro-6-fluoroaniline and at position 5 by a methyl group. A highly selective cyclooxygenase 2 inhibitor, it was briefly used for the treatment of osteoarthritis, but was withdrawn due to concersns of hepatotoxicity. | 3.61 | 2 | 0 | amino acid; monocarboxylic acid; organochlorine compound; organofluorine compound; secondary amino compound | cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| conivaptan conivaptan : The amide resulting from the formal condensation of 4-[(biphenyl-2-ylcarbonyl)amino]benzoic acid with the benzazepine nitrogen of 2-methyl-1,4,5,6-tetrahydroimidazo[4,5-d][1]benzazepine. It is an antagonist for two of the three types of arginine vasopressin (AVP) receptors, V1a and V2. It is used as its hydrochloride salt for the treatment of hyponatraemia (low blood sodium levels) caused by syndrome of inappropriate antidiuretic hormone (SIADH). | 3.23 | 1 | 0 | benzazepine | aquaretic; vasopressin receptor antagonist |
| moxifloxacin Moxifloxacin: A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.. moxifloxacin : A quinolone that consists of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid bearing a cyclopropyl substituent at position 1, a fluoro substitiuent at position 6, a (4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl group at position 7 and a methoxy substituent at position 8. A member of the fluoroquinolone class of antibacterial agents. | 3.23 | 1 | 0 | aromatic ether; cyclopropanes; fluoroquinolone antibiotic; pyrrolidinopiperidine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antibacterial drug |
| pralnacasan pralnacasan: NSAID, ICE inhibitor & metastasis inhibitor; RN & structure in first source | 3.23 | 1 | 0 | ||
| clevidipine clevidipine: a calcium channel blocker and antihypertensive agent; structure in first source | 3.23 | 1 | 0 | dihydropyridine | |
| solifenacin [no description available] | 3.23 | 1 | 0 | isoquinolines | |
| dexmethylphenidate dexmethylphenidate : A methyl phenyl(piperidin-2-yl)acetate in which both stereocentres have R configuration. It is the active enantiomer in the racemic drug methylphenidate. | 3.23 | 1 | 0 | methyl phenyl(piperidin-2-yl)acetate | adrenergic agent |
| xamoterol Xamoterol: A phenoxypropanolamine derivative that is a selective beta-1-adrenergic agonist. | 2.08 | 1 | 0 | morpholines | |
| naproxen Naproxen: An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.. naproxen : A methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes. | 12.7 | 10 | 1 | methoxynaphthalene; monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; gout suppressant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| cinacalcet cinacalcet : A secondary amino compound that is (1R)-1-(naphthalen-1-yl)ethanamine in which one of the hydrogens attached to the nitrogen is substituted by a 3-[3-(trifluoromethyl)phenyl]propyl group. | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; naphthalenes; secondary amino compound | calcimimetic; P450 inhibitor |
| lubiprostone [no description available] | 3.23 | 1 | 0 | ||
| telbivudine [no description available] | 3.61 | 2 | 0 | pyrimidine 2'-deoxyribonucleoside | antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| ly 300164 talampanel: AMPA receptor antagonist | 3.13 | 1 | 0 | benzodioxoles | |
| chlorocarbonic acid [no description available] | 2.08 | 1 | 0 | organooxygen compound | |
| paromomycin Paromomycin: An aminoglycoside antibacterial and antiprotozoal agent produced by species of STREPTOMYCES.. paromomycin : An amino cyclitol glycoside that is the 1-O-(2-amino-2-deoxy-alpha-D-glucopyranoside) and the 3-O-(2,6-diamino-2,6-dideoxy-beta-L-idopyranosyl)-beta-D-ribofuranoside of 4,6-diamino-2,3-dihydroxycyclohexane (the 1R,2R,3S,4R,6S diastereoisomer). It is obtained from various Streptomyces species. A broad-spectrum antibiotic, it is used (generally as the sulfate salt) for the treatment of acute and chronic intestinal protozoal infections, but is not effective for extraintestinal protozoal infections. It is also used as a therapeutic against visceral leishmaniasis. | 3.23 | 1 | 0 | amino cyclitol glycoside; aminoglycoside antibiotic | anthelminthic drug; antibacterial drug; antiparasitic agent; antiprotozoal drug |
| anidulafungin Anidulafungin: Echinocandin antifungal agent that is used in the treatment of CANDIDEMIA and CANDIDIASIS.. anidulafungin : A semisynthetic echinocandin anti-fungal drug. It is active against Aspergillus and Candida species and is used for the treatment of invasive candidiasis. | 3.23 | 1 | 0 | antibiotic antifungal drug; azamacrocycle; echinocandin; heterodetic cyclic peptide; semisynthetic derivative | |
| 17 alpha-hydroxyprogesterone caproate 17 alpha-Hydroxyprogesterone Caproate: Hydroxyprogesterone derivative that acts as a PROGESTIN and is used to reduce the risk of recurrent MISCARRIAGE and of PREMATURE BIRTH. It is also used in combination with ESTROGEN in the management of MENSTRUATION DISORDERS. | 3.23 | 1 | 0 | corticosteroid hormone | |
| varenicline Varenicline: A benzazepine derivative that functions as an ALPHA4-BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.. varenicline : An organic heterotetracyclic compound that acts as a partial agonist for nicotinic cholinergic receptors and is used (in the form of its tartate salt) as an aid to giving up smoking. | 3.23 | 1 | 0 | ||
| angiotensin ii Giapreza: injectable form of angiotensin II used to increase blood pressure in adult patients with septic or other distributive shock. Ile(5)-angiotensin II : An angiotensin II that acts on the central nervous system (PDB entry: 1N9V). | 2.25 | 1 | 0 | amino acid zwitterion; angiotensin II | human metabolite |
| fiduxosin fiduxosin: fiduxosin (ABT-980) is the (3aR,9bR)-isomer; structure in first source | 3.23 | 1 | 0 | ||
| atropine tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate : A tropane alkaloid that is (1R,5)-8-methyl-8-azabicyclo[3.2.1]octane substituted by a (3-hydroxy-2-phenylpropanoyl)oxy group at position 3. | 3.61 | 2 | 0 | ||
| ropivacaine Ropivacaine: An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.. ropivacaine : The piperidinecarboxamide obtained by the formal condensation of N-propylpipecolic acid and 2,6-dimethylaniline.. (S)-ropivacaine : A piperidinecarboxamide-based amide-type local anaesthetic (amide caine) in which (S)-N-propylpipecolic acid and 2,6-dimethylaniline are combined to form the amide bond. | 10.89 | 4 | 1 | piperidinecarboxamide; ropivacaine | local anaesthetic |
| erlotinib [no description available] | 3.23 | 1 | 0 | aromatic ether; quinazolines; secondary amino compound; terminal acetylenic compound | antineoplastic agent; epidermal growth factor receptor antagonist; protein kinase inhibitor |
| dexketoprofen trometamol dexketoprofen trometamol: a water-soluble tromethamine salt of the racemic ketoprofen, rac(+-)-ketoprofen | 3.51 | 1 | 1 | ||
| eslicarbazepine acetate eslicarbazepine acetate : The acetate ester, with S configuration, of licarbazepine. An anticonvulsant, it is approved for use in Europe and the United States as an adjunctive therapy for epilepsy. | 3.71 | 2 | 0 | acetate ester; carboxamide; dibenzoazepine; ureas | anticonvulsant; drug allergen |
| memantine hydrochloride [no description available] | 2.02 | 1 | 0 | hydrochloride | antidepressant; antiparkinson drug; dopaminergic agent; neuroprotective agent; NMDA receptor antagonist |
| esketamine esketamine : The S- (more active) enantiomer of ketamine. | 4.95 | 3 | 2 | ketamine | analgesic; intravenous anaesthetic; NMDA receptor antagonist |
| etravirine [no description available] | 3.23 | 1 | 0 | aminopyrimidine; aromatic ether; dinitrile; organobromine compound | antiviral agent; HIV-1 reverse transcriptase inhibitor |
| dronedarone Dronedarone: A non-iodinated derivative of amiodarone that is used for the treatment of ARRHYTHMIA.. dronedarone : A member of the class of 1-benzofurans used for the treatment of cardiac arrhythmias. | 8.66 | 2 | 0 | 1-benzofurans; aromatic ether; aromatic ketone; sulfonamide; tertiary amino compound | anti-arrhythmia drug; environmental contaminant; xenobiotic |
| ramelteon ramelteon: melatonin MT1/MT2 receptor agonist | 4.25 | 5 | 0 | indanes | |
| lapatinib [no description available] | 4.09 | 2 | 0 | furans; organochlorine compound; organofluorine compound; quinazolines | antineoplastic agent; tyrosine kinase inhibitor |
| darunavir Darunavir: An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS.. darunavir : An N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors. | 3.23 | 1 | 0 | carbamate ester; furofuran; sulfonamide | antiviral drug; HIV protease inhibitor |
| eglumetad eglumetad: LY-354740 is the active isomer, LY-366563 is the inactive isomer, and LY 314582 is the racemate; structure given in first source | 2.03 | 1 | 0 | L-alpha-amino acid | |
| deferasirox Deferasirox: A triazole and benzoate derivative that acts as a selective iron chelator. It is used in the management of chronic IRON OVERLOAD due to blood transfusion or non-transfusion dependent THALASSEMIA.. deferasirox : A member of the class of triazoles, deferasirox is 1,2,4-triazole substituted by a 4-carboxyphenyl group at position 1 and by 2-hydroxyphenyl groups at positions 3 and 5. An orally active iron chelator, it is used to manage chronic iron overload in patients receiving long-term blood transfusions. | 3.86 | 3 | 0 | benzoic acids; monocarboxylic acid; phenols; triazoles | iron chelator |
| bms204352 BMS204352: a calcium-sensitive opener of maxi-K potassium channels; structure in first source | 2.08 | 1 | 0 | ||
| tbc-11251 sitaxsentan: endothelin A receptor antagonist; structure in first source | 3.61 | 2 | 0 | benzodioxoles | |
| tolvaptan [no description available] | 3.61 | 2 | 0 | benzazepine; benzenedicarboxamide | aquaretic; vasopressin receptor antagonist |
| sorafenib [no description available] | 3.65 | 2 | 0 | (trifluoromethyl)benzenes; aromatic ether; monochlorobenzenes; phenylureas; pyridinecarboxamide | angiogenesis inhibitor; anticoronaviral agent; antineoplastic agent; EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor; ferroptosis inducer; tyrosine kinase inhibitor |
| lenalidomide [no description available] | 3.61 | 2 | 0 | aromatic amine; dicarboximide; isoindoles; piperidones | angiogenesis inhibitor; antineoplastic agent; immunomodulator |
| solifenacin succinate Solifenacin Succinate: A quinuclidine and tetrahydroisoquinoline derivative and selective M3 MUSCARINIC ANTAGONIST. It is used as a UROLOGIC AGENT in the treatment of URINARY INCONTINENCE. | 3.53 | 1 | 1 | isoquinolines | |
| regadenoson [no description available] | 3.23 | 1 | 0 | purine nucleoside | |
| lacosamide Lacosamide: An acetamide derivative that acts as a blocker of VOLTAGE-GATED SODIUM CHANNELS. It is used as an anticonvulsant, for adjunctive or monotherapy, in the treatment of PARTIAL SEIZURES. | 11.81 | 25 | 4 | N-acyl-amino acid | |
| vincaleukoblastine [no description available] | 3.61 | 2 | 0 | acetate ester; indole alkaloid fundamental parent; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; tertiary alcohol; tertiary amino compound; vinca alkaloid | antineoplastic agent; immunosuppressive agent; microtubule-destabilising agent; plant metabolite |
| vincristine sulfate [no description available] | 2.08 | 1 | 0 | organic sulfate salt | antineoplastic agent; geroprotector |
| potassium bromide potassium bromide : A metal bromide salt with a K(+) counterion. | 8.43 | 1 | 1 | potassium salt | |
| benzarone benzarone: antihemorrhagic agent; structure | 3.23 | 1 | 0 | 1-benzofurans | |
| estramustine Estramustine: A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.. estramustine : A carbamate ester obtained by the formal condensation of the hydroxy group of 17beta-estradiol with the carboxy group of bis(2-chloroethyl)carbamic acid. | 3.23 | 1 | 0 | 17beta-hydroxy steroid; carbamate ester; organochlorine compound | alkylating agent; antineoplastic agent; radiation protective agent |
| wortmannin [no description available] | 2.08 | 1 | 0 | acetate ester; cyclic ketone; delta-lactone; organic heteropentacyclic compound | anticoronaviral agent; antineoplastic agent; autophagy inhibitor; EC 2.7.1.137 (phosphatidylinositol 3-kinase) inhibitor; geroprotector; Penicillium metabolite; radiosensitizing agent |
| bortezomib [no description available] | 4.11 | 4 | 0 | amino acid amide; L-phenylalanine derivative; pyrazines | antineoplastic agent; antiprotozoal drug; protease inhibitor; proteasome inhibitor |
| ritonavir Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. | 3.61 | 2 | 0 | 1,3-thiazoles; carbamate ester; carboxamide; L-valine derivative; ureas | antiviral drug; environmental contaminant; HIV protease inhibitor; xenobiotic |
| leupeptins Leupeptins: A group of acylated oligopeptides produced by Actinomycetes that function as protease inhibitors. They have been known to inhibit to varying degrees trypsin, plasmin, KALLIKREINS, papain and the cathepsins. | 2.17 | 1 | 0 | ||
| lithium chloride Lithium Chloride: A salt of lithium that has been used experimentally as an immunomodulator.. lithium chloride : A metal chloride salt with a Li(+) counterion. | 2.04 | 1 | 0 | inorganic chloride; lithium salt | antimanic drug; geroprotector |
| oxytocin Oxytocin: A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.. oxytocin : A cyclic nonapeptide hormone with amino acid sequence CYIQNCPLG that also acts as a neurotransmitter in the brain; the principal uterine-contracting and milk-ejecting hormone of the posterior pituitary. Together with the neuropeptide vasopressin, it is believed to influence social cognition and behaviour. | 4.12 | 2 | 0 | heterodetic cyclic peptide; peptide hormone | oxytocic; vasodilator agent |
| pentostatin Pentostatin: A potent inhibitor of ADENOSINE DEAMINASE. The drug induces APOPTOSIS of LYMPHOCYTES, and is used in the treatment of many lymphoproliferative malignancies, particularly HAIRY CELL LEUKEMIA. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.. pentostatin : A member of the class of coformycins that is coformycin in which the hydroxy group at position 2' is replaced with a hydrogen. It is a drug used for the treatment of hairy cell leukaemia. | 3.61 | 2 | 0 | coformycins | antimetabolite; antineoplastic agent; Aspergillus metabolite; bacterial metabolite; EC 3.5.4.4 (adenosine deaminase) inhibitor |
| nitroarginine Nitroarginine: An inhibitor of nitric oxide synthetase which has been shown to prevent glutamate toxicity. Nitroarginine has been experimentally tested for its ability to prevent ammonia toxicity and ammonia-induced alterations in brain energy and ammonia metabolites. (Neurochem Res 1995:200(4):451-6). N(gamma)-nitro-L-arginine : An L-arginine derivative that is L-arginine in which the terminal nitrogen of the guanidyl group is replaced by a nitro group. | 2.06 | 1 | 0 | guanidines; L-arginine derivative; N-nitro compound; non-proteinogenic L-alpha-amino acid | |
| quinidine Quinidine: An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.. quinidine : A cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy. | 3.61 | 2 | 0 | cinchona alkaloid | alpha-adrenergic antagonist; anti-arrhythmia drug; antimalarial; drug allergen; EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor; EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor; muscarinic antagonist; P450 inhibitor; potassium channel blocker; sodium channel blocker |
| meropenem Meropenem: A thienamycin derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of bacterial infections, including infections in immunocompromised patients.. meropenem : A carbapenemcarboxylic acid in which the azetidine and pyrroline rings carry 1-hydroxymethyl and in which the azetidine and pyrroline rings carry 1-hydroxymethyl and 5-(dimethylcarbamoyl)pyrrolidin-3-ylthio substituents respectively. | 3.61 | 2 | 0 | alpha,beta-unsaturated monocarboxylic acid; carbapenemcarboxylic acid; organic sulfide; pyrrolidinecarboxamide | antibacterial agent; antibacterial drug; drug allergen |
| griseofulvin Griseofulvin: An antifungal agent used in the treatment of TINEA infections.. griseofulvin : An oxaspiro compound produced by Penicillium griseofulvum. It is used by mouth as an antifungal drug for infections involving the scalp, hair, nails and skin that do not respond to topical treatment. | 3.23 | 1 | 0 | 1-benzofurans; antibiotic antifungal drug; benzofuran antifungal drug; organochlorine compound; oxaspiro compound | antibacterial agent; Penicillium metabolite |
| cefoxitin Cefoxitin: A semisynthetic cephamycin antibiotic resistant to beta-lactamase.. cefoxitin : A semisynthetic cephamycin antibiotic which, in addition to the methoxy group at the 7alpha position, has 2-thienylacetamido and carbamoyloxymethyl side-groups. It is resistant to beta-lactamase. | 3.23 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; cephamycin; semisynthetic derivative | antibacterial drug |
| digitoxin Digitoxin: A cardiac glycoside sometimes used in place of DIGOXIN. It has a longer half-life than digoxin; toxic effects, which are similar to those of digoxin, are longer lasting. (From Martindale, The Extra Pharmacopoeia, 30th ed, p665). digitoxin : A cardenolide glycoside in which the 3beta-hydroxy group of digitoxigenin carries a 2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl-(1->4)-2,6-dideoxy-beta-D-ribo-hexopyranosyl trisaccharide chain. | 2.08 | 1 | 0 | cardenolide glycoside | EC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor |
| saquinavir Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease. | 3.61 | 2 | 0 | L-asparagine derivative; quinolines | antiviral drug; HIV protease inhibitor |
| pancuronium Pancuronium: A bis-quaternary steroid that is a competitive nicotinic antagonist. As a neuromuscular blocking agent it is more potent than CURARE but has less effect on the circulatory system and on histamine release.. pancuronium : A steroid ester in which a 5alpha-androstane skeleton is C-3alpha- and C-17beta-disubstituted with acetoxy groups and 2beta- and 16beta-disubstituted with 1-methylpiperidinium-1-yl groups. It is a non-depolarizing curare-mimetic muscle relaxant. | 3.23 | 1 | 0 | acetate ester; steroid ester | cholinergic antagonist; muscle relaxant; nicotinic antagonist |
| abacavir abacavir: a carbocyclic nucleoside with potent selective anti-HIV activity. abacavir : A 2,6-diaminopurine that is (1S)-cyclopent-2-en-1-ylmethanol in which the pro-R hydrogen at the 4-position is substituted by a 2-amino-6-(cyclopropylamino)-9H-purin-9-yl group. A nucleoside analogue reverse transcriptase inhibitor (NRTI) with antiretroviral activity against HIV, it is used (particularly as the sulfate) with other antiretrovirals in combination therapy of HIV infection. | 3.23 | 1 | 0 | 2,6-diaminopurines | antiviral drug; drug allergen; HIV-1 reverse transcriptase inhibitor |
| perindopril erbumine [no description available] | 2.08 | 1 | 0 | addition compound | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| miglitol [no description available] | 3.61 | 2 | 0 | piperidines | |
| mometasone furoate Mometasone Furoate: A pregnadienediol derivative ANTI-ALLERGIC AGENT and ANTI-INFLAMMATORY AGENT that is used in the management of ASTHMA and ALLERGIC RHINITIS. It is also used as a topical treatment for skin disorders. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 2-furoate ester; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; organochlorine compound; steroid ester | anti-allergic agent; anti-inflammatory drug |
| metyrosine alpha-methyl-L-tyrosine : An L-tyrosine derivative that consists of L-tyrosine bearing an additional methyl substituent at position 2. An inhibitor of the enzyme tyrosine 3-monooxygenase, and consequently of the synthesis of catecholamines. It is used to control the symptoms of excessive sympathetic stimulation in patients with pheochromocytoma. | 3.23 | 1 | 0 | L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | antihypertensive agent; EC 1.14.16.2 (tyrosine 3-monooxygenase) inhibitor |
| rocuronium bromide rocuronium bromide : The organic bromide salt of a 5alpha androstane compound having 3alpha-hydroxy-, 17beta-acetoxy-, 2beta-morpholino- and 16beta-N-allyllyrrolidinium substituents. | 2.08 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent |
| linezolid [no description available] | 3.87 | 3 | 0 | acetamides; morpholines; organofluorine compound; oxazolidinone | antibacterial drug; protein synthesis inhibitor |
| naringin [no description available] | 7.6 | 1 | 0 | (2S)-flavan-4-one; 4'-hydroxyflavanones; dihydroxyflavanone; disaccharide derivative; neohesperidoside | anti-inflammatory agent; antineoplastic agent; metabolite |
| clindamycin phosphate [no description available] | 3.23 | 1 | 0 | ||
| pemirolast potassium salt [no description available] | 2.08 | 1 | 0 | ||
| eplerenone Eplerenone: A spironolactone derivative and selective ALDOSTERONE RECEPTOR antagonist that is used in the management of HYPERTENSION and CONGESTIVE HEART FAILURE, post-MYOCARDIAL INFARCTION. | 3.61 | 2 | 0 | 3-oxo-Delta(4) steroid; epoxy steroid; gamma-lactone; methyl ester; organic heteropentacyclic compound; oxaspiro compound; steroid acid ester | aldosterone antagonist; antihypertensive agent |
| tolterodine [no description available] | 3.23 | 1 | 0 | tertiary amine | antispasmodic drug; muscarinic antagonist; muscle relaxant |
| ao 128 AO 128: alpha-glucosidase inhibitor; structure given in first source | 2.08 | 1 | 0 | organic molecular entity | |
| loteprednol etabonate Loteprednol Etabonate: An androstadiene derivative corticosteroid that is used as an ANTI-ALLERGIC AGENT for the treatment of inflammatory and allergic eye conditions. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; etabonate ester; organochlorine compound; steroid acid ester; steroid ester | anti-inflammatory drug |
| darifenacin darifenacin : 2-[(3S)-1-Ethylpyrrolidin-3-yl]-2,2-diphenylacetamide in which one of the hydrogens at the 2-position of the ethyl group is substituted by a 2,3-dihydro-1-benzofuran-5-yl group. It is a selective antagonist for the M3 muscarinic acetylcholine receptor, which is primarily responsible for bladder muscle contractions, and is used as the hydrobromide salt in the management of urinary incontinence. | 3.23 | 1 | 0 | 1-benzofurans; monocarboxylic acid amide; pyrrolidines | antispasmodic drug; muscarinic antagonist |
| fluticasone propionate fluticasone propionate : A trifluorinated corticosteroid that consists of 6alpha,9-difluoro-11beta,17alpha-dihydroxy-17beta-{[(fluoromethyl)sulfanyl]carbonyl}-16-methyl-3-oxoandrosta-1,4-diene bearing a propionyl substituent at position 17; has anti-inflammatory, anti-asthmatic and anti-allergic activity. | 2.08 | 1 | 0 | 11beta-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; corticosteroid; fluorinated steroid; propanoate ester; steroid ester; thioester | adrenergic agent; anti-allergic agent; anti-asthmatic drug; anti-inflammatory drug; bronchodilator agent; dermatologic drug |
| e-z cinnamic acid cinnamic acid : A monocarboxylic acid that consists of acrylic acid bearing a phenyl substituent at the 3-position. It is found in Cinnamomum cassia.. trans-cinnamic acid : The E (trans) isomer of cinnamic acid | 2.02 | 1 | 0 | cinnamic acid | plant metabolite |
| tretinoin Tretinoin: An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).. retinoic acid : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraenoic acid substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified).. all-trans-retinoic acid : A retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry. | 3.61 | 2 | 0 | retinoic acid; vitamin A | anti-inflammatory agent; antineoplastic agent; antioxidant; AP-1 antagonist; human metabolite; keratolytic drug; retinoic acid receptor agonist; retinoid X receptor agonist; signalling molecule |
| retinol Vitamin A: Retinol and derivatives of retinol that play an essential role in metabolic functioning of the retina, the growth of and differentiation of epithelial tissue, the growth of bone, reproduction, and the immune response. Dietary vitamin A is derived from a variety of CAROTENOIDS found in plants. It is enriched in the liver, egg yolks, and the fat component of dairy products.. vitamin A : Any member of a group of fat-soluble retinoids produced via metabolism of provitamin A carotenoids that exhibit biological activity against vitamin A deficiency. Vitamin A is involved in immune function, vision, reproduction, and cellular communication.. all-trans-retinol : A retinol in which all four exocyclic double bonds have E- (trans-) geometry.. retinol : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraen-1-ol substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified). | 4.14 | 2 | 0 | retinol; vitamin A | human metabolite; mouse metabolite; plant metabolite |
| tacrolimus Tacrolimus: A macrolide isolated from the culture broth of a strain of Streptomyces tsukubaensis that has strong immunosuppressive activity in vivo and prevents the activation of T-lymphocytes in response to antigenic or mitogenic stimulation in vitro.. tacrolimus (anhydrous) : A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis. | 5.81 | 8 | 0 | macrolide lactam | bacterial metabolite; immunosuppressive agent |
| rosuvastatin rosuvastatin : A dihydroxy monocarboxylic acid that is (6E)-7-{4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2-yl)pyrimidin-5-yl} hept-6-enoic acid carrying two hydroxy substituents at positions 3 and 5 (the 3R,5S-diastereomer). | 3.23 | 1 | 0 | dihydroxy monocarboxylic acid; monofluorobenzenes; pyrimidines; statin (synthetic); sulfonamide | anti-inflammatory agent; antilipemic drug; cardioprotective agent; CETP inhibitor; environmental contaminant; xenobiotic |
| cocaine Cocaine: An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.. cocaine : A tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca. | 7.87 | 3 | 0 | benzoate ester; methyl ester; tertiary amino compound; tropane alkaloid | adrenergic uptake inhibitor; central nervous system stimulant; dopamine uptake inhibitor; environmental contaminant; local anaesthetic; mouse metabolite; plant metabolite; serotonin uptake inhibitor; sodium channel blocker; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
| eicosapentaenoic acid icosapentaenoic acid : Any straight-chain, C20 polyunsaturated fatty acid having five C=C double bonds.. all-cis-5,8,11,14,17-icosapentaenoic acid : An icosapentaenoic acid having five cis-double bonds at positions 5, 8, 11, 14 and 17. | 2.03 | 1 | 0 | icosapentaenoic acid; omega-3 fatty acid | anticholesteremic drug; antidepressant; antineoplastic agent; Daphnia galeata metabolite; fungal metabolite; micronutrient; mouse metabolite; nutraceutical |
| mycophenolic acid Mycophenolic Acid: Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.. mycophenolate : A monocarboxylic acid anion resulting from the removal of a proton from the carboxy group of mycophenolic acid.. mycophenolic acid : A member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases. | 4.18 | 2 | 0 | 2-benzofurans; gamma-lactone; monocarboxylic acid; phenols | anticoronaviral agent; antimicrobial agent; antineoplastic agent; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; environmental contaminant; immunosuppressive agent; mycotoxin; Penicillium metabolite; xenobiotic |
| mupirocin Mupirocin: A topically used antibiotic from a strain of Pseudomonas fluorescens. It has shown excellent activity against gram-positive staphylococci and streptococci. The antibiotic is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and wound healing.. mupirocin : An alpha,beta-unsaturated ester resulting from the formal condensation of the alcoholic hydroxy group of 9-hydroxynonanoic acid with the carboxy group of (2E)-4-[(2S)-tetrahydro-2H-pyran-2-yl]-3-methylbut-2-enoic acid in which the tetrahydropyranyl ring is substituted at positions 3 and 4 by hydroxy groups and at position 5 by a {(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl}methyl group. Originally isolated from the Gram-negative bacterium Pseudomonas fluorescens, it is used as a topical antibiotic for the treatment of Gram-positive bacterial infections. | 2.08 | 1 | 0 | alpha,beta-unsaturated carboxylic ester; epoxide; monocarboxylic acid; oxanes; secondary alcohol; triol | antibacterial drug; bacterial metabolite; protein synthesis inhibitor |
| clindamycin Clindamycin: An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.. clindamycin : A carbohydrate-containing antibiotic that is the semisynthetic derivative of lincomycin, a natural antibiotic. | 3.23 | 1 | 0 | ||
| fosfomycin Fosfomycin: An antibiotic produced by Streptomyces fradiae.. fosfomycin : A phosphonic acid having an (R,S)-1,2-epoxypropyl group attached to phosphorus. | 3.23 | 1 | 0 | epoxide; phosphonic acids | antimicrobial agent; EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor |
| zithromax Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections. | 3.61 | 2 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; xenobiotic |
| octreotide [no description available] | 3.23 | 1 | 0 | ||
| eptifibatide [no description available] | 3.23 | 1 | 0 | homodetic cyclic peptide; macrocycle; organic disulfide | anticoagulant; platelet aggregation inhibitor |
| h 89 N-(2-(4-bromocinnamylamino)ethyl)-5-isoquinolinesulfonamide: structure given in first source. N-[2-(4-bromocinnamylamino)ethyl]isoquinoline-5-sulfonamide : A member of the class of isoquinolines that is the sulfonamide obtained by formal condensation of the sulfo group of isoquinoline-5-sulfonic acid with the primary amino group of N(1)-[3-(4-bromophenyl)prop-2-en-1-yl]ethane-1,2-diamine. It is a protein kinase A inhibitor.. (E)-N-[2-(4-bromocinnamylamino)ethyl]isoquinoline-5-sulfonamide : A N-[2-(4-bromocinnamylamino)ethyl]isoquinoline-5-sulfonamide in which the double bond adopts a trans-configuration. | 2.1 | 1 | 0 | N-[2-(4-bromocinnamylamino)ethyl]isoquinoline-5-sulfonamide | |
| decitabine [no description available] | 3.61 | 2 | 0 | 2'-deoxyribonucleoside | |
| teniposide [no description available] | 3.61 | 2 | 0 | aromatic ether; beta-D-glucoside; cyclic acetal; furonaphthodioxole; gamma-lactone; monosaccharide derivative; phenols; thiophenes | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
| kt 5720 KT 5720: indolocarbazole; synthetic derivative of K 252a. KT 5720 : An organic heterooctacyclic compound that is 1H,1'H-2,2'-biindole in which the nitrogens have undergone formal oxidative coupling to positions 2 and 5 of hexyl (3S)-3-hydroxy-2-methyltetrahydrofuran-3-carboxylate (the 2R,3S,5S product), and in which the 3 and 3' positions of the biindole moiety have also undergone formal oxidative coupling to positions 3 and 4 of 1,5-dihydro-2H-pyrrol-2-one. | 2.1 | 1 | 0 | carboxylic ester; gamma-lactam; hemiaminal; indolocarbazole; organic heterooctacyclic compound; semisynthetic derivative; tertiary alcohol | EC 2.7.11.11 (cAMP-dependent protein kinase) inhibitor |
| valrubicin [no description available] | 2.08 | 1 | 0 | anthracycline; trifluoroacetamide | |
| dactinomycin Dactinomycin: A compound composed of a two CYCLIC PEPTIDES attached to a phenoxazine that is derived from STREPTOMYCES parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015) | 3.23 | 1 | 0 | actinomycin | mutagen |
| melphalan Melphalan: An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.. melphalan : A phenylalanine derivative comprising L-phenylalanine having [bis(2-chloroethyl)amino group at the 4-position on the phenyl ring. | 9.14 | 4 | 0 | L-phenylalanine derivative; nitrogen mustard; non-proteinogenic L-alpha-amino acid; organochlorine compound | alkylating agent; antineoplastic agent; carcinogenic agent; drug allergen; immunosuppressive agent |
| tenofovir tenofovir (anhydrous) : A member of the class of phosphonic acids that is methylphosphonic acid in which one of the methyl hydrogens is replaced by a [(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy group. An inhibitor of HIV-1 reverse transcriptase, the bis(isopropyloxycarbonyloxymethyl) ester (disoproxil ester) prodrug is used as the fumaric acid salt in combination therapy for the treatment of HIV infection. | 3.23 | 1 | 0 | nucleoside analogue; phosphonic acids | antiviral drug; drug metabolite; HIV-1 reverse transcriptase inhibitor |
| posaconazole [no description available] | 3.61 | 2 | 0 | aromatic ether; conazole antifungal drug; N-arylpiperazine; organofluorine compound; oxolanes; triazole antifungal drug; triazoles | trypanocidal drug |
| rubitecan rubitecan: RN refers to (+-)-isomer; anti-HIV agent; DNA Topoisomerases, Type I inhibitor. rubitecan : A pyranoindolizinoquinoline that is camptothecin in which the hydrogen at position 9 has been replaced by a nitro group. It is a prodrug for 9-aminocamptothecin. | 2.08 | 1 | 0 | C-nitro compound; delta-lactone; pyranoindolizinoquinoline; semisynthetic derivative; tertiary alcohol | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor; prodrug |
| micafungin Micafungin: A cyclic lipo-hexapeptide echinocandin antifungal agent that is used for the treatment and prevention of CANDIDIASIS.. micafungin : A cyclic hexapeptide echinocandin antibiotic which exerts its effect by inhibiting the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. It is used as the sodium salt for the treatment of invasive candidiasis, and of aspergillosis in patients who are intolerant of other therapy. | 3.23 | 1 | 0 | antibiotic antifungal drug; echinocandin | antiinfective agent |
| riboflavin vitamin B2 : Any member of a group of vitamers that belong to the chemical structural class called flavins that exhibit biological activity against vitamin B2 deficiency. Symptoms associated with vitamin B2 deficiency include glossitis, seborrhea, angular stomaitis, cheilosis and photophobia. The vitamers include riboflavin and its phosphate derivatives (and includes their salt, ionised and hydrate forms). | 3.23 | 1 | 0 | flavin; vitamin B2 | anti-inflammatory agent; antioxidant; cofactor; Escherichia coli metabolite; food colouring; fundamental metabolite; human urinary metabolite; mouse metabolite; photosensitizing agent; plant metabolite |
| sodium bicarbonate Sodium Bicarbonate: A white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions. | 3.23 | 1 | 0 | one-carbon compound; organic sodium salt | antacid; food anticaking agent |
| arsenic trioxide Tetraarsenic Oxide: A form of As2O3 that exists as As4O6 in the solid state. It dissociates to As2O3 upon heating to the vapor phase above 800 degrees Celsius. | 3.23 | 1 | 0 | arsenic oxide | antineoplastic agent; insecticide |
| dipyrone Dipyrone: A drug that has analgesic, anti-inflammatory, and antipyretic properties. It is the sodium sulfonate of AMINOPYRINE.. metamizole sodium : An organic sodium salt of antipyrine substituted at C-4 by a methyl(sulfonatomethyl)amino group, commonly used as a powerful analgesic and antipyretic. | 3.08 | 4 | 0 | organic sodium salt | anti-inflammatory agent; antipyretic; antirheumatic drug; cyclooxygenase 3 inhibitor; non-narcotic analgesic; peripheral nervous system drug; prodrug |
| bd 1063 [no description available] | 2.07 | 1 | 0 | primary amine | |
| sr 90107 fondaparinux sodium : An organic sodium salt, being the decasodium salt of fondaparinux. | 3.23 | 1 | 0 | ||
| meglumine iodipamide [no description available] | 3.23 | 1 | 0 | organoammonium salt | radioopaque medium |
| isomethyleugenol Methylation: Addition of methyl groups. In histo-chemistry methylation is used to esterify carboxyl groups and remove sulfate groups by treating tissue sections with hot methanol in the presence of hydrochloric acid. (From Stedman, 25th ed) | 2.21 | 1 | 0 | isomethyleugenol | |
| retinaldehyde Retinaldehyde: A diterpene derived from the carotenoid VITAMIN A which functions as the active component of the visual cycle. It is the prosthetic group of RHODOPSIN (i.e., covalently bonded to ROD OPSIN as 11-cis-retinal). When stimulated by visible light, rhodopsin transforms this cis-isomer of retinal to the trans-isomer (11-trans-retinal). This transformation straightens-out the bend of the retinal molecule and causes a change in the shape of rhodopsin triggering the visual process. A series of energy-requiring enzyme-catalyzed reactions convert the 11-trans-retinal back to the cis-isomer.. all-trans-retinal : A retinal in which all four exocyclic double bonds have E- (trans-) geometry. | 3.23 | 1 | 0 | retinal; vitamin A | gap junctional intercellular communication inhibitor; human metabolite; mouse metabolite |
| piperine piperine : A N-acylpiperidine that is piperidine substituted by a (1E,3E)-1-(1,3-benzodioxol-5-yl)-5-oxopenta-1,3-dien-5-yl group at the nitrogen atom. It is an alkaloid isolated from the plant Piper nigrum. | 7.6 | 1 | 0 | benzodioxoles; N-acylpiperidine; piperidine alkaloid; tertiary carboxamide | food component; human blood serum metabolite; NF-kappaB inhibitor; plant metabolite |
| thyrotropin-releasing hormone PR 546: no other info available 9/89. protirelin : A tripeptide composed of L-pyroglutamyl, L-histidyl and L-prolinamide residues joined in sequence. | 3.23 | 1 | 0 | peptide hormone; tripeptide | human metabolite |
| cannabidiol Cannabidiol: Compound isolated from Cannabis sativa extract.. cannabidiol : An cannabinoid that is cyclohexene which is substituted by a methyl group at position 1, a 2,6-dihydroxy-4-pentylphenyl group at position 3, and a prop-1-en-2-yl group at position 4. | 4.65 | 4 | 0 | olefinic compound; phytocannabinoid; resorcinols | antimicrobial agent; plant metabolite |
| buprenorphine Buprenorphine: A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.. buprenorphine : A morphinane alkaloid that is 7,8-dihydromorphine 6-O-methyl ether in which positions 6 and 14 are joined by a -CH2CH2- bridge, one of the hydrogens of the N-methyl group is substituted by cyclopropyl, and a hydrogen at position 7 is substituted by a 2-hydroxy-3,3-dimethylbutan-2-yl group. It is highly effective for the treatment of opioid use disorder and is also increasingly being used in the treatment of chronic pain. | 6.37 | 7 | 2 | morphinane alkaloid | delta-opioid receptor antagonist; kappa-opioid receptor antagonist; mu-opioid receptor agonist; opioid analgesic |
