Page last updated: 2024-12-05

gabapentin

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Description

Gabapentin is an anticonvulsant medication that is used to treat seizures. It is also used to treat nerve pain, such as pain caused by shingles or diabetic neuropathy. Gabapentin is a synthetic compound, meaning that it is not found naturally. It is a derivative of the amino acid gamma-aminobutyric acid (GABA). Gabapentin is thought to work by increasing the levels of GABA in the brain. GABA is a neurotransmitter that helps to regulate nerve activity. Increasing GABA levels may help to reduce seizures and nerve pain. Gabapentin is generally well-tolerated, but it can cause side effects such as drowsiness, dizziness, and fatigue. It is important to talk to your doctor about the potential risks and benefits of gabapentin before taking it. Gabapentin is a popular drug for research because it is effective for treating a variety of conditions. It is also relatively safe and well-tolerated. Researchers are studying gabapentin to learn more about how it works and to find new ways to use it to treat diseases.'

Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

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. [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]

Cross-References

ID SourceID
PubMed CID3446
CHEMBL ID940
CHEBI ID42797
SCHEMBL ID8343
MeSH IDM0119421

Synonyms (188)

Synonym
AC-1485
BIDD:GT0656
dm-5689
gabapentin-er
dds-2003
gabapentin gr
goe-3450
serada
ci-945
dm-1796
neurentin
gralise
gabapen
EU-0100582
gabapentin, solid
aclonium
einecs 262-076-3
c9h17no2
neurontin
gabapentine [inn-french]
gabapentino [inn-spanish]
ccris 7210
gabapentin (neurontin)
gabapentino [spanish]
1-(aminomethyl)cyclohexaneacetic acid
cyclohexaneacetic acid, 1-(aminomethyl)-
gabapetin
ci 945
brn 2359739
go 3450
hsdb 7364
gabapentine
goe 2450
gabapentinum [inn-latin]
PRESTWICK_151
cas-60142-96-3
NCGC00015466-01
NCGC00021545-02
tocris-0806
lopac-g-154
NCGC00016891-01
LOPAC0_000582
BSPBIO_000901
BPBIO1_000993
gabapentin
C07018
60142-96-3
[1-(aminomethyl)cyclohexyl]acetic acid
GBN ,
DB00996
gralise (tn)
neurontin (tn)
D00332
gabapentin (jan/usp/inn)
PRESTWICK2_000861
MLS000069358
smr000058311
PRESTWICK1_000861
SPBIO_002822
PRESTWICK0_000861
PRESTWICK3_000861
NCGC00021545-04
NCGC00015466-02
NCGC00021545-05
NCGC00015466-06
HMS2089J03
1-(aminomethyl)-cyclohexaneacetic acid
G-154 ,
G0318
NCGC00015466-09
(1-aminomethyl-cyclohexyl)-acetic acid
2-(1-(aminomethyl)cyclohexyl)acetic acid
bdbm50080153
AKOS000280865
goe 3450
nsc-759254
CHEMBL940 ,
chebi:42797 ,
L000733
FT-0668920
nsc-742194
gabapentinium
gabapentina
nsc742194
HMS1570N03
2-[1-(aminomethyl)cyclohexyl]acetic acid
NCGC00015466-08
HMS2097N03
HMS3261F06
EN300-52516
BBL010794
tox21_110157
dtxcid5074
dtxsid0020074 ,
CCG-204671
STK598009
HMS2236O03
NCGC00015466-04
NCGC00015466-05
NCGC00015466-03
NCGC00015466-07
gabarone
nsc 742194
gabapentin [usan:usp:inn:ban]
unii-6cw7f3g59x
6cw7f3g59x ,
gabapentinum
neuontin
nsc 759254
therapentin-90
gabapentino
vultin
sefelsa
fanatrex
FT-0626586
AM20070538
LP00582
AB07485
gabapentin [ep impurity]
gabapentin [inn]
gabapentin [who-dd]
gabapentin [usan]
gabapentin [vandf]
gabapentin [ep monograph]
gabapentin [mart.]
gabapentin [mi]
gabapentin [usp-rs]
gabapentin [orange book]
gabapentin [jan]
gabapentin [hsdb]
gabapentin [usp monograph]
carbatin
S2133
gabapentin; neurontin
gtpl5483
CS-1545
HY-A0057
SCHEMBL8343
NCGC00015466-11
tox21_110157_1
KS-1064
tox21_500582
NCGC00261267-01
1-aminomethyl-1cyclohexane-acetic acid
1-(aminomethyl)cyclohexanacetic acid
1-aminomethyl-1-cyclohexane-acetic acid
1-(aminomethyl)cyclohexyl-acetic acid
1-aminomethyl cyclohexaneacetic acid
1-(aminomethyl)cyclohexaneacetate
HMS3650A20
sr-01000000019
SR-01000000019-2
gabapentin, united states pharmacopeia (usp) reference standard
novo-gabapentine
gabapentin, european pharmacopoeia (ep) reference standard
gabapentin, pharmaceutical secondary standard; certified reference material
SR-01000000019-6
SBI-0206904.P001
HMS3714N03
1-(aminomethyl)cyclohexaneaceticacid
BCP25698
Q410352
SR-01000000019-11
SDCCGSBI-0050564.P002
NCGC00015466-27
1-aminomethylcyclohexane acetic acid
gabapentin 100 microg/ml in acetonitrile:methanol
1126623-20-8
gabapentin-d10
10b - known drug blood quantification sample
ae1 - newer anti-epileptic drug mixtures 1
gabapentin (usp-rs)
gabapentin (usan:usp:inn:ban)
gabapentino (inn-spanish)
(1-aminomethylcyclohexyl)acetic acid
gabapentin (ep monograph)
gabapentin (mart.)
solutitionkits
(1-(aminomethyl)cyclohexyl)acetic acid
gabapentinum (inn-latin)
gralisestarter pack
gaba 300-ezs
gabapentine (inn-french)
gabapentin (ep impurity)
gabapentin (usp monograph)
gabapentinum (latin)
Z336079954
gabapentin, 1mg/ml in methanol

Research Excerpts

Overview

Gabapentin (GBP) is an anticonvulsant drug with poor chemical stability that is particularly sensitive to heat and mechanical stress, which can lead to intramolecular lactamization. Gabapentin is a structural analog of gamma-aminobutyric acid (GABA) that is commonly used in palliative care for symptom management indications.

ExcerptReferenceRelevance
"Gabapentin is a widely prescribed analgesic with increased popularity over recent years. "( Gabapentin initiation in the inpatient setting: A characterization of prescribing.
Covvey, JR; Jackson, S; Karuga, D; Knauss, G; Montepara, CA; Nemecek, BD; Rozic, M; Waterloo, M; Zimmerman, DE, 2022
)
3.61
"Gabapentin (GBP) is an anticonvulsant drug with poor chemical stability that is particularly sensitive to heat and mechanical stress, which can lead to intramolecular lactamization. "( Modulation of Solid-State Chemical Stability of Gabapentin by Pyridinecarboxylic Acid.
Cai, T; Guo, M; Sun, X; Zhang, S, 2022
)
2.42
"Gabapentin is a γ-aminobutyric acid analog formally indicated for the treatment of epilepsy and neuropathic pain that is gaining increased popularity. "( Gabapentin Use During Pregnancy and Lactation With and Without Concurrent Opioid Exposure: Considerations and Future Directions.
DeLisle, A; Jansson, LM; Jones, HE,
)
3.02
"Gabapentin is a crucial component of the BSTOP protocol."( Effectiveness of Bariatric Surgery Targeting Opioid Prescriptions (BSTOP) protocol on postoperative pain control.
Appiah, D; Camacho, D; Choi, J; Goriacko, P; Kim, J; Moran-Atkin, E; Pereira, X; Seu, R; Yaghdjian, V, 2023
)
1.63
"Gabapentin is a recommended first-line agent for treating neuropathic pain; however, its efficacy rate is reportedly low, and the risk of adverse events is high. "( Gabapentin-Friend or foe?
Graham, B; Russo, M; Santarelli, DM, 2023
)
3.8
"Gabapentin is an antiepileptic medication with evidence of benefit in alcohol use disorder patients. "( Gabapentin to treat acute alcohol withdrawal in hospitalized patients: A systematic review and meta-analysis.
Kersten, B; Kunadharaju, R; Mammen, MJ; Mattle, AG; McGrath, P; Sanu, A; Zammit, K, 2022
)
3.61
"Gabapentin (GBP) is a structural analog of gamma-aminobutyric acid (GABA) that is commonly used in palliative care for symptom management indications including neuropathic pain syndromes, hiccups, cough, and anxiety. "( Gabapentin-Induced Overflow Urinary Incontinence: A Case Report and Review of the Literature.
Juba, KM; Kenney, AE; Masri, S; Scigliano, D, 2023
)
3.8
"Gabapentin is an effective therapeutic alternative for chronic low back pain, indicated in several guidelines for treating neuropathic pain as first-line medication. "( Pharmacodynamic effect of gabapentin on central nervous system in patients with chronic low back pain: a [99mTc]Tc-ECD SPECT study.
Alexandre-Santos, L; Coelho, EB; Dach, F; Della Pasqua, O; Lanchote, VL; Lia, EN; Papassidero, P; Trevisan, AC; Wichert-Ana, L, 2023
)
2.65
"Gabapentin is a commonly prescribed antiepileptic agent for seizures, which is also used for pain and addiction management. "( Effect of Gabapentin-Fluoxetine Derivative GBP1F in a Murine Model of Depression, Anxiety and Cognition.
Ali, G; Alkahramaan, YMSA; Arif, M; Gohar, A; Khan, MS; Rashid, U; Rauf, K; Sewell, RDE, 2023
)
2.76
"Gabapentin is an anticonvulsant drug that is also used for post-herpetic neuralgia and neuropathic pain. "( Gabapentin attenuates intestinal inflammation: Role of PPAR-gamma receptor.
Barbosa, ALDR; Carneiro, TB; da Cruz Júnior, JS; da Silva Costa, DV; da Silva Monteiro, CE; de Brito, TV; de Oliveira, JS; de Souza, MHLP; Franco, AX; Gomes Duarte, AS; Júnior, GJD; Silva, RO; Soares, PMG; Vasconcelos, DFP, 2020
)
3.44
"Gabapentin is a drug used to treat epilepsy and peripheral neuropathic pain. "( Liquid chromatography/mass spectrometry analytical determination of gabapentin transformation products by heterogeneous photocatalysis and environmental evaluation.
Calza, P; Dal Bello, F; Fabbri, D; Kuck, B; Medana, C; Zorzi, M, 2020
)
2.24
"Gabapentin is an analog of gamma-aminobutyric acid (GABA), but its complete mechanism is not well understood. "( Patient Case Report: Gabapentin-Induced Hypoglycemia.
Berendse, J; Ferdinand, A; Hayes, KM; Hayes, WJ; Kappes, JA; Neabore, S, 2022
)
2.48
"Gabapentin is a potential option to manage PLP after amputation in pediatric oncology."( Gabapentin for phantom limb pain after amputation in pediatric oncology: a systematic review protocol.
Bai, JH; Jiang, S; Xia, R; Yan, LH; Zhou, MM, 2021
)
2.79
"Gabapentin is an antiepileptic drug currently licensed to treat epilepsy and neuropathic pain but has been used off-label to treat acute postoperative pain. "( Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study).
Abbadi, R; Alzetani, A; Baos, S; Casali, G; Chauhan, N; Collett, L; Culliford, L; de Jesus, SE; Edwards, M; Gibbison, B; Goddard, N; Lamb, J; McKeon, H; Molyneux, M; Pufulete, M; Rogers, CA; Stokes, EA; Wordsworth, S, 2020
)
2.26
"Gabapentin is a commonly used medication for neuropathic pain and epilepsy that is prescribed by a wide range of medical specialties. "( Gabapentin-Induced Myokymia: A Case Report.
Brown, A; Esechie, A; Gogia, B; Shanina, E,
)
3.02
"Gabapentin (GBP) is an FDA-approved drug for the treatment of partial and secondary generalized seizures, apart from being used for diabetic neuropathic pain. "( In-Silico Validation and Fabrication of Matrix Diffusion-Based Polymeric Transdermal Patches for Repurposing Gabapentin Hydrochloride in Neuropathic Pain.
Agarwal, S; Agarwal, V; Kaur, H; Kaur, R; Pancham, P; Singh, M, 2021
)
2.28
"Gabapentin (GBP) is an established drug that has been used in the management of symptoms of neuropathy but it is associated with unwanted side effects such as sedation and motor incoordination. "( A novel gabapentin analogue assuages neuropathic pain response in chronic sciatic nerve constriction model in rats.
Ahmad, N; Akbar, S; Amin, MU; Islam, NU; Khurram, M; Sewell, RDE; Shahid, M; Subhan, F; Ullah, I; Ullah, N; Ullah, R, 2021
)
2.5
"Gabapentin is a pharmacological agent used in the treatment of epileptic seizures. "( Rapid and simple determination of gabapentin in urine by ion mobility spectrometry.
Ilbeigi, V; Mamozai, W; Soleimani, M; Valadbeigi, Y, 2021
)
2.34
"Gabapentin is an anticonvulsant medication used as an adjuvant in the treatment of neuropathic pain; few cases have been reported in which it causes acute liver injury."( [Hepatotoxicity probably associated with gabapentin].
Contreras-Mota, M; Rosales-Cortés, V, 2021
)
2.33
"Gabapentin is a safe and well-tolerated medication, FDA-approved to treat other neurological diseases, that restores GABA/glutamate homeostasis, with treatment studies supporting efficacy in treating CUD, as well as anxiety and sleep disorders that are common to both BD and CUD."( Results from a randomized, double-blind, placebo-controlled, crossover, multimodal-MRI pilot study of gabapentin for co-occurring bipolar and cannabis use disorders.
Arnold, L; Hix, S; Mellick, W; Prisciandaro, JJ; Squeglia, LM; Tolliver, BK, 2022
)
1.66
"Gabapentin (GBP) is a first-line therapy for neuropathic pain, but its mechanisms and sites of action remain uncertain. "( Multiple sites and actions of gabapentin-induced relief of ongoing experimental neuropathic pain.
Bannister, K; Dickenson, AH; King, T; Navratilova, E; Oyarzo, J; Porreca, F; Qu, C; Xie, JY, 2017
)
2.19
"Gabapentin (GBP) is an effective analgesic for neuropathic pain conditions but its clinical efficacy in cisplatin-induced neuropathic pain (CINP) is limited, in addition to generating unwanted side-effects."( Gabapentin and its salicylaldehyde derivative alleviate allodynia and hypoalgesia in a cisplatin-induced neuropathic pain model.
Ahmad, N; Islam, NU; Rahman, FU; Sewell, RDE; Shahid, M; Subhan, F, 2017
)
2.62
"Gabapentin is an antiepileptic drug widely approved as an add-on therapy for epilepsy treatment in human and dogs. "( Effects of premedication with oral gabapentin on intraocular pressure changes following tracheal intubation in clinically normal dogs.
Capik, I; Ghaffari, MS; Trbolova, A, 2017
)
2.17
"Gabapentin is an anticonvulsant drug widely prescribed for various ailments, including orofacial pain. "( Abuse potential of gabapentin in dentistry.
Insler, JS; Segelnick, SL; Weinberg, MA,
)
1.9
"Gabapentin is a third-generation antiepileptic drug that selectively affects the nociceptive process and has been used for pain relief after surgery."( The Efficacy of Preoperative Gabapentin in Spinal Surgery: A Meta-Analysis of Randomized Controlled Trials.