| arginine vasopressin Arginine Vasopressin: The predominant form of mammalian antidiuretic hormone. It is a nonapeptide containing an ARGININE at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. Arg-vasopressin is used to treat DIABETES INSIPIDUS or to improve vasomotor tone and BLOOD PRESSURE.. argipressin : The predominant form of mammalian vasopressin (antidiuretic hormone). It is a nonapeptide containing an arginine at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. | 3.61 | 2 | 0 | vasopressin | cardiovascular drug; hematologic agent; mitogen |
| s 1033 [no description available] | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; imidazoles; pyridines; pyrimidines; secondary amino compound; secondary carboxamide | anticoronaviral agent; antineoplastic agent; tyrosine kinase inhibitor |
| trilostane trilostane: inhibits conversion of pregnenolone to progesterone; adrenal blocking agent used in treatment of Cushing's syndrome. trilostane : An epoxy steroid that is 3,17beta-dihydroxy-5alpha-androst-2-ene-2-carbonitrile in which the oxygen of the epoxy group is joined to the 4alpha and 5 alpha positions. | 2.08 | 1 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; androstanoid; epoxy steroid; nitrile | abortifacient; antineoplastic agent; EC 1.1.1.210 [3beta(or 20alpha)-hydroxysteroid dehydrogenase] inhibitor |
| tropisetron Tropisetron: An indole derivative and 5-HT3 RECEPTOR antagonist that is used for the prevention of nausea and vomiting.. tropisetron : An indolyl carboxylate ester obtained by formal condensation of the carboxy group of indole-3-carboxylic acid with the hydroxy group of tropine. | 3.99 | 1 | 1 | indolyl carboxylic acid | |
| leuprolide acetate leuprolide acetate : An acetate salt obtained by combining the nonapeptide leuprolide with acetic acid. A long lasting GnRH analog, LH-Rh agonist. It is a synthetic nonapeptide analogue of gonadotropin-releasing hormone, and is used as a subcutaneous hydrogel implant for the treatment of prostate cancer and for the suppression of gonadal sex hormone production in children with central precocious puberty. | 2.08 | 1 | 0 | acetate salt | antineoplastic agent; gonadotropin releasing hormone agonist |
| propylthiouracil Propylthiouracil: A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534). 6-propyl-2-thiouracil : A pyrimidinethione consisting of uracil in which the 2-oxo group is substituted by a thio group and the hydrogen at position 6 is substituted by a propyl group. | 3.61 | 2 | 0 | pyrimidinethione | antidote to paracetamol poisoning; antimetabolite; antioxidant; antithyroid drug; carcinogenic agent; EC 1.14.13.39 (nitric oxide synthase) inhibitor; hormone antagonist |
| etomidate Etomidate: Imidazole derivative anesthetic and hypnotic with little effect on blood gases, ventilation, or the cardiovascular system. It has been proposed as an induction anesthetic.. etomidate : The ethyl ester of 1-[(1R)-1-phenylethyl]-1H-imidazole-5-carboxylic acid. It is an intravenous general anaesthetic with no analgesic activity. | 3.23 | 1 | 0 | ethyl ester; imidazoles | intravenous anaesthetic; sedative |
| mercaptopurine Mercaptopurine: An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia.. purine-6-thiol : A thiol that is the tautomer of mercaptopurine.. mercaptopurine : A member of the class of purines that is 6,7-dihydro-1H-purine carrying a thione group at position 6. An adenine analogue, it is used in the treatment of acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), Crohn's disease, and ulcerative colitis. | 3.61 | 2 | 0 | aryl thiol; purines; thiocarbonyl compound | anticoronaviral agent; antimetabolite; antineoplastic agent |
| levosulpiride (S)-(-)-sulpiride : An optically active form of sulpiride having (S)-configuration. The active enantiomer of the racemic drug sulpiride. Selective D2-like dopamine antagonist (Ki values are ~ 0.015. ~ 0.013, 1, ~ 45 and ~ 77 muM at D2, D3, D4, D1 and D5 receptors respectively). | 2.08 | 1 | 0 | sulpiride | antidepressant; antiemetic; antipsychotic agent; dopaminergic antagonist |
| pyrantel Pyrantel: A depolarizing neuromuscular-blocking agent, that causes persistent nicotinic activation resulting in spastic paralysis of susceptible nematodes. It is a drug of second-choice after benzimidazoles for treatment of ascariasis, hookworm, and pinworm infections, being effective after a single dose. (From Smith and Reynard, Textbook of Pharmacology, 1992, p920). pyrantel : A carboxamidine that is 1,4,5,6-tetrahydropyrimidine that is substituted at position 1 by a methyl group and at position 2 by an (E)-2-(2-thienyl)vinyl group. It is used, particularly as the embonate [4,4'-methylenebis(3-hydroxy-2-naphthoate)] salt, as an anthelmintic that is effective against intestinal nematodes including threadworms, roundworms and hookworms, and is included in the WHO 'Model List of Essential Medicines'. | 3.23 | 1 | 0 | 1,4,5,6-tetrahydropyrimidines; carboxamidine; thiophenes | antinematodal drug |
| thiothixene [no description available] | 3.23 | 1 | 0 | N-methylpiperazine | anticoronaviral agent |
| eszopiclone Eszopiclone: A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.. eszopiclone : The (5S)- (active) enantiomer of zopiclone. Unlike almost all other hypnotic sedatives, which are approved only for the relief of short-term (6-8 weeks) insomnia, eszopiclone is approved by the U.S. Food and Drug Administration for long-term use. | 3.61 | 2 | 0 | zopiclone | central nervous system depressant; sedative |
| curcumin Curcumin: A yellow-orange dye obtained from tumeric, the powdered root of CURCUMA longa. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes.. curcumin : A beta-diketone that is methane in which two of the hydrogens are substituted by feruloyl groups. A natural dyestuff found in the root of Curcuma longa. | 7.25 | 1 | 0 | aromatic ether; beta-diketone; diarylheptanoid; enone; polyphenol | anti-inflammatory agent; antifungal agent; antineoplastic agent; biological pigment; contraceptive drug; dye; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; EC 1.1.1.21 (aldehyde reductase) inhibitor; EC 1.1.1.25 (shikimate dehydrogenase) inhibitor; EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor; EC 1.8.1.9 (thioredoxin reductase) inhibitor; EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor; EC 3.5.1.98 (histone deacetylase) inhibitor; flavouring agent; food colouring; geroprotector; hepatoprotective agent; immunomodulator; iron chelator; ligand; lipoxygenase inhibitor; metabolite; neuroprotective agent; nutraceutical; radical scavenger |
| ica-121431 ICA-121431: structure in first source | 2.15 | 1 | 0 | ||
| hc 030031 2-(1,3-dimethyl-2,6-dioxo-1,2,3,6-tetrahydro-7H-purin-7-yl)-N-(4-isopropylphenyl)acetamide: a TRPA1 channel blocker | 2.61 | 2 | 0 | ||
| benztropine Benztropine: A centrally active muscarinic antagonist that has been used in the symptomatic treatment of PARKINSON DISEASE. Benztropine also inhibits the uptake of dopamine.. benzatropine : Tropane in which a hydrogen at position 3 is substituted by a diphenylmethoxy group (endo-isomer). An acetylcholine receptor antagonist, it is used (particularly as its methanesulphonate salt) in the treatment of Parkinson's disease, and to reduce parkinsonism and akathisia side effects of antipsychotic treatments. | 3.23 | 1 | 0 | diarylmethane | |
| methimazole Methimazole: A thioureylene antithyroid agent that inhibits the formation of thyroid hormones by interfering with the incorporation of iodine into tyrosyl residues of thyroglobulin. This is done by interfering with the oxidation of iodide ion and iodotyrosyl groups through inhibition of the peroxidase enzyme.. methimazole : A member of the class of imidazoles that it imidazole-2-thione in which a methyl group replaces the hydrogen which is attached to a nitrogen. | 3.61 | 2 | 0 | 1,3-dihydroimidazole-2-thiones | antithyroid drug |
| cinnarizine Cinnarizine: A piperazine derivative having histamine H1-receptor and calcium-channel blocking activity with vasodilating and antiemetic properties but it induces PARKINSONIAN DISORDERS. | 2.08 | 1 | 0 | diarylmethane; N-alkylpiperazine; olefinic compound | anti-allergic agent; antiemetic; calcium channel blocker; geroprotector; H1-receptor antagonist; histamine antagonist; muscarinic antagonist |
| sulindac Sulindac: A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.. sulindac : A monocarboxylic acid that is 1-benzylidene-1H-indene which is substituted at positions 2, 3, and 5 by methyl, carboxymethyl, and fluorine respectively, and in which the phenyl group of the benzylidene moiety is substituted at the para position by a methylsulfinyl group. It is a prodrug for the corresponding sulfide, a non-steroidal anti-inflammatory drug, used particularly in the treatment of acute and chronic inflammatory conditions. | 3.61 | 2 | 0 | monocarboxylic acid; organofluorine compound; sulfoxide | analgesic; antineoplastic agent; antipyretic; apoptosis inducer; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug; tocolytic agent |
| capsaicin ALGRX-4975: an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief. capsaicinoid : A family of aromatic fatty amides produced as secondary metabolites by chilli peppers. | 14.75 | 38 | 9 | capsaicinoid | non-narcotic analgesic; TRPV1 agonist; voltage-gated sodium channel blocker |
| terbinafine [no description available] | 3.23 | 1 | 0 | acetylenic compound; allylamine antifungal drug; enyne; naphthalenes; tertiary amine | EC 1.14.13.132 (squalene monooxygenase) inhibitor; P450 inhibitor; sterol biosynthesis inhibitor |
| epalrestat epalrestat : A monocarboxylic acid that is 1,3-thiazolidine which is substituted on the nitrogen by a carboxymethyl group, at positions 2 and 4 by thioxo and oxo groups, respectively, and at position 5 by a 2-methyl-3-phenylprop-2-en-1-ylidene group. It is an inhibitor of aldose reductase (which catalyses the conversion of glucose to sorbitol) and is used for the treatment of some diabetic complications, including neuropathy. | 2.08 | 1 | 0 | monocarboxylic acid; thiazolidines | EC 1.1.1.21 (aldehyde reductase) inhibitor |
| oxazolone Oxazolone: Immunologic adjuvant and sensitizing agent. | 7.06 | 1 | 0 | ||
| drotaverin drotaverin: Hungarian drug; RN given refers to parent cpd; structure | 2.08 | 1 | 0 | isoquinolines | |
| longifolene longifolene: from plant products; RN given refers to (1S-(1alpha,3abeta,4alpha,8abeta))-isomer; structure given in first source | 2.6 | 1 | 0 | longifolene | |
| thioguanine anhydrous Thioguanine: An antineoplastic compound which also has antimetabolite action. The drug is used in the therapy of acute leukemia.. tioguanine : A 2-aminopurine that is the 6-thiono derivative of 2-amino-1,9-dihydro-6H-purine. Incorporates into DNA and inhibits synthesis. Used in the treatment of leukaemia. | 3.23 | 1 | 0 | 2-aminopurines | anticoronaviral agent; antimetabolite; antineoplastic agent |
| D-fructopyranose [no description available] | 7.21 | 22 | 0 | cyclic hemiketal; D-fructose; fructopyranose | sweetening agent |
| succimer Succimer: A mercaptodicarboxylic acid used as an antidote to heavy metal poisoning because it forms strong chelates with them.. succimer : A sulfur-containing carboxylic acid that is succinic acid bearing two mercapto substituents at positions 2 and 3. A lead chelator used as an antedote to lead poisoning. | 3.23 | 1 | 0 | dicarboxylic acid; dithiol; sulfur-containing carboxylic acid | chelator |
| digoxin Digoxin: A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666). digoxin : A cardenolide glycoside that is digitoxin beta-hydroxylated at C-12. A cardiac glycoside extracted from the foxglove plant, Digitalis lanata, it is used to control ventricular rate in atrial fibrillation and in the management of congestive heart failure with atrial fibrillation, but the margin between toxic and therapeutic doses is small. | 3.57 | 2 | 0 | cardenolide glycoside; steroid saponin | anti-arrhythmia drug; cardiotonic drug; EC 3.6.3.9 (Na(+)/K(+)-transporting ATPase) inhibitor; epitope |
| streptozocin [no description available] | 3.23 | 1 | 0 | ||
| capsazepine capsazepine: modified capsaicin molecule; a capsaicin receptor antagonist. capsazepine : A benzazepine that is 2,3,4,5-tetrahydro-1H-2-benzazepine which is substituted by hydroxy groups at positions 7 and 8 and on the nitrogen atom by a 2-(p-chlorophenyl)ethylaminothiocarbonyl group. A synthetic analogue of capsaicin, it was the first reported capsaicin receptor antagonist. | 2.08 | 1 | 0 | benzazepine; catechols; monochlorobenzenes; thioureas | capsaicin receptor antagonist |
| tamoxifen [no description available] | 3.61 | 2 | 0 | stilbenoid; tertiary amino compound | angiogenesis inhibitor; antineoplastic agent; bone density conservation agent; EC 1.2.3.1 (aldehyde oxidase) inhibitor; EC 2.7.11.13 (protein kinase C) inhibitor; estrogen antagonist; estrogen receptor antagonist; estrogen receptor modulator |
| ethionamide Ethionamide: A second-line antitubercular agent that inhibits mycolic acid synthesis.. ethionamide : A thiocarboxamide that is pyridine-4-carbothioamide substituted by an ethyl group at position 2. A prodrug that undergoes metabolic activation by conversion to the corresponding S-oxide. | 3.23 | 1 | 0 | pyridines; thiocarboxamide | antilipemic drug; antitubercular agent; fatty acid synthesis inhibitor; leprostatic drug; prodrug |
| cancidas [no description available] | 3.23 | 1 | 0 | ||
| 3-(n,n-dimethylsulfonamido)-4-methyl-nitrobenzene BRL-50481 : A C-nitro compound that is benzene substituted by N,N-dimethylaminosulfonyl, methyl and nitro groups at positions 1, 2 and 5, respectively. It is a phosphodiesterase inhibitor selective for the PDE7 subtype (Ki = 180 nM). | 2.17 | 1 | 0 | C-nitro compound; sulfonamide; toluenes | bone density conservation agent; EC 3.1.4.53 (3',5'-cyclic-AMP phosphodiesterase) inhibitor; geroprotector |
| fusidic acid Fusidic Acid: An antibiotic isolated from the fermentation broth of Fusidium coccineum. (From Merck Index, 11th ed). It acts by inhibiting translocation during protein synthesis.. fusidic acid : A steroid antibiotic that is isolated from the fermentation broth of Fusidium coccineum. | 2.52 | 2 | 0 | 11alpha-hydroxy steroid; 3alpha-hydroxy steroid; alpha,beta-unsaturated monocarboxylic acid; steroid acid; steroid antibiotic; sterol ester | EC 2.7.1.33 (pantothenate kinase) inhibitor; Escherichia coli metabolite; protein synthesis inhibitor |
| lincomycin Lincomycin: An antibiotic produced by Streptomyces lincolnensis var. lincolnensis. It has been used in the treatment of staphylococcal, streptococcal, and Bacteroides fragilis infections.. lincomycin : A carbohydrate-containing antibiotic produced by the actinomyces Streptomyces lincolnensis. | 3.23 | 1 | 0 | carbohydrate-containing antibiotic; L-proline derivative; monocarboxylic acid amide; pyrrolidinecarboxamide; S-glycosyl compound | antimicrobial agent; bacterial metabolite |
| valinomycin Valinomycin: A cyclododecadepsipeptide ionophore antibiotic produced by Streptomyces fulvissimus and related to the enniatins. It is composed of 3 moles each of L-valine, D-alpha-hydroxyisovaleric acid, D-valine, and L-lactic acid linked alternately to form a 36-membered ring. (From Merck Index, 11th ed) Valinomycin is a potassium selective ionophore and is commonly used as a tool in biochemical studies.. valinomycin : A twelve-membered cyclodepsipeptide composed of three repeating D-alpha-hydroxyisovaleryl-D-valyl-L-lactoyl-L-valyl units joined in sequence. An antibiotic found in several Streptomyces strains. | 2.08 | 1 | 0 | cyclodepsipeptide; macrocycle | antimicrobial agent; antiviral agent; bacterial metabolite; potassium ionophore |
| thiopental Thiopental: A barbiturate that is administered intravenously for the induction of general anesthesia or for the production of complete anesthesia of short duration.. thiopental : A barbiturate, the structure of which is that of 2-thiobarbituric acid substituted at C-5 by ethyl and sec-pentyl groups. | 2.08 | 1 | 0 | barbiturates | anticonvulsant; drug allergen; environmental contaminant; intravenous anaesthetic; sedative; xenobiotic |
| ranitidine Ranitidine: A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.. ranitidine : A member of the class of furans used to treat peptic ulcer disease (PUD) and gastroesophageal reflux disease. | 3.23 | 1 | 0 | C-nitro compound; furans; organic sulfide; tertiary amino compound | anti-ulcer drug; drug allergen; environmental contaminant; H2-receptor antagonist; xenobiotic |
| aplaviroc aplaviroc: a spiro-diketo-piperazine; a potent noncompetitive allosteric antagonist of the CCR5 receptor with concomitantly potent antiviral effects for HIV-1; structure in first source | 3.23 | 1 | 0 | ||
| hmr 3647 [no description available] | 3.61 | 2 | 0 | ||
| latoconazole latoconazole: RN refers to cpd without isomeric designation; latoconazole is (E)-isomer; structure given in first source | 2.08 | 1 | 0 | conazole antifungal drug; imidazole antifungal drug | |
| maraviroc [no description available] | 3.61 | 2 | 0 | tropane alkaloid | |
| toremifene citrate [no description available] | 2.08 | 1 | 0 | stilbenoid | anticoronaviral agent |
| toremifene Toremifene: A first generation selective estrogen receptor modulator (SERM). Like TAMOXIFEN, it is an estrogen agonist for bone tissue and cholesterol metabolism but is antagonistic on mammary and uterine tissue. | 3.23 | 1 | 0 | aromatic ether; organochlorine compound; tertiary amine | antineoplastic agent; bone density conservation agent; estrogen antagonist; estrogen receptor modulator |
| nelarabine nelarabine: prodrug of ara-G. nelarabine : A purine nucleoside in which O-methylguanine is attached to arabinofuranose via a beta-N(9)-glycosidic bond. Inhibits DNA synthesis and causes cell death; a prodrug of 9-beta-D-arabinofuranosylguanine (ara-G). | 3.61 | 2 | 0 | beta-D-arabinoside; monosaccharide derivative; purine nucleoside | antineoplastic agent; DNA synthesis inhibitor; prodrug |
| 6-methyl-2-(phenylethynyl)pyridine 6-methyl-2-(phenylethynyl)pyridine: an mGlu5 antagonist. 2-methyl-6-(phenylethynyl)pyridine : A methylpyridine that coinsists of 2-methylp[yridine bearing an additional phenylethynyl group at position 6. Potent and highly selective non-competitive antagonist at the mGlu5 receptor subtype (IC50 = 36 nM) and a positive allosteric modulator at mGlu4 receptors. Centrally active following systemic administration in vivo. Reverses mechanical hyperalgesia in the inflamed rat hind paw. | 2.55 | 2 | 0 | acetylenic compound; methylpyridines | anxiolytic drug; metabotropic glutamate receptor antagonist |
| lithium Lithium: An element in the alkali metals family. It has the atomic symbol Li, atomic number 3, and atomic weight [6.938; 6.997]. Salts of lithium are used in treating BIPOLAR DISORDER. | 7.01 | 1 | 0 | alkali metal atom | |
| dermatan sulfate Dermatan Sulfate: A naturally occurring glycosaminoglycan found mostly in the skin and in connective tissue. It differs from CHONDROITIN SULFATE A (see CHONDROITIN SULFATES) by containing IDURONIC ACID in place of glucuronic acid, its epimer, at carbon atom 5. (from Merck, 12th ed). alpha-L-IdopA-(1->3)-beta-D-GalpNAc4S : An oligosaccharide sulfate that is 2-acetamido-2-deoxy-4-O-sulfo-beta-D-galactopyranose in which the hydroxy group at position 3 has been converted to the corresponding alpha-L-idopyranuronoside.. dermatan sulfate : Any of a group of glycosaminoglycans with repeating units consisting of variously sulfated beta1->4-linked L-iduronyl-(alpha1->3)-N-acetyl-D-galactosamine units. | 3.23 | 1 | 0 | amino disaccharide; glycosylgalactose derivative; iduronic acids; oligosaccharide sulfate | |
| dezocine dezocine: potent analgesic; RN given refers to ((5R-(5alpha,11alpha,13S*)))-isomer (dezocin); structure. dezocine : (7S,8S)-7-Amino-8-methyl-5,6,7,8-tetrahydronaphthalen-2-ol in which the hydrogen at position 8 and one of the hydrogens at position 6 are substituted by each end of a tetramethylene bridge. A synthetic opioid analgesic, it has mixed opiod agonist and antagonist properties. Although it is used for pain management, it can produce opioid withdrawal syndrome in patients already dependent on other opioids, and its clinical application is limited by side effects such as dizziness. | 3.31 | 1 | 0 | phenols; primary amino compound | opioid analgesic |
| dolasetron [no description available] | 3.23 | 1 | 0 | indolyl carboxylic acid | |
| gestodene Gestodene: synthetic steroid with progestational activity; RN given refers to (17alpha)-isomer | 2.08 | 1 | 0 | steroid | estrogen |
| orlistat Orlistat: A lactone derivative of LEUCINE that acts as a pancreatic lipase inhibitor to limit the absorption of dietary fat; it is used in the management of obesity.. orlistat : A carboxylic ester resulting from the formal condensation of the carboxy group of N-formyl-L-leucine with the hydroxy group of (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one. A pancreatic lipase inhibitor, it is used as an anti-obesity drug. | 3.61 | 2 | 0 | beta-lactone; carboxylic ester; formamides; L-leucine derivative | anti-obesity agent; bacterial metabolite; EC 2.3.1.85 (fatty acid synthase) inhibitor; EC 3.1.1.3 (triacylglycerol lipase) inhibitor |
| quinine [no description available] | 3.61 | 2 | 0 | cinchona alkaloid | antimalarial; muscle relaxant; non-narcotic analgesic |
| sch 23390 SCH 23390: a selective D1-receptor antagonist. SCH 23390 : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine bearing a phenyl substituent at position 1, a methyl substituent at position 3, a chloro substituent at position 7 and a hydroxy substituent at position 8. | 2.17 | 1 | 0 | benzazepine | |
| fospropofol [no description available] | 3.23 | 1 | 0 | alkylbenzene | |
| azilect [no description available] | 2.08 | 1 | 0 | ||
| rasagiline [no description available] | 3.23 | 1 | 0 | indanes; secondary amine; terminal acetylenic compound | EC 1.4.3.4 (monoamine oxidase) inhibitor; neuroprotective agent |
| dasatinib N-(2-chloro-6-methylphenyl)-2-((6-(4-(2-hydroxyethyl)piperazin-1-yl)-2-methylpyrimidin-4-yl)amino)-1,3-thiazole-5-carboxamide: a dasatinib prodrug; structure in first source. dasatinib (anhydrous) : An aminopyrimidine that is 2-methylpyrimidine which is substituted at position 4 by the primary amino group of 2-amino-1,3-thiazole-5-carboxylic acid and at position 6 by a 4-(2-hydroxyethyl)piperazin-1-yl group, and in which the carboxylic acid group has been formally condensed with 2-chloro-6-methylaniline to afford the corresponding amide. A multi-targeted kinase inhibitor, it is used, particularly as the monohydrate, for the treatment of chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia. Note that the name 'dasatinib' is used to refer to the monohydrate (USAN) as well as to anhydrous dasatinib (INN). | 3.61 | 2 | 0 | 1,3-thiazoles; aminopyrimidine; monocarboxylic acid amide; N-(2-hydroxyethyl)piperazine; N-arylpiperazine; organochlorine compound; secondary amino compound; tertiary amino compound | anticoronaviral agent; antineoplastic agent; tyrosine kinase inhibitor |
| 2,3-dioxo-6-nitro-7-sulfamoylbenzo(f)quinoxaline 2,3-dioxo-6-nitro-7-sulfamoylbenzo(f)quinoxaline: structure given in first source; neuroprotectant for cerebral ischemia; AMPA receptor antagonist | 2.01 | 1 | 0 | naphthalenes; sulfonic acid derivative | |
| alizarin red s Alizarin Red S: RN given refers to parent cpd; structure. alizarin red S : An organic sodium salt having 3,4-dihydroxy-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate as the counterion. It is commonly used to stain embryo skeletons in cleared whole mounts, usually of small mammals. | 2.08 | 1 | 0 | organic sodium salt; organosulfonate salt | histological dye |
| sitagliptin sitagliptin : A triazolopyrazine that exhibits hypoglycemic activity. | 3.61 | 2 | 0 | triazolopyrazine; trifluorobenzene | EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor; environmental contaminant; hypoglycemic agent; serine proteinase inhibitor; xenobiotic |
| osteoprotegerin Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B. | 2.21 | 1 | 0 | long-chain fatty acid | |
| 3-(2-hydroxy-4-(1,1-dimethylheptyl)phenyl)-4-(3-hydroxypropyl)cyclohexanol 3-(2-hydroxy-4-(1,1-dimethylheptyl)phenyl)-4-(3-hydroxypropyl)cyclohexanol: (-)-CP-55,940 and (+)-CP-56,667 are enantiomers; RN refers to CP-55,940 | 2.08 | 1 | 0 | alkylbenzene; ring assembly | |
| rhodamine 123 Rhodamine 123: A fluorescent probe with low toxicity which is a potent substrate for ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 and the bacterial multidrug efflux transporter. It is used to assess mitochondrial bioenergetics in living cells and to measure the efflux activity of ATP BINDING CASSETTE TRANSPORTER, SUBFAMILY B, MEMBER 1 in both normal and malignant cells. (Leukemia 1997;11(7):1124-30). rhodamine 123(1+) : A cationic fluorescent dye derived from 9-phenylxanthene. | 2.1 | 1 | 0 | organic cation; xanthene dye | fluorochrome |
| tolcapone Tolcapone: A benzophenone and nitrophenol compound that acts as an inhibitor of CATECHOL O-METHYLTRANSFERASE, an enzyme involved in the metabolism of DOPAMINE and LEVODOPA. It is used in the treatment of PARKINSON DISEASE in patients for whom levodopa is ineffective or contraindicated.. tolcapone : Benzophenone substituted on one of the phenyl rings at C-3 and C-4 by hydroxy groups and at C-5 by a nitro group, and on the other phenyl ring by a methyl group at C-4. It is an inhibitor of catechol O-methyltransferase. | 3.61 | 2 | 0 | 2-nitrophenols; benzophenones; catechols | antiparkinson drug; EC 2.1.1.6 (catechol O-methyltransferase) inhibitor |
| mrs2159 MRS2159: an antagonist of both P2X1 and P2X7 receptors | 2.08 | 1 | 0 | ||
| sphingosine sphing-4-enine : A sphingenine in which the C=C double bond is located at the 4-position.. sphingenine : A 2-aminooctadecene-1,3-diol having (2S,3R)-configuration.. sphingoid : Sphinganine, its homologs and stereoisomers, and the hydroxy and unsaturated derivatives of these compounds.. 2-aminooctadec-4-ene-1,3-diol : A 2-aminooctadecene-1,3-diol having its double bond at position 4. | 2.11 | 1 | 0 | sphing-4-enine | human metabolite; mouse metabolite |
| quercetin [no description available] | 2.08 | 1 | 0 | 7-hydroxyflavonol; pentahydroxyflavone | antibacterial agent; antineoplastic agent; antioxidant; Aurora kinase inhibitor; chelator; EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor; geroprotector; phytoestrogen; plant metabolite; protein kinase inhibitor; radical scavenger |
| bilirubin [no description available] | 2.06 | 1 | 0 | biladienes; dicarboxylic acid | antioxidant; human metabolite; mouse metabolite |
| calcitriol dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes | 3.61 | 2 | 0 | D3 vitamins; hydroxycalciol; triol | antineoplastic agent; antipsoriatic; bone density conservation agent; calcium channel agonist; calcium channel modulator; hormone; human metabolite; immunomodulator; metabolite; mouse metabolite; nutraceutical |
| alprostadil [no description available] | 6.1 | 5 | 2 | prostaglandins E | anticoagulant; human metabolite; platelet aggregation inhibitor; vasodilator agent |
| vitamin d 2 Ergocalciferols: Derivatives of ERGOSTEROL formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. They differ from CHOLECALCIFEROL in having a double bond between C22 and C23 and a methyl group at C24.. vitamin D2 : A vitamin D supplement and has been isolated from alfalfa. | 3.61 | 2 | 0 | hydroxy seco-steroid; seco-ergostane; vitamin D | bone density conservation agent; nutraceutical; plant metabolite; rodenticide |
| gamma-linolenic acid gamma-Linolenic Acid: An omega-6 fatty acid produced in the body as the delta 6-desaturase metabolite of linoleic acid. It is converted to dihomo-gamma-linolenic acid, a biosynthetic precursor of monoenoic prostaglandins such as PGE1. (From Merck Index, 11th ed). gamma-linolenic acid : A C18, omega-6 acid fatty acid comprising a linolenic acid having cis- double bonds at positions 6, 9 and 12. | 4.13 | 2 | 0 | linolenic acid; omega-6 fatty acid | human metabolite; mouse metabolite; plant metabolite |
| amphotericin b Amphotericin B: Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.. amphotericin B : A macrolide antibiotic used to treat potentially life-threatening fungal infections. | 3.23 | 1 | 0 | antibiotic antifungal drug; macrolide antibiotic; polyene antibiotic | antiamoebic agent; antiprotozoal drug; bacterial metabolite |
| pulmicort Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis. | 3.61 | 2 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic acetal; glucocorticoid; primary alpha-hydroxy ketone | anti-inflammatory drug; bronchodilator agent; drug allergen |
| oxymetholone Oxymetholone: A synthetic hormone with anabolic and androgenic properties. It is used mainly in the treatment of anemias. According to the Fourth Annual Report on Carcinogens (NTP 85-002), this compound may reasonably be anticipated to be a carcinogen. (From Merck Index, 11th ed). oxymetholone : A 3-oxo-5alpha- steroid that is 4,5alpha-dihydrotestosterone which is substituted by a hydroxymethylidene group at position 2 and by a methyl group at the 17alpha position. A synthetic androgen, it was mainly used for the treatment of anaemias until being replaced by treatments with fewer side effects. | 3.61 | 2 | 0 | ||
| eprosartan eprosartan: angiotensin II receptor antagonist. eprosartan : A member of the class of imidazoles and thiophenes that is an angiotensin II receptor antagonist used for the treatment of high blood pressure. | 3.61 | 2 | 0 | dicarboxylic acid; imidazoles; thiophenes | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| montelukast montelukast: a leukotriene D4 receptor antagonist | 3.23 | 1 | 0 | aliphatic sulfide; monocarboxylic acid; quinolines | anti-arrhythmia drug; anti-asthmatic drug; leukotriene antagonist |
| mivacurium Mivacurium: An isoquinoline derivative that is used as a short-acting non-depolarizing agent. | 3.23 | 1 | 0 | isoquinolines | |
| brompheniramine maleate brompheniramine maleate : The maleic acid salt of brompheniramine. A histamine H1 receptor antagonist, it is used for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 2.08 | 1 | 0 | maleate salt | anti-allergic agent |
| dexchlorpheniramine maleate [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
| hemabate carboprost tromethamine : The tromethamine salt of carboprost. It is used as an abortifacient agent that is effective in both the first and second trimesters of pregnancy. | 3.23 | 1 | 0 | ||
| mycophenolate mofetil mycophenolate mofetil : A carboxylic ester resulting from the formal condensation between the carboxylic acid group of mycophenolic acid and the hydroxy group of 2-(morpholin-4-yl)ethanol. In the liver, it is metabolised to mycophenolic acid, an immunosuppressant for which it is a prodrug. It is widely used to prevent tissue rejection following organ transplants as well as for the treatment of certain autoimmune diseases. | 3.61 | 2 | 0 | carboxylic ester; ether; gamma-lactone; phenols; tertiary amino compound | anticoronaviral agent; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; immunosuppressive agent; prodrug |
| entacapone entacapone: structure given in first source. entacapone : A monocarboxylic acid amide that is N,N-diethylprop-2-enamide in which the hydrogen at position 2 is substituted by a cyano group and the hydrogen at the 3E position is substituted by a 3,4-dihydroxy-5-nitrophenyl group. | 3.61 | 2 | 0 | 2-nitrophenols; catechols; monocarboxylic acid amide; nitrile | antidyskinesia agent; antiparkinson drug; central nervous system drug; EC 2.1.1.6 (catechol O-methyltransferase) inhibitor |
| paricalcitol [no description available] | 3.23 | 1 | 0 | hydroxy seco-steroid; seco-cholestane | antiparathyroid drug |
| humulene humulene: structure given in first source. (1E,4E,8E)-alpha-humulene : The (1E,4E,8E)-isomer of alpha-humulene. | 4.02 | 2 | 1 | alpha-humulene | |
| sdz psc 833 valspodar: nonimmunosuppressive cyclosporin analog which is a potent multidrug resistance modifier; 7-10 fold more potent than cyclosporin A; a potent P glycoprotein inhibitor; MW 1215 | 2.13 | 1 | 0 | homodetic cyclic peptide | |
| l 660,711 [no description available] | 2.08 | 1 | 0 | quinolines | |
| coenzyme q10 coenzyme Q10: Ubiquinone ring with a chain of 10 isoprene units; redox equilibrium with ubiqunol serving in mitochondrial inner membrane to transfer electrons; presence during reconstitution of acetylcholine receptor into phospholipid vesicles yields vesicles active in catalyzing carbamylcholine-sensitive Na+ flux; coenzyme Q10 depletion has been noted with use of statins. coenzyme Q10 : A ubiquinone having a side chain of 10 isoprenoid units. In the naturally occurring isomer, all isoprenyl double bonds are in the E- configuration. | 9.63 | 2 | 2 | ubiquinones | antioxidant; ferroptosis inhibitor; human metabolite |
| travoprost Travoprost: A cloprostenol derivative that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.. travoprost : The isopropyl ester of prostaglandin F2alpha in which the pentyl group is replaced by a 3-(trifluoromethyl)phenoxymethyl group. A synthetic analogue of prostaglandin F2alpha, ophthalmic solutions of travoprost are used as a topical medication for controlling the progression of open-angle glaucoma and ocular hypertension, by reducing intraocular pressure. It is a pro-drug; the isopropyl ester group is hydrolysed by esterases in the cornea to the biologically active free acid, fluprostenol. | 2.08 | 1 | 0 | (trifluoromethyl)benzenes; isopropyl ester; prostaglandins Falpha | antiglaucoma drug; antihypertensive agent; ophthalmology drug; prodrug; prostaglandin receptor agonist |
| tranilast tranilast: antiallergic drug; potent inhibitor of homologous passive cutaneous anaphylaxis. tranilast : An amidobenzoic acid that is anthranilic acid in which one of the anilino hydrogens is replaced by a 3,4-dimethoxycinnamoyl group. | 2.08 | 1 | 0 | amidobenzoic acid; cinnamamides; dimethoxybenzene; secondary carboxamide | anti-allergic agent; anti-asthmatic drug; antineoplastic agent; aryl hydrocarbon receptor agonist; calcium channel blocker; hepatoprotective agent; nephroprotective agent |
| 7432 s Ceftibuten: A cephalosporin antibacterial agent that is used in the treatment of infections, including urinary-tract and respiratory-tract infections.. ceftibuten : A third-generation cephalosporin antibiotic with a [(2Z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino substituent at the 7 position of the cephem skeleton. An orally-administered agent, ceftibuten is used as the dihydrate to treat urinary-tract and respiratory-tract infections. | 3.23 | 1 | 0 | cephalosporin; dicarboxylic acid | antibacterial drug |
| n,n-dimethylsphingenine N,N-dimethylsphingosine: a sphingosine kinase inhibitor. N,N-dimethylsphingosine : A sphingoid that is sphingosine in which the two amino hydrogens are replaced by methyl groups. | 2.11 | 1 | 0 | aminodiol; sphingoid; tertiary amino compound | EC 2.7.1.91 (sphingosine kinase) inhibitor; metabolite |
| imipenem [no description available] | 2.08 | 1 | 0 | carbapenems | |
| etretinate retinoid : Oxygenated derivatives of 3,7-dimethyl-1-(2,6,6-trimethylcyclohex-1-enyl)nona-1,3,5,7-tetraene and derivatives thereof. | 2.08 | 1 | 0 | enoate ester; ethyl ester; retinoid | keratolytic drug |
| isotretinoin Isotretinoin: A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.. isotretinoin : A retinoic acid that is all-trans-retinoic acid in which the double bond which is alpha,beta- to the carboxy group is isomerised to Z configuration. A synthetic retinoid, it is used for the treatment of severe cases of acne and other skin diseases. | 3.61 | 2 | 0 | retinoic acid | antineoplastic agent; keratolytic drug; teratogenic agent |
| misoprostol Misoprostol: A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.. misoprostol : A diastereoisomeric mixture composed of approximately equal amounts of a double racemate of four of the sixteen possible diastereoisomers of methyl (13E)-11,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oate that is racemic prostaglandin E1 which is lacking the hydroxy group at position 15, but which has an additional hydroxy group at position 16. It is a synthetic prostaglandin E1 analogue, used in the treatment of gastric and duodenal ulcers. A weak abortifacient, it is also used for cervical ripening prior to surgical termination of pregnancy. The (11R,16S)-diastereoisomer is the pharmacologically active form. | 8.51 | 4 | 1 | ||
| ketotifen fumarate ketotifen fumarate : An organoammonium salt consisting of equimolar amounts of ketotifen(1+) and fumarate(1-) ions. A blocker of histamine H1 receptors with a stabilising action on mast cells, it is a non-bronchodilator anti-asthmatic drug. | 2.08 | 1 | 0 | organoammonium salt | anti-asthmatic drug; H1-receptor antagonist |
| epoprostenol [no description available] | 3.23 | 1 | 0 | prostaglandins I | mouse metabolite |
| indocyanine green [no description available] | 3.23 | 1 | 0 | 1,1-diunsubstituted alkanesulfonate; benzoindole; cyanine dye | |
| dinoprost tromethamine [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
| triprolidine Triprolidine: Histamine H1 antagonist used in allergic rhinitis; ASTHMA; and URTICARIA. It is a component of COUGH and COLD medicines. It may cause drowsiness.. triprolidine : An N-alkylpyrrolidine that is acrivastine in which the pyridine ring is lacking the propenoic acid substituent. It is a sedating antihistamine that is used (generally as the monohydrochloride monohydrate) for the relief of the symptoms of uticaria, rhinitis, and various pruritic skin disorders. | 3.23 | 1 | 0 | N-alkylpyrrolidine; olefinic compound; pyridines | H1-receptor antagonist |
| pitavastatin pitavastatin : A dihydroxy monocarboxylic acid that is (6E)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]hept-6-enoic acid in which the two hydroxy groups are located at positions 3 and 5 (the 3R,5S-stereoisomer). Used as its calcium salt for treatment of hypercholesterolemia (elevated levels of cholesterol in the blood) on patients unable to sufficiently lower their cholesterol levels by diet and exercise. | 3.23 | 1 | 0 | cyclopropanes; dihydroxy monocarboxylic acid; monofluorobenzenes; quinolines; statin (synthetic) | antioxidant |
| rosuvastatin calcium S 4522: structure in first source | 2.08 | 1 | 0 | N-acyl-15-methylhexadecasphinganine-1-phosphoethanolamine; organic calcium salt | anti-inflammatory agent; cardioprotective agent; CETP inhibitor |