Han, C; Kuang, MJ; Ma, JX; Ma, XL, 2017
)
1.47
"Gabapentin is a calcium channel GABAergic modulator that is widely used for pain."( Gabapentin for the treatment of alcohol use disorder.
Mason, BJ; Quello, S; Shadan, F, 2018
)
2.64
"Gabapentin is an effective treatment for chronic neuropathic pain but may cause dizziness, drowsiness, and confusion in some older adults. "( Gabapentin dose and the 30-day risk of altered mental status in older adults: A retrospective population-based study.
Burneo, J; Dev, VK; Dixon, SN; Fleet, JL; Garg, AX; Kuwornu, PJ; Montero-Odasso, M, 2018
)
3.37
"Gabapentin is an adjuvant antiepileptic agent and helps to reduce acute postoperative pain in several surgery settings. "( Preoperative Gabapentin Administration Improves Acute Postoperative Analgesia in Patients Undergoing Craniotomy: A Randomized Controlled Trial.
Dong, J; Han, R; Lin, N; Peng, K; Peng, Y; Wang, D; Zeng, M; Zhang, K; Zhang, W; Zhao, Y, 2019
)
2.33
"Gabapentin is a widely prescribed medication, with numerous drug reactions previously reported."( Gabapentin-induced eczematous drug eruption of the bilateral foot.
Ernst, JJ; Ryba, D, 2018
)
2.64
"Gabapentin is an antiepileptic drug. "( [Effect of melatonin on the daytime sleepiness side-effect of gabapentin in adults patients with neuropathic pain].
Altiparmak, B; Celebi, N; Cil, H,
)
1.81
"Gabapentin is a non-opioid medication that has been used perioperatively to improve postoperative pain and limit opioid requirements."( Perioperative gabapentin and post cesarean pain control: A systematic review and meta-analysis of randomized controlled trials.
Berghella, V; Carvalho, JCA; Felder, L; Monks, DT; Saccone, G; Scuotto, S; Zullo, F, 2019
)
1.6
"Gabapentin is a gamma-aminobutyric acid (GABA) analog approved by the Food and Drug Administration (FDA) for partial seizures and post-herpetic neuralgia. "( Trending gabapentin exposures in Kentucky after legislation requiring use of the state prescription drug monitoring program for all opioid prescriptions
Bhandari, B; Bosse, GM; Faryar, KA; Price, TG; Webb, AN, 2019
)
2.37
"Gabapentin (GBP) is an analog of γ-aminobutyric acid and was originally designed as an anticonvulsant. "( Gabapentin-Associated Urinary Incontinence: A Case Verified by Rechallenge.
Caprara, ALF; Rissardo, JP,
)
3.02
"Gabapentin is a structural analog of the inhibitory neurotransmitter γ-aminobutyric acid (GABA). "( Gabapentin increases expression of δ subunit-containing GABA
Alavian-Ghavanini, A; Baker, GB; Bonin, RP; Orser, BA; Penna, A; Rauw, G; Wang, DS; Yu, J; Zurek, AA, 2019
)
3.4
"Gabapentin is an anticonvulsant medication with an indication from the US Food and Drug Administration for use in partial onset seizures and postherpetic neuralgia in the United States. "( Commentary on "A Call for Caution in Prescribing Gabapentin to Individuals with Concurrent Polysubstance Abuse: A Case Report".
Kahn, DA, 2019
)
2.21
"Gabapentin is an anticonvulsant medication with an indication from the US Food and Drug Administration for use in partial onset seizures and postherpetic neuralgia in the United States. "( A Call for Caution in Prescribing Gabapentin to Individuals With Concurrent Polysubstance Abuse: A Case Report.
Hasan, S; Martinez, GM; Olabisi, J; Ruekert, L, 2019
)
2.24
"Gabapentin is an anti-epileptic agent but now it is also recommended as first line agent in neuropathic pain, particularly in diabetic neuropathy and post herpetic neuralgia. "( Implications and mechanism of action of gabapentin in neuropathic pain.
Bali, A; Jaggi, AS; Kukkar, A; Singh, N, 2013
)
2.1
"Gabapentin is an inhibitory neurotransmitter of the central nervous system. "( Effect of gabapentin pretreatment on propofol consumption, hemodynamic variables, and postoperative pain relief in breast cancer surgery.
Bala, I; Bharti, N; Narayan, V; Singh, G, 2013
)
2.23
"Gabapentin is a potentially useful drug in alleviating the hyperexcitatory painful states in the control of opiate dependence in acute detoxification and the stabilization phase. "( The effects of gabapentin on methadone based addiction treatment: a randomized controlled trial.
Alavinia, M; Moghadam, MS, 2013
)
2.19
"Gabapentin (GBP) is an anti-convulsive drug often used as analgesic to control neuropathic pain. "( Oral gabapentin treatment accentuates nerve and peripheral inflammatory responses following experimental nerve constriction in Wistar rats.
Araújo, CV; Barbosa, AL; Brito, GA; Câmara, CC; Costa, CM; da Silva, AP; Gomes, AS; Oriá, RB; Ramos, HF; Ribeiro, RA; Vale, ML, 2013
)
2.35
"Gabapentin (GPN) is a new antiepileptic agent currently in used as add-on therapy in adult patients suffering from partial seizures. "( Chronic effect of gabapentin on liver function in adult male rats.
Abdollahi, A; Meshkibaf, MH; Miladpoor, B; Shole Var, F, 2013
)
2.17
"Gabapentin is an analogue of the gamma amino butyric acid (GABA), which regulates the conductance of calcium channels. "( Gabapentin versus naproxen in the management of failed back surgery syndrome; a randomized controlled trial.
Azemati, S; Khosravi, MB; Sahmeddini, MA, 2014
)
3.29
"Gabapentin is a good option for the treatment of severe itching caused by nostalgia paresthetica."( Efficacy of gabapentin in the improvement of pruritus and quality of life of patients with notalgia paresthetica.
Cunha, PR; Laraia, IO; Maciel, AA; Trevisan, F,
)
1.95
"Gabapentin is a popular anticonvulsant drug that has been used as an oral nonopioid analgesic in recent years."( The effects of gabapentin on severity of post spinal anesthesia headache.
Izadi, F; Nadri, S; Vahabi, S, 2014
)
1.48
"Gabapentin is a viable treatment for conservatively managed CKD and ESKD patients with pruritus and/or RLS, but side effects are common. "( Efficacy and safety of gabapentin for uremic pruritus and restless legs syndrome in conservatively managed patients with chronic kidney disease.
Brennan, F; Brown, MA; Cheikh Hassan, HI; Collett, G; Josland, EA, 2015
)
2.17
"Gabapentin appears to be an effective treatment for children with severe impairment of the CNS and recurrent pain behaviors, including intermittent changes in muscle tone. "( Gabapentin for management of recurrent pain in 22 nonverbal children with severe neurological impairment: a retrospective analysis.
Hauer, JM; Solodiuk, JC, 2015
)
3.3
"Gabapentin (GBP) is a drug with different indications.Is not metabolized and is excreted by the kidney. "( [Rhabdomyolysis from gabapentin: a case report].
Brunetti, C; De Prisco, O; Falconi, D; Formica, M; Gherzi, M; Marazzi, F; Marengo, M; Serra, I; Tamagnone, M; Tattoli, F,
)
1.89
"Gabapentin is a bitter drug so an attempt was made to mask its taste."( Nanosponge-based pediatric-controlled release dry suspension of Gabapentin for reconstitution.
Bhingole, RC; Rao, MR, 2015
)
1.38
"Gabapentin is a reasonable first-line choice, and opioid medications can be added for more severe pain but there are few clinical trials to inform specific recommendations."( Headache and Pain in Guillain-Barré Syndrome.
Farmakidis, C; Herskovitz, S; Inan, S; Milstein, M, 2015
)
1.14
"Gabapentin is an antiepileptic drug approved for adjunctive therapy for partial seizures. "( THROMBOCYTOPENIA WITH GABAPENTIN USAGE.