| terbinafine hydrochloride terbinafine hydrochloride : A hydrochloride obtained by reaction of terbinafine with one molar equivalent of hydrogen chloride. | 2.08 | 1 | 0 | allylamine antifungal drug; hydrochloride | EC 1.14.13.132 (squalene monooxygenase) inhibitor; P450 inhibitor |
| ethamolin monoethanolamine oleate: used for treatment of pyogenic granuloma | 3.23 | 1 | 0 | long-chain fatty acid | |
| alatrofloxacin mesylate [no description available] | 3.23 | 1 | 0 | ||
| n-oleoylethanolamine N-oleoylethanolamine: ceramidase inhibitor. oleoyl ethanolamide : An N-(long-chain-acyl)ethanolamine that is the ethanolamide of oleic acid. The monounsaturated analogue of the endocannabinoid anandamide. | 2.11 | 1 | 0 | endocannabinoid; N-(long-chain-acyl)ethanolamine; N-acylethanolamine 18:1 | EC 3.5.1.23 (ceramidase) inhibitor; geroprotector; PPARalpha agonist |
| codeine [no description available] | 12.05 | 7 | 2 | morphinane alkaloid; organic heteropentacyclic compound | antitussive; drug allergen; environmental contaminant; opioid analgesic; opioid receptor agonist; prodrug; xenobiotic |
| cyclosporine ramihyphin A: one of the metabolites produced by Fusarium sp. S-435; RN given refers to cpd with unknown MF | 3.61 | 2 | 0 | homodetic cyclic peptide | anti-asthmatic drug; anticoronaviral agent; antifungal agent; antirheumatic drug; carcinogenic agent; dermatologic drug; EC 3.1.3.16 (phosphoprotein phosphatase) inhibitor; geroprotector; immunosuppressive agent; metabolite |
| natamycin [no description available] | 2.08 | 1 | 0 | antibiotic antifungal drug; dicarboxylic acid monoester; epoxide; macrolide antibiotic; monosaccharide derivative; polyene antibiotic | antifungal agrochemical; antimicrobial food preservative; apoptosis inducer; bacterial metabolite; ophthalmology drug |
| acitretin Acitretin: An oral retinoid effective in the treatment of psoriasis. It is the major metabolite of ETRETINATE with the advantage of a much shorter half-life when compared with etretinate.. acitretin : A retinoid that consists of 3,7-dimethylnona-2,4,6,8-tetraenoic acid having a 4-methoxy-2,3,6-trimethylphenyl group attached at position 9. | 3.61 | 2 | 0 | acitretin; alpha,beta-unsaturated monocarboxylic acid; retinoid | keratolytic drug |
| dihydrocodeine dihydrocodeine: RN refers to parent cpd(5alpha,6alpha)-isomer | 2.07 | 1 | 0 | morphinane alkaloid | |
| estropipate estropipate: used therapeutically in menopausal patients | 3.23 | 1 | 0 | piperazinium salt; steroid sulfate | |
| hydrocodone Hydrocodone: Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.. hydrocodone : A morphinane-like compound that is a semi-synthetic opioid synthesized from codeine. | 3.35 | 1 | 0 | morphinane-like compound; organic heteropentacyclic compound | antitussive; mu-opioid receptor agonist; opioid analgesic |
| hydromorphone Hydromorphone: An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.. hydromorphone : A morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class. | 10.7 | 5 | 0 | morphinane alkaloid; organic heteropentacyclic compound | mu-opioid receptor agonist; opioid analgesic |
| levetiracetam Levetiracetam: A pyrrolidinone and acetamide derivative that is used primarily for the treatment of SEIZURES and some movement disorders, and as a nootropic agent.. levetiracetam : A pyrrolidinone and carboxamide that is N-methylpyrrolidin-2-one in which one of the methyl hydrogens is replaced by an aminocarbonyl group, while another is replaced by an ethyl group (the S enantiomer). An anticonvulsant, it is used for the treatment of epilepsy in both human and veterinary medicine. | 12.04 | 35 | 3 | pyrrolidin-2-ones | anticonvulsant; environmental contaminant; xenobiotic |
| ly 163892 loracarbef: 1-carbacephem antibiotic; has a broad spectrum of antimicrobial activity; structure given in first source; carbacephems differ from cephalosporins in the substitution of a sulfur atom in the dihydrothiazine ring with a methylene group to form a tetrahydropyridine ring. loracarbef : A synthetic "carba" analogue of cefaclor, with carbon replacing sulfur at position 1. Used to treat a wide range of infections caused by both gram-positive and gram-negative bacteria. | 3.23 | 1 | 0 | carbacephem; zwitterion | antibacterial drug; antimicrobial agent |
| nabilone nabilone: cannabinol deriv; RN given refers to cpd without isomeric designation; structure | 3.23 | 1 | 0 | ||
| nalmefene nalmefene: RN given refers to 5-alpha isomer | 2.08 | 1 | 0 | morphinane alkaloid | |
| naloxone Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. | 11.73 | 9 | 2 | morphinane alkaloid; organic heteropentacyclic compound; tertiary alcohol | antidote to opioid poisoning; central nervous system depressant; mu-opioid receptor antagonist |
| oxycodone Oxycodone: A semisynthetic derivative of CODEINE.. oxycodone : A semisynthetic opioid of formula C18H21NO4 that is derived from thebaine. It is a moderately potent opioid analgesic, generally used for relief of moderate to severe pain. | 14.79 | 45 | 24 | organic heteropentacyclic compound; semisynthetic derivative | antitussive; mu-opioid receptor agonist; opioid analgesic |
| oxymorphone Oxymorphone: An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092) | 3.23 | 1 | 0 | morphinane alkaloid | |
| vitamin k 1 Vitamin K 1: A family of phylloquinones that contains a ring of 2-methyl-1,4-naphthoquinone and an isoprenoid side chain. Members of this group of vitamin K 1 have only one double bond on the proximal isoprene unit. Rich sources of vitamin K 1 include green plants, algae, and photosynthetic bacteria. Vitamin K1 has antihemorrhagic and prothrombogenic activity.. phylloquinone : A member of the class of phylloquinones that consists of 1,4-naphthoquinone having methyl and phytyl groups at positions 2 and 3 respectively. The parent of the class of phylloquinones. | 3.23 | 1 | 0 | phylloquinones; vitamin K | cofactor; human metabolite; plant metabolite |
| sirolimus Sirolimus: A macrolide compound obtained from Streptomyces hygroscopicus that acts by selectively blocking the transcriptional activation of cytokines thereby inhibiting cytokine production. It is bioactive only when bound to IMMUNOPHILINS. Sirolimus is a potent immunosuppressant and possesses both antifungal and antineoplastic properties.. sirolimus : A macrolide lactam isolated from Streptomyces hygroscopicus consisting of a 29-membered ring containing 4 trans double bonds, three of which are conjugated. It is an antibiotic, immunosupressive and antineoplastic agent. | 4.19 | 2 | 0 | antibiotic antifungal drug; cyclic acetal; cyclic ketone; ether; macrolide lactam; organic heterotricyclic compound; secondary alcohol | antibacterial drug; anticoronaviral agent; antineoplastic agent; bacterial metabolite; geroprotector; immunosuppressive agent; mTOR inhibitor |
| topiramate Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. | 8.11 | 32 | 0 | cyclic ketal; ketohexose derivative; sulfamate ester | anticonvulsant; sodium channel blocker |
| trospium chloride trospium chloride : An organic chloride salt of trospium. It is an antispasmodic drug used for the treatment of overactive bladder. | 3.23 | 1 | 0 | ||
| morphine Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn. | 17.68 | 86 | 39 | morphinane alkaloid; organic heteropentacyclic compound; tertiary amino compound | anaesthetic; drug allergen; environmental contaminant; geroprotector; mu-opioid receptor agonist; opioid analgesic; plant metabolite; vasodilator agent; xenobiotic |
| demycarosylturimycin h [no description available] | 2.08 | 1 | 0 | ||
| acipimox acipimox: lipolysis inhibitor | 2.08 | 1 | 0 | pyrazinecarboxylic acid | |
| arachidonyl-2-chloroethylamide arachidonyl-2-chloroethylamide: a potent and selective agonist of the neuronal cannabinoid receptor; structure in first source. arachidonyl-2'-chloroethylamide : A fatty amide obtained by the formal condensation of arachidonic acid with 2-chloroethanamine. It is a potent agonist of the CB1 receptor (Ki = 1.4 nM) and also has a low affinity for the CB2 receptor (Ki = 3100 nM). | 7.11 | 1 | 0 | fatty amide; organochlorine compound; secondary carboxamide; synthetic cannabinoid | CB1 receptor agonist; CB2 receptor agonist; neuroprotective agent |
| atosiban [no description available] | 2.08 | 1 | 0 | oligopeptide | |
| benzphetamine Benzphetamine: A sympathomimetic agent with properties similar to DEXTROAMPHETAMINE. It is used in the treatment of obesity. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1222). benzphetamine : Dextroamphetamine in which the the hydrogens attached to the amino group are substituted by a methyl and a benzyl group. A sympathomimetic agent with properties similar to dextroamphetamine, it is used as its hydrochloride salt in the treatment of obesity. | 3.23 | 1 | 0 | amphetamines; tertiary amine | adrenergic uptake inhibitor; appetite depressant; dopamine uptake inhibitor; sympathomimetic agent |
| bimatoprost Bimatoprost: A cloprostenol-derived amide that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION. | 2.08 | 1 | 0 | monocarboxylic acid amide | antiglaucoma drug; antihypertensive agent |
| cp 99994 3-(2-methoxybenzylamino)-2-phenylpiperidine: selective NK(1) receptor antagonist; CP-100263 is the inactive enantiomer | 2 | 1 | 0 | ||
| deamino arginine vasopressin Deamino Arginine Vasopressin: A synthetic analog of the pituitary hormone, ARGININE VASOPRESSIN. Its action is mediated by the VASOPRESSIN receptor V2. It has prolonged antidiuretic activity, but little pressor effects. It also modulates levels of circulating FACTOR VIII and VON WILLEBRAND FACTOR. | 3.23 | 1 | 0 | heterodetic cyclic peptide | diagnostic agent; renal agent; vasopressin receptor agonist |
| dexmedetomidine [no description available] | 7 | 6 | 2 | medetomidine | alpha-adrenergic agonist; analgesic; non-narcotic analgesic; sedative |
| goserelin Goserelin: A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer. | 3.23 | 1 | 0 | organic molecular entity | |
| iloprost Iloprost: An eicosanoid, derived from the cyclooxygenase pathway of arachidonic acid metabolism. It is a stable and synthetic analog of EPOPROSTENOL, but with a longer half-life than the parent compound. Its actions are similar to prostacyclin. Iloprost produces vasodilation and inhibits platelet aggregation.. iloprost : A carbobicyclic compound that is prostaglandin I2 in which the endocyclic oxygen is replaced by a methylene group and in which the (1E,3S)-3-hydroxyoct-1-en-1-yl side chain is replaced by a (3R)-3-hydroxy-4-methyloct-1-en-6-yn-1-yl group. A synthetic analogue of prostacyclin, it is used as the trometamol salt (generally by intravenous infusion) for the treatment of peripheral vascular disease and pulmonary hypertension. | 2.03 | 1 | 0 | carbobicyclic compound; monocarboxylic acid; secondary alcohol | platelet aggregation inhibitor; vasodilator agent |
| l 365260 L 365260: a CCK-B antagonist; structure given in first source; potent & selective CCK-B & gastrin receptor ligand; L 365260 and L 365346 are (R)- and (S)-stereoisomers, respectively | 7.71 | 5 | 0 | benzodiazepine | |
| latanoprost Latanoprost: A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.. latanoprost : A prostaglandin Falpha that is the isopropyl ester prodrug of latanoprost free acid. Used in the treatment of open-angle glaucoma and ocular hypertension. | 2.08 | 1 | 0 | isopropyl ester; prostaglandins Falpha; triol | antiglaucoma drug; antihypertensive agent; EC 4.2.1.1 (carbonic anhydrase) inhibitor; prodrug |
| lysophosphatidic acid lysophosphatidic acid: RN given refers to parent cpd. 1-oleoyl-sn-glycerol 3-phosphate : A 1-acyl-sn-glycerol 3-phosphate having oleoyl as the 1-O-acyl group.. lysophosphatidic acid : A member of the class of lysophosphatidic acids obtained by hydrolytic removal of one of the two acyl groups of any phosphatidic acid. A 'closed' class. | 2.07 | 1 | 0 | 1-acyl-sn-glycerol 3-phosphate | |
| lysophosphatidylcholines lysophosphatidylcholine : An acylglycerophosphocholine resulting from partial hydrolysis of a phosphatidylcholine, which removes one of the fatty acyl groups. The structure is depicted in the image where R1 = acyl, R2 = H or where R1 = H, R2 = acyl. | 2.15 | 1 | 0 | 1-O-acyl-sn-glycero-3-phosphocholine | |
| nalbuphine Nalbuphine: A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS. | 4.16 | 2 | 0 | organic heteropentacyclic compound | mu-opioid receptor antagonist; opioid analgesic |
| nateglinide Nateglinide: A phenylalanine and cyclohexane derivative that acts as a hypoglycemic agent by stimulating the release of insulin from the pancreas. It is used in the treatment of TYPE 2 DIABETES.. nateglinide : An N-acyl-D-phenylalanine resulting from the formal condensation of the amino group of D-phenylalanine with the carboxy group of trans-4-isopropylcyclohexanecarboxylic acid. An orally-administered, rapidly-absorbed, short-acting insulinotropic agent, it is used for the treatment of type 2 diabetes mellitus. | 3.61 | 2 | 0 | phenylalanine derivative | |
| stiripentol stiripentol: structure | 3.13 | 1 | 0 | ||
| vinorelbine [no description available] | 3.23 | 1 | 0 | acetate ester; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; ring assembly; vinca alkaloid | antineoplastic agent; photosensitizing agent |
| silodosin silodosin: an alpha(1a)-adrenoceptor-selective antagonist; structure given in first source | 3.23 | 1 | 0 | indolecarboxamide | |
| kn 62 KN 62: inhibitor of Ca/calmodulin-dependent protein kinase II | 2.5 | 2 | 0 | piperazines | |
| caryophyllene caryophyllene: RN given refers to cpd without isomeric designation; structure given in first source | 2.6 | 1 | 0 | ||
| fluvoxamine Fluvoxamine: A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS.. fluvoxamine : An oxime O-ether that is benzene substituted by a (1E)-N-(2-aminoethoxy)-5-methoxypentanimidoyl group at position 1 and a trifluoromethyl group at position 4. It is a selective serotonin reuptake inhibitor that is used for the treatment of obsessive-compulsive disorder. | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; 5-methoxyvalerophenone O-(2-aminoethyl)oxime | antidepressant; anxiolytic drug; serotonin uptake inhibitor |
| su 11248 [no description available] | 3.65 | 2 | 0 | monocarboxylic acid amide; pyrroles | angiogenesis inhibitor; antineoplastic agent; EC 2.7.10.1 (receptor protein-tyrosine kinase) inhibitor; immunomodulator; neuroprotective agent; vascular endothelial growth factor receptor antagonist |
| 6,7-dihydroxyflavone 6,7-dihydroxyflavone: intensifies effect of antibiotics on Staphylococcus aureus; structure in first source | 2.21 | 1 | 0 | ||
| (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid : A dihydroxy monocarboxylic acid that is N-isopropylindole which is substituted at position 3 by a p-fluorophenyl group and at position 2 by a 6-carboxy-3,5-dihydroxyhex-1-en-1-yl group. It has four possible diastereoisomers. | 3.61 | 2 | 0 | dihydroxy monocarboxylic acid; indoles; organofluorine compound | |
| molsidomine [no description available] | 2.08 | 1 | 0 | ethyl ester; morpholines; oxadiazole; zwitterion | antioxidant; apoptosis inhibitor; cardioprotective agent; nitric oxide donor; vasodilator agent |
| levorphanol Levorphanol: A narcotic analgesic that may be habit-forming. It is nearly as effective orally as by injection. | 3.23 | 1 | 0 | morphinane alkaloid | |
| bismuth Bismuth: A metallic element that has the atomic symbol Bi, and atomic number 83. Its principal isotope is Bismuth 209. | 3.31 | 1 | 0 | metal atom; pnictogen | |
| naltrexone Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. | 11.7 | 3 | 1 | cyclopropanes; morphinane-like compound; organic heteropentacyclic compound | antidote to opioid poisoning; central nervous system depressant; environmental contaminant; mu-opioid receptor antagonist; xenobiotic |
| dextromethorphan Dextromethorphan: Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.. dextromethorphan : A 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. | 4.59 | 4 | 0 | 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene | antitussive; environmental contaminant; neurotoxin; NMDA receptor antagonist; oneirogen; prodrug; xenobiotic |
| butorphanol Butorphanol: A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.. butorphanol : Levorphanol in which a hydrogen at position 14 of the morphinan skeleton is substituted by hydroxy and one of the hydrogens of the N-methyl group is substituted by cyclopropyl. A semi-synthetic opioid agonist-antagonist analgesic, it is used as its (S,S)-tartaric acid salt for relief or moderate to severe pain. | 3.61 | 2 | 0 | morphinane alkaloid | antitussive; kappa-opioid receptor agonist; mu-opioid receptor agonist; opioid analgesic |
| cefixime [no description available] | 3.61 | 2 | 0 | cephalosporin | antibacterial drug; drug allergen |
| lisinopril Lisinopril: One of the ANGIOTENSIN-CONVERTING ENZYME INHIBITORS (ACE inhibitors), orally active, that has been used in the treatment of hypertension and congestive heart failure. | 5 | 4 | 0 | dipeptide | EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| benazepril benazepril: structure given in first source. benazepril : A benzazepine that is benazeprilat in which the carboxy group of the 2-amino-4-phenylbutanoic acid moiety has been converted to the corresponding ethyl ester. It is used (generally as its hydrochloride salt) as a prodrug for the angiotensin-converting enzyme inhibitor benazeprilat in the treatment of hypertension and heart failure. | 3.23 | 1 | 0 | benzazepine; dicarboxylic acid monoester; ethyl ester; lactam | EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| ramipril Ramipril: A long-acting angiotensin-converting enzyme inhibitor. It is a prodrug that is transformed in the liver to its active metabolite ramiprilat.. ramipril : A dipeptide that is the prodrug for ramiprilat, the active metabolite obtained by hydrolysis of the ethyl ester group. An angiotensin-converting enzyme (ACE) inhibitor, used to treat high blood pressure and congestive heart failure.. quark : Quarks comprise one of two classes of the fundamental particles. Quarks possess fractional electric charges and are not observed in free state. The word "quark" first appears in James Joyce's Finnegans Wake and has been chosen by Murray Gell-Mann as a name for fundamental building blocks of particles. | 3.61 | 2 | 0 | azabicycloalkane; cyclopentapyrrole; dicarboxylic acid monoester; dipeptide; ethyl ester | bradykinin receptor B2 agonist; cardioprotective agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; matrix metalloproteinase inhibitor; prodrug |
| verteporfin (2R,2(1)S)-8-ethenyl-2(1),2(2)-bis(methoxycarbonyl)-17-(3-methoxy-3-oxopropyl)-2,7,12,18-tetramethyl-2,2(1)-dihydrobenzo[b]porphyrin-13-propanoic acid : The 2(1),2(2),17-trimethyl ester of (2R,2(1)S)-2(1),2(2)-dicarboxy-8-ethenyl-2,7,12,18-tetramethyl-2,2(1)-dihydrobenzo[b]porphyrin-13,17-dipropanoic acid. | 3.23 | 1 | 0 | ||
| indinavir sulfate Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. | 3.61 | 2 | 0 | dicarboxylic acid diamide; N-(2-hydroxyethyl)piperazine; piperazinecarboxamide | HIV protease inhibitor |
| glyceryl behenate 1-behenoylglycerol : A fatty acid ester resulting from the formal condensation of the hydroxy group at position-1 of glycerol with the carboxy group of docosanoic acid. | 8.5 | 1 | 1 | 1-monoglyceride; fatty acid ester | antineoplastic agent; plant metabolite |
| zimeldine Zimeldine: One of the SEROTONIN UPTAKE INHIBITORS formerly used for depression but was withdrawn worldwide in September 1983 because of the risk of GUILLAIN-BARRE SYNDROME associated with its use. (From Martindale, The Extra Pharmacopoeia, 29th ed, p385) | 3.23 | 1 | 0 | styrenes | |
| enalapril maleate enalapril maleate : The maleic acid salt of enalapril. It contains one molecule of maleic acid for each molecule of enalapril. Following oral administration, the ethyl ester group of enalapril is hydrolysed to afford the corresponding carboxylic acid, enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor. Enalapril is thus a prodrug for enalaprilat (which, unlike enalapril, is not absorbed by mouth), and its maleate is used in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. | 2.08 | 1 | 0 | maleate salt | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| enalapril Enalapril: An angiotensin-converting enzyme inhibitor that is used to treat HYPERTENSION and HEART FAILURE.. enalapril : A dicarboxylic acid monoester that is ethyl 4-phenylbutanoate in which a hydrogen alpha to the carboxy group is substituted by the amino group of L-alanyl-L-proline (S-configuration). | 3.23 | 1 | 0 | dicarboxylic acid monoester; dipeptide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; geroprotector; prodrug |
| trientine hydrochloride [no description available] | 3.23 | 1 | 0 | ||
| n-methylscopolamine bromide scopolamine methobromide : A quaternary ammonium salt resulting from the reaction of the amino group of scopolamine with methyl bromide. | 3.23 | 1 | 0 | ||
| bleomycin [no description available] | 3.23 | 1 | 0 | bleomycin | antineoplastic agent; metabolite |
| heroin Heroin: A narcotic analgesic that may be habit-forming. It is a controlled substance (opium derivative) listed in the U.S. Code of Federal Regulations, Title 21 Parts 329.1, 1308.11 (1987). Sale is forbidden in the United States by Federal statute. (Merck Index, 11th ed). heroin : A morphinane alkaloid that is morphine bearing two acetyl substituents on the O-3 and O-6 positions. As with other opioids, heroin is used as both an analgesic and a recreational drug. Frequent and regular administration is associated with tolerance and physical dependence, which may develop into addiction. Its use includes treatment for acute pain, such as in severe physical trauma, myocardial infarction, post-surgical pain, and chronic pain, including end-stage cancer and other terminal illnesses. | 3.07 | 3 | 0 | morphinane alkaloid | mu-opioid receptor agonist; opioid analgesic; prodrug |
| enalaprilat anhydrous Enalaprilat: The active metabolite of ENALAPRIL and one of the potent, intravenously administered, ANGIOTENSIN-CONVERTING ENZYME INHIBITORS. It is an effective agent for the treatment of essential hypertension and has beneficial hemodynamic effects in heart failure. The drug produces renal vasodilation with an increase in sodium excretion.. enalaprilat dihydrate : The dihydrate form of enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor that is used (often in the form of its prodrug, enalapril) in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. Unlike enalapril, enalaprilat is not absorbed by mouth but is administered by intravenous injection.. enalaprilat (anhydrous) : Enalapril in which the ethyl ester group has been hydrolysed to the corresponding carboxylic acid. Enalaprilat is an angiotensin-converting enzyme (ACE) inhibitor and is used (often in the form of its prodrug, enalapril) in the treatment of hypertension and heart failure, for reduction of proteinuria and renal disease in patients with nephropathies, and for the prevention of stroke, myocardial infarction, and cardiac death in high-risk patients. Unlike enalapril, enalaprilat is not absorbed by mouth but is given by intravenous injection, usually as the dihydrate. | 3.61 | 2 | 0 | dicarboxylic acid; dipeptide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| ximelagatran ximelagatran: prodrug (via hydroxylation) of melagatran & a direct thrombin inhibitor; liver toxicity concerns so AZD0837 being developed to replace this. ximelagatran : A member of the class of azetidines that is melagatran in which the carboxylic acid group has been converted to the corresponding ethyl ester and in which the amidine group has been converted into the corresponding amidoxime. A prodrug for melagatran, ximelagatran was the first orally available direct thrombin inhibitor to be brought to market as an anticoagulant, but was withdrawn in 2006 following reports of it causing liver damage. | 3.23 | 1 | 0 | amidoxime; azetidines; carboxamide; ethyl ester; hydroxylamines; secondary amino compound; secondary carboxamide; tertiary carboxamide | anticoagulant; EC 3.4.21.5 (thrombin) inhibitor; prodrug; serine protease inhibitor |
| cefuroxime [no description available] | 3.23 | 1 | 0 | 3-(carbamoyloxymethyl)cephalosporin; furans; oxime O-ether | drug allergen |
| ceftriaxone [no description available] | 3.23 | 1 | 0 | 1,2,4-triazines; 1,3-thiazoles; cephalosporin; oxime O-ether | antibacterial drug; drug allergen; EC 3.5.2.6 (beta-lactamase) inhibitor |
| cefepime Cefepime: A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA.. cefepime : A cephalosporin bearing (1-methylpyrrolidinium-1-yl)methyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 3.23 | 1 | 0 | cephalosporin; oxime O-ether | antibacterial drug |
| pafuramidine pafuramidine: a prodrug of furamidine | 3.23 | 1 | 0 | ||
| ceftazidime [no description available] | 3.23 | 1 | 0 | cephalosporin; oxime O-ether | antibacterial drug; drug allergen; EC 2.4.1.129 (peptidoglycan glycosyltransferase) inhibitor |
| trandolapril trandolapril : A heterobicylic compound that is (2S,3aR,7aS)-1-[(2S)-2-aminopropanoyl]octahydro-1H-indole-2-carboxylic acid in which the hydrogen of the amino group is substituted by a (2R)-1-ethoxy-1-oxo-4-phenylbutan-2-yl group. It is a angiotensin-converting enzyme inhibitor and a prodrug used for the treatment of hypertension. | 3.61 | 2 | 0 | dicarboxylic acid monoester; dipeptide; ethyl ester; organic heterobicyclic compound; secondary amino compound; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| alvimopan anhydrous alvimopan: mu opioid receptor antagonist; intended to treat constipation in patients taking opiates for pain | 3.61 | 2 | 0 | peptide | |
| aliskiren aliskiren: orally active nonpeptidic renin inhibitor. aliskiren : A monomethoxybenzene compound having a 3-methoxypropoxy group at the 2-position and a multi-substituted branched alkyl substituent at the 4-position. | 3.23 | 1 | 0 | monocarboxylic acid amide; monomethoxybenzene | antihypertensive agent |
| famotidine [no description available] | 3.61 | 2 | 0 | 1,3-thiazoles; guanidines; sulfonamide | anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
| resiniferatoxin resiniferatoxin: phorbol related diterpene ester; potent agonist of vanilloid TRPV1 receptors. resiniferatoxin : A heteropentacyclic compound found in Euphorbia poissonii with molecular formula C37H40O9. It is an agonist of the transient receptor potential cation channel subfamily V member 1 (TrpV1). | 2.04 | 1 | 0 | carboxylic ester; diterpenoid; enone; monomethoxybenzene; organic heteropentacyclic compound; ortho ester; phenols; tertiary alpha-hydroxy ketone | analgesic; neurotoxin; plant metabolite; TRPV1 agonist |
| cefotaxime Cefotaxime: Semisynthetic broad-spectrum cephalosporin.. cefotaxime : A cephalosporin compound having acetoxymethyl and [2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino side groups. | 3.23 | 1 | 0 | 1,3-thiazoles; cephalosporin; oxime O-ether | antibacterial drug; drug allergen |
| aztreonam [no description available] | 3.23 | 1 | 0 | beta-lactam antibiotic allergen; monobactam | antibacterial drug; drug allergen; EC 2.4.1.129 (peptidoglycan glycosyltransferase) inhibitor |
| cci 15641 [no description available] | 2.08 | 1 | 0 | cephalosporin | |
| tetrodotoxin Tetrodotoxin: An aminoperhydroquinazoline poison found mainly in the liver and ovaries of fishes in the order TETRAODONTIFORMES, which are eaten. The toxin causes paresthesia and paralysis through interference with neuromuscular conduction.. tetrodotoxin : A quinazoline alkaloid that is a marine toxin isolated from fish such as puffer fish. It has been shown to exhibit potential neutotoxicity due to its ability to block voltage-gated sodium channels. | 2.44 | 2 | 0 | azatetracycloalkane; oxatetracycloalkane; quinazoline alkaloid | animal metabolite; bacterial metabolite; marine metabolite; neurotoxin; voltage-gated sodium channel blocker |
| cefpodoxime [no description available] | 3.23 | 1 | 0 | carboxylic acid; cephalosporin | antibacterial drug |
| palonosetron Palonosetron: Isoquinoline and quinuclidine derivative that acts as a 5-HT3 RECEPTOR antagonist. It is used in the prevention of nausea and vomiting induced by cytotoxic chemotherapy, and for the prevention of post-operative nausea and vomiting.. palonosetron : An organic heterotricyclic compound that is an antiemetic used (as its hydrochloride salt) in combination with netupitant (under the trade name Akynzeo) to treat nausea and vomiting in patients undergoing cancer chemotherapy. | 3.23 | 1 | 0 | azabicycloalkane; delta-lactam; organic heterotricyclic compound | antiemetic; serotonergic antagonist |
| tenofovir disoproxil fumarate tenofovir disoproxil fumarate : A fumarate salt prepared from equimolar amounts of tenofovir disoproxil and fumaric acid. It is used in combination therapy for the treatment of HIV infection. | 2.08 | 1 | 0 | fumarate salt | antiviral drug; HIV-1 reverse transcriptase inhibitor; prodrug |
| dizocilpine maleate Dizocilpine Maleate: A potent noncompetitive antagonist of the NMDA receptor (RECEPTORS, N-METHYL-D-ASPARTATE) used mainly as a research tool. The drug has been considered for the wide variety of neurodegenerative conditions or disorders in which NMDA receptors may play an important role. Its use has been primarily limited to animal and tissue experiments because of its psychotropic effects.. dizocilpine maleate : A maleate salt obtained by reaction of dizocilpine with one equivalent of maleic acid. | 2.03 | 1 | 0 | maleate salt; tetracyclic antidepressant | anaesthetic; anticonvulsant; neuroprotective agent; nicotinic antagonist; NMDA receptor antagonist |
| dexbrompheniramine maleate dexbrompheniramine maleate : The maleic acid salt of the (pharmacologically active) (S)-(+)-enantiomer of brompheniramine. A histamine H1 receptor antagonist, it is used for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. | 2.08 | 1 | 0 | brompheniramine maleate | anti-allergic agent; H1-receptor antagonist |
| rifaximin [no description available] | 3.61 | 2 | 0 | acetate ester; cyclic ketal; lactam; macrocycle; organic heterohexacyclic compound; rifamycins; semisynthetic derivative | antimicrobial agent; gastrointestinal drug; orphan drug |
| limaprost limaprost: RN given refers to (2E,11alpha,13E,15S,17S)-isomer | 5.94 | 4 | 2 | long-chain fatty acid | |
| everolimus [no description available] | 4.45 | 3 | 0 | cyclic acetal; cyclic ketone; ether; macrolide lactam; primary alcohol; secondary alcohol | anticoronaviral agent; antineoplastic agent; geroprotector; immunosuppressive agent; mTOR inhibitor |
| trk 820 TRK 820: structure in first source | 4.13 | 2 | 0 | phenanthrenes | |
| ixabepilone [no description available] | 3.23 | 1 | 0 | 1,3-thiazoles; beta-hydroxy ketone; epoxide; lactam; macrocycle | antineoplastic agent; microtubule-destabilising agent |
| rilpivirine [no description available] | 2.31 | 1 | 0 | aminopyrimidine; nitrile | EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor |
| cefpodoxime proxetil cefpodoxime proxetil: structure given in first source; prodrug for cefpodoxime. cefpodoxime proxetil : The 1-[(isopropoxycarbonyl)oxy]ethyl (proxetil) ester prodrug of cefpodoxime. After swallowing, hydrolysis of the ester group occurs in the intestinal epithelium, to release active cefpodoxime in the bloodstream. It is used to treat acute otitis media, pharyngitis, and sinusitis. | 2.08 | 1 | 0 | carboxylic acid; carboxylic ester; cephalosporin | antibacterial drug; prodrug |
| ceftizoxime [no description available] | 3.23 | 1 | 0 | cephalosporin | antibacterial drug |
| 1-methyl-d-lysergic acid butanolamide [no description available] | 3.23 | 1 | 0 | ergot alkaloid; monocarboxylic acid amide | serotonergic antagonist; sympatholytic agent; vasoconstrictor agent |
| fluphenazine [no description available] | 2.08 | 1 | 0 | ||
| nitrofurantoin Nitrofurantoin: A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.. nitrofurantoin : An imidazolidine-2,4-dione that is hydantoin substituted at position 1 by a [(5-nitro-2-furyl)methylene]amino group. An antibiotic that damages bacterial DNA. | 3.61 | 2 | 0 | imidazolidine-2,4-dione; nitrofuran antibiotic; organonitrogen heterocyclic antibiotic; organooxygen heterocyclic antibiotic | antibacterial drug; antiinfective agent; hepatotoxic agent |
| morphinans Morphinans: Compounds based on a partially saturated iminoethanophenanthrene, which can be described as ethylimino-bridged benzo-decahydronaphthalenes. They include some of the OPIOIDS found in PAPAVER that are used as ANALGESICS. | 4.13 | 2 | 0 | isoquinoline alkaloid fundamental parent; morphinane alkaloid | |
| ergoline Ergolines: A series of structurally-related alkaloids that contain the ergoline backbone structure.. ergoline : An indole alkaloid whose structural skeleton is found in many naturally occurring and synthetic ergolines which are known to bind to neurotransmitter receptors, such as dopamine, noradrenaline and serotonin receptors and function as unselective agonists or antagonists at these receptors. | 3.17 | 1 | 0 | diamine; ergoline alkaloid; indole alkaloid fundamental parent; indole alkaloid; organic heterotetracyclic compound | |
| dantrolene [no description available] | 3.23 | 1 | 0 | ||
| roxithromycin (E)-roxithromycin : A major geometrical isomer of roxithromycin. | 2.08 | 1 | 0 | roxithromycin | environmental contaminant; xenobiotic |
| cefdinir [no description available] | 3.61 | 2 | 0 | cephalosporin; ketoxime | antibacterial drug |
| etonogestrel [no description available] | 3.23 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin |
| bisoprolol, fumarate (1:1) salt [no description available] | 2.08 | 1 | 0 | ||
| tiapamil hydrochloride Tiapamil Hydrochloride: A phenylethylamine derivative that acts as a calcium antagonist showing hemodynamic effects in patients with acute myocardial infarction. | 3.44 | 1 | 1 | ||
| artesunate artesunic acid: RN given for (3R-(3alpha,5abeta,6beta,8abeta,9alpha,10alpha,12beta,(2aR*))-isomer; succinic ester of artemether | 2.08 | 1 | 0 | artemisinin derivative; cyclic acetal; dicarboxylic acid monoester; hemisuccinate; semisynthetic derivative; sesquiterpenoid | antimalarial; antineoplastic agent; ferroptosis inducer |
| etoposide phosphate [no description available] | 2.08 | 1 | 0 | furonaphthodioxole | |
| ciclesonide ciclesonide: nasal spray approved for seasonal and perennial allergic rhinitis | 2.08 | 1 | 0 | organic molecular entity | |
| temsirolimus [no description available] | 3.61 | 2 | 0 | macrolide lactam | |
| dutasteride Dutasteride: A 5-ALPHA-REDUCTASE INHIBITOR that is reported to inhibit both type-1 and type2 isoforms of the enzyme and is used to treat BENIGN PROSTATIC HYPERPLASIA.. dutasteride : An aza-steroid that is inasteride in which the tert-butyl group is replaced by a 2,5-bis(trifluoromethyl)phenyl group. A synthetic 4-azasteroid, dutasteride is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5alpha-reductase, an intracellular enzyme that converts testosterone to 5alpha-dihydrotestosterone. Dutasteride is used for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate gland. | 3.61 | 2 | 0 | (trifluoromethyl)benzenes; aza-steroid; delta-lactam | antihyperplasia drug; EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor |
| ganaxolone ganaxolone: a selective, high-affinity, steroid modulator of the GABA(A) receptor; structure given in first source; RN given refers to (3alpha,5alpha)-isomer | 3.13 | 1 | 0 | corticosteroid hormone | |
| tekturna [no description available] | 2.08 | 1 | 0 | fumarate salt | antihypertensive agent |
| lu 208075 ambrisentan: an ET(A) receptor antagonist and antihypertensive agent; studied for use in pulmonary arterial hypertension | 3.23 | 1 | 0 | diarylmethane | |
| bibx 1382bs BIBX 1382BS: an ErbB receptor kinase inhibitor; no further information available 4/2001 | 3.23 | 1 | 0 | substituted aniline | |
| vildagliptin [no description available] | 2.08 | 1 | 0 | amino acid amide | |
| fesoterodine fesoterodine: a muscarinic antagonist for treatment of overactive bladder | 3.23 | 1 | 0 | diarylmethane | |
| taxane taxane: produced by Taxomyces andreanae | 9.55 | 1 | 1 | diterpene; terpenoid fundamental parent | |
| sgd 301-76 [no description available] | 2.08 | 1 | 0 | conazole antifungal drug; imidazole antifungal drug; organic nitrate salt | antiinfective agent |
| fluvoxamine maleate [no description available] | 2.08 | 1 | 0 | (trifluoromethyl)benzenes | |
| thioacetazone Thioacetazone: A thiosemicarbazone that is used in association with other antimycobacterial agents in the initial and continuation phases of antituberculosis regimens. Thiacetazone containing regimens are less effective than the short-course regimen recommended by the International Union Against Tuberculosis and are used in some developing countries to reduce drug costs. (From Martindale, The Extra Pharmacopoeia, 30th ed, p217). thiosemicarbazone : A hydrazone resulting from the formal condensation of an aldehyde or ketone with the non-thioacylated nitrogen of thiosemicarbazide or its substituted derivatives. | 2.08 | 1 | 0 | ||
| gemifloxacin Gemifloxacin: A naphthyridine and fluoroquinolone derivative antibacterial agent and DNA TOPOISOMERASE II inhibitor that is used for the treatment of community-acquired pneumonia and acute bacterial infections associated with chronic bronchitis.. gemifloxacin : A 1,4-dihydro-1,8-naphthyridine with a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a substituted pyrrolin-1-yl group at the 7-position. | 3.23 | 1 | 0 | 1,8-naphthyridine derivative; fluoroquinolone antibiotic; monocarboxylic acid; quinolone antibiotic | antibacterial drug; antimicrobial agent; topoisomerase IV inhibitor |
| dexlansoprazole Dexlansoprazole: The R-isomer of lansoprazole that is used to treat severe GASTROESOPHAGEAL REFLUX DISEASE. | 3.61 | 2 | 0 | benzimidazoles; sulfoxide | |
| gemifloxacin mesylate gemifloxacin mesylate : The mesylate salt of gemifloxacin. | 2.08 | 1 | 0 | methanesulfonate salt | antimicrobial agent; topoisomerase IV inhibitor |
| fosinopril [no description available] | 3.23 | 1 | 0 | ||