Ak, PD; Atakli, D; Sari, H; Sariahmetoglu, H; Yuksel, B, 2015
)
2.17
"Gabapentin (GBP) is an anti-convulsive drug often used as analgesic to control neuropathic pain. "( Gabapentin attenuates neuropathic pain and improves nerve myelination after chronic sciatic constriction in rats.
Araújo, CV; Brito, GAC; Câmara, CC; de Sousa, KKO; Martinez, AMB; Mendonça, FE; Mietto, BS; Oriá, RB; Raposo, RDS; Vale, ML, 2015
)
3.3
"Gabapentin (GPT) is an antiepilepsy drug, which affects the glutamic acid neuron system and the γ-amino butyric acid neuron system."( A Case of Parkinson Disease With Both Visual Hallucination and Pain Improved by Gabapentin.
Abe, K; Chiba, Y; Hirayasu, Y; Katsuse, O,
)
1.08
"Gabapentin is a good alternative therapeutic option to anesthetic blockade."( Auriculotemporal Neuralgia: Eight New Cases Report.
Cuadrado, ML; de la Cruz, C; Garcia-Ptacek, S; Guerrero, AL; Porta-Etessam, J; Ruiz, M, 2016
)
1.16
"Gabapentin is a widely prescribed medication used primarily for the treatment of epilepsy and neuropathic pain. "( Gabapentin concentrations and postmortem distribution.
Gary, RD; Hamm, CE; McIntyre, IM, 2016
)
3.32
"Gabapentin is a promising and a well-tolerated treatment option for patients with UP. "( Gabapentin: A promising therapy for uremic pruritus in hemodialysis patients: A randomized-controlled trial and review of literature.
Abdelkhalik, Z; Alkot, R; Eldesouky, F; Farag, F; Nofal, A; Nofal, E, 2016
)
3.32
"Gabapentin is a good alternative to oxybutynin for management of neurogenic bladder, both as monotherapy and as an add-on therapy. "( Role of gabapentin and anticholinergics in management of neurogenic bladder after repair of spina bifida - a randomized controlled study.
Bawa, M; Dash, V; Kanojia, RP; Mahajan, JK; Rao, KL; Samujh, R, 2016
)
2.31
"Gabapentin (GBP) is a widely used antiepileptic drug, with potential for use in the treatment of epilepsy in pregnant women. "( Involvement of l-type amino acid transporter 1 in the transport of gabapentin into human placental choriocarcinoma cells.
Furugen, A; Hirano, T; Iseki, K; Ishiguro, Y; Kobayashi, M; Narumi, K; Nishimura, A, 2017
)
2.13
"Gabapentin is an anticonvulsant type of analgesic that could prevent the onset of PHN by its antihypersensitivity action in dorsal horn neurons."( Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial.
Bulilete, O; González-Bals, MJ; Leiva, A; Llobera, J; Lorente, P; Roca, A; Rullán, M; Soler, A, 2017
)
2.28
"Gabapentin is an antiepileptic that is used to manage neuropathic pain."( Gabapentin-Induced Bullous Pemphigoid.
Dufresne, F; Flamm, A; Sachdev, S, 2017
)
2.62
"Gabapentin is a well-established anticonvulsant drug which is also effective for the treatment of neuropathic pain. "( Gabapentin Inhibits Protein Kinase C Epsilon Translocation in Cultured Sensory Neurons with Additive Effects When Coapplied with Paracetamol (Acetaminophen).
Giacomoni, C; Vellani, V, 2017
)
3.34
"Gabapentin is a structural analog of GABA that has anticonvulsant properties. "( Cellular and behavioral interactions of gabapentin with alcohol dependence.
Cruz, MT; Gilpin, NW; Koob, GF; Morse, AC; O'Dell, LE; Roberto, M; Siggins, GR, 2008
)
2.06
"Gabapentin is an antiepileptic drug (AED) by design expected to mimic the action of the neurotransmitter gamma-aminobutyric acid (GABA). "( Gabapentin: a Ca2+ channel alpha 2-delta ligand far beyond epilepsy therapy.
Striano, P; Striano, S, 2008
)
3.23
"Gabapentin (GBP) is a water soluble low molecular weight drug with anticonvulsivant and antinociceptive activity. "( In vitro/in vivo characterization of melt-molded gabapentin-loaded poly(epsilon-caprolactone) implants for sustained release in animal studies.
Baratti, CM; Blake, MG; Boccia, MM; Carcaboso, AM; Chiappetta, DA; Höcht, C; Sosnik, A, 2008
)
2.04
"Gabapentin (Neurontin) is an agent commonly used to control neuropathic pain."( Combined preoperative use of celecoxib and gabapentin in the management of postoperative pain.
Jackowe, DJ; Lee, M; Oyama, J; Parsa, AA; Parsa, FD; Sprouse-Blum, AS, 2009
)
1.34
"Gabapentin is an antiepileptic agent indicated for use as an adjunct therapy in partial seizures and postherpetic neuralgia but is also prescribed for the treatment of diabetic peripheral neuropathy."( A probable case of gabapentin-related reversible hearing loss in a patient with acute renal failure.
Holt, SR; Pierce, DA; Reeves-Daniel, A, 2008
)
1.4
"Gabapentin is an anticonvulsant that the United States Food and Drug Administration approved as an adjunct therapy for partial seizures and postherpetic neuralgia."( Use of gabapentin in patients experiencing hot flashes.
Brown, JN; Wright, BR, 2009
)
1.53
"Gabapentin is an effective agent in treating uremic pruritus."( Gabapentin and uremic pruritus in hemodialysis patients.
Eskandari, D; Ganji, MR; Khashayar, P; Meysamie, AP; Razeghi, E; Togha, M, 2009
)
3.24
"Gabapentin (GBP) is a drug which is frequently used in diabetic neuropathy. "( Gabapentin-induced rhabdomyolysis in a patient with diabetic neuropathy.
Bilgir, F; Bilgir, O; Calan, M; Kebapçilar, L; Sari, I; Yildiz, Y; Yüksel, A, 2009
)
3.24
"Gabapentin is a central nervous system inhibitory agent with likely gamma-aminobutyric acid (GABA)-ergic and non-GABAergic mechanisms of action."( Gabapentin-induced delirium and dependence.
Kahn, DA; Kruszewski, SP; Paczynski, RP, 2009
)
2.52
"Gabapentin is a gamma-aminobutyric acid analog used for numerous neurologic conditions, including neuropathic pain and epilepsy. "( Gabapentin therapy for pain and irritability in a neurologically impaired infant.
Cox, TH; Garner, SS; Haney, AL, 2009
)
3.24
"Gabapentin is an anticonvulsant drug that has analgesic properties for acute postoperative pain. "( The analgesic effect of gabapentin as a prophylactic anticonvulsant drug on postcraniotomy pain: a prospective randomized study.
Aykac, B; Bingol, CA; Karlikaya, G; Sayin, M; Türe, H; Türe, U, 2009
)
2.1
"Gabapentin (Neurontin) is an antiepileptic drug commonly prescribed for pain treatment. "( Prevalence of gabapentin in impaired driving cases in Washington State in 2003-2007.
Peterson, BL, 2009
)
2.16
"Gabapentin is a structural analogue of GABA used in the treatment of the partial epilepsies of adult and child of more than 12 years, in monotherapy or in association with other anticonvulsant drugs. "( [Therapeutic drug monitoring of gabapentin].
Bentué-Ferrer, D; Tribut, O; Verdier, MC,
)
1.86
"Gabapentin is a useful agent for the relief of trigeminal neuralgia and orofacial phantom pain. "( [Interaction between gabapentin and D-serin in the formalin orofacial test].
González, LE; Hernández, L; Quiñónez, B; Silva, E, 2009
)
2.11
"Gabapentin is an anti-epileptic drug which is also used for the treatment of postoperative pain and a variety of psychiatric diseases including chronic anxiety disorders. "( Gabapentin does not reduce preoperative anxiety when given prior to total hip arthroplasty.