| armodafinil armodafinil : A 2-[(diphenylmethyl)sulfinyl]acetamide that has R configuration at the sulfur atom. Like its racemate, modafinil, it is used for the treatment of sleeping disorders such as narcolepsy, obstructive sleep apnoea, and shift-work sleep disorder. Peak concentration in the blood later occurs later following administration than with modafinil, so it is thought that armodafinil may be more effective than modafinil in treating people with excessive daytime sleepiness. | 3.23 | 1 | 0 | 2-[(diphenylmethyl)sulfinyl]acetamide | central nervous system stimulant; eugeroic |
| desvenlafaxine succinate Desvenlafaxine Succinate: A cyclohexanol and phenol derivative and metabolite of venlafaxine that functions as a SEROTONIN AND NORADRENALINE REUPTAKE INHIBITOR (SNRI) and is used as an ANTIDEPRESSIVE AGENT. | 5.33 | 3 | 1 | ||
| amoxicillin-potassium clavulanate combination Amoxicillin-Potassium Clavulanate Combination: A fixed-ratio combination of amoxicillin trihydrate and potassium clavulanate. | 2.6 | 1 | 0 | ||
| a-317491 A-317491: structure in first source | 2.08 | 1 | 0 | ||
| omacor Omacor: a drug containing the n-3 fatty acids that corrects plasma lipid; antiarrhthymic | 2.03 | 1 | 0 | ||
| gw406381x GW406381X: cyclooxygenase-2 inhibitor | 3.21 | 1 | 0 | ||
| sincalide Sincalide: An octapeptide hormone present in the intestine and brain. When secreted from the gastric mucosa, it stimulates the release of bile from the gallbladder and digestive enzymes from the pancreas. | 3.23 | 1 | 0 | oligopeptide | |
| ucb 34714 brivaracetam: A pyrrolidinone compound that is used to treat partial onset seizures in adult patients; structure in first source.. brivaracetam : A non-proteinogenic amino acid derivative that is butanamide in which the pro-S hydrogen at position 2 is replaced by a (4R)-2-oxo-4-propylpyrrolidin-1-yl. Used for treatment of partial onset seizures related to epilepsy. | 4.42 | 3 | 0 | gamma-lactam; non-proteinogenic amino acid derivative | anticonvulsant |
| tapentadol Tapentadol: An opioid analgesic, MU OPIOID RECEPTOR agonist, and noradrenaline reuptake inhibitor that is used in the treatment of moderate to severe pain, and of pain associated with DIABETIC NEUROPATHIES. | 10.58 | 13 | 4 | alkylbenzene | |
| ro 64-6198 Ro 64-6198: an orphanin FQ/nociceptin receptor agonist; structure in first source | 2.03 | 1 | 0 | ||
| pentagastrin Pentagastrin: A synthetic pentapeptide that has effects like gastrin when given parenterally. It stimulates the secretion of gastric acid, pepsin, and intrinsic factor, and has been used as a diagnostic aid. | 3.23 | 1 | 0 | organic molecular entity | |
| mocetinostat mocetinostat: undergoing phase II clinical trials for treatment of cancer. mocetinostat : A benzamide obtained by formal condensation of the carboxy group of 4-({[4-(pyridin-3-yl)pyrimidin-2-yl]amino}methyl)benzoic acid with one of the amino groups of benzene-1,2-diamine. It is an orally active and isotype-selective HDAC inhibitor which exhibits antitumour activity (IC50 = 0.15, 0.29, 1.66 and 0.59 muM for HDAC1, HDAC2, HDAC3 and HDAC11). | 2.73 | 3 | 0 | aminopyrimidine; benzamides; pyridines; secondary amino compound; secondary carboxamide; substituted aniline | antineoplastic agent; apoptosis inducer; autophagy inducer; cardioprotective agent; EC 3.5.1.98 (histone deacetylase) inhibitor; hepatotoxic agent |
| cefditoren cefditoren: structure given in first source; RN given refers to the (6R-(3(Z),6alpha,7beta(Z)))-isomer. cefditoren : A broad spectrum, third-generation cephalosporin antibiotic with (Z)-2-(4-methyl-1,3-thiazol-5-yl)ethenyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. Generally administered as its orally absorbed pivaloyloxymethyl ester prodrug, it is used for the treatment of mild to moderate infections caused by susceptible strains of microorganisms in acute bacterial exacerbation of chronic bronchitis, community-acquired pneumonia, pharyngitis/tonsillitis, and uncomplicated skin and skin-structure infections. | 3.23 | 1 | 0 | carboxylic acid; cephalosporin | antibacterial drug |
| ssr 69071 SSR 69071: structure in first source | 2.15 | 1 | 0 | pyridopyrimidine | |
| rivaroxaban Rivaroxaban: A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.. rivaroxaban : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. An anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. | 2.08 | 1 | 0 | aromatic amide; lactam; monocarboxylic acid amide; morpholines; organochlorine compound; oxazolidinone; thiophenes | anticoagulant; EC 3.4.21.6 (coagulation factor Xa) inhibitor |
| eslicarbazepine [no description available] | 3.35 | 1 | 0 | dibenzooxazepine | |
| sb 705498 SB 705498: structure in first source | 2.41 | 1 | 0 | ||
| hki 272 [no description available] | 2.08 | 1 | 0 | nitrile; quinolines | antineoplastic agent; tyrosine kinase inhibitor |
| 3,9-bis((ethylthio)methyl)-k-252a 3,9-bis((ethylthio)methyl)-K-252a: RN given for (9S-(9alpha,10beta,12alpha))-isomer; mixed lineage kinase inhibitor, neuroprotective agent, and neurotrophic agent derived from K-252a; structure in first source | 2.02 | 1 | 0 | ||
| perampanel perampanel : A member of the class of bipyridines that is 2,3'-bipyridin-6'-one substituted at positions 1' and 5' by phenyl and 2-cyanophenyl groups respectively. Used as an adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy. | 7.69 | 2 | 0 | bipyridines; nitrile; pyridone | AMPA receptor antagonist; anticonvulsant |
| tofacitinib tofacitinib : A pyrrolopyrimidine that is pyrrolo[2,3-d]pyrimidine substituted at position 4 by an N-methyl,N-(1-cyanoacetyl-4-methylpiperidin-3-yl)amino moiety. Used as its citrate salt to treat moderately to severely active rheumatoid arthritis. | 2.08 | 1 | 0 | N-acylpiperidine; nitrile; pyrrolopyrimidine; tertiary amino compound | antirheumatic drug; EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor |
| n-(4-tert-butylphenyl)-4-(3-chloropyridin-2-yl)tetrahydropyrazine-1(2h)-carboxamide N-(4-tert-butylphenyl)-4-(3-chloropyridin-2-yl)tetrahydropyrazine-1(2H)-carboxamide: a vanilloid receptor 1 antagonist and analgesic; structure in first source | 2.46 | 2 | 0 | piperazines; pyridines | |
| sapunifiram sapunifiram: structure in first source | 2.06 | 1 | 0 | ||
| pimavanserin pimavanserin: A 5-HT(2A) inverse agonist; ACP-103 is the dihydroxybutanedioate (2:1) salt. It is used to treat hallucinations and delusions associated with PARKINSON DISEASE; structure in first source.. pimavanserin : A member of the class of ureas in which three of the four hydrogens are replaced by 4-fluorobenzyl, 1-methylpiperidin-4-yl, and 4-(isopropyloxy)benzyl groups. An atypical antipsychotic that is used (in the form of its tartrate salt) for treatment of hallucinations and delusions associated with Parkinson's disease. | 2.6 | 1 | 0 | aromatic ether; monofluorobenzenes; piperidines; tertiary amino compound; ureas | 5-hydroxytryptamine 2A receptor inverse agonist; antipsychotic agent; serotonergic antagonist |
| pazopanib pazopanib: a protein kinase inhibitor. pazopanib : A pyrimidine that is 5-(pyrimidin-2-yl}amino-2-methylbenzenesulfonamide substituted at position 4 by a (2,3-dimethylindazol-6-yl)(methyl)amino group. Used as its hydrochloride salt for treatment of kidney cancer. | 3.61 | 2 | 0 | aminopyrimidine; indazoles; sulfonamide | angiogenesis modulating agent; antineoplastic agent; tyrosine kinase inhibitor; vascular endothelial growth factor receptor antagonist |
| prasugrel hydrochloride Prasugrel Hydrochloride: A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.. prasugrel hydrochloride : A racemate comprising equal amounts of (R)- and (S)-prasugrel hydrochloride. Used to prevent blood clots in people with acute coronary syndrome who are undergoing a procedure after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. | 3.23 | 1 | 0 | ||
| amg 009 AMG 009: an anti-inflammatory agent; structure in first source | 2.08 | 1 | 0 | ||
| oxadiazoles Oxadiazoles: Compounds containing five-membered heteroaromatic rings containing two carbons, two nitrogens, and one oxygen atom which exist in various regioisomeric forms. | 2.05 | 1 | 0 | ||
| cefotaxime sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
| baci-im [no description available] | 3.23 | 1 | 0 | homodetic cyclic peptide; polypeptide; zwitterion | antibacterial agent; antimicrobial agent |
| bms 477118 [no description available] | 3.23 | 1 | 0 | adamantanes; azabicycloalkane; monocarboxylic acid amide; nitrile; tertiary alcohol | EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor; hypoglycemic agent |
| nystatin a1 Nystatin: Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.. nystatin : A heterogeneous mixture of polyene compounds produced by cultures of Streptomyces noursei. It mainly consists of three biologically active components designated nystatin A1, nystatin A2, and nystatin A3. It is used to treat oral and dermal fungal infections.. nystatin A1 : A polyene macrolide antibiotic; part of the nystatin complex produced by several Streptomyces species. It is an antifungal antibiotic used for the treatment of topical fungal infections caused by a broad spectrum of fungal pathogens comprising yeast-like and filamentous species. | 3.23 | 1 | 0 | nystatins | |
| resolvin d2 resolvin D2: structure in first source; a potent endogenous regulator of excessive inflammatory responses that acts via multiple cellular targets to stimulate resolution and preserve immune vigilance. resolvin D2 : A member of the class of resolvins that is (4Z,8E,10Z,12E,14E,19Z)-docosahexaenoic acid carrying three hydroxy substituents at positions 7, 16 and 17 (the 7S,16R,17S-stereoisomer). | 2.1 | 1 | 0 | hydroxy polyunsaturated fatty acid; resolvin; secondary allylic alcohol; triol | anti-inflammatory agent; anti-obesity agent; estrogen receptor agonist; human xenobiotic metabolite; rat metabolite |
| sitagliptin phosphate Sitagliptin Phosphate: A pyrazine-derived DIPEPTIDYL-PEPTIDASE IV INHIBITOR and HYPOGLYCEMIC AGENT that increases the levels of the INCRETIN hormones GLUCAGON-LIKE PEPTIDE-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). It is used in the treatment of TYPE 2 DIABETES. | 3.91 | 3 | 0 | ||
| veratridine Veratridine: A benzoate-cevane found in VERATRUM and Schoenocaulon. It activates SODIUM CHANNELS to stay open longer than normal. | 2.06 | 1 | 0 | ||
| milnacipran [no description available] | 3.23 | 1 | 0 | acetamides | |
| lorcaserin lorcaserin: orally active, small-molecule 5-hydroxytryptamine 2C agonist for the potential treatment of obesity and diabetes. lorcaserin : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine substituted at position 1 by a methyl group and a t position 6 by a chloro group. | 3.14 | 1 | 0 | benzazepine; organochlorine compound | anti-obesity agent; appetite depressant |
| losartan potassium Erythropoietin: Glycoprotein hormone, secreted chiefly by the KIDNEY in the adult and the LIVER in the FETUS, that acts on erythroid stem cells of the BONE MARROW to stimulate proliferation and differentiation. | 3.64 | 2 | 0 | ||
| indocyanine green Indocyanine Green: A tricarbocyanine dye that is used diagnostically in liver function tests and to determine blood volume and cardiac output. | 3.31 | 1 | 0 | 1,1-diunsubstituted alkanesulfonate; benzoindole; cyanine dye | |
| scopolamine hydrobromide [no description available] | 3.64 | 2 | 0 | ||
| dactolisib dactolisib: antineoplastic agent that inhibits both phosphatidylinositol 3-kinase and mTOR. dactolisib : An imidazoquinoline that is 3-methyl-2-oxo-2,3-dihydro-1H-imidazo[4,5-c]quinoline substituted at position 1 by a 4-(1-cyanoisopropyl)phenyl group and at position 8 by a quinolin-3-yl group. A dual PI3K/mTOR inhibitor used in cancer treatment. | 2.08 | 1 | 0 | imidazoquinoline; nitrile; quinolines; ring assembly; ureas | antineoplastic agent; EC 2.7.1.137 (phosphatidylinositol 3-kinase) inhibitor; mTOR inhibitor |
| rabeprazole sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
| cnv1014802 vixotrigine: a sodium channel blocker | 2.13 | 1 | 0 | ||
| bivalirudin bivalirudin: designed to bind to the alpha-thrombin catalytic site and anion-binding exosite for fibrin(ogen) recognition. bivalirudin : A synthetic peptide of 20 amino acids, comprising D-Phe, Pro, Arg, Pro, Gly, Gly, Gly, Gly, Asn, Gly, Asp, Phe, Glu, Glu, Ile, Pro, Glu, Glu, Tyr, and Leu in sequence. A congener of hirudin (a naturally occurring drug found in the saliva of the medicinal leech), it a specific and reversible inhibitor of thrombin, and is used as an anticoagulant. | 3.61 | 2 | 0 | polypeptide | anticoagulant; EC 3.4.21.5 (thrombin) inhibitor |
| somatostatin [no description available] | 2.08 | 1 | 0 | heterodetic cyclic peptide; peptide hormone | |
| enfuvirtide Enfuvirtide: A synthetic 36-amino acid peptide that corresponds to the heptad repeat sequence of HIV-1 gp41. It blocks HIV cell fusion and viral entry and is used with other anti-retrovirals for combination therapy of HIV INFECTIONS and AIDS.. enfuvirtide : A synthetic 36-amino acid peptide consisting of N-acetyltyrosyl, threonyl, seryl, leucyl, isoleucyl, histidyl, seryl, leucyl, isoleucyl, alpha-glutamyl, alpha-glutamyl, seryl, glutaminyl, asparaginyl, glutaminyl, glutaminyl, alpha-glutamyl, lysyl, asparaginyl, alpha-glutamyl, alpha-glutamyl, alpha-glutamyl, leucyl, leucyl, alpha-glutamyl, leucyl, alpha-aspartyl, lysyl, tryptophyl, alanyl, seryl, leucyl, tryptophyl, asparaginyl, tryptophyl, and phenylalaninamide residues joined in sequence. An HIV fusion inhibitor, it was the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It interferes with entry of HIV into cells by binding to the gp41 sub-unit of the viral envelope glycoprotein, so inhibiting fusion of viral and cellular membranes. | 3.23 | 1 | 0 | ||
| ganirelix [no description available] | 3.23 | 1 | 0 | polypeptide | |
| teriparatide [no description available] | 3.23 | 1 | 0 | polypeptide | |
| salmon calcitonin [no description available] | 3.23 | 1 | 0 | heterodetic cyclic peptide; peptide hormone; polypeptide | bone density conservation agent; metabolite |
| ly-146032 [no description available] | 3.61 | 2 | 0 | heterodetic cyclic peptide; lipopeptide antibiotic; lipopeptide; macrocycle; macrolide | antibacterial drug; bacterial metabolite; calcium-dependent antibiotics |
| ziconotide ziconotide: amino acid sequence in first source; from venom of South Pacific sea cone snail, Conus magus; calcium channel blocker; administered by injection into Cerebrospinal Fluid; Prialt is synthetic form. omega-conotoxin MVIIA : A heterodetic cyclic polypeptide consisting of the linear sequence Cys-Lys-Gly-Lys-Gly-Ala-Lys-Cys-Ser-Arg-Leu-Met-Tyr-Asp-Cys-Cys-Thr-Gly-Ser-Cys-Arg-Ser-Gly-Lys-Cys-NH2 with three disulfide bridges between cysteine residues 1-16, 8-20 and 15-25. A neuronal N-type Ca(2+) channel blocker in mammalian and amphibian brain, it blocks release of GABA and glutamate at neuronal synapses. Used as a probe for calcium channel receptors, it is selective for different receptor subtypes. A synthetic form, named ziconotide, is an atypical analgesic agent for the amelioration of severe and chronic pain. | 4.75 | 3 | 0 | ||
| acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ilys-prolyl-alaninamide acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide: FE-200486 is the acetate salt | 3.23 | 1 | 0 | polypeptide | |
| exenatide [no description available] | 3.23 | 1 | 0 | ||
| warfarin sodium warfarin sodium : A racemate comprising equal amounts of (R)- and (S)-warfarin sodium. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice. | 2.08 | 1 | 0 | ||
| cellulose DEAE-Cellulose: Cellulose derivative used in chromatography, as ion-exchange material, and for various industrial applications. | 3.92 | 2 | 1 | glycoside | |
| pravastatin sodium pravastatin sodium : An organic sodium salt that is the sodium salt of pravastatin. A reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA), it is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin. | 2.08 | 1 | 0 | organic sodium salt; statin (semi-synthetic) | anticholesteremic drug |
| alendronate sodium [no description available] | 2.08 | 1 | 0 | ||
| ubiquinone Ubiquinone: A lipid-soluble benzoquinone which is involved in ELECTRON TRANSPORT in mitochondrial preparations. The compound occurs in the majority of aerobic organisms, from bacteria to higher plants and animals. | 4.63 | 2 | 2 | ||
| sl 80.0750 [no description available] | 2.08 | 1 | 0 | ||
| calpain Calpain: Cysteine proteinase found in many tissues. Hydrolyzes a variety of endogenous proteins including NEUROPEPTIDES; CYTOSKELETAL PROTEINS; proteins from SMOOTH MUSCLE; CARDIAC MUSCLE; liver; platelets; and erythrocytes. Two subclasses having high and low calcium sensitivity are known. Removes Z-discs and M-lines from myofibrils. Activates phosphorylase kinase and cyclic nucleotide-independent protein kinase. This enzyme was formerly listed as EC 3.4.22.4. | 2.17 | 1 | 0 | ||
| mesna Mesna: A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE. | 3.61 | 2 | 0 | organosulfonic acid | |
| sodium oxybate Sodium Oxybate: The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA. | 2.07 | 1 | 0 | ||
| clavulanate potassium potassium clavulanate : A potassium salt having clavulanate as the counterion. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes and has only weak anitbiotic activity when administered alone. However it can be used in combination with amoxicillin trihydrate (under the trade name Augmentin) for treatment of a variety of bacterial infections, where it prevents antibiotic inactivation by microbial lactamases. | 2.08 | 1 | 0 | potassium salt | antibacterial drug; antimicrobial agent; EC 3.5.2.6 (beta-lactamase) inhibitor |
| sodium lactate Sodium Lactate: The sodium salt of racemic or inactive lactic acid. It is a hygroscopic agent used intravenously as a systemic and urinary alkalizer.. sodium lactate : An organic sodium salt having lactate as the counterion. | 3.23 | 1 | 0 | lactate salt; organic sodium salt | food acidity regulator; food preservative |
| piperacillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
| sodium iothalamate [no description available] | 3.23 | 1 | 0 | ||
| oxacillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
| cefazolin sodium cefazolin sodium : A cephalosporin organic sodium salt having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups. | 2.08 | 1 | 0 | organic sodium salt | |
| ro13-9904 Ceftriaxone: A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.. ceftriaxone : A third-generation cephalosporin compound having 2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetylamino and [(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl side-groups. | 3.35 | 1 | 0 | ||
| azlocillin sodium [no description available] | 2.08 | 1 | 0 | organic sodium salt | |
| quetiapine fumarate Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER. | 4.97 | 7 | 1 | fumarate salt | |
| cardiovascular agents Cardiovascular Agents: Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. | 2.15 | 1 | 0 | ||
| cetrorelix cetrorelix: LHRH antagonist. cetrorelix : A synthetic ten-membered oligopeptide comprising N-acetyl-3-(naphthalen-2-yl)-D-alanyl, 4-chloro-D-phenylalanyl, 3-(pyridin-3-yl)-D-alanyl, L-seryl, L-tyrosyl, N(5)-carbamoyl-D-ornithyl, L-leucyl, L-arginyl, L-prolyl, and D-alaninamide residues coupled in sequence. A gonadotrophin-releasing hormone (GnRH) antagonist, it is used for treatment of infertility and of hormone-sensitive cancers of the prostate and breast. | 3.23 | 1 | 0 | oligopeptide | antineoplastic agent; GnRH antagonist |
| tolterodine tartrate Tolterodine Tartrate: An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE. | 5.03 | 2 | 1 | tartrate salt | |
| a 967079 A 967079: a TRPA1 channel antagonist; structure in first source | 2.25 | 1 | 0 | ||
| gw 1000 nabiximols: a combination of the above cpds for treatment of multiple sclerosis pain | 2.13 | 1 | 0 | ||
| piperidines Piperidines: A family of hexahydropyridines. | 5.44 | 7 | 2 | ||
| e-52862 [no description available] | 2.5 | 2 | 0 | ||
| resolvin d1 resolvin D1: an anti-inflammatory lipid mediator; structure in first source. resolvin D1 : A resolvin that is docosa-4Z,9E,11E,13Z,15E,19Z-hexaenoic acid which is substituted by hydroxy groups at the 7, 8, and 17 positions (the 7S,8R,17S-stereoisomer). | 2.1 | 1 | 0 | hydroxy polyunsaturated fatty acid; resolvin; triol | anti-inflammatory agent |
| interleukin-8 Interleukin-8: A member of the CXC chemokine family that plays a role in the regulation of the acute inflammatory response. It is secreted by variety of cell types and induces CHEMOTAXIS of NEUTROPHILS and other inflammatory cells. | 2.15 | 1 | 0 | ||
| dabrafenib [no description available] | 7.11 | 1 | 0 | 1,3-thiazoles; aminopyrimidine; organofluorine compound; sulfonamide | anticoronaviral agent; antineoplastic agent; B-Raf inhibitor |
| exenatide Exenatide: A synthetic form of exendin-4, a 39-amino acid peptide isolated from the venom of the Gila monster lizard (Heloderma suspectum). Exenatide increases CYCLIC AMP levels in pancreatic acinar cells and acts as a GLUCAGON-LIKE PEPTIDE-1 RECEPTOR (GLP-1) agonist and incretin mimetic, enhancing insulin secretion in response to increased glucose levels; it also suppresses inappropriate glucagon secretion and slows gastric emptying. It is used an anti-diabetic and anti-obesity agent. | 2.43 | 2 | 0 | ||
| natriuretic peptide, brain Natriuretic Peptide, Brain: A PEPTIDE that is secreted by the BRAIN and the HEART ATRIA, stored mainly in cardiac ventricular MYOCARDIUM. It can cause NATRIURESIS; DIURESIS; VASODILATION; and inhibits secretion of RENIN and ALDOSTERONE. It improves heart function. It contains 32 AMINO ACIDS. | 2.63 | 2 | 0 | polypeptide | |
| ascorbic acid Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.. L-ascorbic acid : The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.. L-ascorbate : The L-enantiomer of ascorbate and conjugate base of L-ascorbic acid, arising from selective deprotonation of the 3-hydroxy group. Required for a range of essential metabolic reactions in all animals and plants.. vitamin C : Any member of a group of vitamers that belong to the chemical structural class called butenolides that exhibit biological activity against vitamin C deficiency in animals. The vitamers include L-ascorbic acid and its salt, ionized and oxidized forms. | 3.59 | 2 | 0 | ascorbic acid; vitamin C | coenzyme; cofactor; flour treatment agent; food antioxidant; food colour retention agent; geroprotector; plant metabolite; skin lightening agent |
| raltegravir [no description available] | 3.23 | 1 | 0 | 1,2,4-oxadiazole; dicarboxylic acid amide; hydroxypyrimidine; monofluorobenzenes; pyrimidone; secondary carboxamide | antiviral drug; HIV-1 integrase inhibitor |
| tetracycline Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria. | 4.43 | 3 | 0 | ||
| oxytetracycline, anhydrous Oxytetracycline: A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES RIMOSUS and used in a wide variety of clinical conditions.. oxytetracycline : A tetracycline used for treatment of infections caused by a variety of Gram positive and Gram negative microorganisms including Mycoplasma pneumoniae, Pasteurella pestis, Escherichia coli, Haemophilus influenzae (respiratory infections), and Diplococcus pneumoniae. | 3.23 | 1 | 0 | ||
| minocycline Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5. | 11.55 | 5 | 1 | ||
| piroxicam [no description available] | 3.89 | 3 | 0 | benzothiazine; monocarboxylic acid amide; pyridines | analgesic; antirheumatic drug; cyclooxygenase 1 inhibitor; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
| roquinimex roquinimex: structure in first source | 2.08 | 1 | 0 | aromatic amide | |
| mobic Meloxicam: A benzothiazine and thiazole derivative that acts as a NSAID and cyclooxygenase-2 (COX-2) inhibitor. It is used in the treatment of RHEUMATOID ARTHRITIS; OSTEOARTHRITIS; and ANKYLOSING SPONDYLITIS.. meloxicam : A benzothiazine that is piroxicam in which the pyridin-2-yl group is replaced by a 5-methyl-1,3-thiazol-2-yl group. A non-steroidal anti-inflammatory drug and selective inhibitor of COX-2, it is used particularly for the management of rheumatoid arthritis. | 5.52 | 4 | 1 | 1,3-thiazoles; benzothiazine; monocarboxylic acid amide | analgesic; antirheumatic drug; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| mobiflex tenoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. It is also indicated for short term treatment of acute musculoskeletal disorders including strains, sprains and other soft-tissue injuries. | 2.49 | 2 | 0 | heteroaryl hydroxy compound; monocarboxylic acid amide; pyridines; thienothiazine | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| isoxicam isoxicam : A monocarboxylic acid amide that is piroxicam in which the pyrid-2-yl group is replaced by a 5-methyl-1,2-oxazol-3-yl group. A non-steroidal anti-inflammatory drug, it was withdrawn from the market in the 1980s following its association with cases of Stevens-Johnson syndrome. | 2.08 | 1 | 0 | benzothiazine; isoxazoles; monocarboxylic acid amide | antirheumatic drug; non-steroidal anti-inflammatory drug |
| warfarin Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. | 3.23 | 1 | 0 | benzenes; hydroxycoumarin; methyl ketone | |
| demeclocycline Demeclocycline: A TETRACYCLINE analog having a 7-chloro and a 6-methyl. Because it is excreted more slowly than tetracycline, it maintains effective blood levels for longer periods of time.. demeclocycline : Tetracycline which lacks the methyl substituent at position 7 and in which the hydrogen para- to the phenolic hydroxy group is substituted by chlorine. Like tetracycline, it is an antibiotic, but being excreted more slowly, effective blood levels are maintained for longer. It is used (mainly as the hydrochloride) for the treatment of Lyme disease, acne and bronchitis, as well as for hyponatraemia (low blood sodium concentration) due to the syndrome of inappropriate antidiuretic hormone (SIADH) where fluid restriction alone has been ineffective. | 3.23 | 1 | 0 | ||
| tipranavir tipranavir: inhibits HIV-1 protease. tipranavir : A pyridine-2-sulfonamide substituted at C-5 by a trifluoromethyl group and at the sulfonamide nitrogen by a dihydropyrone-containing m-tolyl substituent. It is an HIV-1 protease inhibitor. | 3.23 | 1 | 0 | sulfonamide | antiviral drug; HIV protease inhibitor |
| minocycline hydrochloride [no description available] | 2.08 | 1 | 0 | ||
| tigecycline [no description available] | 4.07 | 4 | 0 | ||
| lornoxicam lornoxicam : A thienothiazine-derived monocarboxylic acid amide obtained by formal condensation of the carboxy group of 6-chloro-4-hydroxy-2-methylthieno[2,3-e][1,2]thiazine-3-carboxylic acid 1,1-dioxide with the amino group of 2-aminopyridine. Used for the treatment of pain, primarily resulting from inflammatory diseases of the joints, osteoarthritis, surgery, sciatica and other inflammations. | 2.08 | 1 | 0 | heteroaryl hydroxy compound; monocarboxylic acid amide; organochlorine compound; pyridines; thienothiazine | antipyretic; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| s 1 (combination) S 1 (combination): consists of tegafur, 5-chloro-2,4-dihydroxyuridine & potassium oxonate; an inhibitor of fluorouracil(5-FU) degradation; prolongs the blood 5-FU level as well as increases selective toxicity to tumor; used for the treatment of colon cancer | 3.25 | 1 | 0 | ||
| omega-agatoxin iva omega-Agatoxin IVA: A neuropeptide toxin from the venom of the funnel web spider, Agelenopsis aperta. It inhibits CALCIUM CHANNELS, P-TYPE by altering the voltage-dependent gating so that very large depolarizations are needed for channel opening. It also inhibits CALCIUM CHANNELS, Q-TYPE. | 2.01 | 1 | 0 | ||
| snx 230 omega-conotoxin-MVIIC: isolated from Conus magus; amino acid sequence given in first source | 2.92 | 1 | 0 | ||
| transforming growth factor beta Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins. | 2.17 | 1 | 0 | ||
| phytoestrogens Phytoestrogens: Compounds derived from plants, primarily ISOFLAVONES that mimic or modulate endogenous estrogens, usually by binding to ESTROGEN RECEPTORS. | 4.78 | 3 | 0 | ||
| mirogabalin mirogabalin: for the treatment of diabetic peripheral neuropathic pain | 11.32 | 15 | 6 | ||
| fertinex [no description available] | 3.23 | 1 | 0 | ||
| angiotensin i Angiotensin I: A decapeptide that is cleaved from precursor angiotensinogen by RENIN. Angiotensin I has limited biological activity. It is converted to angiotensin II, a potent vasoconstrictor, after the removal of two amino acids at the C-terminal by ANGIOTENSIN CONVERTING ENZYME.. angiotensin I : A ten amino acid peptide formed by renin cleavage of angiotensinogen. Angiotensin I has no direct biological function except that high levels can stimulate catecholamine production. It is metabolized to its biologically active byproduct angiotensin II, a potent vasoconstrictor, by angiotensin converting enzyme (ACE) through cleavage of the two terminal amino acids.. angiotensin I dizwitterion : A peptide zwitterion that is the dizwitterionic form of angiotensin I having both carboxy groups deprotonated and the aspartyl amino group and arginine side-chain protonated. It is the major species at pH 7.3. | 2.25 | 1 | 0 | angiotensin; peptide zwitterion | human metabolite; neurotransmitter agent |
| cobamamide cobamamide : A member of the class of cobalamins that is vitamin B12 in which the cyano group is replaced by a 5'-deoxyadenos-5'-yl moiety. It is one of the two metabolically active form of vitamin B12. | 3.53 | 1 | 1 | ||
| vitamin b 12 Vitamin B 12: A cobalt-containing coordination compound produced by intestinal micro-organisms and found also in soil and water. Higher plants do not concentrate vitamin B 12 from the soil and so are a poor source of the substance as compared with animal tissues. INTRINSIC FACTOR is important for the assimilation of vitamin B 12. | 5.41 | 2 | 2 | ||
| cyclosporine Cyclosporine: A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed). | 2.54 | 2 | 0 | ||
| myelin oligodendrocyte glycoprotein (35-55) [no description available] | 2.25 | 1 | 0 | ||
| entecavir entecavir (anhydrous) : Guanine substituted at the 9 position by a 4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl group. A synthetic analogue of 2'-deoxyguanosine, it is a nucleoside reverse transcriptase inhibitor with selective antiviral activity against hepatitis B virus. Entecavir is phosphorylated intracellularly to the active triphosphate form, which competes with deoxyguanosine triphosphate, the natural substrate of hepatitis B virus reverse transcriptase, inhibiting every stage of the enzyme's activity, although it has no activity against HIV. It is used for the treatment of chronic hepatitis B. | 3.9 | 3 | 0 | 2-aminopurines; oxopurine; primary alcohol; secondary alcohol | antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| acyclovir Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections. | 4.48 | 6 | 0 | 2-aminopurines; oxopurine | antimetabolite; antiviral drug |
| levoleucovorin Levoleucovorin: A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.. (6S)-5-formyltetrahydrofolic acid : The pharmacologically active (6S)-stereoisomer of 5-formyltetrahydrofolic acid. | 2.31 | 1 | 0 | 5-formyltetrahydrofolic acid | antineoplastic agent; metabolite |
| guanine [no description available] | 2.13 | 1 | 0 | 2-aminopurines; oxopurine; purine nucleobase | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| folic acid folcysteine: used to promote fertility in chickens. vitamin B9 : Any B-vitamin that exhibits biological activity against vitamin B9 deficiency. Vitamin B9 refers to the many forms of folic acid and its derivatives, including tetrahydrofolic acid (the active form), methyltetrahydrofolate (the primary form found in blood), methenyltetrahydrofolate, folinic acid amongst others. They are present in abundance in green leafy vegetables, citrus fruits, and animal products. Lack of vitamin B9 leads to anemia, a condition in which the body cannot produce sufficient number of red blood cells. Symptoms of vitamin B9 deficiency include fatigue, muscle weakness, and pale skin. | 3.23 | 1 | 0 | folic acids; N-acyl-amino acid | human metabolite; mouse metabolite; nutrient |
| rifampin Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160) | 4.41 | 3 | 0 | cyclic ketal; hydrazone; N-iminopiperazine; N-methylpiperazine; rifamycins; semisynthetic derivative; zwitterion | angiogenesis inhibitor; antiamoebic agent; antineoplastic agent; antitubercular agent; DNA synthesis inhibitor; EC 2.7.7.6 (RNA polymerase) inhibitor; Escherichia coli metabolite; geroprotector; leprostatic drug; neuroprotective agent; pregnane X receptor agonist; protein synthesis inhibitor |
| clozapine Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia. | 4.44 | 6 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine; organochlorine compound | adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; GABA antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; xenobiotic |
| dacarbazine (E)-dacarbazine : A dacarbazine in which the N=N double bond adopts a trans-configuration. | 3.61 | 2 | 0 | dacarbazine | |
| didanosine Didanosine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.. didanosine : A purine 2',3'-dideoxyribonucleoside that is inosine in which the hydroxy groups at both the 2' and the 3' positions on the sugar moiety have been replaced by hydrogen. An antiviral drug, it is used as a medication to treat HIV/AIDS. | 3.61 | 2 | 0 | purine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; EC 2.4.2.1 (purine-nucleoside phosphorylase) inhibitor; geroprotector; HIV-1 reverse transcriptase inhibitor |
| ganciclovir [no description available] | 3.61 | 2 | 0 | 2-aminopurines; oxopurine | antiinfective agent; antiviral drug |
| valtrex [no description available] | 2.08 | 1 | 0 | organic molecular entity | |
| valacyclovir Valacyclovir: A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES. | 3.63 | 2 | 0 | L-valyl ester | antiviral drug |
| sildenafil sildenafil : A pyrazolo[4,3-d]pyrimidin-7-one having a methyl substituent at the 1-position, a propyl substituent at the 3-position and a 2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl group at the 5-position. | 3.66 | 2 | 0 | piperazines; pyrazolopyrimidine; sulfonamide | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
| olanzapine Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4. | 4.18 | 4 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine | antiemetic; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; serotonin uptake inhibitor |
| zaprinast zaprinast: anaphylaxis inhibitor; structure | 2.21 | 1 | 0 | triazolopyrimidines | |
| raltitrexed [no description available] | 2.08 | 1 | 0 | N-acyl-amino acid | |
| vardenafil vardenafil : The sulfonamide resulting from formal condensation of the sulfo group of 4-ethoxy-3-(5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one-2-yl)benzenesulfonic acid and the secondary amino group of 4-ethylpiperazine. | 3.23 | 1 | 0 | imidazotriazine; N-alkylpiperazine; N-sulfonylpiperazine | EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; vasodilator agent |
| allopurinol Allopurinol: A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.. allopurinol : A bicyclic structure comprising a pyrazole ring fused to a hydroxy-substituted pyrimidine ring. | 3.61 | 2 | 0 | nucleobase analogue; organic heterobicyclic compound | antimetabolite; EC 1.17.3.2 (xanthine oxidase) inhibitor; gout suppressant; radical scavenger |
| citrovorum factor [no description available] | 3.61 | 2 | 0 | tetrahydrofolic acid | |
| leucovorin 5-formyltetrahydrofolic acid : A formyltetrahydrofolic acid in which the formyl group is located at position 5. | 3.23 | 1 | 0 | formyltetrahydrofolic acid | Escherichia coli metabolite; mouse metabolite |
| rifapentine rifapentine: cyclopentyl derivative of rifampicin | 3.61 | 2 | 0 | N-alkylpiperazine; N-iminopiperazine; rifamycins | antitubercular agent; leprostatic drug |
| bl 4162a anagrelide: imidazoquinazoline derivative which lowers platelet count probably by inhibiting thrombopoiesis and reduces platelet aggregation; used for thrombocythemia; structure in first source. anagrelide : A 1,5-dihydroimidazo[2,1-]quinazoline having an oxo substituent at the 2-position and chloro substituents at the 6- and 7-positions. | 3.23 | 1 | 0 | imidazoquinazoline | anticoagulant; antifibrinolytic drug; cardiovascular drug; platelet aggregation inhibitor |
| tegaserod tegaserod: a nonbenzamide 5-hydroxytryptamine(4) agonist; used in treatment of irritable bowel syndrome; marketing suspended 2007 in US due to higher incidence of MI, stroke, and unstable angina; structure given in first source | 3.23 | 1 | 0 | carboxamidine; guanidines; hydrazines; indoles | gastrointestinal drug; serotonergic agonist |
| pemetrexed pemetrexed disodium : An organic sodium salt that is the disodium salt of N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamic acid. Inhibits thymidylate synthase (TS), 421 dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT). | 3.23 | 1 | 0 | N-acyl-L-glutamic acid; pyrrolopyrimidine | antimetabolite; antineoplastic agent; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; EC 2.1.1.45 (thymidylate synthase) inhibitor; EC 2.1.2.2 (phosphoribosylglycinamide formyltransferase) inhibitor |
| sildenafil citrate Sildenafil Citrate: A PHOSPHODIESTERASE TYPE-5 INHIBITOR; VASODILATOR AGENT and UROLOGICAL AGENT that is used in the treatment of ERECTILE DYSFUNCTION and PRIMARY PULMONARY HYPERTENSION.. sildenafil citrate : The citrate salt of sildenafil. | 2.98 | 4 | 0 | citrate salt | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
| valganciclovir Valganciclovir: A ganciclovir prodrug and antiviral agent that is used to treat CYTOMEGALOVIRUS RETINITIS in patients with AIDS, and for the prevention of CYTOMEGALOVIRUS INFECTIONS in organ transplant recipients who have received an organ from a CMV-positive donor.. valganciclovir : The L-valinyl ester of ganciclovir, into which it is rapidly converted by intestinal and hepatic esterases. It is a synthetic analogue of 2'-deoxyguanosine. | 3.23 | 1 | 0 | L-valyl ester; purines | antiviral drug; prodrug |