Clarke, H; Gollish, J; Katz, J; Kay, J; Mitsakakis, N; Orser, BA, 2010
)
3.25
"Gabapentin is an antiepileptic drug, also used in the treatment of neuropathic pain, which is the subject of a Cochrane review, currently under revision. "( Single dose oral gabapentin for established acute postoperative pain in adults.
Derry, S; McQuay, HJ; Moore, RA; Straube, S; Wiffen, PJ, 2010
)
2.14
"Gabapentin is a structural analog of gamma-aminobutyric acid, one of the inhibitory neurotransmitters of the mammalian central nervous system. "( The effects of intravenous gabapentin administration on the minimum alveolar concentration of isoflurane in cats.
Ilkiw, JE; Pypendop, BH; Reid, P, 2010
)
2.1
"Gabapentin is a zwitterionic drug that exhibits low and variable oral absorption at therapeutic doses. "( Synthesis and in vitro evaluation of gabapentin prodrugs that target the human apical sodium-dependent bile acid transporter (hASBT).
Fletcher, S; Polli, JE; Rais, R, 2011
)
2.08
"Gabapentin is a γ-aminobutyric acid (GABA) analogue indicated for treatment of neuropathic pain. "( Pharmacokinetics of oral gabapentin alone or co-administered with meloxicam in ruminant beef calves.
Coetzee, JF; Cull, CA; Kelly, LL; Kohake, LE; KuKanich, B; Mosher, RA; Mueting, SL, 2011
)
2.12
"Gabapentin is a novelty, and the working mechanism of cannabis has been elucidated."( Spasticity: revisiting the role and the individual value of several pharmacological treatments.
Kuks, JB; Lapeyre, E; Meijler, WJ, 2010
)
1.08
"Gabapentin is an antiepileptic drug which has been successfully used to manage neuropathic pain, and is reporting to be successful in management of all forms of itch."( A comparative analysis of cetirizine, gabapentin and their combination in the relief of post-burn pruritus.
Ahuja, RB; Gupta, G; Gupta, R; Shrivastava, P, 2011
)
1.36
"Gabapentin (GPT) is an antiepileptic drug that was approved in 1993 for use in the management of neurotrophic pain and as an adjunctive therapy for refractory partial seizure in humans. "( Analysis of gabapentin in equine plasma with measurement uncertainty estimation by liquid chromatography-tandem mass spectrometry.
Chen, JW; Guan, F; Li, X; Liu, Y; Rudy, JA; Soma, LR; Uboh, CE; You, Y, 2011
)
2.19
"Gabapentin is an anticonvulsant and adjuvant analgesic. "( Chronic intrathecal infusion of gabapentin prevents nerve ligation-induced pain in rats.
Chen, CC; Cheng, JK; Chu, LC; Hung, YC; Lin, CS; Tsaur, ML; Wang, TY, 2011
)
2.1
"Gabapentin is a low-cost strategy to improve complete control of CINV, specially delayed CINV control."( Gabapentin for the prevention of chemotherapy- induced nausea and vomiting: a pilot study.
Carrasco, MM; Cruz, FM; da Costa Miranda, M; da Cunha Vieira, M; de Afonseca, SO; de Iracema Gomes Cubero, D; de Souza Fêde, AB; del Giglio, A; Lera, AT; Lerner, T; Pinczowski, H; Schindler, F; Taranto, P, 2012
)
3.26
"Gabapentin is an antiepileptic drug that is prescribed for both FDA-approved and multiple off-label conditions, and has a relatively safe side-effect profile. "( Suicide by gabapentin overdose.
Middleton, O, 2011
)
2.2
"Gabapentin is a structural analogue of gamma-amino-butyric acid with anticonvulsant activity. "( Dose-dependent opposite effects of gabapentin on the depressive action of morphine on a C-fibre reflex in the rat.
Adam, F; le Bars, D; Pollin, B; Roy-Ledoux, R, 2011
)
2.09
"Gabapentin is an antiepileptic drug used as adjunct therapy in the treatment of seizures. "( Performance characteristics of the ARK diagnostics gabapentin immunoassay.
Anderson, BL; Johnson-Davis, KL; Juenke, JM; McMillin, GA; Wienhoff, KA, 2011
)
2.06
"Gabapentin (GAB) is a newer second-line antiepileptic drug (AED) used in children. "( Retention rate of Gabapentin in children with intractable epilepsies at 1 year.
Ali, I; Gupta, R; Lewis, TG; Mills, JK; Mordekar, SR; Mughal, K; Ruslan, NE; Sasidharan, L; Sharma, R; Siddiqua, A; Ugar, A; Wassmer, E; Whitehouse, WP, 2012
)
2.16
"Gabapentin appears to be a promising medication for the treatment of intractable hiccups in thoracic transplant recipients because of its lack of serious side effects at low doses, rapid onset of action, and lack of drug-drug interactions with transplant medications."( Low-dose gabapentin for intractable hiccups in a heart transplant recipient.
Brieke, A; Lindenfeld, J; Luna, M; Page, RL, 2011
)
1.51
"Gabapentin is an antiepileptic drug. "( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
2.15
"Gabapentin (GBP) is an anticonvulsant that acts at the α2δ-1 submit of the L-type calcium channel. "( Gabapentin decreases epileptiform discharges in a chronic model of neocortical trauma.
Barres, BA; Graber, KD; Jin, S; Li, H; McDonald, W; Prince, DA, 2012
)
3.26
"Gabapentin is a structural analog of gamma aminobutyric acid that binds to the α(2)-δ site of voltage-dependent calcium channels and modulates the influx of calcium, with a resulting reduction in excitatory neurotransmitter release."( Gabapentin for once-daily treatment of post-herpetic neuralgia: a review.
Beal, B; Moeller-Bertram, T; Schilling, JM; Wallace, MS, 2012
)
2.54
"Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug."( Effect of gabapentin on postoperative pain and operation complications: a randomized placebo controlled trial.
Abrishamkar, M; Ayatollahi, V; Bafghi, AT; Behdad, S; Tezerjani, MD, 2012
)
1.5
"Gabapentin is a widely used drug with anticonvulsant, antinociceptive and anxiolytic properties. "( Gabapentin inhibits presynaptic Ca(2+) influx and synaptic transmission in rat hippocampus and neocortex.
Dougherty, JJ; Endeman, D; Nichols, RA; van Hooft, JA; Wadman, WJ, 2002
)
3.2
"Gabapentin (GBP) is a gamma-aminobutyric acid analog effective in the treatment of seizures. "( Long-term regulation of voltage-gated Ca(2+) channels by gabapentin.
Campbell, KP; Felix, R; Kang, MG, 2002
)
2
"Gabapentin is a drug that shares a similar structure to that of GABA, although its mechanism of action cannot be explained solely by a direct gaba mimetic effect. "( [Characteristics and indications of gabapentin].
Sancho-Rieger, J, 2002
)
2.03
"Gabapentin (GBP) is a commonly used drug in the treatment of partial seizures, but its mode of action is still unclear. "( Gabapentin increases the hyperpolarization-activated cation current Ih in rat CA1 pyramidal cells.
Feuerstein, TJ; Freiman, TM; Surges, R, 2003
)
3.2
"Gabapentin is a new antiepileptic drug that may additionally have a role in the treatment of neuropathic pain."( Gabapentin effect on neuropathic pain compared among patients with spinal cord injury and different durations of symptoms.
Ahn, SH; Bae, JH; Jang, SH; Lee, BS; Moon, HW; Park, HW; Sakong, J, 2003
)
2.48
"Gabapentin is an anticonvulsant that is being used for an increasing number of off-label indications. "( Characterization of gabapentin overdose using a poison center case series.
Dahl, B; Gorman, S; Klein-Schwartz, W; Shepherd, JG, 2003
)
2.09
"Gabapentin is a very promising medication in the treatment of post-herpetic neuralgia and pain. "( The role of gabapentin in treating diseases with cutaneous manifestations and pain.