| aprepitant Aprepitant: A morpholine neurokinin-1 (NK1) receptor antagonist that is used in the management of nausea and vomiting caused by DRUG THERAPY, and for the prevention of POSTOPERATIVE NAUSEA AND VOMITING.. aprepitant : A morpholine-based antiemetic, which is or the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. | 11.91 | 4 | 1 | (trifluoromethyl)benzenes; cyclic acetal; morpholines; triazoles | antidepressant; antiemetic; neurokinin-1 receptor antagonist; peripheral nervous system drug; substance P receptor antagonist |
| fosaprepitant fosaprepitant: a pro-drug form of aprepitant. fosaprepitant : A morpholine derivative that is the (1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethyl ether of (3-{[(2R,3S)-3-(4-fluorophenyl)-2-hydroxymorpholin-4-yl]methyl}-5-oxo-4,5-dihydro-1H-1,2,4-triazol-1-yl)phosphonic acid. | 3.23 | 1 | 0 | (trifluoromethyl)benzenes; cyclic acetal; morpholines; phosphoramide; triazoles | antiemetic; neurokinin-1 receptor antagonist; prodrug |
| tegaserod maleate [no description available] | 2.08 | 1 | 0 | maleate salt | serotonergic agonist |
| da 8159 udenafil: a pyrazolo-pyrimidinone similar to sildenafil; phosphodiesterase type 5 inhibitor; | 3.14 | 1 | 0 | sulfonamide | |
| rifabutin [no description available] | 3.61 | 2 | 0 | ||
| clozapine n-oxide clozapine N-oxide: structure given in first source | 2.15 | 1 | 0 | dibenzodiazepine | |
| levomefolate calcium levomefolate calcium: an ingredient in Contraceptives, Oral, Combined. levomefolate calcium : An organic calcium salt of (6S)-5-methyltetrahydrofolic acid. | 3.23 | 1 | 0 | organic calcium salt | antidepressant |
| cholestyramine resin Cholestyramine Resin: A strongly basic anion exchange resin whose main constituent is polystyrene trimethylbenzylammonium Cl(-) anion. | 3.23 | 1 | 0 | ||
| concanavalin a Concanavalin A: A MANNOSE/GLUCOSE binding lectin isolated from the jack bean (Canavalia ensiformis). It is a potent mitogen used to stimulate cell proliferation in lymphocytes, primarily T-lymphocyte, cultures. | 7.25 | 1 | 0 | ||
| leptin Leptin: A 16-kDa peptide hormone secreted from WHITE ADIPOCYTES. Leptin serves as a feedback signal from fat cells to the CENTRAL NERVOUS SYSTEM in regulation of food intake, energy balance, and fat storage. | 7.25 | 1 | 0 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Chronic Illness [description not available] | 0 | 27.25 | 1,100 | 1,047 |
| Lesion of Sciatic Nerve [description not available] | 0 | 3.93 | 12 | 0 |
| Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. | 0 | 13.97 | 157 | 0 |
| Ache [description not available] | 0 | 23.39 | 380 | 76 |
| Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). | 0 | 27.25 | 1,100 | 1,047 |
| Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. | 1 | 25.39 | 380 | 76 |
| Absence Seizure [description not available] | 0 | 13.15 | 52 | 9 |
| Seizures Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder. | 1 | 17.78 | 104 | 18 |
| Audiogenic Epilepsy [description not available] | 0 | 2.03 | 1 | 0 |
| Epilepsy, Reflex A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8) | 0 | 2.03 | 1 | 0 |
| Arthritis, Degenerative [description not available] | 0 | 25.01 | 1,037 | 1,026 |
| Osteoarthritis A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans. | 1 | 27.01 | 1,037 | 1,026 |
| Allodynia [description not available] | 0 | 13.31 | 114 | 15 |
| Nerve Pain [description not available] | 0 | 30.1 | 1,612 | 1,120 |
| Neuralgia Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve. | 1 | 34.87 | 3,224 | 2,240 |
| Amnesia-Memory Loss [description not available] | 0 | 2.81 | 3 | 0 |
| Amnesia Pathologic partial or complete loss of the ability to recall past experiences (AMNESIA, RETROGRADE) or to form new memories (AMNESIA, ANTEROGRADE). This condition may be of organic or psychologic origin. Organic forms of amnesia are usually associated with dysfunction of the DIENCEPHALON or HIPPOCAMPUS. (From Adams et al., Principles of Neurology, 6th ed, pp426-7) | 0 | 7.81 | 3 | 0 |
| Acute Liver Injury, Drug-Induced [description not available] | 0 | 4.61 | 9 | 0 |
| Adverse Drug Event [description not available] | 0 | 8.42 | 20 | 4 |
| Chemical and Drug Induced Liver Injury A spectrum of clinical liver diseases ranging from mild biochemical abnormalities to ACUTE LIVER FAILURE, caused by drugs, drug metabolites, herbal and dietary supplements and chemicals from the environment. | 0 | 4.61 | 9 | 0 |
| Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. | 0 | 8.42 | 20 | 4 |
| Pain, Chronic [description not available] | 0 | 19.76 | 148 | 20 |
| Innate Inflammatory Response [description not available] | 0 | 8.33 | 24 | 1 |
| Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. | 0 | 8.33 | 24 | 1 |
| Chronic Pain Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain. | 1 | 21.76 | 148 | 20 |
| Central Nervous System Disease [description not available] | 0 | 5.3 | 4 | 1 |
| Central Nervous System Diseases Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord. | 0 | 5.3 | 4 | 1 |
| Constriction, Pathological [description not available] | 0 | 3.33 | 6 | 0 |
| Constriction, Pathologic The condition of an anatomical structure's being constricted beyond normal dimensions. | 0 | 3.33 | 6 | 0 |
| Adjuvant Arthritis [description not available] | 0 | 2.55 | 2 | 0 |
| Anasarca [description not available] | 0 | 7.99 | 16 | 2 |
| Edema Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE. | 0 | 7.99 | 16 | 2 |
| Benign Neoplasms [description not available] | 0 | 16.39 | 48 | 10 |
| Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. | 0 | 16.39 | 48 | 10 |
| Alloxan Diabetes [description not available] | 0 | 4.2 | 15 | 0 |
| Autoimmune Diabetes [description not available] | 0 | 13.62 | 34 | 3 |
| Diabetes Mellitus, Adult-Onset [description not available] | 0 | 14.82 | 41 | 7 |
| Diabetes Mellitus, Type 1 A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence. | 0 | 13.62 | 34 | 3 |
| Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY. | 0 | 14.82 | 41 | 7 |
| Peripheral Nerve Diseases [description not available] | 0 | 17.82 | 93 | 26 |
| Peripheral Nervous System Diseases Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves. | 1 | 22.55 | 186 | 52 |
| Neurogenic Inflammation Inflammation caused by an injurious stimulus of peripheral neurons and resulting in release of neuropeptides which affect vascular permeability and help initiate proinflammatory and immune reactions at the site of injury. | 0 | 2.25 | 1 | 0 |
| Acute Edematous Pancreatitis [description not available] | 0 | 2.63 | 2 | 0 |
| Pancreatitis INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis. | 0 | 2.63 | 2 | 0 |
| Congenital Zika Syndrome [description not available] | 0 | 2.25 | 1 | 0 |
| Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME. | 0 | 2.25 | 1 | 0 |
| Indigestion [description not available] | 0 | 4.39 | 3 | 1 |
| Dyspepsia Impaired digestion, especially after eating. | 0 | 4.39 | 3 | 1 |
| Poisoning Used with drugs, chemicals, and industrial materials for human or animal poisoning, acute or chronic, whether the poisoning is accidental, occupational, suicidal, by medication error, or by environmental exposure. | 0 | 4.21 | 5 | 0 |
| Lock Jaw [description not available] | 0 | 3.77 | 3 | 0 |
| Diffuse Myofascial Pain Syndrome [description not available] | 0 | 29.12 | 1,319 | 1,100 |
| Myofascial Trigger Point Pain [description not available] | 0 | 4.62 | 1 | 1 |
| Fibromyalgia A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95) | 1 | 31.12 | 1,319 | 1,100 |
| Myofascial Pain Syndromes Muscular pain in numerous body regions that can be reproduced by pressure on TRIGGER POINTS, localized hardenings in skeletal muscle tissue. Pain is referred to a location distant from the trigger points. A prime example is the TEMPOROMANDIBULAR JOINT DYSFUNCTION SYNDROME. | 0 | 4.62 | 1 | 1 |
| Acute Post-operative Pain [description not available] | 0 | 27.34 | 658 | 313 |
| Pain, Postoperative Pain during the period after surgery. | 0 | 27.34 | 658 | 313 |
| Neuralgia, Sciatic [description not available] | 0 | 10.94 | 23 | 8 |
| Low Back Ache [description not available] | 0 | 26.21 | 1,053 | 1,030 |
| Sciatica A condition characterized by pain radiating from the back into the buttock and posterior/lateral aspects of the leg. Sciatica may be a manifestation of SCIATIC NEUROPATHY; RADICULOPATHY (involving the SPINAL NERVE ROOTS; L4, L5, S1, or S2, often associated with INTERVERTEBRAL DISK DISPLACEMENT); or lesions of the CAUDA EQUINA. | 0 | 10.94 | 23 | 8 |
| Low Back Pain Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions. | 0 | 26.21 | 1,053 | 1,030 |
| Depression, Involutional Form of depression in those MIDDLE AGE with feelings of ANXIETY. | 0 | 5.91 | 8 | 1 |
| Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. | 0 | 12.9 | 36 | 12 |
| Depressive Disorder, Major Disorder in which five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. Symptoms include: depressed mood most of the day, nearly every daily; markedly diminished interest or pleasure in activities most of the day, nearly every day; significant weight loss when not dieting or weight gain; Insomnia or hypersomnia nearly every day; psychomotor agitation or retardation nearly every day; fatigue or loss of energy nearly every day; feelings of worthlessness or excessive or inappropriate guilt; diminished ability to think or concentrate, or indecisiveness, nearly every day; or recurrent thoughts of death, recurrent suicidal ideation without a specific plan, or a suicide attempt. (DSM-5) | 0 | 5.91 | 8 | 1 |
| Hemorrhage, Subarachnoid [description not available] | 0 | 2.72 | 2 | 0 |
| Subarachnoid Hemorrhage Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status. | 0 | 2.72 | 2 | 0 |
| Gastritis Inflammation of the GASTRIC MUCOSA, a lesion observed in a number of unrelated disorders. | 0 | 2.72 | 2 | 0 |
| Postherpetic Neuralgia [description not available] | 0 | 18.08 | 104 | 32 |
| Neuralgia, Postherpetic Pain in nerves, frequently involving facial SKIN, resulting from the activation the latent varicella-zoster virus (HERPESVIRUS 3, HUMAN). The two forms of the condition preceding the pain are HERPES ZOSTER OTICUS; and HERPES ZOSTER OPHTHALMICUS. Following the healing of the rashes and blisters, the pain sometimes persists. | 1 | 20.08 | 104 | 32 |
| Debility [description not available] | 0 | 4.07 | 2 | 0 |
| Drug Overdose Accidental or deliberate use of a medication or street drug in excess of normal dosage. | 0 | 13.06 | 28 | 0 |
| Fasting Hypoglycemia HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast. | 0 | 2.91 | 3 | 0 |
| Hypoglycemia A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH. | 0 | 2.91 | 3 | 0 |
| Affective Psychosis, Bipolar [description not available] | 0 | 7.49 | 19 | 0 |
| Chronic Insomnia [description not available] | 0 | 13.96 | 31 | 14 |
| Anxiety Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS. | 1 | 17.51 | 68 | 29 |
| Bipolar Disorder A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence. | 0 | 7.49 | 19 | 0 |
| Sleep Initiation and Maintenance Disorders Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition. | 1 | 15.96 | 31 | 14 |
| Cancer of Pancreas [description not available] | 0 | 5.64 | 8 | 0 |
| Pancreatic Neoplasms Tumors or cancer of the PANCREAS. Depending on the types of ISLET CELLS present in the tumors, various hormones can be secreted: GLUCAGON from PANCREATIC ALPHA CELLS; INSULIN from PANCREATIC BETA CELLS; and SOMATOSTATIN from the SOMATOSTATIN-SECRETING CELLS. Most are malignant except the insulin-producing tumors (INSULINOMA). | 0 | 5.64 | 8 | 0 |
| Muscle Pain [description not available] | 0 | 4.78 | 5 | 1 |
| Myalgia Painful sensation in the muscles. | 0 | 4.78 | 5 | 1 |
| Chronic Kidney Diseases [description not available] | 0 | 10.75 | 13 | 2 |
| Brain Disorders [description not available] | 0 | 2.83 | 3 | 0 |
| Acute Hypercapnic Respiratory Failure [description not available] | 0 | 7.83 | 12 | 1 |
| Brain Diseases Pathologic conditions affecting the BRAIN, which is composed of the intracranial components of the CENTRAL NERVOUS SYSTEM. This includes (but is not limited to) the CEREBRAL CORTEX; intracranial white matter; BASAL GANGLIA; THALAMUS; HYPOTHALAMUS; BRAIN STEM; and CEREBELLUM. | 0 | 2.83 | 3 | 0 |
| Respiratory Insufficiency Failure to adequately provide oxygen to cells of the body and to remove excess carbon dioxide from them. (Stedman, 25th ed) | 0 | 7.83 | 12 | 1 |
| Renal Insufficiency, Chronic Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002) | 0 | 10.75 | 13 | 2 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 1 | 16.31 | 52 | 3 |
| Dry Eye [description not available] | 0 | 7.82 | 2 | 0 |
| Dry Eye Syndromes Corneal and conjunctival dryness due to deficient tear production, predominantly in menopausal and post-menopausal women. Filamentary keratitis or erosion of the conjunctival and corneal epithelium may be caused by these disorders. Sensation of the presence of a foreign body in the eye and burning of the eyes may occur. | 1 | 4.82 | 2 | 0 |
| Eye Pain A dull or sharp painful sensation associated with the outer or inner structures of the eyeball, having different causes. | 0 | 11.97 | 5 | 1 |
| Injuries, Spinal Cord [description not available] | 0 | 11.95 | 32 | 4 |
| Spinal Cord Injuries Penetrating and non-penetrating injuries to the spinal cord resulting from traumatic external forces (e.g., WOUNDS, GUNSHOT; WHIPLASH INJURIES; etc.). | 1 | 13.95 | 32 | 4 |
| Asymmetric Diabetic Proximal Motor Neuropathy [description not available] | 0 | 21.81 | 242 | 60 |
| Diabetes Mellitus A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE. | 1 | 11.6 | 15 | 5 |
| Diabetic Neuropathies Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325) | 1 | 23.81 | 242 | 60 |
| Cancer-Associated Pain [description not available] | 0 | 8.87 | 11 | 4 |
| Cancer Pain Pain that may be caused by or related to cellular, tissue, and systemic changes that occur during NEOPLASM growth, tissue invasion, and METASTASIS. | 0 | 8.87 | 11 | 4 |
| Chronic Liver Failure [description not available] | 0 | 2.41 | 1 | 0 |
| Cirrhosis, Liver [description not available] | 0 | 6.78 | 4 | 1 |
| Restless Leg Syndrome [description not available] | 0 | 16.83 | 21 | 6 |
| Liver Cirrhosis Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules. | 0 | 11.78 | 4 | 1 |
| Restless Legs Syndrome A disorder characterized by aching or burning sensations in the lower and rarely the upper extremities that occur prior to sleep or may awaken the patient from sleep. | 1 | 13.83 | 21 | 6 |
| End Stage Liver Disease Final stage of a liver disease when the liver failure is irreversible and LIVER TRANSPLANTATION is needed. | 0 | 2.41 | 1 | 0 |
| Cramp [description not available] | 0 | 9.72 | 1 | 1 |
| Muscle Cramp A sustained and usually painful contraction of muscle fibers. This may occur as an isolated phenomenon or as a manifestation of an underlying disease process (e.g., UREMIA; HYPOTHYROIDISM; MOTOR NEURON DISEASE; etc.). (From Adams et al., Principles of Neurology, 6th ed, p1398) | 1 | 11.72 | 1 | 1 |
| Critical Illness A disease or state in which death is possible or imminent. | 0 | 7.41 | 1 | 0 |
| Amyotrophy, Thenar, Of Carpal Origin [description not available] | 0 | 4.4 | 2 | 1 |
| Carpal Tunnel Syndrome Entrapment of the MEDIAN NERVE in the carpal tunnel, which is formed by the flexor retinaculum and the CARPAL BONES. This syndrome may be associated with repetitive occupational trauma (CUMULATIVE TRAUMA DISORDERS); wrist injuries; AMYLOID NEUROPATHIES; rheumatoid arthritis (see ARTHRITIS, RHEUMATOID); ACROMEGALY; PREGNANCY; and other conditions. Symptoms include burning pain and paresthesias involving the ventral surface of the hand and fingers which may radiate proximally. Impairment of sensation in the distribution of the median nerve and thenar muscle atrophy may occur. (Joynt, Clinical Neurology, 1995, Ch51, p45) | 0 | 9.4 | 2 | 1 |
| Exanthem [description not available] | 0 | 3.6 | 2 | 0 |
| Exanthema Diseases in which skin eruptions or rashes are a prominent manifestation. Classically, six such diseases were described with similar rashes; they were numbered in the order in which they were reported. Only the fourth (Duke's disease), fifth (ERYTHEMA INFECTIOSUM), and sixth (EXANTHEMA SUBITUM) numeric designations survive as occasional synonyms in current terminology. | 0 | 3.6 | 2 | 0 |
| Delayed Effects, Prenatal Exposure [description not available] | 0 | 4.33 | 5 | 0 |
| Earache Pain in the ear. | 0 | 2.63 | 2 | 0 |
| Cardiac Failure [description not available] | 0 | 5.48 | 14 | 0 |
| Heart Failure A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION. | 0 | 5.48 | 14 | 0 |
| Epileptiform Neuralgia [description not available] | 0 | 8.29 | 21 | 2 |
| Trigeminal Neuralgia A syndrome characterized by recurrent episodes of excruciating pain lasting several seconds or longer in the sensory distribution of the TRIGEMINAL NERVE. Pain may be initiated by stimulation of trigger points on the face, lips, or gums or by movement of facial muscles or chewing. Associated conditions include MULTIPLE SCLEROSIS, vascular anomalies, ANEURYSMS, and neoplasms. (Adams et al., Principles of Neurology, 6th ed, p187) | 0 | 8.29 | 21 | 2 |
| Drug Refractory Epilepsy [description not available] | 0 | 7 | 5 | 1 |
| Abdominal Epilepsy [description not available] | 0 | 17.15 | 75 | 29 |
| Epilepsies, Partial Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317) | 1 | 19.15 | 75 | 29 |
| Chemical Dependence [description not available] | 0 | 13.29 | 90 | 3 |
| Substance-Related Disorders Disorders related to substance use or abuse. | 0 | 13.29 | 90 | 3 |
| Dizzyness [description not available] | 0 | 20.65 | 139 | 21 |
| Dizziness An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness. | 0 | 20.65 | 139 | 21 |
| Osteoarthritis of Knee [description not available] | 0 | 6.3 | 4 | 3 |
| Osteoarthritis, Knee Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019) | 0 | 6.3 | 4 | 3 |
| Alcohol Abuse [description not available] | 0 | 9.56 | 12 | 2 |
| Drug Withdrawal Symptoms [description not available] | 0 | 13.52 | 45 | 8 |
| Alcoholism A primary, chronic disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. The disease is often progressive and fatal. It is characterized by impaired control over drinking, preoccupation with the drug alcohol, use of alcohol despite adverse consequences, and distortions in thinking, most notably denial. Each of these symptoms may be continuous or periodic. (Morse & Flavin for the Joint Commission of the National Council on Alcoholism and Drug Dependence and the American Society of Addiction Medicine to Study the Definition and Criteria for the Diagnosis of Alcoholism: in JAMA 1992;268:1012-4) | 1 | 11.56 | 12 | 2 |
| Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug. | 0 | 13.52 | 45 | 8 |
| Abortion, Tubal [description not available] | 0 | 9.42 | 10 | 0 |
| Abortion, Spontaneous Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference. | 0 | 9.42 | 10 | 0 |
| Itching [description not available] | 0 | 13.95 | 36 | 8 |
| Pruritus An intense itching sensation that produces the urge to rub or scratch the skin to obtain relief. | 1 | 15.95 | 36 | 8 |
| Uremia A clinical syndrome associated with the retention of renal waste products or uremic toxins in the blood. It is usually the result of RENAL INSUFFICIENCY. Most uremic toxins are end products of protein or nitrogen CATABOLISM, such as UREA or CREATININE. Severe uremia can lead to multiple organ dysfunctions with a constellation of symptoms. | 0 | 11.91 | 16 | 6 |
| Aura [description not available] | 0 | 17.07 | 83 | 10 |
| Epilepsy A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313) | 1 | 19.07 | 83 | 10 |
| Morbid Obesity [description not available] | 0 | 3.33 | 1 | 0 |
| Emesis [description not available] | 0 | 7.24 | 4 | 1 |
| Nausea An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses. | 1 | 10.33 | 6 | 2 |
| Obesity, Morbid The condition of weighing two, three, or more times the ideal weight, so called because it is associated with many serious and life-threatening disorders. In the BODY MASS INDEX, morbid obesity is defined as having a BMI greater than 40.0 kg/m2. | 0 | 3.33 | 1 | 0 |
| Vomiting The forcible expulsion of the contents of the STOMACH through the MOUTH. | 0 | 7.24 | 4 | 1 |
| Lassitude [description not available] | 0 | 12.66 | 20 | 13 |
| Fatigue The state of weariness following a period of exertion, mental or physical, characterized by a decreased capacity for work and reduced efficiency to respond to stimuli. | 0 | 17.66 | 20 | 13 |
| Arrhythmia [description not available] | 0 | 2.41 | 1 | 0 |
| Coma A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION. | 0 | 2.41 | 1 | 0 |
| Blood Pressure, Low [description not available] | 0 | 2.41 | 1 | 0 |
| Tachyarrhythmia [description not available] | 0 | 4.15 | 2 | 1 |
| Arrhythmias, Cardiac Any disturbances of the normal rhythmic beating of the heart or MYOCARDIAL CONTRACTION. Cardiac arrhythmias can be classified by the abnormalities in HEART RATE, disorders of electrical impulse generation, or impulse conduction. | 0 | 2.41 | 1 | 0 |
| Hypotension Abnormally low BLOOD PRESSURE that can result in inadequate blood flow to the brain and other vital organs. Common symptom is DIZZINESS but greater negative impacts on the body occur when there is prolonged depravation of oxygen and nutrients. | 0 | 2.41 | 1 | 0 |
| Tachycardia Abnormally rapid heartbeat, usually with a HEART RATE above 100 beats per minute for adults. Tachycardia accompanied by disturbance in the cardiac depolarization (cardiac arrhythmia) is called tachyarrhythmia. | 0 | 4.15 | 2 | 1 |
| Peripheral Nerve Injury [description not available] | 0 | 4.83 | 11 | 0 |
| Peripheral Nerve Injuries Injuries to the PERIPHERAL NERVES. | 0 | 4.83 | 11 | 0 |
| Hallucination of Body Sensation [description not available] | 0 | 3.23 | 5 | 0 |
| Hallucinations Subjectively experienced sensations in the absence of an appropriate stimulus, but which are regarded by the individual as real. They may be of organic origin or associated with MENTAL DISORDERS. | 0 | 3.23 | 5 | 0 |
| Nerve Root Avulsion [description not available] | 0 | 7.3 | 8 | 3 |
| Radiculopathy Disease involving a spinal nerve root (see SPINAL NERVE ROOTS) which may result from compression related to INTERVERTEBRAL DISK DISPLACEMENT; SPINAL CORD INJURIES; SPINAL DISEASES; and other conditions. Clinical manifestations include radicular pain, weakness, and sensory loss referable to structures innervated by the involved nerve root. | 1 | 9.3 | 8 | 3 |
| Encephalopathy, Toxic [description not available] | 0 | 6.3 | 12 | 1 |
| Becker Muscular Dystrophy [description not available] | 0 | 2.76 | 2 | 0 |
| Atrophy, Muscle [description not available] | 0 | 2.41 | 1 | 0 |
| Muscular Atrophy Derangement in size and number of muscle fibers occurring with aging, reduction in blood supply, or following immobilization, prolonged weightlessness, malnutrition, and particularly in denervation. | 0 | 2.41 | 1 | 0 |
| Muscular Dystrophy, Duchenne An X-linked recessive muscle disease caused by an inability to synthesize DYSTROPHIN, which is involved with maintaining the integrity of the sarcolemma. Muscle fibers undergo a process that features degeneration and regeneration. Clinical manifestations include proximal weakness in the first few years of life, pseudohypertrophy, cardiomyopathy (see MYOCARDIAL DISEASES), and an increased incidence of impaired mentation. Becker muscular dystrophy is a closely related condition featuring a later onset of disease (usually adolescence) and a slowly progressive course. (Adams et al., Principles of Neurology, 6th ed, p1415) | 0 | 2.76 | 2 | 0 |
| Abnormalities, Congenital [description not available] | 0 | 2.66 | 2 | 0 |
| Apoplexy [description not available] | 0 | 7.2 | 14 | 1 |
| Cardiovascular Stroke [description not available] | 0 | 2.41 | 1 | 0 |
| Embolism, Pulmonary [description not available] | 0 | 2.41 | 1 | 0 |
| Diseases, Peripheral Vascular [description not available] | 0 | 4.07 | 2 | 1 |
| Cardiovascular Diseases Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM. | 0 | 4.97 | 5 | 0 |
| Myocardial Infarction NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION). | 0 | 2.41 | 1 | 0 |
| Pulmonary Embolism Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS. | 0 | 2.41 | 1 | 0 |
| Peripheral Vascular Diseases Pathological processes involving any one of the BLOOD VESSELS in the vasculature outside the HEART. | 0 | 4.07 | 2 | 1 |
| Stroke A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810) | 0 | 7.2 | 14 | 1 |
| Priapism A prolonged painful erection that may lasts hours and is not associated with sexual activity. It is seen in patients with SICKLE CELL ANEMIA, advanced malignancy, spinal trauma; and certain drug treatments. | 0 | 2.76 | 2 | 0 |
| Urinary Tract Infections Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA. | 0 | 2.41 | 1 | 0 |
| Acute Brain Injuries [description not available] | 0 | 3.03 | 4 | 0 |
| Brain Injuries Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits. | 0 | 3.03 | 4 | 0 |
| Cranial Nerve IX Diseases [description not available] | 0 | 4.1 | 5 | 0 |
| Dysphagia [description not available] | 0 | 3.33 | 1 | 0 |
| Infarct [description not available] | 0 | 3.55 | 2 | 0 |
| Bernard Syndrome [description not available] | 0 | 3.33 | 1 | 0 |
| Deglutition Disorders Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS. | 0 | 3.33 | 1 | 0 |
| Glossopharyngeal Nerve Diseases Diseases of the ninth cranial (glossopharyngeal) nerve or its nuclei in the medulla. The nerve may be injured by diseases affecting the lower brain stem, floor of the posterior fossa, jugular foramen, or the nerve's extracranial course. Clinical manifestations include loss of sensation from the pharynx, decreased salivation, and syncope. Glossopharyngeal neuralgia refers to a condition that features recurrent unilateral sharp pain in the tongue, angle of the jaw, external auditory meatus and throat that may be associated with SYNCOPE. Episodes may be triggered by cough, sneeze, swallowing, or pressure on the tragus of the ear. (Adams et al., Principles of Neurology, 6th ed, p1390) | 0 | 4.1 | 5 | 0 |
| Autism Spectrum Disorder Wide continuum of associated cognitive and neurobehavioral disorders, including, but not limited to, three core-defining features: impairments in socialization, impairments in verbal and nonverbal communication, and restricted and repetitive patterns of behaviors. (from DSM-V) | 0 | 3.33 | 1 | 0 |
| Cryptogenic Infantile Spasms [description not available] | 0 | 3.33 | 1 | 0 |
| Spasms, Infantile An epileptic syndrome characterized by the triad of infantile spasms, hypsarrhythmia, and arrest of psychomotor development at seizure onset. The majority present between 3-12 months of age, with spasms consisting of combinations of brief flexor or extensor movements of the head, trunk, and limbs. The condition is divided into two forms: cryptogenic (idiopathic) and symptomatic (secondary to a known disease process such as intrauterine infections; nervous system abnormalities; BRAIN DISEASES, METABOLIC, INBORN; prematurity; perinatal asphyxia; TUBEROUS SCLEROSIS; etc.). (From Menkes, Textbook of Child Neurology, 5th ed, pp744-8) | 0 | 3.33 | 1 | 0 |
| Astrocytosis [description not available] | 0 | 2.58 | 2 | 0 |
| Weight Gain Increase in BODY WEIGHT over existing weight. | 0 | 9.2 | 13 | 4 |
| Shingles [description not available] | 0 | 14.09 | 32 | 9 |
| Herpes Zoster An acute infectious, usually self-limited, disease believed to represent activation of latent varicella-zoster virus (HERPESVIRUS 3, HUMAN) in those who have been rendered partially immune after a previous attack of CHICKENPOX. It involves the SENSORY GANGLIA and their areas of innervation and is characterized by severe neuralgic pain along the distribution of the affected nerve and crops of clustered vesicles over the area. (From Dorland, 27th ed) | 1 | 21.09 | 32 | 9 |
| Acute Pain Intensely discomforting, distressful, or agonizing sensation associated with trauma or disease, with well-defined location, character, and timing. | 0 | 15.24 | 45 | 4 |
| Injury, Ischemia-Reperfusion [description not available] | 0 | 4.93 | 7 | 1 |
| Ischemia A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION. | 0 | 3.01 | 4 | 0 |
| Reperfusion Injury Adverse functional, metabolic, or structural changes in tissues that result from the restoration of blood flow to the tissue (REPERFUSION) following ISCHEMIA. | 0 | 4.93 | 7 | 1 |
| Social Anxiety Disorder [description not available] | 0 | 5.69 | 6 | 0 |
| Phobia, Social Anxiety disorder characterized by the persistent and irrational fear, anxiety, or avoidance of social or performance situations. | 0 | 5.69 | 6 | 0 |
| Genital Warts [description not available] | 0 | 2.6 | 1 | 0 |
| Condylomata Acuminata Sexually transmitted form of anogenital warty growth caused by the human papillomaviruses. | 0 | 2.6 | 1 | 0 |
| Carcinoma, Non-Small Cell Lung [description not available] | 0 | 3.47 | 2 | 0 |
| Cancer of Lung [description not available] | 0 | 6.28 | 7 | 1 |
| Carcinoma, Non-Small-Cell Lung A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy. | 0 | 3.47 | 2 | 0 |
| Lung Neoplasms Tumors or cancer of the LUNG. | 0 | 6.28 | 7 | 1 |
| Urinary Incontinence Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE. | 0 | 3.52 | 1 | 0 |
| Complex Regional Pain Syndrome [description not available] | 0 | 5.49 | 7 | 0 |
| Complex Regional Pain Syndromes Conditions characterized by pain involving an extremity or other body region, HYPERESTHESIA, and localized autonomic dysfunction following injury to soft tissue or nerve. The pain is usually associated with ERYTHEMA; SKIN TEMPERATURE changes, abnormal sudomotor activity (i.e., changes in sweating due to altered sympathetic innervation) or edema. The degree of pain and other manifestations is out of proportion to that expected from the inciting event. Two subtypes of this condition have been described: type I; (REFLEX SYMPATHETIC DYSTROPHY) and type II; (CAUSALGIA). (From Pain 1995 Oct;63(1):127-33) | 1 | 7.49 | 7 | 0 |
| Autosomal Dominant Juvenile Parkinson Disease [description not available] | 0 | 2.94 | 3 | 0 |
| Parkinsonian Disorders A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA. | 0 | 2.94 | 3 | 0 |
| Spinal Neoplasms New abnormal growth of tissue in the SPINE. | 0 | 8.99 | 1 | 1 |
| Idiopathic Parkinson Disease [description not available] | 0 | 2.6 | 1 | 0 |
| Parkinson Disease A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75) | 0 | 2.6 | 1 | 0 |
| ACL Injuries [description not available] | 0 | 2.6 | 1 | 0 |
| Preterm Birth [description not available] | 0 | 3.82 | 3 | 0 |
| Stillbirth The event that a FETUS is born dead or stillborn. | 0 | 3.52 | 1 | 0 |
| Deficiency, Mental [description not available] | 0 | 5.08 | 3 | 1 |
| Intellectual Disability Subnormal intellectual functioning which originates during the developmental period. This has multiple potential etiologies, including genetic defects and perinatal insults. Intelligence quotient (IQ) scores are commonly used to determine whether an individual has an intellectual disability. IQ scores between 70 and 79 are in the borderline range. Scores below 67 are in the disabled range. (from Joynt, Clinical Neurology, 1992, Ch55, p28) | 0 | 10.08 | 3 | 1 |
| Premature Birth CHILDBIRTH before 37 weeks of PREGNANCY (259 days from the first day of the mother's last menstrual period, or 245 days after FERTILIZATION). | 0 | 3.82 | 3 | 0 |
| Anxiety Neuroses [description not available] | 0 | 17.45 | 103 | 20 |
| Anxiety Disorders Persistent and disabling ANXIETY. | 1 | 19.45 | 103 | 20 |
| Breast Cancer [description not available] | 0 | 12.27 | 16 | 8 |
| Breast Neoplasms Tumors or cancer of the human BREAST. | 1 | 14.27 | 16 | 8 |
| Bladder Cancer [description not available] | 0 | 2.6 | 1 | 0 |
| Urinary Bladder Neoplasms Tumors or cancer of the URINARY BLADDER. | 0 | 2.6 | 1 | 0 |
| Carcinoma, Transitional Cell A malignant neoplasm derived from TRANSITIONAL EPITHELIAL CELLS, occurring chiefly in the URINARY BLADDER; URETERS; or RENAL PELVIS. | 0 | 2.6 | 1 | 0 |
| Cough A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs. | 1 | 9.92 | 12 | 2 |
| Dyslipidemia [description not available] | 0 | 7.6 | 1 | 0 |
| Dyslipidemias Abnormalities in the serum levels of LIPIDS, including overproduction or deficiency. Abnormal serum lipid profiles may include high total CHOLESTEROL, high TRIGLYCERIDES, low HIGH DENSITY LIPOPROTEIN CHOLESTEROL, and elevated LOW DENSITY LIPOPROTEIN CHOLESTEROL. | 0 | 2.6 | 1 | 0 |
| Acute Onset Aura Migraine [description not available] | 0 | 2.6 | 1 | 0 |
| Abdominal Migraine [description not available] | 0 | 7.3 | 12 | 2 |
| Migraine Disorders A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 1 | 9.3 | 12 | 2 |
| Migraine with Aura A subtype of migraine disorder, characterized by recurrent attacks of reversible neurological symptoms (aura) that precede or accompany the headache. Aura may include a combination of sensory disturbances, such as blurred VISION; HALLUCINATIONS; VERTIGO; NUMBNESS; and difficulty in concentrating and speaking. Aura is usually followed by features of the COMMON MIGRAINE, such as PHOTOPHOBIA; PHONOPHOBIA; and NAUSEA. (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 0 | 2.6 | 1 | 0 |
| Delirium of Mixed Origin [description not available] | 0 | 5.42 | 4 | 1 |
| Symptom Cluster [description not available] | 0 | 5.85 | 11 | 0 |
| Delirium A disorder characterized by CONFUSION; inattentiveness; disorientation; ILLUSIONS; HALLUCINATIONS; agitation; and in some instances autonomic nervous system overactivity. It may result from toxic/metabolic conditions or structural brain lesions. (From Adams et al., Principles of Neurology, 6th ed, pp411-2) | 0 | 5.42 | 4 | 1 |
| Syndrome A characteristic symptom complex. | 0 | 5.85 | 11 | 0 |
| Teratogenesis The formation of CONGENITAL ABNORMALITIES. | 0 | 2.82 | 2 | 0 |
| Birth Weight The mass or quantity of heaviness of an individual at BIRTH. It is expressed by units of pounds or kilograms. | 0 | 3.12 | 1 | 0 |
| Cardiac Remodeling, Ventricular [description not available] | 0 | 3.12 | 1 | 0 |
| Cardiometabolic Syndrome A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components not only include metabolic dysfunctions of METABOLIC SYNDROME but also HYPERTENSION, and ABDOMINAL OBESITY. | 0 | 3.12 | 1 | 0 |
| Glucose Metabolic Disorder [description not available] | 0 | 3.12 | 1 | 0 |
| Co-infection [description not available] | 0 | 3.12 | 1 | 0 |
| Neonatal Death The death of a live-born INFANT less than 28 days of age. | 0 | 3.12 | 1 | 0 |
| Pulmonary Arterial Remodeling [description not available] | 0 | 3.12 | 1 | 0 |
| Encephalopathy, Traumatic [description not available] | 0 | 4.5 | 4 | 0 |
| Arthritis, Juvenile Chronic [description not available] | 0 | 3.12 | 1 | 0 |
| Hepatocellular Carcinoma [description not available] | 0 | 4.9 | 2 | 1 |
| Infant, Newborn, Diseases Diseases of newborn infants present at birth (congenital) or developing within the first month of birth. It does not include hereditary diseases not manifesting at birth or within the first 30 days of life nor does it include inborn errors of metabolism. Both HEREDITARY DISEASES and METABOLISM, INBORN ERRORS are available as general concepts. | 0 | 3.12 | 1 | 0 |
| Insulin Sensitivity [description not available] | 0 | 3.12 | 1 | 0 |
| Chronic Kidney Failure [description not available] | 0 | 10.59 | 16 | 2 |
| Cancer of Liver [description not available] | 0 | 4.9 | 2 | 1 |
| Central Retinal Edema, Cystoid [description not available] | 0 | 4.59 | 3 | 0 |
| MS (Multiple Sclerosis) [description not available] | 0 | 4.89 | 5 | 0 |
| Coxarthrosis [description not available] | 0 | 3.12 | 1 | 0 |
| Infections, Helicobacter [description not available] | 0 | 3.89 | 2 | 0 |
| Cardiac Arrest, Sudden [description not available] | 0 | 3.12 | 1 | 0 |
| Central Nervous System Toxoplasmosis [description not available] | 0 | 3.12 | 1 | 0 |
| Atrioventricular Nodal Re-Entrant Tachycardia [description not available] | 0 | 3.12 | 1 | 0 |
| Coccidioides immitis Infection [description not available] | 0 | 3.12 | 1 | 0 |
| AIDS-Related Opportunistic Infections Opportunistic infections found in patients who test positive for human immunodeficiency virus (HIV). The most common include PNEUMOCYSTIS PNEUMONIA, Kaposi's sarcoma, cryptosporidiosis, herpes simplex, toxoplasmosis, cryptococcosis, and infections with Mycobacterium avium complex, Microsporidium, and Cytomegalovirus. | 0 | 3.12 | 1 | 0 |
| Brain Injuries, Traumatic A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain. | 0 | 4.5 | 4 | 0 |
| Aging The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time. | 0 | 6.05 | 5 | 2 |
| Arthritis, Juvenile Arthritis in children, with onset before 16 years of age. The terms juvenile rheumatoid arthritis (JRA) and juvenile idiopathic arthritis (JIA) refer to classification systems for chronic arthritis in children. Only one subtype of juvenile arthritis (polyarticular-onset, rheumatoid factor-positive) clinically resembles adult rheumatoid arthritis and is considered its childhood equivalent. | 0 | 3.12 | 1 | 0 |
| Coccidioidomycosis Infection with a fungus of the genus COCCIDIOIDES, endemic to the SOUTHWESTERN UNITED STATES. It is sometimes called valley fever but should not be confused with RIFT VALLEY FEVER. Infection is caused by inhalation of airborne, fungal particles known as arthroconidia, a form of FUNGAL SPORES. A primary form is an acute, benign, self-limited respiratory infection. A secondary form is a virulent, severe, chronic, progressive granulomatous disease with systemic involvement. It can be detected by use of COCCIDIOIDIN. | 0 | 3.12 | 1 | 0 |
| Diabetic Retinopathy Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION. | 0 | 5.02 | 5 | 0 |
| Electrolytes Substances that dissociate into two or more ions, to some extent, in water. Solutions of electrolytes thus conduct an electric current and can be decomposed by it (ELECTROLYSIS). (Grant & Hackh's Chemical Dictionary, 5th ed) | 0 | 3.12 | 1 | 0 |
| Carcinoma, Hepatocellular A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested. | 0 | 4.9 | 2 | 1 |
| Insulin Resistance Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. | 0 | 3.12 | 1 | 0 |
| Kidney Failure, Chronic The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION. | 0 | 10.59 | 16 | 2 |
| Liver Neoplasms Tumors or cancer of the LIVER. | 0 | 4.9 | 2 | 1 |
| Macular Edema Fluid accumulation in the outer layer of the MACULA LUTEA that results from intraocular or systemic insults. It may develop in a diffuse pattern where the macula appears thickened or it may acquire the characteristic petaloid appearance referred to as cystoid macular edema. Although macular edema may be associated with various underlying conditions, it is most commonly seen following intraocular surgery, venous occlusive disease, DIABETIC RETINOPATHY, and posterior segment inflammatory disease. (From Survey of Ophthalmology 2004; 49(5) 470-90) | 0 | 4.59 | 3 | 0 |
| Multiple Sclerosis An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903) | 0 | 9.89 | 5 | 0 |
| Uveitis Inflammation of part or all of the uvea, the middle (vascular) tunic of the eye, and commonly involving the other tunics (sclera and cornea, and the retina). (Dorland, 27th ed) | 0 | 3.12 | 1 | 0 |
| Ventricular Fibrillation A potentially lethal cardiac arrhythmia that is characterized by uncoordinated extremely rapid firing of electrical impulses (400-600/min) in HEART VENTRICLES. Such asynchronous ventricular quivering or fibrillation prevents any effective cardiac output and results in unconsciousness (SYNCOPE). It is one of the major electrocardiographic patterns seen with CARDIAC ARREST. | 0 | 3.12 | 1 | 0 |
| Osteoarthritis, Hip Noninflammatory degenerative disease of the hip joint which usually appears in late middle or old age. It is characterized by growth or maturational disturbances in the femoral neck and head, as well as acetabular dysplasia. A dominant symptom is pain on weight-bearing or motion. | 0 | 3.12 | 1 | 0 |
| Helicobacter Infections Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease. | 0 | 3.89 | 2 | 0 |
| Death, Sudden, Cardiac Unexpected rapid natural death due to cardiovascular collapse within one hour of initial symptoms. It is usually caused by the worsening of existing heart diseases. The sudden onset of symptoms, such as CHEST PAIN and CARDIAC ARRHYTHMIAS, particularly VENTRICULAR TACHYCARDIA, can lead to the loss of consciousness and cardiac arrest followed by biological death. (from Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine, 7th ed., 2005) | 0 | 3.12 | 1 | 0 |
| Toxoplasmosis, Cerebral Infections of the BRAIN caused by the protozoan TOXOPLASMA gondii that primarily arise in individuals with IMMUNOLOGIC DEFICIENCY SYNDROMES (see also AIDS-RELATED OPPORTUNISTIC INFECTIONS). The infection may involve the brain diffusely or form discrete abscesses. Clinical manifestations include SEIZURES, altered mentation, headache, focal neurologic deficits, and INTRACRANIAL HYPERTENSION. (From Joynt, Clinical Neurology, 1998, Ch27, pp41-3) | 0 | 3.12 | 1 | 0 |
| Tachycardia, Ventricular An abnormally rapid ventricular rhythm usually in excess of 150 beats per minute. It is generated within the ventricle below the BUNDLE OF HIS, either as autonomic impulse formation or reentrant impulse conduction. Depending on the etiology, onset of ventricular tachycardia can be paroxysmal (sudden) or nonparoxysmal, its wide QRS complexes can be uniform or polymorphic, and the ventricular beating may be independent of the atrial beating (AV dissociation). | 0 | 3.12 | 1 | 0 |
| Metabolic Syndrome A cluster of symptoms that are risk factors for CARDIOVASCULAR DISEASES and TYPE 2 DIABETES MELLITUS. The major components of metabolic syndrome include ABDOMINAL OBESITY; atherogenic DYSLIPIDEMIA; HYPERTENSION; HYPERGLYCEMIA; INSULIN RESISTANCE; a proinflammatory state; and a prothrombotic (THROMBOSIS) state. | 0 | 3.12 | 1 | 0 |
| Blood Pressure, High [description not available] | 0 | 6.11 | 6 | 1 |
| Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. | 0 | 6.11 | 6 | 1 |
| Menopause The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age. | 0 | 5.38 | 5 | 0 |
| Hot Flashes A sudden, temporary sensation of heat predominantly experienced by some women during MENOPAUSE. (Random House Unabridged Dictionary, 2d ed) | 0 | 12.57 | 7 | 2 |
| Addiction, Opioid [description not available] | 0 | 6.29 | 17 | 2 |
| Opioid-Related Disorders Disorders related to or resulting from abuse or misuse of OPIOIDS. | 1 | 8.29 | 17 | 2 |
| Emesis, Postoperative [description not available] | 0 | 16.63 | 50 | 44 |
| Postoperative Nausea and Vomiting Emesis and queasiness occurring after anesthesia. | 0 | 16.63 | 50 | 44 |
| Blood Poisoning [description not available] | 0 | 2.83 | 3 | 0 |
| Sepsis Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK. | 0 | 2.83 | 3 | 0 |
| DRESS Syndrome [description not available] | 0 | 2.61 | 2 | 0 |
| Eosinophilia, Tropical [description not available] | 0 | 3.08 | 4 | 0 |
| Experimental Lung Inflammation Inflammation of any part, segment or lobe, of the lung parenchyma. | 0 | 2.21 | 1 | 0 |
| Eosinophilia Abnormal increase of EOSINOPHILS in the blood, tissues or organs. | 0 | 8.08 | 4 | 0 |
| Pneumonia Infection of the lung often accompanied by inflammation. | 0 | 2.21 | 1 | 0 |
| Anankastic Personality [description not available] | 0 | 6.94 | 7 | 4 |
| Obsessive-Compulsive Disorder An anxiety disorder characterized by recurrent, persistent obsessions or compulsions. Obsessions are the intrusive ideas, thoughts, or images that are experienced as senseless or repugnant. Compulsions are repetitive and seemingly purposeful behavior which the individual generally recognizes as senseless and from which the individual does not derive pleasure although it may provide a release from tension. | 0 | 6.94 | 7 | 4 |
| Glaucoma An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed) | 0 | 7.21 | 1 | 0 |
| Intraocular Pressure The pressure of the fluids in the eye. | 0 | 2.61 | 2 | 0 |
| Orphan Diseases Rare diseases that have not been well studied. | 0 | 2.25 | 1 | 0 |
| Alarm Clock Headache [description not available] | 0 | 2.49 | 2 | 0 |
| Cardiac Toxicity [description not available] | 0 | 7.69 | 2 | 0 |
| Cardiac Diseases [description not available] | 0 | 2.55 | 2 | 0 |
| Heart Diseases Pathological conditions involving the HEART including its structural and functional abnormalities. | 0 | 2.55 | 2 | 0 |
| Cardiotoxicity Damage to the HEART or its function secondary to exposure to toxic substances such as drugs used in CHEMOTHERAPY; IMMUNOTHERAPY; or RADIATION. | 0 | 7.69 | 2 | 0 |
| Hiccough [description not available] | 0 | 4.1 | 5 | 0 |
| Disease, Pulmonary [description not available] | 0 | 3.17 | 1 | 0 |
| Complication, Postoperative [description not available] | 0 | 12.48 | 22 | 12 |
| Lung Diseases Pathological processes involving any part of the LUNG. | 0 | 3.17 | 1 | 0 |
| Postoperative Complications Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery. | 0 | 12.48 | 22 | 12 |
| Pain, Breakthrough [description not available] | 0 | 6.29 | 6 | 2 |
| Breakthrough Pain Acute pain that comes on rapidly despite the use of pain medication. | 0 | 11.29 | 6 | 2 |
| 6th Nerve Palsy [description not available] | 0 | 2.53 | 2 | 0 |
| Diplopia A visual symptom in which a single object is perceived by the visual cortex as two objects rather than one. Disorders associated with this condition include REFRACTIVE ERRORS; STRABISMUS; OCULOMOTOR NERVE DISEASES; TROCHLEAR NERVE DISEASES; ABDUCENS NERVE DISEASES; and diseases of the BRAIN STEM and OCCIPITAL LOBE. | 0 | 2.59 | 2 | 0 |
| Herpes Zoster, Ocular [description not available] | 0 | 2.25 | 1 | 0 |
| Herpes Zoster Ophthalmicus Virus infection of the Gasserian ganglion and its nerve branches characterized by pain and vesicular eruptions with much swelling. Ocular involvement is usually heralded by a vesicle on the tip of the nose. This area is innervated by the nasociliary nerve. | 0 | 2.25 | 1 | 0 |
| Sleepiness Compelling urge to sleep. | 0 | 4.3 | 3 | 0 |
| Light Sensitivity [description not available] | 0 | 2.25 | 1 | 0 |
| Night Blindness Failure or imperfection of vision at night or in dim light, with good vision only on bright days. (Dorland, 27th ed) | 0 | 2.25 | 1 | 0 |
| Idiopathic Inflammatory Myopathies [description not available] | 0 | 2.53 | 2 | 0 |
| Myositis Inflammation of a muscle or muscle tissue. | 0 | 7.53 | 2 | 0 |
| Ejaculatio Praecox [description not available] | 0 | 3.64 | 1 | 1 |
| Premature Ejaculation The emission of SEMEN and seminal fluid during the act of preparation for sexual intercourse, i.e. before there is penetration, or shortly after penetration. | 0 | 3.64 | 1 | 1 |
| Fasciculation Involuntary contraction of the muscle fibers innervated by a motor unit. Fasciculations may be visualized as a muscle twitch or dimpling under the skin, but usually do not generate sufficient force to move a limb. They may represent a benign condition or occur as a manifestation of MOTOR NEURON DISEASE or PERIPHERAL NERVOUS SYSTEM DISEASES. (Adams et al., Principles of Neurology, 6th ed, p1294) | 0 | 4.37 | 3 | 1 |
| Canine Diseases [description not available] | 0 | 5.94 | 6 | 4 |
| Hydrosyringomyelia [description not available] | 0 | 5 | 4 | 2 |
| Polyneuropathy, Acquired [description not available] | 0 | 10.06 | 11 | 7 |
| Polyneuropathies Diseases of multiple peripheral nerves simultaneously. Polyneuropathies usually are characterized by symmetrical, bilateral distal motor and sensory impairment with a graded increase in severity distally. The pathological processes affecting peripheral nerves include degeneration of the axon, myelin or both. The various forms of polyneuropathy are categorized by the type of nerve affected (e.g., sensory, motor, or autonomic), by the distribution of nerve injury (e.g., distal vs. proximal), by nerve component primarily affected (e.g., demyelinating vs. axonal), by etiology, or by pattern of inheritance. | 0 | 10.06 | 11 | 7 |
| Injuries Used with anatomic headings, animals, and sports for wounds and injuries. Excludes cell damage, for which pathology is used. | 0 | 9.74 | 9 | 6 |
| Wounds and Injuries Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity. | 0 | 9.74 | 9 | 6 |
| Allergic Encephalomyelitis [description not available] | 0 | 2.84 | 3 | 0 |
| Rheumatoid Arthritis [description not available] | 0 | 3.79 | 3 | 0 |
| Arthritis, Rheumatoid A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated. | 0 | 3.79 | 3 | 0 |
| Alcohol Drinking Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking. | 0 | 10.54 | 5 | 1 |
| Acathisia, Drug-Induced [description not available] | 0 | 2.81 | 3 | 0 |
| Pain, Procedural Pain associated with examination, treatment or procedures. | 0 | 2.66 | 2 | 0 |
| Burns Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like. | 0 | 8.85 | 9 | 3 |
| Psychoses [description not available] | 0 | 3.05 | 4 | 0 |
| Psychotic Disorders Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994) | 0 | 3.05 | 4 | 0 |
| Eczema, Atopic [description not available] | 0 | 2.25 | 1 | 0 |
| Actinic Reticuloid Syndrome [description not available] | 0 | 2.25 | 1 | 0 |
| Dermatitis, Atopic A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema. | 0 | 2.25 | 1 | 0 |
| Concussive Convulsion [description not available] | 0 | 3.17 | 1 | 0 |
| Cancer of Head [description not available] | 0 | 6.15 | 3 | 1 |
| Mucositis, Oral [description not available] | 0 | 3.23 | 1 | 0 |
| Head and Neck Neoplasms Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651) | 0 | 6.15 | 3 | 1 |
| Stomatitis INFLAMMATION of the soft tissues of the MOUTH, such as MUCOSA; PALATE; GINGIVA; and LIP. | 0 | 3.23 | 1 | 0 |
| Depression, Endogenous [description not available] | 0 | 8.54 | 12 | 2 |
| Depressive Disorder An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent. | 1 | 10.54 | 12 | 2 |
| Deafness, Transitory [description not available] | 0 | 2.25 | 1 | 0 |
| Hearing Loss A general term for the complete or partial loss of the ability to hear from one or both ears. | 0 | 7.25 | 1 | 0 |
| Degenerative Disc Disease [description not available] | 0 | 4.19 | 3 | 1 |
| Disc, Herniated [description not available] | 0 | 7.83 | 8 | 5 |
| Intervertebral Disc Displacement An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region. | 0 | 7.83 | 8 | 5 |
| Intervertebral Disc Degeneration Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates. | 1 | 6.19 | 3 | 1 |
| Myelopathy [description not available] | 0 | 8.64 | 1 | 1 |
| Spinal Cord Diseases Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord. | 0 | 3.64 | 1 | 1 |
| Atherosclerotic Parkinsonism [description not available] | 0 | 2.31 | 1 | 0 |
| Parkinson Disease, Secondary Conditions which feature clinical manifestations resembling primary Parkinson disease that are caused by a known or suspected condition. Examples include parkinsonism caused by vascular injury, drugs, trauma, toxin exposure, neoplasms, infections and degenerative or hereditary conditions. Clinical features may include bradykinesia, rigidity, parkinsonian gait, and masked facies. In general, tremor is less prominent in secondary parkinsonism than in the primary form. (From Joynt, Clinical Neurology, 1998, Ch38, pp39-42) | 0 | 2.31 | 1 | 0 |
| Benign Neoplasms, Brain [description not available] | 0 | 4.57 | 5 | 1 |
| Astrocytoma, Grade IV [description not available] | 0 | 2.81 | 3 | 0 |
| Brain Neoplasms Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain. | 0 | 4.57 | 5 | 1 |
| Glioblastoma A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures. | 0 | 7.81 | 3 | 0 |
| Infections, Plasmodium [description not available] | 0 | 2.25 | 1 | 0 |
| Malaria A protozoan disease caused in humans by four species of the PLASMODIUM genus: PLASMODIUM FALCIPARUM; PLASMODIUM VIVAX; PLASMODIUM OVALE; and PLASMODIUM MALARIAE; and transmitted by the bite of an infected female mosquito of the genus ANOPHELES. Malaria is endemic in parts of Asia, Africa, Central and South America, Oceania, and certain Caribbean islands. It is characterized by extreme exhaustion associated with paroxysms of high FEVER; SWEATING; shaking CHILLS; and ANEMIA. Malaria in ANIMALS is caused by other species of plasmodia. | 0 | 2.25 | 1 | 0 |
| Drug Abuse, Intravenous [description not available] | 0 | 2.25 | 1 | 0 |
| Palsy [description not available] | 0 | 2.53 | 2 | 0 |
| Paralysis A general term most often used to describe severe or complete loss of muscle strength due to motor system disease from the level of the cerebral cortex to the muscle fiber. This term may also occasionally refer to a loss of sensory function. (From Adams et al., Principles of Neurology, 6th ed, p45) | 0 | 2.53 | 2 | 0 |
| Autism [description not available] | 0 | 7.25 | 1 | 0 |
| Autistic Disorder A disorder beginning in childhood. It is marked by the presence of markedly abnormal or impaired development in social interaction and communication and a markedly restricted repertoire of activity and interest. Manifestations of the disorder vary greatly depending on the developmental level and chronological age of the individual. (DSM-V) | 0 | 2.25 | 1 | 0 |
| Anhedonia Inability to experience pleasure due to impairment or dysfunction of normal psychological and neurobiological mechanisms. It is a symptom of many PSYCHOTIC DISORDERS (e.g., DEPRESSIVE DISORDER, MAJOR; and SCHIZOPHRENIA). | 0 | 2.25 | 1 | 0 |
| Stammering [description not available] | 0 | 3.17 | 1 | 0 |
| Blepharospasm Excessive winking; tonic or clonic spasm of the orbicularis oculi muscle. | 0 | 8.17 | 1 | 0 |
| Stuttering A disturbance in the normal fluency and time patterning of speech that is inappropriate for the individual's age. This disturbance is characterized by frequent repetitions or prolongations of sounds or syllables. Various other types of speech dysfluencies may also be involved including interjections, broken words, audible or silent blocking, circumlocutions, words produced with an excess of physical tension, and monosyllabic whole word repetitions. Stuttering may occur as a developmental condition in childhood or as an acquired disorder which may be associated with BRAIN INFARCTIONS and other BRAIN DISEASES. (From DSM-IV, 1994) | 0 | 8.17 | 1 | 0 |
| Ataxia Impairment of the ability to perform smoothly coordinated voluntary movements. This condition may affect the limbs, trunk, eyes, pharynx, larynx, and other structures. Ataxia may result from impaired sensory or motor function. Sensory ataxia may result from posterior column injury or PERIPHERAL NERVE DISEASES. Motor ataxia may be associated with CEREBELLAR DISEASES; CEREBRAL CORTEX diseases; THALAMIC DISEASES; BASAL GANGLIA DISEASES; injury to the RED NUCLEUS; and other conditions. | 0 | 4.57 | 5 | 1 |
| Cancer of Prostate [description not available] | 0 | 3.45 | 2 | 0 |
| Prostatic Neoplasms Tumors or cancer of the PROSTATE. | 0 | 3.45 | 2 | 0 |
| Acrocephaly Premature closing of the lambdoid and coronal sutures. | 0 | 2.25 | 1 | 0 |
| Arnold-Chiari Deformity [description not available] | 0 | 4.44 | 4 | 1 |
| Cat Diseases Diseases of the domestic cat (Felis catus or F. domesticus). This term does not include diseases of the so-called big cats such as CHEETAHS; LIONS; tigers, cougars, panthers, leopards, and other Felidae for which the heading CARNIVORA is used. | 0 | 2.59 | 2 | 0 |
| Aggression Behavior which may be manifested by destructive and attacking action which is verbal or physical, by covert attitudes of hostility or by obstructionism. | 0 | 4.58 | 4 | 0 |
| Craniosynostoses Premature closure of one or more CRANIAL SUTURES. It often results in plagiocephaly. Craniosynostoses that involve multiple sutures are sometimes associated with congenital syndromes such as ACROCEPHALOSYNDACTYLIA; and CRANIOFACIAL DYSOSTOSIS. | 0 | 2.25 | 1 | 0 |
| Glenoid Labral Tears [description not available] | 0 | 4.15 | 2 | 1 |
| Rotator Cuff Injuries Injuries to the ROTATOR CUFF of the shoulder joint. | 0 | 4.15 | 2 | 1 |
| Long Sleeper Syndrome [description not available] | 0 | 15.43 | 42 | 23 |
| Sleep Wake Disorders Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle. | 0 | 15.43 | 42 | 23 |
| Spinal Stenosis Narrowing of the spinal canal. | 0 | 8.31 | 11 | 4 |
| Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 4.38 | 7 | 0 |
| Bruxism A disorder characterized by grinding and clenching of the teeth. | 0 | 7.25 | 1 | 0 |
| Calciphylaxes [description not available] | 0 | 2.25 | 1 | 0 |
| Pneumorrhachis Presence of air or gas within the spinal canal cavity (EPIDURAL SPACE; or SUBARACHNOID SPACE). It may result from traumatic injuries, emphysema, infection and other conditions. It can also develop as a complication of various SURGICAL PROCEDURES (e.g., MYELOGRAPHY). | 0 | 2.31 | 1 | 0 |
| Child Mental Disorders [description not available] | 0 | 2.25 | 1 | 0 |
| Complications, Pregnancy [description not available] | 0 | 5.42 | 9 | 0 |
| Neurodevelopmental Disorders These are a group of conditions with onset in the developmental period. The disorders typically manifest early in development, often before the child enters grade school, and are characterized by developmental deficits that produce impairments of personal, social, academic, or occupational functioning. (From DSM-5). | 0 | 2.25 | 1 | 0 |
| Complication, Intraoperative [description not available] | 0 | 3.7 | 1 | 1 |
| Chronic Pancreatitis [description not available] | 0 | 10.94 | 14 | 12 |
| Pancreatitis, Chronic INFLAMMATION of the PANCREAS that is characterized by recurring or persistent ABDOMINAL PAIN with or without STEATORRHEA or DIABETES MELLITUS. It is characterized by the irregular destruction of the pancreatic parenchyma which may be focal, segmental, or diffuse. | 1 | 12.94 | 14 | 12 |
| Radius Fractures Fractures of the RADIUS. | 0 | 3.93 | 2 | 1 |
| Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 3.7 | 9 | 0 |
| Agitation, Psychomotor [description not available] | 0 | 5.1 | 3 | 1 |
| Psychomotor Agitation A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions. | 0 | 5.1 | 3 | 1 |
| Hangman Fracture [description not available] | 0 | 3.7 | 1 | 1 |
| Spinal Fractures Broken bones in the vertebral column. | 0 | 3.7 | 1 | 1 |
| Emergencies Situations or conditions requiring immediate intervention to avoid serious adverse results. | 0 | 7.31 | 1 | 0 |
| Hospital-Acquired Condition [description not available] | 0 | 2.81 | 3 | 0 |
| Anesthesia A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures. | 0 | 11.28 | 6 | 2 |
| Adhesions, Tissue [description not available] | 0 | 5.77 | 2 | 1 |
| Colicky Pain [description not available] | 0 | 9.87 | 11 | 6 |
| Pelvic Pain Pain in the pelvic region of genital and non-genital origin. | 0 | 12.35 | 6 | 1 |
| Local Neoplasm Recurrence [description not available] | 0 | 4.88 | 2 | 1 |
| Abdominal Pain Sensation of discomfort, distress, or agony in the abdominal region. | 0 | 9.87 | 11 | 6 |
| Muscle Spasm [description not available] | 0 | 2.6 | 1 | 0 |
| Spasm An involuntary contraction of a muscle or group of muscles. Spasms may involve SKELETAL MUSCLE or SMOOTH MUSCLE. | 0 | 2.6 | 1 | 0 |
| Neuralgia, Pudendal [description not available] | 0 | 3.7 | 1 | 1 |
| Acrania [description not available] | 0 | 2.31 | 1 | 0 |
| Neural Tube Defects Congenital malformations of the central nervous system and adjacent structures related to defective neural tube closure during the first trimester of pregnancy generally occurring between days 18-29 of gestation. Ectodermal and mesodermal malformations (mainly involving the skull and vertebrae) may occur as a result of defects of neural tube closure. (From Joynt, Clinical Neurology, 1992, Ch55, pp31-41) | 0 | 2.31 | 1 | 0 |
| Cannabis Abuse [description not available] | 0 | 4.43 | 4 | 1 |
| Marijuana Abuse Use of marijuana associated with abnormal psychological, social, and or occupational functioning. | 1 | 6.43 | 4 | 1 |
| Injuries, Whiplash [description not available] | 0 | 4.6 | 2 | 2 |
| Heroin Abuse [description not available] | 0 | 4.65 | 5 | 1 |
| Heroin Dependence Strong dependence or addiction, both physiological and emotional, upon HEROIN. | 0 | 4.65 | 5 | 1 |
| Kahler Disease [description not available] | 0 | 2.55 | 2 | 0 |
| Multiple Myeloma A malignancy of mature PLASMA CELLS engaging in monoclonal immunoglobulin production. It is characterized by hyperglobulinemia, excess Bence-Jones proteins (free monoclonal IMMUNOGLOBULIN LIGHT CHAINS) in the urine, skeletal destruction, bone pain, and fractures. Other features include ANEMIA; HYPERCALCEMIA; and RENAL INSUFFICIENCY. | 0 | 2.55 | 2 | 0 |
| HIV Coinfection [description not available] | 0 | 10.14 | 9 | 5 |
| HIV Infections Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS). | 0 | 10.14 | 9 | 5 |
| Amyloid Deposits [description not available] | 0 | 2.31 | 1 | 0 |
| Acute Confusional Senile Dementia [description not available] | 0 | 3.98 | 4 | 0 |
| Alzheimer Disease A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57) | 0 | 3.98 | 4 | 0 |
| 2019 Novel Coronavirus Disease [description not available] | 0 | 2.31 | 1 | 0 |
| Fractures, Ununited A fracture in which union fails to occur, the ends of the bone becoming rounded and eburnated, and a false joint occurs. (Stedman, 25th ed) | 0 | 3.23 | 1 | 0 |
| Weight Reduction [description not available] | 0 | 3.23 | 1 | 0 |
| Weight Loss Decrease in existing BODY WEIGHT. | 0 | 3.23 | 1 | 0 |
| Hypercapnia A clinical manifestation of abnormal increase in the amount of carbon dioxide in arterial blood. | 0 | 7.15 | 1 | 0 |
| Flaccid Quadriplegia [description not available] | 0 | 2.15 | 1 | 0 |
| Back Ache [description not available] | 0 | 7.55 | 11 | 1 |
| Back Pain Acute or chronic pain located in the posterior regions of the THORAX; LUMBOSACRAL REGION; or the adjacent regions. | 0 | 7.55 | 11 | 1 |
| Joint Pain [description not available] | 0 | 2.17 | 1 | 0 |
| Arthralgia Pain in the joint. | 0 | 2.17 | 1 | 0 |
| Abnormalities, Drug-Induced Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment. | 0 | 3.22 | 5 | 0 |
| Carcinoma, Epidermoid [description not available] | 0 | 2.52 | 2 | 0 |
| Dermatitis Medicamentosa [description not available] | 0 | 3.2 | 5 | 0 |
| Cancer of Skin [description not available] | 0 | 2.78 | 3 | 0 |
| Carcinoma, Squamous Cell A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed) | 1 | 4.52 | 2 | 0 |
| Skin Neoplasms Tumors or cancer of the SKIN. | 0 | 2.78 | 3 | 0 |
| Convulsions, Grand Mal [description not available] | 0 | 4.31 | 2 | 0 |
| Epilepsy, Tonic-Clonic A generalized seizure disorder characterized by recurrent major motor seizures. The initial brief tonic phase is marked by trunk flexion followed by diffuse extension of the trunk and extremities. The clonic phase features rhythmic flexor contractions of the trunk and limbs, pupillary dilation, elevations of blood pressure and pulse, urinary incontinence, and tongue biting. This is followed by a profound state of depressed consciousness (post-ictal state) which gradually improves over minutes to hours. The disorder may be cryptogenic, familial, or symptomatic (caused by an identified disease process). (From Adams et al., Principles of Neurology, 6th ed, p329) | 1 | 6.31 | 2 | 0 |
| Neurologic Voice Disorder [description not available] | 0 | 2.15 | 1 | 0 |
| Voice Disorders Pathological processes that affect voice production, usually involving VOCAL CORDS and the LARYNGEAL MUCOSA. Voice disorders can be caused by organic (anatomical), or functional (emotional or psychological) factors leading to DYSPHONIA; APHONIA; and defects in VOICE QUALITY, loudness, and pitch. | 0 | 2.15 | 1 | 0 |
| Diabetic Glomerulosclerosis [description not available] | 0 | 4.27 | 6 | 0 |
| Diabetic Nephropathies KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE. | 0 | 4.27 | 6 | 0 |
| Atypical Lipomatous Tumor [description not available] | 0 | 2.15 | 1 | 0 |
| Phantom Limb Perception of painful and nonpainful phantom sensations that occur following the complete or partial loss of a limb. The majority of individuals with an amputated extremity will experience the impression that the limb is still present, and in many cases, painful. (From Neurol Clin 1998 Nov;16(4):919-36; Brain 1998 Sep;121(Pt 9):1603-30) | 0 | 2.55 | 2 | 0 |
| Cancer of Muscle [description not available] | 0 | 2.15 | 1 | 0 |
| Liposarcoma A malignant tumor derived from primitive or embryonal lipoblastic cells. It may be composed of well-differentiated fat cells or may be dedifferentiated: myxoid (LIPOSARCOMA, MYXOID), round-celled, or pleomorphic, usually in association with a rich network of capillaries. Recurrences are common and dedifferentiated liposarcomas metastasize to the lungs or serosal surfaces. (From Dorland, 27th ed; Stedman, 25th ed) | 0 | 2.15 | 1 | 0 |
| Ectopic Ossification [description not available] | 0 | 2.53 | 2 | 0 |
| Pyrexia [description not available] | 0 | 7.15 | 1 | 0 |
| Fever An abnormal elevation of body temperature, usually as a result of a pathologic process. | 0 | 2.15 | 1 | 0 |
| Graft-Versus-Host Disease [description not available] | 0 | 2.15 | 1 | 0 |
| Dysmyelopoietic Syndromes [description not available] | 0 | 2.15 | 1 | 0 |
| Graft vs Host Disease The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION. | 0 | 2.15 | 1 | 0 |
| Myelodysplastic Syndromes Clonal hematopoietic stem cell disorders characterized by dysplasia in one or more hematopoietic cell lineages. They predominantly affect patients over 60, are considered preleukemic conditions, and have high probability of transformation into ACUTE MYELOID LEUKEMIA. | 0 | 2.15 | 1 | 0 |
| Behavior Disorders [description not available] | 0 | 9.77 | 18 | 0 |
| Mental Disorders Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function. | 0 | 9.77 | 18 | 0 |
| Intraventricular Septal Defects [description not available] | 0 | 2.17 | 1 | 0 |
| Heart Septal Defects, Ventricular Developmental abnormalities in any portion of the VENTRICULAR SEPTUM resulting in abnormal communications between the two lower chambers of the heart. Classification of ventricular septal defects is based on location of the communication, such as perimembranous, inlet, outlet (infundibular), central muscular, marginal muscular, or apical muscular defect. | 0 | 2.17 | 1 | 0 |
| Infant, Small for Gestational Age An infant having a birth weight lower than expected for its gestational age. | 0 | 2.17 | 1 | 0 |
| Nociceptive Pain Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN. | 0 | 13.63 | 32 | 1 |
| Craniofacial Pain [description not available] | 0 | 6.35 | 13 | 0 |
| Facial Neoplasms New abnormal growth of tissue in the FACE. | 0 | 2.52 | 2 | 0 |
| Facial Pain Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES. | 0 | 6.35 | 13 | 0 |
| Nasal Polyps Focal accumulations of EDEMA fluid in the NASAL MUCOSA accompanied by HYPERPLASIA of the associated submucosal connective tissue. Polyps may be NEOPLASMS, foci of INFLAMMATION, degenerative lesions, or malformations. | 0 | 3.53 | 1 | 1 |
| HbS Disease [description not available] | 0 | 5.11 | 3 | 1 |
| Anemia, Sickle Cell A disease characterized by chronic hemolytic anemia, episodic painful crises, and pathologic involvement of many organs. It is the clinical expression of homozygosity for hemoglobin S. | 0 | 5.11 | 3 | 1 |
| Anaplastic Astrocytoma [description not available] | 0 | 2.15 | 1 | 0 |
| Astrocytoma Neoplasms of the brain and spinal cord derived from glial cells which vary from histologically benign forms to highly anaplastic and malignant tumors. Fibrillary astrocytomas are the most common type and may be classified in order of increasing malignancy (grades I through IV). In the first two decades of life, astrocytomas tend to originate in the cerebellar hemispheres; in adults, they most frequently arise in the cerebrum and frequently undergo malignant transformation. (From Devita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2013-7; Holland et al., Cancer Medicine, 3d ed, p1082) | 0 | 7.15 | 1 | 0 |
| Recrudescence [description not available] | 0 | 6.8 | 8 | 3 |
| Electrocardiogram QT Prolonged [description not available] | 0 | 2.17 | 1 | 0 |
| Drop Attack [description not available] | 0 | 3.02 | 4 | 0 |
| Long QT Syndrome A condition that is characterized by episodes of fainting (SYNCOPE) and varying degree of ventricular arrhythmia as indicated by the prolonged QT interval. The inherited forms are caused by mutation of genes encoding cardiac ion channel proteins. The two major forms are ROMANO-WARD SYNDROME and JERVELL-LANGE NIELSEN SYNDROME. | 0 | 2.17 | 1 | 0 |
| Syncope A transient loss of consciousness and postural tone caused by diminished blood flow to the brain (i.e., BRAIN ISCHEMIA). Presyncope refers to the sensation of lightheadedness and loss of strength that precedes a syncopal event or accompanies an incomplete syncope. (From Adams et al., Principles of Neurology, 6th ed, pp367-9) | 0 | 3.02 | 4 | 0 |
| Lethargy A general state of sluggishness, listless, or uninterested, with being tired, and having difficulty concentrating and doing simple tasks. It may be related to DEPRESSION or DRUG ADDICTION. | 0 | 2.15 | 1 | 0 |
| Benign Psychomotor Epilepsy, Childhood [description not available] | 0 | 2.78 | 3 | 0 |
| Sclerosis A pathological process consisting of hardening or fibrosis of an anatomical structure, often a vessel or a nerve. | 0 | 2.15 | 1 | 0 |
| Central Nervous System Origin Vertigo [description not available] | 0 | 2.8 | 3 | 0 |
| Day Blindness [description not available] | 0 | 6.56 | 7 | 0 |
| Epilepsy, Temporal Lobe A localization-related (focal) form of epilepsy characterized by recurrent seizures that arise from foci within the TEMPORAL LOBE, most commonly from its mesial aspect. A wide variety of psychic phenomena may be associated, including illusions, hallucinations, dyscognitive states, and affective experiences. The majority of complex partial seizures (see EPILEPSY, COMPLEX PARTIAL) originate from the temporal lobes. Temporal lobe seizures may be classified by etiology as cryptogenic, familial, or symptomatic. (From Adams et al., Principles of Neurology, 6th ed, p321). | 0 | 2.78 | 3 | 0 |
| Vertigo An illusion of movement, either of the external world revolving around the individual or of the individual revolving in space. Vertigo may be associated with disorders of the inner ear (EAR, INNER); VESTIBULAR NERVE; BRAINSTEM; or CEREBRAL CORTEX. Lesions in the TEMPORAL LOBE and PARIETAL LOBE may be associated with FOCAL SEIZURES that may feature vertigo as an ictal manifestation. (From Adams et al., Principles of Neurology, 6th ed, pp300-1) | 0 | 2.8 | 3 | 0 |
| Cranial Nerve V Diseases [description not available] | 0 | 3.07 | 4 | 0 |
| Cicatrization The formation of fibrous tissue in the place of normal tissue during the process of WOUND HEALING. It includes scar tissue formation occurring in healing internal organs as well as in the skin after surface injuries. | 0 | 2.15 | 1 | 0 |
| Facial Dermatoses Skin diseases involving the FACE. | 0 | 2.53 | 2 | 0 |
| Cicatrix The fibrous tissue that replaces normal tissue during the process of WOUND HEALING. | 0 | 2.15 | 1 | 0 |
| Dementia Praecox [description not available] | 0 | 4.57 | 5 | 1 |
| Schizophrenia A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior. | 1 | 6.57 | 5 | 1 |
| Hypesthesia Absent or reduced sensitivity to cutaneous stimulation. | 0 | 6.07 | 5 | 2 |
| Cranial Nerve V Injury [description not available] | 0 | 4.87 | 4 | 0 |
| Myoclonic Jerk [description not available] | 0 | 6.1 | 6 | 1 |
| Acute Disease Disease having a short and relatively severe course. | 0 | 10.8 | 22 | 1 |
| Spinal Curvatures Deformities of the SPINE characterized by abnormal bending or flexure in the vertebral column. They may be bending forward (KYPHOSIS), backward (LORDOSIS), or sideway (SCOLIOSIS). | 0 | 3.56 | 1 | 1 |
| Generalized Vulvodynia [description not available] | 0 | 3.46 | 2 | 0 |
| Briquet Syndrome [description not available] | 0 | 4.36 | 4 | 0 |
| Somatoform Disorders Disorders having the presence of physical symptoms that suggest a general medical condition but that are not fully explained by another medical condition, by the direct effects of a substance, or by another mental disorder. The MEDICALLY UNEXPLAINED SYMPTOMS must cause clinically significant distress or impairment in social, occupational, or other areas of functioning. In contrast to FACTITIOUS DISORDERS and MALINGERING, the physical symptoms are not under voluntary control. (APA, DSM-V) | 0 | 9.36 | 4 | 0 |
| Anterior Cervical Pain [description not available] | 0 | 3.56 | 1 | 1 |
| Neck Pain Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to pain in the posterior or lateral regions of the neck. | 0 | 3.56 | 1 | 1 |
| Pain, Intractable Persistent pain that is refractory to some or all forms of treatment. | 0 | 7.46 | 9 | 2 |
| Amyloid Neuropathies Disorders of the peripheral nervous system associated with the deposition of AMYLOID in nerve tissue. Familial, primary (nonfamilial), and secondary forms have been described. Some familial subtypes demonstrate an autosomal dominant pattern of inheritance. Clinical manifestations include sensory loss, mild weakness, autonomic dysfunction, and CARPAL TUNNEL SYNDROME. (Adams et al., Principles of Neurology, 6th ed, p1349) | 0 | 2.17 | 1 | 0 |
| Atrioventricular Conduction Block [description not available] | 0 | 2.79 | 3 | 0 |
| Central Nervous System Tuberculosis [description not available] | 0 | 2.15 | 1 | 0 |
| Atrioventricular Block Impaired impulse conduction from HEART ATRIA to HEART VENTRICLES. AV block can mean delayed or completely blocked impulse conduction. | 0 | 2.79 | 3 | 0 |
| Atrophic Muscular Disorders [description not available] | 0 | 2.17 | 1 | 0 |
| Musculoskeletal Pain Discomfort stemming from muscles, LIGAMENTS, tendons, and bones. | 0 | 7.59 | 2 | 0 |
| Benign Monoclonal Gammopathies [description not available] | 0 | 2.17 | 1 | 0 |
| Autoimmune Demyelinating Disease, Peripheral [description not available] | 0 | 2.17 | 1 | 0 |
| Acquired Facial Neuropathy [description not available] | 0 | 2.17 | 1 | 0 |
| Locomotor Ataxia [description not available] | 0 | 2.17 | 1 | 0 |
| Action Tremor [description not available] | 0 | 5.3 | 4 | 1 |
| Tremor Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE. | 0 | 5.3 | 4 | 1 |
| Brain Swelling [description not available] | 0 | 2.47 | 2 | 0 |
| Brain Edema Increased intracellular or extracellular fluid in brain tissue. Cytotoxic brain edema (swelling due to increased intracellular fluid) is indicative of a disturbance in cell metabolism, and is commonly associated with hypoxic or ischemic injuries (see HYPOXIA, BRAIN). An increase in extracellular fluid may be caused by increased brain capillary permeability (vasogenic edema), an osmotic gradient, local blockages in interstitial fluid pathways, or by obstruction of CSF flow (e.g., obstructive HYDROCEPHALUS). (From Childs Nerv Syst 1992 Sep; 8(6):301-6) | 0 | 7.47 | 2 | 0 |
| Polyradiculitis [description not available] | 0 | 2.54 | 2 | 0 |
| Abscess Accumulation of purulent material in tissues, organs, or circumscribed spaces, usually associated with signs of infection. | 0 | 2.17 | 1 | 0 |
| Polyradiculopathy Disease or injury involving multiple SPINAL NERVE ROOTS. Polyradiculitis refers to inflammation of multiple spinal nerve roots. | 0 | 2.54 | 2 | 0 |
| Bone Fractures [description not available] | 0 | 2.59 | 2 | 0 |
| Fractures, Bone Breaks in bones. | 1 | 4.59 | 2 | 0 |
| Microscopic Colitis [description not available] | 0 | 2.17 | 1 | 0 |
| Chronic Fatigue and Immune Dysfunction Syndrome [description not available] | 0 | 4.8 | 2 | 1 |
| Colitis Inflammation of the COLON section of the large intestine (INTESTINE, LARGE), usually with symptoms such as DIARRHEA (often with blood and mucus), ABDOMINAL PAIN, and FEVER. | 0 | 2.17 | 1 | 0 |
| Fatigue Syndrome, Chronic A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9) | 0 | 4.8 | 2 | 1 |
| Colitis, Microscopic A condition characterized by chronic watery DIARRHEA of unknown origin, a normal COLONOSCOPY but abnormal histopathology on BIOPSY. This syndrome was first described in 1980 by Read and associates. Subtypes include COLLAGENOUS COLITIS and LYMPHOCYTIC COLITIS. Both have similar clinical symptoms and are distinguishable only by histology. | 0 | 2.17 | 1 | 0 |
| Disease Exacerbation [description not available] | 0 | 6.46 | 9 | 1 |
| Auricular Fibrillation [description not available] | 0 | 2.49 | 2 | 0 |
| Atrial Fibrillation Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation. | 0 | 7.49 | 2 | 0 |
| Dysesthesia [description not available] | 0 | 9.58 | 5 | 1 |