Scheinfeld, N, 2003
)
2.14
"Gabapentin appears to be a safe and effective treatment in geriatric mania when combined with antipsychotic medications or valproate."( Gabapentin in geriatric mania.
Devanand, DP; Mehta, R; Sethi, MA, 2003
)
2.48
"Gabapentin is a clinically effective anticonvulsant with an unclear mechanism of action. "( Gabapentin actions on Kir3 currents and N-type Ca2+ channels via GABAB receptors in hippocampal pyramidal cells.
Bertrand, S; Lacaille, JC; Morin, F; Nagy, F; Nouel, D, 2003
)
3.2
"Gabapentin is a structural analogue of the neurotransmitter gamma-aminobutyric acid (GABA) approved for use in adults with postherpetic neuralgia. "( Gabapentin: in postherpetic neuralgia.
Curran, MP; Wagstaff, AJ, 2003
)
3.2
"Gabapentin is an important adjuvant to the management of opiate dependence both in acute detoxification as well as stabilisation phase."( Gabapentin in the management of pentazocine dependence: a potent analgesic--anticraving agent.
Jain, MK; Kumar, P, 2003
)
3.2
"Gabapentin appeared to be a safe and efficacious medication to reduce cocaine usage in a community sample of psychiatric patients."( Gabapentin reduces cocaine use among addicts from a community clinic sample.
Coomaraswamy, S; Raby, WN, 2004
)
3.21
"Gabapentin is a lipophilic analog of gamma-amino butyric acid (GABA) with therapeutic activity against certain forms of epilepsy and neuropathic pain. "( Gabapentin may inhibit synaptic transmission in the mouse spinal cord dorsal horn through a preferential block of P/Q-type Ca2+ channels.
Ahmadi, S; Bayer, K; Zeilhofer, HU, 2004
)
3.21
"Gabapentin is a promising new agent in the treatment of tamoxifen induced hot flashes, and should be studied further."( Pilot study using gabapentin for tamoxifen-induced hot flashes in women with breast cancer.
Griggs, JJ; Guttuso, TJ; Morrow, GR; Pandya, KJ; Roscoe, JA; Rosenblatt, JD; Sahasrabudhe, DM; Thummala, AR, 2004
)
1.38
"Gabapentin is an antiepileptic drug shown to be effective in the treatment of pain disorders and appears to be useful as well for several psychiatric disorders, including bipolar disorder, anxiety disorders, alcohol withdrawal and cocaine dependence. "( Add-on gabapentin in the treatment of opiate withdrawal.
Castellano, M; Cervera, G; Martínez-Raga, J; Perez-Galvez, B; Sabater, A, 2004
)
2.22
"Gabapentin is an antiepileptic agent that has a role in the management of behavioral problems in demented patients such as agitation and aggression."( Treatment of sexual disinhibition in dementia: case reports and review of the literature.
Alkhalil, B; Alkhalil, C; Lowenthal, DT; Tanvir, F,
)
0.85
"Gabapentin is an antiepileptic drug that increases the synthesis and release of GABA."( Effects of gabapentin on the motor response to levodopa: a double-blind, placebo-controlled, crossover study in patients with complicated Parkinson disease.
Lasa, A; Linazasoro, G; Masramón, X; Sastre, VM; Van Blercom, N; Verger, K,
)
1.24
"Gabapentin (GBP) is an amino acid that is structurally analogous to GABA with the capacity to cross the blood-brain barrier and an antiepileptic action. "( [The safety and tolerability profile of gabapentin in optimal doses].
Cañadillas-Hidalgo, FM,
)
1.84
"Gabapentin is an anticonvulsant that alleviates neuropathic pain."( Gabapentin therapy for pruritus in haemodialysis patients: a randomized, placebo-controlled, double-blind trial.
Celiker, H; Gunal, AI; Gunal, SY; Kirciman, E; Ozalp, G; Yoldas, TK, 2004
)
2.49
"Gabapentin (GBP) is a new antiepileptic agent with an original spectrum of activity. "( [Gabapentin (Neurontin) and cancer pain: a pilot study].
Body, JJ; Lossignol, DA; Plehiers, B, 2004
)
2.68
"Gabapentin is a drug with anticonvulsant and analgesic properties causing the reduction of neurotransmitter release. "( Presynaptic NMDA autoreceptors facilitate axon excitability: a new molecular target for the anticonvulsant gabapentin.
Del Olmo, N; González-Escalada, JR; Ruiz, M; Solís, JM; Suárez, F; Suárez, LM, 2005
)
1.98
"Gabapentin is an antiepileptic medication that also has been used for restless legs syndrome. "( Gabapentin-induced myopathy in 2 patients on short daily hemodialysis.
Lavoie, S; Lipson, J; Zimmerman, D, 2005
)
3.21
"Gabapentin is an anticonvulsant that successfully treats many neuropathic pain syndromes, although the mechanism of its antihyperalgesic action remains elusive. "( Evidence that gabapentin reduces neuropathic pain by inhibiting the spinal release of glutamate.
Coderre, TJ; Kumar, N; Lefebvre, CD; Yu, JS, 2005
)
2.13
"Gabapentin is an anticonvulsant medication that increases human brain GABA levels."( A randomized placebo-controlled trial of gabapentin for cocaine dependence.
Aharonovich, E; Bisaga, A; Garawi, F; Levin, FR; Nunes, EV; Raby, WN; Rubin, E, 2006
)
1.32
"Gabapentin is an antiepileptic drug approved for the treatment of postherpetic neuralgia and as adjunctive therapy for partial seizures. "( Gabapentin-induced neurologic toxicities.
Bookwalter, T; Gitlin, M, 2005
)
3.21
"Gabapentin is a novel analgesic whose mechanism of action is not known. "( The antiallodynic action target of intrathecal gabapentin: Ca2+ channels, KATP channels or N-methyl-d-aspartic acid receptors?
Chen, CC; Cheng, JK; Chiou, LC; Yang, JR, 2006
)
2.03
"Gabapentin seems to be a safe and effective treatment for idiopathic sweating in advanced cancer patients."( Gabapentin in the treatment of severe sweating experienced by advanced cancer patients.
Aielli, F; Aloisi, P; Cannita, K; Ficorella, C; Marchetti, P; Porto, C; Porzio, G; Ricevuto, E; Verna, L, 2006
)
2.5
"Gabapentin (GBP) is an anticonvulsant and widely used in the treatment of epilepsy."( Simple and sensitive liquid chromatographic method with fluorimetric detection for the analysis of gabapentin in human plasma.
Chung, TC; Tai, CT; Wu, HL, 2006
)
1.27
"Gabapentin is an antiepileptic drug. "( Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study.
Ambesh, SP; Pandey, CK; Priye, S; Singh, PK; Singh, S; Singh, U,
)
1.94
"Gabapentin is an anticonvulsant that has been shown to be effective in the treatment of neuropathic and inflammatory pain in animal and human studies. "( The analgesic effects of perioperative gabapentin on postoperative pain: a meta-analysis.
Cohen, SP; Hurley, RW; Rowlingson, AJ; Williams, KA; Wu, CL,
)
1.84
"Gabapentin thus appears to be an effective treatment for Isaacs' syndrome."( Isaacs' syndrome: clinical and electrophysiological response to gabapentin.
Dhand, UK, 2006
)
1.29
"Gabapentin is an established therapy in neuropathic pain and reduces cutaneous pain in healthy volunteers."( Multiple dose gabapentin attenuates cutaneous pain and central sensitisation but not muscle pain in healthy volunteers.
Segerdahl, M, 2006
)
1.42
"Gabapentin is a drug that has been widely used in the treatment of chronic pain states. "( alpha2delta and the mechanism of action of gabapentin in the treatment of pain.
Lee, K; Luo, ZD; Maneuf, YP, 2006
)
2.04
"Gabapentin (Gp) is an antihyperalgesic drug that selectively affects central sensitization."( Effects of gabapentin on morphine consumption and pain in severely burned patients.