| Skin Ulcer An ULCER of the skin and underlying tissues. | 0 | 2.21 | 1 | 0 |
| Autoimmune Disease [description not available] | 0 | 2.17 | 1 | 0 |
| Acute Bacterial Prostatitis [description not available] | 0 | 6 | 3 | 1 |
| Autoimmune Diseases Disorders that are characterized by the production of antibodies that react with host tissues or immune effector cells that are autoreactive to endogenous peptides. | 0 | 2.17 | 1 | 0 |
| Prostatitis Infiltration of inflammatory cells into the parenchyma of PROSTATE. The subtypes are classified by their varied laboratory analysis, clinical presentation and response to treatment. | 1 | 8 | 3 | 1 |
| Cervical Spondylosis [description not available] | 0 | 4.45 | 2 | 2 |
| Spondylosis A degenerative spinal disease that can involve any part of the VERTEBRA, the INTERVERTEBRAL DISK, and the surrounding soft tissue. | 0 | 4.45 | 2 | 2 |
| Dilatation, Pathologic The condition of an anatomical structure's being dilated beyond normal dimensions. | 0 | 2.49 | 2 | 0 |
| Adjustment Sleep Disorder [description not available] | 0 | 7.53 | 16 | 0 |
| Shoulder Pain Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin. | 0 | 8.69 | 10 | 5 |
| Medically Unexplained Symptoms Persistent health symptoms which remain unexplained after a complete medical evaluation. A cluster of symptoms that consistently appear together but without a known cause are referred to as a MEDICALLY UNEXPLAINED SYNDROME (MUS). | 0 | 2.21 | 1 | 0 |
| Allergic Reaction [description not available] | 0 | 10.67 | 12 | 1 |
| Fungal Diseases [description not available] | 0 | 2.21 | 1 | 0 |
| Hypersensitivity Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen. | 0 | 10.67 | 12 | 1 |
| Mycoses Diseases caused by FUNGI. | 0 | 2.21 | 1 | 0 |
| Degenerative Diseases, Central Nervous System [description not available] | 0 | 2.17 | 1 | 0 |
| Neurodegenerative Diseases Hereditary and sporadic conditions which are characterized by progressive nervous system dysfunction. These disorders are often associated with atrophy of the affected central or peripheral nervous system structures. | 0 | 2.17 | 1 | 0 |
| Inadequate Sleep [description not available] | 0 | 7.53 | 16 | 0 |
| Mandibular Diseases Diseases involving the MANDIBLE. | 0 | 2.21 | 1 | 0 |
| CACH Syndrome [description not available] | 0 | 2.17 | 1 | 0 |
| Cognition Disorders Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment. | 0 | 8.49 | 8 | 3 |
| Erythema Migrans, Lingual [description not available] | 0 | 2.21 | 1 | 0 |
| Kidney Failure A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. | 0 | 6.56 | 3 | 2 |
| Renal Insufficiency Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. | 0 | 6.56 | 3 | 2 |
| Vitiligo A disorder consisting of areas of macular depigmentation, commonly on extensor aspects of extremities, on the face or neck, and in skin folds. Age of onset is often in young adulthood and the condition tends to progress gradually with lesions enlarging and extending until a quiescent state is reached. | 0 | 7.17 | 1 | 0 |
| Injuries, Radiation [description not available] | 0 | 4.51 | 1 | 1 |
| Acute Kidney Failure [description not available] | 0 | 3.12 | 1 | 0 |
| Acute Kidney Injury Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions. | 0 | 3.12 | 1 | 0 |
| Motor Disorders Motor skills deficits that significantly and persistently interfere with ACTIVITIES OF DAILY LIVING appropriate to chronological age. (from DSM-5) | 0 | 2.21 | 1 | 0 |
| Acute Post-Traumatic Stress Disorder [description not available] | 0 | 7.68 | 9 | 1 |
| Stress Disorders, Post-Traumatic A class of traumatic stress disorders with symptoms that last more than one month. | 0 | 7.68 | 9 | 1 |
| Colitis, Mucous [description not available] | 0 | 6.88 | 9 | 3 |
| Colonic Inertia Symptom characterized by the passage of stool once a week or less. | 0 | 5.88 | 4 | 2 |
| Constipation Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. | 0 | 10.88 | 4 | 2 |
| Diarrhea An increased liquidity or decreased consistency of FECES, such as running stool. Fecal consistency is related to the ratio of water-holding capacity of insoluble solids to total water, rather than the amount of water present. Diarrhea is not hyperdefecation or increased fecal weight. | 0 | 3.59 | 1 | 1 |
| Irritable Bowel Syndrome A disorder with chronic or recurrent colonic symptoms without a clearcut etiology. This condition is characterized by chronic or recurrent ABDOMINAL PAIN, bloating, MUCUS in FECES, and an erratic disturbance of DEFECATION. | 1 | 8.88 | 9 | 3 |
| Paralysis, Legs [description not available] | 0 | 2.79 | 3 | 0 |
| Paraplegia Severe or complete loss of motor function in the lower extremities and lower portions of the trunk. This condition is most often associated with SPINAL CORD DISEASES, although BRAIN DISEASES; PERIPHERAL NERVOUS SYSTEM DISEASES; NEUROMUSCULAR DISEASES; and MUSCULAR DISEASES may also cause bilateral leg weakness. | 0 | 2.79 | 3 | 0 |
| Chronic Infantile Neurologic, Cutaneous, and Articular Syndrome [description not available] | 0 | 2.57 | 2 | 0 |
| Cryopyrin-Associated Periodic Syndromes A group of rare autosomal dominant diseases, commonly characterized by atypical URTICARIA (hives) with systemic symptoms that develop into end-organ damage. The atypical hives do not involve T-cell or autoantibody. Cryopyrin-associated periodic syndrome includes three previously distinct disorders: Familial cold autoinflammatory syndrome; Muckle-Wells Syndrome; and CINCA Syndrome, that are now considered to represent a disease continuum, all caused by NLRP3 PROTEIN mutations. | 0 | 2.57 | 2 | 0 |
| Nasopharyngeal Carcinoma A carcinoma that originates in the EPITHELIUM of the NASOPHARYNX and includes four subtypes: keratinizing squamous cell, non-keratinizing, basaloid squamous cell, and PAPILLARY ADENOCARCINOMA. It is most prevalent in Southeast Asian populations and is associated with EPSTEIN-BARR VIRUS INFECTIONS. Somatic mutations associated with this cancer have been identified in NPCR, BAP1, UBAP1, ERBB2, ERBB3, MLL2, PIK3CA, KRAS, NRAS, and ARID1A genes. | 0 | 7.21 | 1 | 0 |
| Cancer of Nasopharynx [description not available] | 0 | 2.21 | 1 | 0 |
| Nasopharyngeal Neoplasms Tumors or cancer of the NASOPHARYNX. | 0 | 2.21 | 1 | 0 |
| Chemotherapy-Induced Acral Erythema [description not available] | 0 | 2.55 | 2 | 0 |
| Adenocarcinoma, Basal Cell [description not available] | 0 | 3.93 | 4 | 0 |
| Cancer of Stomach [description not available] | 0 | 2.21 | 1 | 0 |
| Adenocarcinoma A malignant epithelial tumor with a glandular organization. | 0 | 3.93 | 4 | 0 |
| Stomach Neoplasms Tumors or cancer of the STOMACH. | 0 | 2.21 | 1 | 0 |
| Hand-Foot Syndrome Chemotherapy-induced dermal side effects that are associated with the use of various CYTOSTATIC AGENTS. Symptoms range from mild ERYTHEMA and/or PARESTHESIA to severe ulcerative dermatitis with debilitating pain involving typically palmoplantar and intertriginous areas. These cutaneous manifestations are sometimes accompanied by nail anomalies. | 0 | 7.55 | 2 | 0 |
| Hematologic Malignancies [description not available] | 0 | 2.21 | 1 | 0 |
| Mononeuritis [description not available] | 0 | 2.77 | 3 | 0 |
| Hematologic Neoplasms Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES. | 0 | 2.21 | 1 | 0 |
| Mononeuropathies Disease or trauma involving a single peripheral nerve in isolation, or out of proportion to evidence of diffuse peripheral nerve dysfunction. Mononeuropathy multiplex refers to a condition characterized by multiple isolated nerve injuries. Mononeuropathies may result from a wide variety of causes, including ISCHEMIA; traumatic injury; compression; CONNECTIVE TISSUE DISEASES; CUMULATIVE TRAUMA DISORDERS; and other conditions. | 1 | 4.77 | 3 | 0 |
| Cachexia General ill health, malnutrition, and weight loss, usually associated with chronic disease. | 0 | 7.21 | 1 | 0 |
| Amentia [description not available] | 0 | 6.61 | 3 | 2 |
| Dementia An acquired organic mental disorder with loss of intellectual abilities of sufficient severity to interfere with social or occupational functioning. The dysfunction is multifaceted and involves memory, behavior, personality, judgment, attention, spatial relations, language, abstract thought, and other executive functions. The intellectual decline is usually progressive, and initially spares the level of consciousness. | 1 | 8.61 | 3 | 2 |
| Bewilderment [description not available] | 0 | 10.96 | 12 | 9 |
| Asystole [description not available] | 0 | 2.21 | 1 | 0 |
| Heart Arrest Cessation of heart beat or MYOCARDIAL CONTRACTION. If it is treated within a few minutes, heart arrest can be reversed in most cases to normal cardiac rhythm and effective circulation. | 0 | 2.21 | 1 | 0 |
| Neutropenia A decrease in the number of NEUTROPHILS found in the blood. | 0 | 2.49 | 2 | 0 |
| Deficiency, Vitamin D [description not available] | 0 | 2.21 | 1 | 0 |
| Vitamin D Deficiency A nutritional condition produced by a deficiency of VITAMIN D in the diet, insufficient production of vitamin D in the skin, inadequate absorption of vitamin D from the diet, or abnormal conversion of vitamin D to its bioactive metabolites. It is manifested clinically as RICKETS in children and OSTEOMALACIA in adults. (From Cecil Textbook of Medicine, 19th ed, p1406) | 0 | 2.21 | 1 | 0 |
| Allergic Contact Dermatitis [description not available] | 0 | 2.21 | 1 | 0 |
| Dermatitis, Allergic Contact A contact dermatitis due to allergic sensitization to various substances. These substances subsequently produce inflammatory reactions in the skin of those who have acquired hypersensitivity to them as a result of prior exposure. | 0 | 2.21 | 1 | 0 |
| Glaucoma, Angle Closure [description not available] | 0 | 2.21 | 1 | 0 |
| Glaucoma, Angle-Closure A form of glaucoma in which the intraocular pressure increases because the angle of the anterior chamber is blocked and the aqueous humor cannot drain from the anterior chamber. | 0 | 2.21 | 1 | 0 |
| Forestier-Certonciny Syndrome [description not available] | 0 | 2.21 | 1 | 0 |
| Polymyalgia Rheumatica A syndrome in the elderly characterized by proximal joint and muscle pain, high erythrocyte sedimentation rate, and a self-limiting course. Pain is usually accompanied by evidence of an inflammatory reaction. Women are affected twice as commonly as men and Caucasians more frequently than other groups. The condition is frequently associated with GIANT CELL ARTERITIS and some theories pose the possibility that the two diseases arise from a single etiology or even that they are the same entity. | 0 | 2.21 | 1 | 0 |
| Absence Status [description not available] | 0 | 3.16 | 5 | 0 |
| Status Epilepticus A prolonged seizure or seizures repeated frequently enough to prevent recovery between episodes occurring over a period of 20-30 minutes. The most common subtype is generalized tonic-clonic status epilepticus, a potentially fatal condition associated with neuronal injury and respiratory and metabolic dysfunction. Nonconvulsive forms include petit mal status and complex partial status, which may manifest as behavioral disturbances. Simple partial status epilepticus consists of persistent motor, sensory, or autonomic seizures that do not impair cognition (see also EPILEPSIA PARTIALIS CONTINUA). Subclinical status epilepticus generally refers to seizures occurring in an unresponsive or comatose individual in the absence of overt signs of seizure activity. (From N Engl J Med 1998 Apr 2;338(14):970-6; Neurologia 1997 Dec;12 Suppl 6:25-30) | 0 | 3.16 | 5 | 0 |
| Impotence [description not available] | 0 | 4.55 | 5 | 1 |
| Age-Related Macular Degeneration [description not available] | 0 | 2.1 | 1 | 0 |
| Erectile Dysfunction The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction. | 0 | 4.55 | 5 | 1 |
| Macular Degeneration Degenerative changes in the RETINA usually of older adults which results in a loss of vision in the center of the visual field (the MACULA LUTEA) because of damage to the retina. It occurs in dry and wet forms. | 0 | 2.1 | 1 | 0 |
| Psychoses, Drug [description not available] | 0 | 2.98 | 4 | 0 |
| Astasia-Abasia [description not available] | 0 | 2.08 | 1 | 0 |
| Female Genital Neoplasms [description not available] | 0 | 2.08 | 1 | 0 |
| Genital Neoplasms, Female Tumor or cancer of the female reproductive tract (GENITALIA, FEMALE). | 0 | 2.08 | 1 | 0 |
| Uterine Rupture A complete separation or tear in the wall of the UTERUS with or without expulsion of the FETUS. It may be due to injuries, multiple pregnancies, large fetus, previous scarring, or obstruction. | 0 | 2.08 | 1 | 0 |
| Complications of Diabetes Mellitus [description not available] | 0 | 2.77 | 3 | 0 |
| Adjustment Disorder [description not available] | 0 | 2.08 | 1 | 0 |
| Adjustment Disorders Maladaptive reactions to identifiable psychosocial stressors occurring within a short time after onset of the stressor. They are manifested by either impairment in social or occupational functioning or by symptoms (depression, anxiety, etc.) that are in excess of a normal and expected reaction to the stressor. | 0 | 2.08 | 1 | 0 |
| Prurigo A name applied to several itchy skin eruptions of unknown cause. The characteristic course is the formation of a dome-shaped papule with a small transient vesicle on top, followed by crusting over or lichenification. (From Dorland, 27th ed) | 0 | 5.48 | 5 | 1 |
| Erythermalgia [description not available] | 0 | 2.08 | 1 | 0 |
| Erythromelalgia A peripheral arterial disease that is characterized by the triad of ERYTHEMA, burning PAIN, and increased SKIN TEMPERATURE of the extremities (or red, painful extremities). Erythromelalgia may be classified as primary or idiopathic, familial or non-familial. Secondary erythromelalgia is associated with other diseases, the most common being MYELOPROLIFERATIVE DISORDERS. | 0 | 7.08 | 1 | 0 |
| Frigidity [description not available] | 0 | 2.08 | 1 | 0 |
| Sexual Dysfunctions, Psychological Disturbances in sexual desire and the psychophysiologic changes that characterize the sexual response cycle and cause marked distress and interpersonal difficulty. (APA, DSM-IV, 1994) | 0 | 2.08 | 1 | 0 |
| Catatonic Schizophrenia [description not available] | 0 | 7.08 | 1 | 0 |
| Erythema Redness of the skin produced by congestion of the capillaries. This condition may result from a variety of disease processes. | 0 | 2.51 | 2 | 0 |
| Colorectal Cancer [description not available] | 0 | 2.08 | 1 | 0 |
| Colorectal Neoplasms Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI. | 0 | 2.08 | 1 | 0 |
| Breathlessness [description not available] | 0 | 2.08 | 1 | 0 |
| Acute Respiratory Distress Syndrome [description not available] | 0 | 2.08 | 1 | 0 |
| Endotoxin Shock [description not available] | 0 | 2.44 | 2 | 0 |
| Dyspnea Difficult or labored breathing. | 0 | 2.08 | 1 | 0 |
| Respiratory Distress Syndrome A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA. | 0 | 2.08 | 1 | 0 |
| Shock, Septic Sepsis associated with HYPOTENSION or hypoperfusion despite adequate fluid resuscitation. Perfusion abnormalities may include but are not limited to LACTIC ACIDOSIS; OLIGURIA; or acute alteration in mental status. | 0 | 2.44 | 2 | 0 |
| Brachial Plexopathy [description not available] | 0 | 2.08 | 1 | 0 |
| Allergy, Drug [description not available] | 0 | 2.08 | 1 | 0 |
| Peripheral Nerve Neoplasms [description not available] | 0 | 2.48 | 2 | 0 |
| Drug Hypersensitivity Immunologically mediated adverse reactions to medicinal substances used legally or illegally. | 0 | 2.08 | 1 | 0 |
| Neurofibroma A moderately firm, benign, encapsulated tumor resulting from proliferation of SCHWANN CELLS and FIBROBLASTS that includes portions of nerve fibers. The tumors usually develop along peripheral or cranial nerves and are a central feature of NEUROFIBROMATOSIS 1, where they may occur intracranially or involve spinal roots. Pathologic features include fusiform enlargement of the involved nerve. Microscopic examination reveals a disorganized and loose cellular pattern with elongated nuclei intermixed with fibrous strands. (From Adams et al., Principles of Neurology, 6th ed, p1016) | 0 | 2.08 | 1 | 0 |
| Peripheral Nervous System Neoplasms Neoplasms which arise from peripheral nerve tissue. This includes NEUROFIBROMAS; SCHWANNOMAS; GRANULAR CELL TUMORS; and malignant peripheral NERVE SHEATH NEOPLASMS. (From DeVita Jr et al., Cancer: Principles and Practice of Oncology, 5th ed, pp1750-1) | 0 | 2.48 | 2 | 0 |
| Brachial Plexus Neuropathies Diseases of the cervical (and first thoracic) roots, nerve trunks, cords, and peripheral nerve components of the BRACHIAL PLEXUS. Clinical manifestations include regional pain, PARESTHESIA; MUSCLE WEAKNESS, and decreased sensation (HYPESTHESIA) in the upper extremity. These disorders may be associated with trauma (including BIRTH INJURIES); THORACIC OUTLET SYNDROME; NEOPLASMS; NEURITIS; RADIOTHERAPY; and other conditions. (From Adams et al., Principles of Neurology, 6th ed, pp1351-2) | 0 | 2.08 | 1 | 0 |
| Palmoplantaris Pustulosis [description not available] | 0 | 2.75 | 3 | 0 |
| Psoriasis A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis. | 0 | 2.75 | 3 | 0 |
| Conus Medullaris Syndrome [description not available] | 0 | 2.48 | 2 | 0 |
| Rhabdomyolysis Necrosis or disintegration of skeletal muscle often followed by myoglobinuria. | 0 | 7.08 | 1 | 0 |
| Affective Disorders [description not available] | 0 | 8.24 | 6 | 3 |
| Daytime Sleepiness [description not available] | 0 | 5.3 | 4 | 1 |
| Sensation Disorders Disorders of the special senses (i.e., VISION; HEARING; TASTE; and SMELL) or somatosensory system (i.e., afferent components of the PERIPHERAL NERVOUS SYSTEM). | 0 | 3.03 | 1 | 0 |
| Disorders of Excessive Somnolence Disorders characterized by hypersomnolence during normal waking hours that may impair cognitive functioning. Subtypes include primary hypersomnia disorders (e.g., IDIOPATHIC HYPERSOMNOLENCE; NARCOLEPSY; and KLEINE-LEVIN SYNDROME) and secondary hypersomnia disorders where excessive somnolence can be attributed to a known cause (e.g., drug affect, MENTAL DISORDERS, and SLEEP APNEA SYNDROME). (From J Neurol Sci 1998 Jan 8;153(2):192-202; Thorpy, Principles and Practice of Sleep Medicine, 2nd ed, p320) | 0 | 5.3 | 4 | 1 |
| Mood Disorders Those disorders that have a disturbance in mood as their predominant feature. | 0 | 8.24 | 6 | 3 |
| Abscess, Psoas [description not available] | 0 | 2.08 | 1 | 0 |
| Genetic Predisposition [description not available] | 0 | 3.01 | 1 | 0 |
| Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY). | 0 | 8.59 | 5 | 4 |
| Cholera Infantum [description not available] | 0 | 4.15 | 3 | 0 |
| Hepatorenal Syndrome Functional KIDNEY FAILURE in patients with liver disease, usually LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL), and in the absence of intrinsic renal disease or kidney abnormality. It is characterized by intense renal vasculature constriction, reduced renal blood flow, OLIGURIA, and sodium retention. | 0 | 3.01 | 1 | 0 |
| Acne Inversa [description not available] | 0 | 3 | 1 | 0 |
| Hidradenitis Suppurativa A chronic suppurative and cicatricial disease of the apocrine glands occurring chiefly in the axillae in women and in the groin and anal regions in men. It is characterized by poral occlusion with secondary bacterial infection, evolving into abscesses which eventually rupture. As the disease becomes chronic, ulcers appear, sinus tracts enlarge, fistulas develop, and fibrosis and scarring become evident. | 0 | 3 | 1 | 0 |
| Conjugate Nystagmus [description not available] | 0 | 2.1 | 1 | 0 |
| Spinal Diseases Diseases involving the SPINE. | 0 | 2.79 | 3 | 0 |
| Cranial Nerve Injuries Dysfunction of one or more cranial nerves causally related to a traumatic injury. Penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA; NECK INJURIES; and trauma to the facial region are conditions associated with cranial nerve injuries. | 0 | 2.49 | 2 | 0 |
| Suicidal Ideation A risk factor for suicide attempts and completions, it is the most common of all suicidal behavior, but only a minority of ideators engage in overt self-harm. | 0 | 5.31 | 4 | 1 |
| Necrosis The death of cells in an organ or tissue due to disease, injury or failure of the blood supply. | 0 | 2.1 | 1 | 0 |
| Adiadochokinesis [description not available] | 0 | 3.85 | 2 | 1 |
| Brown Tendon Sheath Syndrome [description not available] | 0 | 2.52 | 2 | 0 |
| Cerebellar Ataxia Incoordination of voluntary movements that occur as a manifestation of CEREBELLAR DISEASES. Characteristic features include a tendency for limb movements to overshoot or undershoot a target (dysmetria), a tremor that occurs during attempted movements (intention TREMOR), impaired force and rhythm of diadochokinesis (rapidly alternating movements), and GAIT ATAXIA. (From Adams et al., Principles of Neurology, 6th ed, p90) | 0 | 3.85 | 2 | 1 |
| Bone Cancer [description not available] | 0 | 3.87 | 2 | 1 |
| Bone Neoplasms Tumors or cancer located in bone tissue or specific BONES. | 0 | 3.87 | 2 | 1 |
| Adipocere [description not available] | 0 | 2.1 | 1 | 0 |
| Hypersomnia, Post-Traumatic [description not available] | 0 | 8.92 | 6 | 5 |
| Intermittent Claudication A symptom complex characterized by pain and weakness in SKELETAL MUSCLE group associated with exercise, such as leg pain and weakness brought on by walking. Such muscle limpness disappears after a brief rest and is often relates to arterial STENOSIS; muscle ISCHEMIA; and accumulation of LACTATE. | 0 | 4.45 | 2 | 2 |
| Belching [description not available] | 0 | 7.11 | 1 | 0 |
| Ambulation Disorders, Neurologic [description not available] | 0 | 3.48 | 1 | 1 |
| Bladder Diseases [description not available] | 0 | 7.54 | 4 | 4 |
| Morphine Abuse [description not available] | 0 | 2.1 | 1 | 0 |
| Morphine Dependence Strong dependence, both physiological and emotional, upon morphine. | 0 | 2.1 | 1 | 0 |
| Agranulocytosis A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS). | 0 | 7.1 | 1 | 0 |
| Clostridioides difficile Infection [description not available] | 0 | 2.1 | 1 | 0 |
| Clostridium Infections Infections with bacteria of the genus CLOSTRIDIUM and closely related CLOSTRIDIOIDES species. | 0 | 2.1 | 1 | 0 |
| Apnea, Obstructive Sleep [description not available] | 0 | 3.48 | 1 | 1 |
| Sleep Apnea, Obstructive A disorder characterized by recurrent apneas during sleep despite persistent respiratory efforts. It is due to upper airway obstruction. The respiratory pauses may induce HYPERCAPNIA or HYPOXIA. Cardiac arrhythmias and elevation of systemic and pulmonary arterial pressures may occur. Frequent partial arousals occur throughout sleep, resulting in relative SLEEP DEPRIVATION and daytime tiredness. Associated conditions include OBESITY; ACROMEGALY; MYXEDEMA; micrognathia; MYOTONIC DYSTROPHY; adenotonsilar dystrophy; and NEUROMUSCULAR DISEASES. (From Adams et al., Principles of Neurology, 6th ed, p395) | 0 | 3.48 | 1 | 1 |
| Thrombopenia [description not available] | 0 | 2.1 | 1 | 0 |
| Thrombocytopenia A subnormal level of BLOOD PLATELETS. | 0 | 7.1 | 1 | 0 |
| Lip Diseases Diseases involving the LIP. | 0 | 2.1 | 1 | 0 |
| Remission, Spontaneous A spontaneous diminution or abatement of a disease over time, without formal treatment. | 0 | 2.11 | 1 | 0 |
| Entrapment Neuropathies [description not available] | 0 | 3 | 4 | 0 |
| Claustrophobia [description not available] | 0 | 5.93 | 5 | 1 |
| Phobic Disorders Anxiety disorders in which the essential feature is persistent and irrational fear of a specific object, activity, or situation that the individual feels compelled to avoid. The individual recognizes the fear as excessive or unreasonable. | 0 | 5.93 | 5 | 1 |
| Cervicogenic Headache [description not available] | 0 | 8.89 | 2 | 1 |
| Combat Disorders Neurotic reactions to unusual, severe, or overwhelming military stress. | 0 | 4.4 | 1 | 1 |
| Acne [description not available] | 0 | 2.11 | 1 | 0 |
| Alopecia Cicatrisata [description not available] | 0 | 2.11 | 1 | 0 |
| Epulides [description not available] | 0 | 2.11 | 1 | 0 |
| Hirsutism A condition observed in WOMEN and CHILDREN when there is excess coarse body hair of an adult male distribution pattern, such as facial and chest areas. It is the result of elevated ANDROGENS from the OVARIES, the ADRENAL GLANDS, or exogenous sources. The concept does not include HYPERTRICHOSIS, which is an androgen-independent excessive hair growth. | 0 | 2.11 | 1 | 0 |
| Acne Vulgaris A chronic disorder of the pilosebaceous apparatus associated with an increase in sebum secretion. It is characterized by open comedones (blackheads), closed comedones (whiteheads), and pustular nodules. The cause is unknown, but heredity and age are predisposing factors. | 0 | 2.11 | 1 | 0 |
| Alopecia Absence of hair from areas where it is normally present. | 0 | 2.11 | 1 | 0 |
| Gingival Diseases Diseases involving the GINGIVA. | 0 | 2.11 | 1 | 0 |
| Adhesive Capsulitis [description not available] | 0 | 2.11 | 1 | 0 |
| Bursitis Inflammation or irritation of a SYNOVIAL BURSA, the fibrous sac that acts as a cushion between moving structures of bones, muscles, tendons or skin. | 0 | 2.11 | 1 | 0 |
| Dyspareunia Recurrent genital pain occurring during, before, or after SEXUAL INTERCOURSE in either the male or the female. | 0 | 3.03 | 1 | 0 |
| Nervous System Disorders [description not available] | 0 | 5.01 | 5 | 0 |
| Acne Rosacea [description not available] | 0 | 2.11 | 1 | 0 |
| Nervous System Diseases Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle. | 0 | 5.01 | 5 | 0 |
| Rosacea A cutaneous disorder primarily of convexities of the central part of the FACE, such as FOREHEAD; CHEEK; NOSE; and CHIN. It is characterized by FLUSHING; ERYTHEMA; EDEMA; RHINOPHYMA; papules; and ocular symptoms. It may occur at any age but typically after age 30. There are various subtypes of rosacea: erythematotelangiectatic, papulopustular, phymatous, and ocular (National Rosacea Society's Expert Committee on the Classification and Staging of Rosacea, J Am Acad Dermatol 2002; 46:584-7). | 0 | 2.11 | 1 | 0 |
| Cranial Nerve VII Injuries [description not available] | 0 | 2.15 | 1 | 0 |
| Blood Diseases [description not available] | 0 | 2.1 | 1 | 0 |
| Hematologic Diseases Disorders of the blood and blood forming tissues. | 0 | 2.1 | 1 | 0 |
| Hypertriglyceridemia A condition of elevated levels of TRIGLYCERIDES in the blood. | 0 | 2.11 | 1 | 0 |
| Allergic Cutaneous Angiitis [description not available] | 0 | 2.13 | 1 | 0 |
| Bleeding [description not available] | 0 | 2.13 | 1 | 0 |
| Hemorrhage Bleeding or escape of blood from a vessel. | 0 | 2.13 | 1 | 0 |
| Ciguatera [description not available] | 0 | 7.11 | 1 | 0 |
| Ciguatera Poisoning Poisoning caused by ingestion of SEAFOOD containing microgram levels of CIGUATOXINS. The poisoning is characterized by gastrointestinal, neurological and cardiovascular disturbances. | 0 | 2.11 | 1 | 0 |
| Odontalgia [description not available] | 0 | 2.49 | 2 | 0 |
| Toothache Pain in the adjacent areas of the teeth. | 0 | 2.49 | 2 | 0 |
| Apnea, Central [description not available] | 0 | 2.11 | 1 | 0 |
| Carcinoma, Thymic [description not available] | 0 | 2.11 | 1 | 0 |
| Congenital Stiff-Man Syndrome [description not available] | 0 | 2.49 | 2 | 0 |
| Thymoma A neoplasm originating from thymic tissue, usually benign, and frequently encapsulated. Although it is occasionally invasive, metastases are extremely rare. It consists of any type of thymic epithelial cell as well as lymphocytes that are usually abundant. Malignant lymphomas that involve the thymus, e.g., lymphosarcoma, Hodgkin's disease (previously termed granulomatous thymoma), should not be regarded as thymoma. (From Stedman, 25th ed) | 0 | 2.11 | 1 | 0 |
| Stiff-Person Syndrome A condition characterized by persistent spasms (SPASM) involving multiple muscles, primarily in the lower limbs and trunk. The illness tends to occur in the fourth to sixth decade of life, presenting with intermittent spasms that become continuous. Minor sensory stimuli, such as noise and light touch, precipitate severe spasms. Spasms do not occur during sleep and only rarely involve cranial muscles. Respiration may become impaired in advanced cases. (Adams et al., Principles of Neurology, 6th ed, p1492; Neurology 1998 Jul;51(1):85-93) | 0 | 7.49 | 2 | 0 |
| Sleep Apnea, Central A condition associated with multiple episodes of sleep apnea which are distinguished from obstructive sleep apnea (SLEEP APNEA, OBSTRUCTIVE) by the complete cessation of efforts to breathe. This disorder is associated with dysfunction of central nervous system centers that regulate respiration. | 0 | 2.11 | 1 | 0 |
| Abnormal Deep Tendon Reflex [description not available] | 0 | 2.11 | 1 | 0 |
| Reflex, Abnormal An abnormal response to a stimulus applied to the sensory components of the nervous system. This may take the form of increased, decreased, or absent reflexes. | 0 | 2.11 | 1 | 0 |
| Nerve Degeneration Loss of functional activity and trophic degeneration of nerve axons and their terminal arborizations following the destruction of their cells of origin or interruption of their continuity with these cells. The pathology is characteristic of neurodegenerative diseases. Often the process of nerve degeneration is studied in research on neuroanatomical localization and correlation of the neurophysiology of neural pathways. | 0 | 2.11 | 1 | 0 |
| Failed Back Surgery Syndrome A condition of persistent pain and discomfort in the BACK and the LEG following lumbar surgery, often seen in patients enrolled in pain centers. | 0 | 7.13 | 1 | 0 |
| Age-Related Memory Disorders [description not available] | 0 | 2.52 | 2 | 0 |
| Memory Disorders Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions. | 0 | 2.52 | 2 | 0 |
| Cancer of the Uterus [description not available] | 0 | 2.53 | 2 | 0 |
| Leiomyomatosis The state of having multiple leiomyomas throughout the body. (Stedman, 25th ed) | 0 | 2.11 | 1 | 0 |
| Cancer Syndromes, Hereditary [description not available] | 0 | 2.11 | 1 | 0 |
| Uterine Neoplasms Tumors or cancer of the UTERUS. | 0 | 2.53 | 2 | 0 |
| Ankylosing Spondylarthritis [description not available] | 0 | 2.11 | 1 | 0 |
| Intestinal Obstruction Any impairment, arrest, or reversal of the normal flow of INTESTINAL CONTENTS toward the ANAL CANAL. | 0 | 2.11 | 1 | 0 |
| Spondylitis, Ankylosing A chronic inflammatory condition affecting the axial joints, such as the SACROILIAC JOINT and other intervertebral or costovertebral joints. It occurs predominantly in young males and is characterized by pain and stiffness of joints (ANKYLOSIS) with inflammation at tendon insertions. | 0 | 2.11 | 1 | 0 |
| Cerebral Primitive Neuroectodermal Tumor [description not available] | 0 | 2.13 | 1 | 0 |
| Neuroectodermal Tumors, Primitive A group of malignant tumors of the nervous system that feature primitive cells with elements of neuronal and/or glial differentiation. Use of this term is limited by some authors to central nervous system tumors and others include neoplasms of similar origin which arise extracranially (i.e., NEUROECTODERMAL TUMORS, PRIMITIVE, PERIPHERAL). This term is also occasionally used as a synonym for MEDULLOBLASTOMA. In general, these tumors arise in the first decade of life and tend to be highly malignant. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, p2059) | 0 | 2.13 | 1 | 0 |
| Teeth, Impacted [description not available] | 0 | 6.92 | 4 | 4 |
| Acute Hepatic Failure [description not available] | 0 | 2.11 | 1 | 0 |
| Liver Failure, Acute A form of rapid-onset LIVER FAILURE, also known as fulminant hepatic failure, caused by severe liver injury or massive loss of HEPATOCYTES. It is characterized by sudden development of liver dysfunction and JAUNDICE. Acute liver failure may progress to exhibit cerebral dysfunction even HEPATIC COMA depending on the etiology that includes hepatic ISCHEMIA, drug toxicity, malignant infiltration, and viral hepatitis such as post-transfusion HEPATITIS B and HEPATITIS C. | 0 | 2.11 | 1 | 0 |
| Congenital Limb Deformities [description not available] | 0 | 2.11 | 1 | 0 |
| Impaired Glucose Tolerance [description not available] | 0 | 3.51 | 1 | 1 |
| Glucose Intolerance A pathological state in which BLOOD GLUCOSE level is less than approximately 140 mg/100 ml of PLASMA at fasting, and above approximately 200 mg/100 ml plasma at 30-, 60-, or 90-minute during a GLUCOSE TOLERANCE TEST. This condition is seen frequently in DIABETES MELLITUS, but also occurs with other diseases and MALNUTRITION. | 0 | 3.51 | 1 | 1 |
| Arterial Obstructive Diseases [description not available] | 0 | 4.41 | 1 | 1 |
| Arterial Occlusive Diseases Pathological processes which result in the partial or complete obstruction of ARTERIES. They are characterized by greatly reduced or absence of blood flow through these vessels. They are also known as arterial insufficiency. | 0 | 4.41 | 1 | 1 |
| Phlegmon [description not available] | 0 | 2.13 | 1 | 0 |
| Genital Herpes [description not available] | 0 | 2.13 | 1 | 0 |
| Cellulitis An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions. | 0 | 2.13 | 1 | 0 |
| Herpes Genitalis Infection of the genitals (GENITALIA) with HERPES SIMPLEX VIRUS in either the males or the females. | 0 | 2.13 | 1 | 0 |
| Cortical Lewy Body Disease [description not available] | 0 | 2.55 | 2 | 0 |
| Lewy Body Disease A neurodegenerative disease characterized by dementia, mild parkinsonism, and fluctuations in attention and alertness. The neuropsychiatric manifestations tend to precede the onset of bradykinesia, MUSCLE RIGIDITY, and other extrapyramidal signs. DELUSIONS and visual HALLUCINATIONS are relatively frequent in this condition. Histologic examination reveals LEWY BODIES in the CEREBRAL CORTEX and BRAIN STEM. SENILE PLAQUES and other pathologic features characteristic of ALZHEIMER DISEASE may also be present. (From Neurology 1997;48:376-380; Neurology 1996;47:1113-1124) | 0 | 2.55 | 2 | 0 |
| Pancreatic Diseases Pathological processes of the PANCREAS. | 0 | 3.04 | 1 | 0 |
| Clasp-Knife Spasticity [description not available] | 0 | 2.98 | 4 | 0 |
| Muscle Spasticity A form of muscle hypertonia associated with upper MOTOR NEURON DISEASE. Resistance to passive stretch of a spastic muscle results in minimal initial resistance (a free interval) followed by an incremental increase in muscle tone. Tone increases in proportion to the velocity of stretch. Spasticity is usually accompanied by HYPERREFLEXIA and variable degrees of MUSCLE WEAKNESS. (From Adams et al., Principles of Neurology, 6th ed, p54) | 0 | 2.98 | 4 | 0 |
| Retinal Diseases Diseases involving the RETINA. | 0 | 3.67 | 3 | 0 |
| Foot Injuries General or unspecified injuries involving the foot. | 0 | 2.13 | 1 | 0 |
| Biliary or Urinary Stones [description not available] | 0 | 3.51 | 1 | 1 |
| Digestive System Disorders [description not available] | 0 | 2.11 | 1 | 0 |
| Digestive System Diseases Diseases in any part of the GASTROINTESTINAL TRACT or the accessory organs (LIVER; BILIARY TRACT; PANCREAS). | 0 | 2.11 | 1 | 0 |
| Body Weight, Fetal [description not available] | 0 | 2.13 | 1 | 0 |
| Chronic Hepatitis B [description not available] | 0 | 2.13 | 1 | 0 |
| Hepatitis B, Chronic INFLAMMATION of the LIVER in humans caused by HEPATITIS B VIRUS lasting six months or more. It is primarily transmitted by parenteral exposure, such as transfusion of contaminated blood or blood products, but can also be transmitted via sexual or intimate personal contact. | 0 | 2.13 | 1 | 0 |
| Inguinal Hernia [description not available] | 0 | 8.51 | 1 | 1 |
| Hernia, Inguinal An abdominal hernia with an external bulge in the GROIN region. It can be classified by the location of herniation. Indirect inguinal hernias occur through the internal inguinal ring. Direct inguinal hernias occur through defects in the ABDOMINAL WALL (transversalis fascia) in Hesselbach's triangle. The former type is commonly seen in children and young adults; the latter in adults. | 0 | 3.51 | 1 | 1 |
| Atypical Cluster Headache [description not available] | 0 | 2.13 | 1 | 0 |
| Panic Attacks [description not available] | 0 | 3.04 | 1 | 0 |
| Panic Disorder A type of anxiety disorder characterized by unexpected panic attacks that last minutes or, rarely, hours. Panic attacks begin with intense apprehension, fear or terror and, often, a feeling of impending doom. Symptoms experienced during a panic attack include dyspnea or sensations of being smothered; dizziness, loss of balance or faintness; choking sensations; palpitations or accelerated heart rate; shakiness; sweating; nausea or other form of abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest discomfort or pain; fear of dying and fear of not being in control of oneself or going crazy. Agoraphobia may also develop. Similar to other anxiety disorders, it may be inherited as an autosomal dominant trait. | 0 | 3.04 | 1 | 0 |
| Experimental Spinal Cord Ischemia [description not available] | 0 | 2.15 | 1 | 0 |
| Bile Duct Obstruction [description not available] | 0 | 3.39 | 2 | 0 |
| Paraneoplastic Syndromes In patients with neoplastic diseases a wide variety of clinical pictures which are indirect and usually remote effects produced by tumor cell metabolites or other products. | 0 | 3.04 | 1 | 0 |
| Cholestasis Impairment of bile flow due to obstruction in small bile ducts (INTRAHEPATIC CHOLESTASIS) or obstruction in large bile ducts (EXTRAHEPATIC CHOLESTASIS). | 0 | 8.39 | 2 | 0 |
| Bowel Diseases, Inflammatory [description not available] | 0 | 2.13 | 1 | 0 |
| Inflammatory Bowel Diseases Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS. | 0 | 2.13 | 1 | 0 |
| Brain Hemorrhage [description not available] | 0 | 2.13 | 1 | 0 |
| Cerebral Ischemia [description not available] | 0 | 2.13 | 1 | 0 |
| Brain Ischemia Localized reduction of blood flow to brain tissue due to arterial obstruction or systemic hypoperfusion. This frequently occurs in conjunction with brain hypoxia (HYPOXIA, BRAIN). Prolonged ischemia is associated with BRAIN INFARCTION. | 0 | 2.13 | 1 | 0 |
| Intracranial Hemorrhages Bleeding within the SKULL, including hemorrhages in the brain and the three membranes of MENINGES. The escape of blood often leads to the formation of HEMATOMA in the cranial epidural, subdural, and subarachnoid spaces. | 0 | 2.13 | 1 | 0 |
| Benign Essential Tremor [description not available] | 0 | 7.29 | 5 | 3 |