Cuignet, O; Pirson, J; Soudon, O; Zizi, M, 2007
)
1.45
"Gabapentin (GBP) is a prescription drug used for the treatment of neuropathic and post-operative pain. "( Inhibitory effect of gabapentin on N-methyl-D-aspartate receptors expressed in Xenopus oocytes.
Hara, K; Sata, T, 2007
)
2.1
"Gabapentin is a nonhormonal agent that also can reduce hot flashes."( Phase III trial of gabapentin alone or in conjunction with an antidepressant in the management of hot flashes in women who have inadequate control with an antidepressant alone: NCCTG N03C5.
Balcueva, EP; Barton, DL; Burger, KN; Carlson, MD; Corso, SW; Duane, SF; Dueck, AC; Jaslowski, AJ; Johnson, DB; Kugler, JW; Loprinzi, CL; Nelimark, RA; Novotny, PJ; Tschetter, LK, 2007
)
1.39
"Gabapentin is an anticonvulsant structurally similar to gamma - amino- butyric acid considered as the central acting GABA- analogue. "( [Gabapentin (GBP) in panic disorders--case report].
Spila, B; Szumiłło, A,
)
2.48
"Gabapentin is a structural analogue of gamma-aminobutyric acid with strong anticonvulsant and analgesic activities. "( The antinociceptive effect of systemic gabapentin is related to the type of sensitization-induced hyperalgesia.
Curros-Criado, MM; Herrero, JF, 2007
)
2.05
"Gabapentin is an anticonvulsant that is widely prescribed for epilepsy and other neuropathic disorders. "( Effects of genetic variation in the novel organic cation transporter, OCTN1, on the renal clearance of gabapentin.
Brett, CM; Brown, C; Burchard, EG; Castro, RA; Giacomini, KM; Huang, Y; Mercer, R; Shah, N; Urban, TJ, 2008
)
2
"Gabapentin is an effective drug in the management of neuropathic pain."( Gabapentin: a promising drug for the treatment of uremic pruritus.
Harandi, AA; Khanbabapour, S; Mohseni, M; Naini, AE; Seirafiyan, S; Shahidi, S, 2007
)
2.5
"Gabapentin appeared to be a safe, effective, and economical treatment for neuropathic pain in this horse."( Gabapentin for the treatment of neuropathic pain in a pregnant horse.
Davis, JL; Elce, Y; Posner, LP, 2007
)
3.23
"Gabapentin (Neurontin) is an analogue of gamma-aminobutyric acid (GABA) that is effective against partial seizures. "( Inhibitory mechanisms of gabapentin, an antiseizure drug, on platelet aggregation.
Chou, DS; Hsiao, G; Pan, CF; Shen, MY; Sheu, JR; Wu, CJ, 2007
)
2.09
"Gabapentin at 900 mg/day is an effective and well-tolerated treatment for hot flashes."( Gabapentin for the treatment of menopausal hot flashes: a randomized controlled trial.
Butt, DA; Lewis, JE; Lock, M; Moineddin, R; Ross, S,
)
3.02
"Gabapentin is a second generation anticonvulsant that is effective in the treatment of chronic neuropathic pain. "( Gabapentin: a multimodal perioperative drug?
Irwin, MG; Kong, VK, 2007
)
3.23
"Gabapentin is a gamma-aminobutyric acid (GABA) analogue, with GABAmimetic pharmacological properties. "( Effects of gabapentin on cocaine self-administration, cocaine-triggered relapse and cocaine-enhanced nucleus accumbens dopamine in rats.
Ashby, CR; Gagare, PD; Gardner, EL; Li, J; Li, X; Peng, XQ; Pratihar, D; Ramachandran, PV; Xi, ZX, 2008
)
2.18
"Gabapentin is an adjuvant analgesic and may enhance the spread of subarachnoid block. "( Preoperative gabapentin: the effect on ropivacaine subarachnoid block and hemodynamics.
Chatziara, V; Fassoulaki, A; Melemeni, A; Sarantopoulos, C; Zotou, M, 2008
)
2.16
"Gabapentin is a promising medication for the treatment of intractable hiccups for its safety, lack of serious side effects, and rapid onset of action."( Gabapentin for intractable hiccups in palliative care.
Baumrucker, SJ; Tegeler, ML,
)
2.3
"Gabapentin is an effective anticonvulsant. "( Gabapentin activates ROMK1 channels by a protein kinase A (PKA)-dependent mechanism.
Lee, CH; Liou, HH; Tsai, TS, 2008
)
3.23
"Gabapentin is an antiepileptic used for neuropathic pain treatment. "( Gabapentin therapy for painful, blind glaucomatous eye: case report.
Dimou, T; Kavalieratos, CS, 2008
)
3.23
"Gabapentin is an anticonvulsant and had been reported to be effective in some chronic pruritus conditions."( Preoperative gabapentin prevents intrathecal morphine-induced pruritus after orthopedic surgery.
Chang, FL; Ho, ST; Lee, CH; Sheen, MJ; Tsung, YC, 2008
)
1.44
"Gabapentin (GBP) is a cyclic gamma-aminobutyric acid (GABA) analog and investigational antiepileptic drug which is effective in the treatment of a variety of human and experimental seizures. "( Gabapentin actions on ligand- and voltage-gated responses in cultured rodent neurons.
Kelly, KM; Macdonald, RL; Rock, DM, 1993
)
3.17
"Gabapentin is a new antiepileptic drug that is structurally similar to the neurotransmitter GABA and the endogenous amino acid L-leucine."( Emerging perspectives on the mechanism of action of gabapentin.
Taylor, CP, 1994
)
1.26
"Gabapentin is an anticonvulsant drug, which in man is cleared solely by renal excretion and is not bound to plasma proteins. "( Disposition of gabapentin in anuric subjects on hemodialysis.
Bockbrader, HN; Eldon, MA; Halstenson, CE; Keane, WF; Sedman, AJ; Türck, D; Underwood, BA; Wong, MO, 1995
)
2.09
"Gabapentin is an antiepileptic drug with an unknown mechanism of action apparently dissimilar to that of other antiepileptic agents, and possessing some desirable pharmacokinetic traits. "( Gabapentin. A review of its pharmacological properties and clinical potential in epilepsy.
Goa, KL; Sorkin, EM, 1993
)
3.17
"Gabapentin is a new AED not appreciably metabolized by the liver in humans."( Gabapentin treatment of seizures in acute intermittent porphyria.
Tatum, WO; Zachariah, SB, 1995
)
2.46
"Gabapentin appears to be a useful new AED. "( Gabapentin: a new agent for the management of epilepsy.
Andrews, CO; Fischer, JH, 1994
)
3.17
"Gabapentin is a new, water-soluble, antiepileptic agent with properties of an amino acid."( Clinical pharmacokinetics of gabapentin.
McLean, MJ, 1994
)
1.3
"Gabapentin (GBP) is a non-protein-bound gamma amino acid which is not subjected to metabolic degradation in man. "( Seizure frequency and CSF parameters in a double-blind placebo controlled trial of gabapentin in patients with intractable complex partial seizures.
Ben-Menachem, E; Hamberger, A; Hedner, T; Persson, LI; Söderfelt, B, 1995
)
1.96
"Gabapentin is a novel anticonvulsant drug. "( Effects of anticonvulsant drug gabapentin on the enzymes in metabolic pathways of glutamate and GABA.
Goldlust, A; Oxender, DL; Su, TZ; Taylor, CP; Welty, DF, 1995
)
2.02
"Gabapentin is a new antiepileptic drug for add-on therapy in patients above the age of 12 years with otherwise refractory partial seizures. "( [Gabapentin (Neurontin): a new possibility in the add-on therapy of partial epilepsies].
Krämer, G, 1996
)
2.65
"Gabapentin is a new antiepileptic for the combination therapy of partial seizures. "( [Clinical studies on gabapentin in Switzerland].