| Essential Tremor A relatively common disorder characterized by a fairly specific pattern of tremors which are most prominent in the upper extremities and neck, inducing titubations of the head. The tremor is usually mild, but when severe may be disabling. An autosomal dominant pattern of inheritance may occur in some families (i.e., familial tremor). (Mov Disord 1988;13(1):5-10) | 1 | 9.29 | 5 | 3 |
| Dry Macular Degeneration [description not available] | 0 | 3.04 | 1 | 0 |
| Geographic Atrophy A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates. | 0 | 3.04 | 1 | 0 |
| Chronic Motor and Vocal Tic Disorder [description not available] | 0 | 2.13 | 1 | 0 |
| Tourette Syndrome A neuropsychological disorder related to alterations in DOPAMINE metabolism and neurotransmission involving frontal-subcortical neuronal circuits. Both multiple motor and one or more vocal tics need to be present with TICS occurring many times a day, nearly daily, over a period of more than one year. The onset is before age 18 and the disturbance is not due to direct physiological effects of a substance or another medical condition. The disturbance causes marked distress or significant impairment in social, occupational, or other important areas of functioning. (From DSM-IV, 1994; Neurol Clin 1997 May;15(2):357-79) | 0 | 2.13 | 1 | 0 |
| Autoimmune Disease Models, Nervous System [description not available] | 0 | 2.15 | 1 | 0 |
| Autoimmune Demyelinating Diseases, Central Nervous System [description not available] | 0 | 2.15 | 1 | 0 |
| Anterior Cerebral Circulation Infarction [description not available] | 0 | 2.15 | 1 | 0 |
| Hyperglycemia, Postprandial Abnormally high BLOOD GLUCOSE level after a meal. | 0 | 2.44 | 2 | 0 |
| Hyperglycemia Abnormally high BLOOD GLUCOSE level. | 0 | 2.44 | 2 | 0 |
| Brain Infarction Tissue NECROSIS in any area of the brain, including the CEREBRAL HEMISPHERES, the CEREBELLUM, and the BRAIN STEM. Brain infarction is the result of a cascade of events initiated by inadequate blood flow through the brain that is followed by HYPOXIA and HYPOGLYCEMIA in brain tissue. Damage may be temporary, permanent, selective or pan-necrosis. | 0 | 2.15 | 1 | 0 |
| Lung Adenocarcinoma [description not available] | 0 | 3.06 | 1 | 0 |
| Adenocarcinoma of Lung A carcinoma originating in the lung and the most common lung cancer type in never-smokers. Malignant cells exhibit distinct features such as glandular epithelial, or tubular morphology. Mutations in KRAS, EGFR, BRAF, and ERBB2 genes are associated with this cancer. | 0 | 3.06 | 1 | 0 |
| Clinically Isolated CNS Demyelinating Syndrome [description not available] | 0 | 2.15 | 1 | 0 |
| Demyelinating Diseases Diseases characterized by loss or dysfunction of myelin in the central or peripheral nervous system. | 0 | 2.15 | 1 | 0 |
| Flank Pain Pain emanating from below the RIBS and above the ILIUM. | 0 | 3.53 | 1 | 1 |
| Lower Urinary Tract Symptom [description not available] | 0 | 3.53 | 1 | 1 |
| Hematuria Presence of blood in the urine. | 0 | 3.53 | 1 | 1 |
| Sex Disorders [description not available] | 0 | 4.16 | 3 | 1 |
| Ureteral Calculi Stones in the URETER that are formed in the KIDNEY. They are rarely more than 5 mm in diameter for larger renal stones cannot enter ureters. They are often lodged at the ureteral narrowing and can cause excruciating renal colic. | 0 | 3.53 | 1 | 1 |
| Sexual Dysfunction, Physiological Physiological disturbances in normal sexual performance in either the male or the female. | 0 | 4.16 | 3 | 1 |
| Femoral Fractures Fractures of the femur. | 0 | 2.15 | 1 | 0 |
| Cancer of Ovary [description not available] | 0 | 2.48 | 2 | 0 |
| Ovarian Neoplasms Tumors or cancer of the OVARY. These neoplasms can be benign or malignant. They are classified according to the tissue of origin, such as the surface EPITHELIUM, the stromal endocrine cells, and the totipotent GERM CELLS. | 0 | 2.48 | 2 | 0 |
| Alcohol Problem [description not available] | 0 | 5.31 | 2 | 2 |
| Alcohol-Related Disorders Disorders related to or resulting from abuse or misuse of alcohol. | 0 | 5.31 | 2 | 2 |
| Bilateral Headache [description not available] | 0 | 12.32 | 14 | 4 |
| Headache The symptom of PAIN in the cranial region. It may be an isolated benign occurrence or manifestation of a wide variety of HEADACHE DISORDERS. | 0 | 12.32 | 14 | 4 |
| Congenital Familial Lymphedema [description not available] | 0 | 2.04 | 1 | 0 |
| Adiposalgia [description not available] | 0 | 2.04 | 1 | 0 |
| Lymphedema Edema due to obstruction of lymph vessels or disorders of the lymph nodes. | 0 | 2.04 | 1 | 0 |
| Glial Cell Tumors [description not available] | 0 | 2.45 | 2 | 0 |
| Glioma Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21) | 0 | 7.45 | 2 | 0 |
| Neuroblastoma A common neoplasm of early childhood arising from neural crest cells in the sympathetic nervous system, and characterized by diverse clinical behavior, ranging from spontaneous remission to rapid metastatic progression and death. This tumor is the most common intraabdominal malignancy of childhood, but it may also arise from thorax, neck, or rarely occur in the central nervous system. Histologic features include uniform round cells with hyperchromatic nuclei arranged in nests and separated by fibrovascular septa. Neuroblastomas may be associated with the opsoclonus-myoclonus syndrome. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2099-2101; Curr Opin Oncol 1998 Jan;10(1):43-51) | 0 | 7.04 | 1 | 0 |
| Hansen Disease [description not available] | 0 | 2.96 | 1 | 0 |
| Leprosy A chronic granulomatous infection caused by MYCOBACTERIUM LEPRAE. The granulomatous lesions are manifested in the skin, the mucous membranes, and the peripheral nerves. Two polar or principal types are lepromatous and tuberculoid. | 0 | 2.96 | 1 | 0 |
| Esophageal Reflux [description not available] | 0 | 9.11 | 10 | 0 |
| Gastroesophageal Reflux Retrograde flow of gastric juice (GASTRIC ACID) and/or duodenal contents (BILE ACIDS; PANCREATIC JUICE) into the distal ESOPHAGUS, commonly due to incompetence of the LOWER ESOPHAGEAL SPHINCTER. | 0 | 9.11 | 10 | 0 |
| Rheumatism [description not available] | 0 | 2.46 | 2 | 0 |
| Rheumatic Diseases Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement. | 0 | 7.46 | 2 | 0 |
| Icterus [description not available] | 0 | 2.04 | 1 | 0 |
| Jaundice A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction. | 0 | 7.04 | 1 | 0 |
| Benign Supratentorial Neoplasms [description not available] | 0 | 2.05 | 1 | 0 |
| Chronic Progressive Epilepsia Partialis Continua [description not available] | 0 | 2.05 | 1 | 0 |
| Epilepsia Partialis Continua A variant of EPILEPSY characterized by continuous focal jerking of a body part over a period of hours, days, or even years without spreading to other body regions. Contractions may be aggravated by movement and are reduced, but not abolished during sleep. ELECTROENCEPHALOGRAPHY demonstrates epileptiform (spike and wave) discharges over the hemisphere opposite to the affected limb in most instances. The repetitive movements may originate from the CEREBRAL CORTEX or from subcortical structures (e.g., BRAIN STEM; BASAL GANGLIA). This condition is associated with Russian Spring and Summer encephalitis (see ENCEPHALITIS, TICK BORNE); Rasmussen syndrome (see ENCEPHALITIS); MULTIPLE SCLEROSIS; DIABETES MELLITUS; BRAIN NEOPLASMS; and CEREBROVASCULAR DISORDERS. (From Brain, 1996 April;119(pt2):393-407; Epilepsia 1993;34;Suppl 1:S29-S36; and Adams et al., Principles of Neurology, 6th ed, p319) | 0 | 2.05 | 1 | 0 |
| Convulsive Generalized Seizure Disorder [description not available] | 0 | 2.05 | 1 | 0 |
| Bronchospasm [description not available] | 0 | 2.04 | 1 | 0 |
| Hyperesthesia Increased sensitivity to cutaneous stimulation due to a diminished threshold or an increased response to stimuli. | 0 | 2.04 | 1 | 0 |
| Bronchial Spasm Spasmodic contraction of the smooth muscle of the bronchi. | 0 | 2.04 | 1 | 0 |
| Impairment, Light Touch Sensation [description not available] | 0 | 2.05 | 1 | 0 |
| Closed Head Injuries [description not available] | 0 | 2.05 | 1 | 0 |
| Great Pox [description not available] | 0 | 2.96 | 1 | 0 |
| Syphilis A contagious venereal disease caused by the spirochete TREPONEMA PALLIDUM. | 0 | 2.96 | 1 | 0 |
| Deafness-Retinitis Pigmentosa Syndrome [description not available] | 0 | 2.05 | 1 | 0 |
| Anorexia Nervosa An eating disorder that is characterized by the lack or loss of APPETITE, known as ANOREXIA. Other features include excess fear of becoming OVERWEIGHT; BODY IMAGE disturbance; significant WEIGHT LOSS; refusal to maintain minimal normal weight; and AMENORRHEA. This disorder occurs most frequently in adolescent females. (APA, Thesaurus of Psychological Index Terms, 1994) | 0 | 2.05 | 1 | 0 |
| Disorder, Borderline Personality [description not available] | 0 | 2.96 | 1 | 0 |
| As If Personality [description not available] | 0 | 2.96 | 1 | 0 |
| Borderline Personality Disorder A personality disorder marked by a pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity beginning by early adulthood and present in a variety of contexts. (DSM-IV) | 0 | 2.96 | 1 | 0 |
| Alcohol Withdrawal Associated Autonomic Hyperactivity [description not available] | 0 | 4.36 | 1 | 1 |
| Agoraphobia Obsessive, persistent, intense fear of open places. | 0 | 6.03 | 4 | 0 |
| Prostatic Diseases Pathological processes involving the PROSTATE or its component tissues. | 0 | 2.04 | 1 | 0 |
| Laryngeal Diseases Pathological processes involving any part of the LARYNX which coordinates many functions such as voice production, breathing, swallowing, and coughing. | 0 | 2.05 | 1 | 0 |
| Chronic Progressive Multiple Sclerosis [description not available] | 0 | 3.43 | 1 | 1 |
| Acute Relapsing Multiple Sclerosis [description not available] | 0 | 3.43 | 1 | 1 |
| Multiple Sclerosis, Chronic Progressive A form of multiple sclerosis characterized by a progressive deterioration in neurologic function which is in contrast to the more typical relapsing remitting form. If the clinical course is free of distinct remissions, it is referred to as primary progressive multiple sclerosis. When the progressive decline is punctuated by acute exacerbations, it is referred to as progressive relapsing multiple sclerosis. The term secondary progressive multiple sclerosis is used when relapsing remitting multiple sclerosis evolves into the chronic progressive form. (From Ann Neurol 1994;36 Suppl:S73-S79; Adams et al., Principles of Neurology, 6th ed, pp903-914) | 0 | 3.43 | 1 | 1 |
| Multiple Sclerosis, Relapsing-Remitting The most common clinical variant of MULTIPLE SCLEROSIS, characterized by recurrent acute exacerbations of neurologic dysfunction followed by partial or complete recovery. Common clinical manifestations include loss of visual (see OPTIC NEURITIS), motor, sensory, or bladder function. Acute episodes of demyelination may occur at any site in the central nervous system, and commonly involve the optic nerves, spinal cord, brain stem, and cerebellum. (Adams et al., Principles of Neurology, 6th ed, pp903-914) | 0 | 3.43 | 1 | 1 |
| Acquired Neuromyotonia [description not available] | 0 | 2.05 | 1 | 0 |
| Fibroid [description not available] | 0 | 2.05 | 1 | 0 |
| Leiomyoma A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues. | 0 | 7.05 | 1 | 0 |
| Dominant Hereditary Sensory Neuropathy, Type III [description not available] | 0 | 2.05 | 1 | 0 |
| Dysautonomia, Familial An autosomal disorder of the peripheral and autonomic nervous systems limited to individuals of Ashkenazic Jewish descent. Clinical manifestations are present at birth and include diminished lacrimation, defective thermoregulation, orthostatic hypotension (HYPOTENSION, ORTHOSTATIC), fixed pupils, excessive SWEATING, loss of pain and temperature sensation, and absent reflexes. Pathologic features include reduced numbers of small diameter peripheral nerve fibers and autonomic ganglion neurons. (From Adams et al., Principles of Neurology, 6th ed, p1348; Nat Genet 1993;4(2):160-4) | 0 | 2.05 | 1 | 0 |
| Epilepsy, Partial, Sensory A disorder characterized by recurrent focal onset seizures which have sensory (i.e., olfactory, visual, tactile, gustatory, or auditory) manifestations. Partial seizures that feature alterations of consciousness are referred to as complex partial seizures (EPILEPSY, COMPLEX PARTIAL). | 0 | 3.83 | 2 | 0 |
| Cephalgia Syndromes [description not available] | 0 | 2.96 | 1 | 0 |
| Headache Disorders Various conditions with the symptom of HEADACHE. Headache disorders are classified into major groups, such as PRIMARY HEADACHE DISORDERS (based on characteristics of their headache symptoms) and SECONDARY HEADACHE DISORDERS (based on their etiologies). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 0 | 2.96 | 1 | 0 |
| Burning Mouth Syndrome A group of painful oral symptoms associated with a burning or similar sensation. There is usually a significant organic component with a degree of functional overlay; it is not limited to the psychophysiologic group of disorders. | 0 | 7.75 | 3 | 0 |
| Decerebrate Posturing [description not available] | 0 | 2.05 | 1 | 0 |
| Atrial Ectopic Beats [description not available] | 0 | 4.35 | 1 | 1 |
| Arrhythmia, Sinoatrial [description not available] | 0 | 4.35 | 1 | 1 |
| Anterior Fascicular Block [description not available] | 0 | 4.35 | 1 | 1 |
| Acute Autoimmune Neuropathy [description not available] | 0 | 2.05 | 1 | 0 |
| Guillain-Barre Syndrome An acute inflammatory autoimmune neuritis caused by T cell- mediated cellular immune response directed towards peripheral myelin. Demyelination occurs in peripheral nerves and nerve roots. The process is often preceded by a viral or bacterial infection, surgery, immunization, lymphoma, or exposure to toxins. Common clinical manifestations include progressive weakness, loss of sensation, and loss of deep tendon reflexes. Weakness of respiratory muscles and autonomic dysfunction may occur. (From Adams et al., Principles of Neurology, 6th ed, pp1312-1314) | 0 | 7.05 | 1 | 0 |
| Hyponatremia Deficiency of sodium in the blood; salt depletion. (Dorland, 27th ed) | 0 | 7.05 | 1 | 0 |
| Viral Diseases [description not available] | 0 | 2.97 | 1 | 0 |
| Cranial Nerve X Diseases [description not available] | 0 | 2.97 | 1 | 0 |
| Virus Diseases A general term for diseases caused by viruses. | 0 | 2.97 | 1 | 0 |
| Cancer of the Thyroid [description not available] | 0 | 7.48 | 4 | 4 |
| Thyroid Neoplasms Tumors or cancer of the THYROID GLAND. | 0 | 7.48 | 4 | 4 |
| Premenstrual Tension A term used to describe the psychological aspects of PREMENSTRUAL SYNDROME, such as the indescribable tension, depression, hostility, and increased seizure activity in women with seizure disorder. | 0 | 2.05 | 1 | 0 |
| Premenstrual Syndrome A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses. | 0 | 7.05 | 1 | 0 |
| Cancer of Gastrointestinal Tract [description not available] | 0 | 2.05 | 1 | 0 |
| Calcification, Pathologic [description not available] | 0 | 2.46 | 2 | 0 |
| Libman-Sacks Disease [description not available] | 0 | 2.05 | 1 | 0 |
| Metaplasia A condition in which there is a change of one adult cell type to another similar adult cell type. | 0 | 2.05 | 1 | 0 |
| Nephrogenic Systemic Fibrosis [description not available] | 0 | 2.05 | 1 | 0 |
| Calcinosis Pathologic deposition of calcium salts in tissues. | 0 | 2.46 | 2 | 0 |
| Lupus Erythematosus, Systemic A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow. | 0 | 2.05 | 1 | 0 |
| Nephrogenic Fibrosing Dermopathy A chronic, acquired, idiopathic, progressive eruption of the skin that occurs in the context of RENAL FAILURE. It is sometimes accompanied by systemic fibrosis. The pathogenesis seems to be multifactorial, with postulated involvement of circulating fibrocytes. There is a strong association between this disorder and the use of gadolinium-based contrast agents. | 0 | 2.05 | 1 | 0 |
| Bladder, Overactive [description not available] | 0 | 3.86 | 2 | 1 |
| Urinary Bladder, Overactive Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present. | 1 | 5.86 | 2 | 1 |
| Labor Pain Pain associated with OBSTETRIC LABOR in CHILDBIRTH. It is caused primarily by UTERINE CONTRACTION as well as pressure on the CERVIX; BLADDER; and the GASTROINTESTINAL TRACT. Labor pain mostly occurs in the ABDOMEN; the GROIN; and the BACK. | 0 | 3.44 | 1 | 1 |
| Dermatoses [description not available] | 0 | 2.05 | 1 | 0 |
| Skin Diseases Diseases involving the DERMIS or EPIDERMIS. | 0 | 2.05 | 1 | 0 |
| Cancer of the Vagina [description not available] | 0 | 2.05 | 1 | 0 |
| Vaginal Neoplasms Tumors or cancer of the VAGINA. | 0 | 2.05 | 1 | 0 |
| Hallux Abductovalgus [description not available] | 0 | 4.36 | 1 | 1 |
| Hallux Valgus Lateral displacement of the great toe (HALLUX), producing deformity of the first METATARSOPHALANGEAL JOINT with callous, bursa, or BUNION formation over the bony prominence. | 0 | 4.36 | 1 | 1 |
| Hives [description not available] | 0 | 2.06 | 1 | 0 |
| Urticaria A vascular reaction of the skin characterized by erythema and wheal formation due to localized increase of vascular permeability. The causative mechanism may be allergy, infection, or stress. | 0 | 2.06 | 1 | 0 |
| Neurilemoma [description not available] | 0 | 2.06 | 1 | 0 |
| Neurilemmoma A neoplasm that arises from SCHWANN CELLS of the cranial, peripheral, and autonomic nerves. Clinically, these tumors may present as a cranial neuropathy, abdominal or soft tissue mass, intracranial lesion, or with spinal cord compression. Histologically, these tumors are encapsulated, highly vascular, and composed of a homogenous pattern of biphasic fusiform-shaped cells that may have a palisaded appearance. (From DeVita Jr et al., Cancer: Principles and Practice of Oncology, 5th ed, pp964-5) | 0 | 2.06 | 1 | 0 |
| Benign Meningeal Neoplasms [description not available] | 0 | 2.06 | 1 | 0 |
| Acute Myelogenous Leukemia [description not available] | 0 | 2.06 | 1 | 0 |
| Meningeal Neoplasms Benign and malignant neoplastic processes that arise from or secondarily involve the meningeal coverings of the brain and spinal cord. | 0 | 2.06 | 1 | 0 |
| Leukemia, Myeloid, Acute Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES. | 0 | 2.06 | 1 | 0 |
| IgA Vasculitis A systemic non-thrombocytopenic purpura caused by HYPERSENSITIVITY VASCULITIS and deposition of IGA-containing IMMUNE COMPLEXES within the blood vessels throughout the body, including those in the kidney (KIDNEY GLOMERULUS). Clinical symptoms include URTICARIA; ERYTHEMA; ARTHRITIS; GASTROINTESTINAL HEMORRHAGE; and renal involvement. Most cases are seen in children after acute upper respiratory infections. | 0 | 2.05 | 1 | 0 |
| Neuroma A tumor made up of nerve cells and nerve fibers. (Dorland, 27th ed) | 0 | 7.47 | 2 | 0 |
| Diffuse Lymphocytic Lymphoma, Poorly-Differentiated [description not available] | 0 | 2.06 | 1 | 0 |
| Hemosiderosis Conditions in which there is a generalized increase in the iron stores of body tissues, particularly of liver and the MONONUCLEAR PHAGOCYTE SYSTEM, without demonstrable tissue damage. The name refers to the presence of stainable iron in the tissue in the form of hemosiderin. | 0 | 2.06 | 1 | 0 |
| Lymphoma, Mantle-Cell A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1). | 0 | 2.06 | 1 | 0 |
| Chemical and Drug Induced Liver Injury, Chronic Liver disease lasting six months or more, caused by an adverse effect of a drug or chemical. The adverse effect may be caused by drugs, drug metabolites, chemicals from the environment, or an idiosyncratic response. | 0 | 2.06 | 1 | 0 |
| Acute Disseminated Encephalomyelitis [description not available] | 0 | 2.06 | 1 | 0 |
| Celiac Sprue [description not available] | 0 | 2.06 | 1 | 0 |
| Celiac Disease A malabsorption syndrome that is precipitated by the ingestion of foods containing GLUTEN, such as wheat, rye, and barley. It is characterized by INFLAMMATION of the SMALL INTESTINE, loss of MICROVILLI structure, failed INTESTINAL ABSORPTION, and MALNUTRITION. | 0 | 2.06 | 1 | 0 |
| Pulsatile Tinnitus [description not available] | 0 | 2.06 | 1 | 0 |
| Tinnitus A nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Objective tinnitus refers to noises generated from within the ear or adjacent structures that can be heard by other individuals. The term subjective tinnitus is used when the sound is audible only to the affected individual. Tinnitus may occur as a manifestation of COCHLEAR DISEASES; VESTIBULOCOCHLEAR NERVE DISEASES; INTRACRANIAL HYPERTENSION; CRANIOCEREBRAL TRAUMA; and other conditions. | 0 | 2.06 | 1 | 0 |
| Post-Dural Puncture Headache A secondary headache disorder attributed to low CEREBROSPINAL FLUID pressure caused by SPINAL PUNCTURE, usually after dural or lumbar puncture. | 0 | 3.45 | 1 | 1 |
| Visceral Pain Pain originating from internal organs (VISCERA) associated with autonomic phenomena (PALLOR; SWEATING; NAUSEA; and VOMITING). It often becomes a REFERRED PAIN. | 0 | 6.03 | 5 | 2 |
| Dystonia An attitude or posture due to the co-contraction of agonists and antagonist muscles in one region of the body. It most often affects the large axial muscles of the trunk and limb girdles. Conditions which feature persistent or recurrent episodes of dystonia as a primary manifestation of disease are referred to as DYSTONIC DISORDERS. (Adams et al., Principles of Neurology, 6th ed, p77) | 0 | 7.07 | 1 | 0 |
| Foreign Bodies Inanimate objects that become enclosed in the body. | 0 | 2.07 | 1 | 0 |
| Periodontitis, Acute Nonsuppurative [description not available] | 0 | 2.07 | 1 | 0 |
| Periapical Periodontitis Inflammation of the PERIAPICAL TISSUE. It includes general, unspecified, or acute nonsuppurative inflammation. Chronic nonsuppurative inflammation is PERIAPICAL GRANULOMA. Suppurative inflammation is PERIAPICAL ABSCESS. | 0 | 2.07 | 1 | 0 |
| Nicotine Addiction [description not available] | 0 | 3.46 | 1 | 1 |
| Tobacco Use Disorder Tobacco used to the detriment of a person's health or social functioning. Tobacco dependence is included. | 1 | 5.46 | 1 | 1 |
| Smoking Cessation Discontinuing the habit of SMOKING. | 0 | 3.46 | 1 | 1 |
| Lumbar Osteoarthritis [description not available] | 0 | 2.06 | 1 | 0 |
| Osteoarthritis, Spine A degenerative joint disease involving the SPINE. It is characterized by progressive deterioration of the spinal articular cartilage (CARTILAGE, ARTICULAR), usually with hardening of the subchondral bone and outgrowth of bone spurs (OSTEOPHYTE). | 0 | 2.06 | 1 | 0 |
| Esophageal Diseases Pathological processes in the ESOPHAGUS. | 0 | 3.46 | 1 | 1 |
| Herpes Simplex Virus Infection [description not available] | 0 | 2.99 | 1 | 0 |
| Herpes Simplex A group of acute infections caused by herpes simplex virus type 1 or type 2 that is characterized by the development of one or more small fluid-filled vesicles with a raised erythematous base on the skin or mucous membrane. It occurs as a primary infection or recurs due to a reactivation of a latent infection. (Dorland, 27th ed.) | 0 | 2.99 | 1 | 0 |
| Cancer of Esophagus [description not available] | 0 | 2.07 | 1 | 0 |
| Invasiveness, Neoplasm [description not available] | 0 | 2.07 | 1 | 0 |
| Esophageal Neoplasms Tumors or cancer of the ESOPHAGUS. | 0 | 2.07 | 1 | 0 |
| Nephrolithiasis Formation of stones in the KIDNEY. | 0 | 2.07 | 1 | 0 |
| Cranial Nerve Diseases Disorders of one or more of the twelve cranial nerves. With the exception of the optic and olfactory nerves, this includes disorders of the brain stem nuclei from which the cranial nerves originate or terminate. | 0 | 2.07 | 1 | 0 |
| Basilar Artery Insufficiency [description not available] | 0 | 2.07 | 1 | 0 |
| ADPKD [description not available] | 0 | 2.07 | 1 | 0 |
| Polycystic Kidney, Autosomal Dominant Kidney disorders with autosomal dominant inheritance and characterized by multiple CYSTS in both KIDNEYS with progressive deterioration of renal function. | 0 | 2.07 | 1 | 0 |
| ADDH [description not available] | 0 | 3.46 | 1 | 1 |
| Attention Deficit Disorder with Hyperactivity A behavior disorder originating in childhood in which the essential features are signs of developmentally inappropriate inattention, impulsivity, and hyperactivity. Although most individuals have symptoms of both inattention and hyperactivity-impulsivity, one or the other pattern may be predominant. The disorder is more frequent in males than females. Onset is in childhood. Symptoms often attenuate during late adolescence although a minority experience the full complement of symptoms into mid-adulthood. (From DSM-V) | 0 | 3.46 | 1 | 1 |
| Complications, Infectious Pregnancy [description not available] | 0 | 3.04 | 1 | 0 |
| Delusional Disorder Disorder with presentation of a facade of coldness with characteristic pervasive mistrust and suspiciousness of others. | 0 | 2.07 | 1 | 0 |
| Bladder Disorder, Neurogenic [description not available] | 0 | 2.07 | 1 | 0 |
| Urinary Bladder, Neurogenic Dysfunction of the URINARY BLADDER due to disease of the central or peripheral nervous system pathways involved in the control of URINATION. This is often associated with SPINAL CORD DISEASES, but may also be caused by BRAIN DISEASES or PERIPHERAL NERVE DISEASES. | 0 | 2.07 | 1 | 0 |
| Angiosarcoma [description not available] | 0 | 2.77 | 3 | 0 |
| Hemangiosarcoma A rare malignant neoplasm characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood vessels and lining irregular blood-filled or lumpy spaces. (Stedman, 25th ed) | 0 | 2.77 | 3 | 0 |
| Diffuse Large B-Cell Lymphoma [description not available] | 0 | 7.07 | 1 | 0 |
| Lymphoma, Large B-Cell, Diffuse Malignant lymphoma composed of large B lymphoid cells whose nuclear size can exceed normal macrophage nuclei, or more than twice the size of a normal lymphocyte. The pattern is predominantly diffuse. Most of these lymphomas represent the malignant counterpart of B-lymphocytes at midstage in the process of differentiation. | 0 | 2.07 | 1 | 0 |
| Cocaine Abuse [description not available] | 0 | 2.08 | 1 | 0 |
| Cocaine-Related Disorders Disorders related or resulting from use of cocaine. | 0 | 2.08 | 1 | 0 |
| Algodystrophic Syndrome [description not available] | 0 | 2.46 | 2 | 0 |
| Reflex Sympathetic Dystrophy A syndrome characterized by severe burning pain in an extremity accompanied by sudomotor, vasomotor, and trophic changes in bone without an associated specific nerve injury. This condition is most often precipitated by trauma to soft tissue or nerve complexes. The skin over the affected region is usually erythematous and demonstrates hypersensitivity to tactile stimuli and erythema. (Adams et al., Principles of Neurology, 6th ed, p1360; Pain 1995 Oct;63(1):127-33) | 0 | 2.46 | 2 | 0 |
| Wounds, Gunshot Disruption of structural continuity of the body as a result of the discharge of firearms. | 0 | 2.07 | 1 | 0 |
| Cancer of Kidney [description not available] | 0 | 2.07 | 1 | 0 |
| Kidney Neoplasms Tumors or cancers of the KIDNEY. | 0 | 2.07 | 1 | 0 |
| Antidiuretic Hormone, Inappropriate Secretion [description not available] | 0 | 2.07 | 1 | 0 |
| Inappropriate ADH Syndrome A condition of HYPONATREMIA and renal salt loss attributed to overexpansion of BODY FLUIDS resulting from sustained release of ANTIDIURETIC HORMONES which stimulates renal resorption of water. It is characterized by normal KIDNEY function, high urine OSMOLALITY, low serum osmolality, and neurological dysfunction. Etiologies include ADH-producing neoplasms, injuries or diseases involving the HYPOTHALAMUS, the PITUITARY GLAND, and the LUNG. This syndrome can also be drug-induced. | 0 | 2.07 | 1 | 0 |
| Arachnoid Cysts Intracranial or spinal cavities containing a cerebrospinal-like fluid, the wall of which is composed of arachnoidal cells. They are most often developmental or related to trauma. Intracranial arachnoid cysts usually occur adjacent to arachnoidal cistern and may present with HYDROCEPHALUS; HEADACHE; SEIZURES; and focal neurologic signs. (From Joynt, Clinical Neurology, 1994, Ch44, pp105-115) | 0 | 2.07 | 1 | 0 |
| Altered Level of Consciousness [description not available] | 0 | 2.07 | 1 | 0 |
| Cerebral Palsy, Athetoid [description not available] | 0 | 2.08 | 1 | 0 |
| Cerebral Palsy A heterogeneous group of nonprogressive motor disorders caused by chronic brain injuries that originate in the prenatal period, perinatal period, or first few years of life. The four major subtypes are spastic, athetoid, ataxic, and mixed cerebral palsy, with spastic forms being the most common. The motor disorder may range from difficulties with fine motor control to severe spasticity (see MUSCLE SPASTICITY) in all limbs. Spastic diplegia (Little disease) is the most common subtype, and is characterized by spasticity that is more prominent in the legs than in the arms. Pathologically, this condition may be associated with LEUKOMALACIA, PERIVENTRICULAR. (From Dev Med Child Neurol 1998 Aug;40(8):520-7) | 0 | 2.08 | 1 | 0 |
| Orthopedic Disorders [description not available] | 0 | 2.08 | 1 | 0 |
| Musculoskeletal Diseases Diseases of the muscles and their associated ligaments and other connective tissue and of the bones and cartilage viewed collectively. | 0 | 2.08 | 1 | 0 |
| Diaphragmatic Paralysis [description not available] | 0 | 2.08 | 1 | 0 |
| Colonic Diseases Pathological processes in the COLON region of the large intestine (INTESTINE, LARGE). | 0 | 2.01 | 1 | 0 |
| Active Hyperemia [description not available] | 0 | 2.01 | 1 | 0 |
| Hyperemia The presence of an increased amount of blood in a body part or an organ leading to congestion or engorgement of blood vessels. Hyperemia can be due to increase of blood flow into the area (active or arterial), or due to obstruction of outflow of blood from the area (passive or venous). | 0 | 2.01 | 1 | 0 |
| Chicken Pox [description not available] | 0 | 2.01 | 1 | 0 |
| Chickenpox A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed) | 0 | 2.01 | 1 | 0 |
| Respiration Disorders Diseases of the respiratory system in general or unspecified or for a specific respiratory disease not available. | 0 | 6.31 | 9 | 0 |
| Altitude Hypoxia Low ambient oxygen tension associated with ALTITUDE. | 0 | 2.02 | 1 | 0 |
| Altitude Sickness Multiple symptoms associated with reduced oxygen at high ALTITUDE. | 0 | 2.02 | 1 | 0 |
| Dyskinesia, Medication-Induced [description not available] | 0 | 2.02 | 1 | 0 |
| Dyskinesia, Drug-Induced Abnormal movements, including HYPERKINESIS; HYPOKINESIA; TREMOR; and DYSTONIA, associated with the use of certain medications or drugs. Muscles of the face, trunk, neck, and extremities are most commonly affected. Tardive dyskinesia refers to abnormal hyperkinetic movements of the muscles of the face, tongue, and neck associated with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS). (Adams et al., Principles of Neurology, 6th ed, p1199) | 0 | 2.02 | 1 | 0 |
| Asialia [description not available] | 0 | 3.41 | 1 | 1 |
| Xerostomia Decreased salivary flow. | 0 | 3.41 | 1 | 1 |
| B Virus Infection [description not available] | 0 | 3.85 | 1 | 0 |
| Ataxia of Gait [description not available] | 0 | 2.03 | 1 | 0 |
| Facial Spasm, Unilateral [description not available] | 0 | 2.03 | 1 | 0 |
| Autosomal Dominant Cerebellar Ataxia, Type II [description not available] | 0 | 3.35 | 2 | 0 |
| Spinocerebellar Ataxias A group of predominately late-onset, cerebellar ataxias which have been divided into multiple subtypes based on clinical features and genetic mapping. Progressive ataxia is a central feature of these conditions, and in certain subtypes POLYNEUROPATHY; DYSARTHRIA; visual loss; and other disorders may develop. (From Joynt, Clinical Neurology, 1997, Ch65, pp 12-17; J Neuropathol Exp Neurol 1998 Jun;57(6):531-43) | 0 | 3.35 | 2 | 0 |
| Adolescent Gynecomastia [description not available] | 0 | 2.03 | 1 | 0 |
| Gynecomastia Enlargement of the BREAST in the males, caused by an excess of ESTROGENS. Physiological gynecomastia is normally observed in NEWBORNS; ADOLESCENT; and AGING males. | 0 | 7.03 | 1 | 0 |
| Polyarthritis [description not available] | 0 | 3.33 | 2 | 0 |
| Arthritis Acute or chronic inflammation of JOINTS. | 0 | 3.33 | 2 | 0 |
| Muscle Disorders [description not available] | 0 | 2.44 | 2 | 0 |
| Muscular Diseases Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE. | 0 | 2.44 | 2 | 0 |
| Ataxia Telangiectasia Syndrome [description not available] | 0 | 2.03 | 1 | 0 |
| Ataxia Telangiectasia An autosomal recessive inherited disorder characterized by choreoathetosis beginning in childhood, progressive CEREBELLAR ATAXIA; TELANGIECTASIS of CONJUNCTIVA and SKIN; DYSARTHRIA; B- and T-cell immunodeficiency, and RADIOSENSITIVITY to IONIZING RADIATION. Affected individuals are prone to recurrent sinobronchopulmonary infections, lymphoreticular neoplasms, and other malignancies. Serum ALPHA-FETOPROTEINS are usually elevated. (Menkes, Textbook of Child Neurology, 5th ed, p688) The gene for this disorder (ATM) encodes a cell cycle checkpoint protein kinase and has been mapped to chromosome 11 (11q22-q23). | 0 | 2.03 | 1 | 0 |
| Consciousness, Loss of [description not available] | 0 | 2.03 | 1 | 0 |
| Causalgia Syndrome [description not available] | 0 | 2.03 | 1 | 0 |
| Causalgia A complex regional pain syndrome characterized by burning pain and marked sensitivity to touch (HYPERESTHESIA) in the distribution of an injured peripheral nerve. Autonomic dysfunction in the form of sudomotor (i.e., sympathetic innervation to sweat glands), vasomotor, and trophic skin changes may also occur. (Adams et al., Principles of Neurology, 6th ed, p1359) | 0 | 2.03 | 1 | 0 |
| Chondrosarcoma A slowly growing malignant neoplasm derived from cartilage cells, occurring most frequently in pelvic bones or near the ends of long bones, in middle-aged and old people. Most chondrosarcomas arise de novo, but some may develop in a preexisting benign cartilaginous lesion or in patients with ENCHONDROMATOSIS. (Stedman, 25th ed) | 0 | 2.03 | 1 | 0 |
| Cataract, Membranous [description not available] | 0 | 2.03 | 1 | 0 |
| Mitral Incompetence [description not available] | 0 | 2.03 | 1 | 0 |
| Gastric Diseases [description not available] | 0 | 2.03 | 1 | 0 |
| Vulvar Diseases Pathological processes of the VULVA. | 0 | 2.03 | 1 | 0 |
| Cataract Partial or complete opacity on or in the lens or capsule of one or both eyes, impairing vision or causing blindness. The many kinds of cataract are classified by their morphology (size, shape, location) or etiology (cause and time of occurrence). (Dorland, 27th ed) | 0 | 2.03 | 1 | 0 |
| Mitral Valve Insufficiency Backflow of blood from the LEFT VENTRICLE into the LEFT ATRIUM due to imperfect closure of the MITRAL VALVE. This can lead to mitral valve regurgitation. | 0 | 2.03 | 1 | 0 |
| Atrophy Decrease in the size of a cell, tissue, organ, or multiple organs, associated with a variety of pathological conditions such as abnormal cellular changes, ischemia, malnutrition, or hormonal changes. | 0 | 8.42 | 1 | 1 |
| Anterior Ischemic Optic Neuropathy [description not available] | 0 | 3.36 | 2 | 0 |
| Anoxemia [description not available] | 0 | 3.36 | 2 | 0 |
| Hypoxia Sub-optimal OXYGEN levels in the ambient air of living organisms. | 0 | 3.36 | 2 | 0 |
| Proteinuria The presence of proteins in the urine, an indicator of KIDNEY DISEASES. | 0 | 3.36 | 2 | 0 |
| Optic Neuropathy, Ischemic Ischemic injury to the OPTIC NERVE which usually affects the OPTIC DISK (optic neuropathy, anterior ischemic) and less frequently the retrobulbar portion of the nerve (optic neuropathy, posterior ischemic). The injury results from occlusion of arterial blood supply which may result from TEMPORAL ARTERITIS; ATHEROSCLEROSIS; COLLAGEN DISEASES; EMBOLISM; DIABETES MELLITUS; and other conditions. The disease primarily occurs in the sixth decade or later and presents with the sudden onset of painless and usually severe monocular visual loss. Anterior ischemic optic neuropathy also features optic disk edema with microhemorrhages. The optic disk appears normal in posterior ischemic optic neuropathy. (Glaser, Neuro-Ophthalmology, 2nd ed, p135) | 0 | 3.36 | 2 | 0 |
| Crush Syndrome Severe systemic manifestation of trauma and ischemia involving soft tissues, principally skeletal muscle, due to prolonged severe crushing. It leads to increased permeability of the cell membrane and to the release of potassium, enzymes, and myoglobin from within cells. Ischemic renal dysfunction secondary to hypotension and diminished renal perfusion results in acute tubular necrosis and uremia. | 0 | 2.03 | 1 | 0 |
| Benign Infantile Myoclonic Epilepsy [description not available] | 0 | 2.44 | 2 | 0 |
| Epilepsies, Myoclonic A clinically diverse group of epilepsy syndromes characterized either by myoclonic seizures or by myoclonus in association with other seizure types. Myoclonic epilepsy syndromes are divided into three subtypes based on etiology: familial, cryptogenic, and symptomatic. | 0 | 2.44 | 2 | 0 |
| Neuritis A general term indicating inflammation of a peripheral or cranial nerve. Clinical manifestation may include PAIN; PARESTHESIAS; PARESIS; or HYPESTHESIA. | 0 | 2.04 | 1 | 0 |
| Paroxysmal Reciprocal Tachycardia [description not available] | 0 | 2.04 | 1 | 0 |
| Tachycardia, Paroxysmal Abnormally rapid heartbeats with sudden onset and cessation. | 0 | 2.04 | 1 | 0 |
| Brown-Sequard Disease [description not available] | 0 | 2.04 | 1 | 0 |
| Branch Vein Occlusion [description not available] | 0 | 2.04 | 1 | 0 |
| Retinal Vein Occlusion Blockage of the RETINAL VEIN. Those at high risk for this condition include patients with HYPERTENSION; DIABETES MELLITUS; ATHEROSCLEROSIS; and other CARDIOVASCULAR DISEASES. | 0 | 2.04 | 1 | 0 |
| Dysarthosis [description not available] | 0 | 2.04 | 1 | 0 |
| Amyotrophic Neuralgia [description not available] | 0 | 2.04 | 1 | 0 |
| Brachial Plexus Neuritis A syndrome associated with inflammation of the BRACHIAL PLEXUS. Clinical features include severe pain in the shoulder region which may be accompanied by MUSCLE WEAKNESS and loss of sensation in the upper extremity. This condition may be associated with VIRUS DISEASES; IMMUNIZATION; SURGERY; heroin use (see HEROIN DEPENDENCE); and other conditions. The term brachial neuralgia generally refers to pain associated with brachial plexus injury. (From Adams et al., Principles of Neurology, 6th ed, pp1355-6) | 0 | 2.04 | 1 | 0 |