Shokry, A, 1996
)
2.06
"Gabapentin (GBP) is a new antiepileptic drug (AED) approved for adjunctive treatment of complex partial seizures with or without seizures secondarily generalization in adults. "( Gabapentin associated with aggressive behavior in pediatric patients with seizures.
Lo, W; Nahata, MC; Tallian, KB; Tsao, CY, 1996
)
3.18
"Gabapentin is a new antiepileptic drug (AED) with an attractive pharmacokinetic profile. "( Gabapentin: pharmacokinetics, efficacy, and safety.
Beydoun, A; Sackellares, JC; Uthman, BM, 1995
)
3.18
"Gabapentin is a gamma-aminobutyric acid (GABA) analog which passes the blood-brain barrier."( [New medical treatment of epilepsy].
Loiseau, P, 1996
)
1.02
"1. Gabapentin is a novel anticonvulsant with an unknown mechanism of action. "( Comparison of the uptake of [3H]-gabapentin with the uptake of L-[3H]-leucine into rat brain synaptosomes.
Hill, DR; Thurlow, RJ; Woodruff, GN, 1996
)
1.2
"1. Gabapentin is a novel anticonvulsant with an unknown mechanism of action. "( Comparison of the autoradiographic binding distribution of [3H]-gabapentin with excitatory amino acid receptor and amino acid uptake site distributions in rat brain.
Hill, DR; Thurlow, RJ; Woodruff, GN, 1996
)
1.15
"Gabapentin is a novel antiepileptic drug that is generally well tolerated."( Gabapentin for the treatment of hemifacial spasm.
Naritoku, DK; Patel, J, 1996
)
2.46
"Gabapentin is a novel antiepileptic drug that has recently been introduced in Canada. "( Gabapentin.
Bruni, J, 1996
)
3.18
"Gabapentin is a novel anti-epileptic drug which enhances GABA (gamma-aminobutyric acid) turnover in certain brain regions, including substantia nigra. "( The anticonvulsant gabapentin decreases firing rates of substantia nigra pars reticulata neurons.
Bloms-Funke, P; Löscher, W, 1996
)
2.07
"Gabapentin is a well tolerated anticonvulsant, structurally related to gamma-aminobutyric acid, with an unknown mechanism of action. "( Treatment of restless legs syndrome with gabapentin.
Adler, CH, 1997
)
2.01
"Gabapentin (Neurontin) is a novel anticonvulsant with an as yet unknown mechanism of action. "( Gabapentin, ineffective in normal rats, markedly reduces C-fibre evoked responses after inflammation.
Dickenson, AH; Singh, L; Stanfa, LC; Williams, RG, 1997
)
3.18
"Gabapentin is a novel anticonvulsant that may be of value for the relief of clinical pain. "( Spinal gabapentin is antinociceptive in the rat formalin test.
Davis, AM; Elliott, KJ; Inturrisi, CE; Shimoyama, M; Shimoyama, N, 1997
)
2.19
"Gabapentin is a recently available anticonvulsant whose mechanism of action remains unknown. "( Gabapentin for parkinsonism: a double-blind, placebo-controlled, crossover trial.
Gruenthal, M; Mueller, ME; Olson, WH; Olson, WL, 1997
)
3.18
"Gabapentin (GBP) is a recently licensed antiepileptic, drug whose mode of action remains to be fully elucidated. "( Neurochemical actions of gabapentin in mouse brain.
Brodie, MJ; Butler, E; Forrest, G; Leach, JP; Sills, GJ; Thompson, GG, 1997
)
2.04
"1. Gabapentin (neurontin) is a novel antiepileptic agent that binds to the alpha 2 delta subunit of voltage-dependent calcium channels. "( Gabapentin (neurontin) and S-(+)-3-isobutylgaba represent a novel class of selective antihyperalgesic agents.
Field, MJ; Hughes, J; Lewis, AS; McCleary, S; Oles, RJ; Singh, L, 1997
)
2.36
"Gabapentin is a recently introduced antiepileptic drug for the treatment of partial seizures. "( Gabapentin for treatment of epilepsy in children.
Holmes, GL, 1997
)
3.18
"Gabapentin is an oral antiepileptic agent with an unknown mechanism of action. "( Experience with gabapentin for neuropathic pain in the head and neck: report of ten cases.
Filadora, VA; Lema, M; Miner, M; Sist, TC,
)
1.92
"Gabapentin (Neurontin) is a new generation antiepileptic drug which appears to be advantageous in treatment of intractable pain of reflex sympathetic dystrophy."( Open label gabapentin treatment for pain in multiple sclerosis.
Houtchens, MK; Richert, JR; Rose, JW; Sami, A, 1997
)
1.41
"Gabapentin (GBP) is a gamma-aminobutyric acid analog originally synthesized for its anticonvulsant actions."( Gabapentin reverses the allodynia produced by the administration of anti-GD2 ganglioside, an immunotherapeutic drug.
Gillin, S; Sorkin, LS, 1998
)
2.46
"Gabapentin is an anticonvulsant that may represent a novel class of drugs, which has novel spinal antihyperalgesic activity. "( The effect of intrathecal gabapentin and 3-isobutyl gamma-aminobutyric acid on the hyperalgesia observed after thermal injury in the rat.
Jun, JH; Yaksh, TL, 1998
)
2.04
"Gabapentin is an effective option for the treatment of neuropathic pain syndromes because of its efficacy and favorable side-effect profile. "( Gabapentin induced polyneuropathy.
Gould, HJ, 1998
)
3.19
"Gabapentin is a new antiepileptic drug. "( [Gabapentin--a new antiepileptic agent].
Johannessen, SI; Nakken, KO; Rytter, E, 1998
)
2.65
"Gabapentin is an amino acid, with a mechanism that differs from those of other anticonvulsant drugs such as phenytoin, carbamazepine or valproate."( A summary of mechanistic hypotheses of gabapentin pharmacology.
Boden, P; Brown, JP; Dooley, DJ; Gee, NS; Kocsis, JD; Singh, L; Su, TZ; Taylor, CP; Welty, DF, 1998
)
1.29
"Gabapentin is an anticonvulsant proposed to have mood-stabilizing properties. "( Clinical experience using gabapentin adjunctively in patients with a history of mania or hypomania.
Knoll, J; Stegman, K; Suppes, T, 1998
)
2.04
"Gabapentin is a new antiepileptic drug with an unknown mechanism of action and very favorable pharmacokinetic and safety profiles. "( Gabapentin in the treatment of adolescent mania: a case report.
Casuto, LS; Keck, PE; Soutullo, CA, 1998
)
3.19
"Gabapentin (GBP) is a non-metabolized antiepileptic drug that is eliminated by renal excretion and displays saturable, dose dependent absorption. "( Gabapentin bioavailability: effect of dose and frequency of administration in adult patients with epilepsy.
Bockbrader, HN; DeCerce, J; Gidal, BE; Gonzalez, J; Kruger, S; Pitterle, ME; Ramsay, RE; Rutecki, P, 1998
)
3.19
"Gabapentin is an antiepileptic drug used in the treatment of partial and generalized tonic-clonic seizures. "( Gabapentin. Antiepileptic mechanism of action.
Kelly, KM, 1998
)
3.19
"Gabapentin is a new antiepileptic drug not appreciably metabolized by the liver in humans, and it appears to be safe and effective in the maintenance therapy of epilepsy in these patients."( Treatment of seizures in acute intermittent porphyria: safety and efficacy of gabapentin.
Brambilla, A; Erli, LC; Grandi, R; Mirabile, D; Zadra, M, 1998
)
1.25
"Gabapentin is a modulator of the glutamatergic system and has been shown to prolong survival in the transgenic model of familial ALS."( The natural history and the effects of gabapentin in amyotrophic lateral sclerosis.
Balzarini, C; Brigatti, M; Comazzi, F; Mazzini, L; Mora, G; Pastore, E; Pirali, I, 1998
)
1.29
"Gabapentin (GP) is a new anticonvulsant used in refractory epilepsy. "( In vivo monitoring of gabapentin in rats: a microdialysis study coupled to capillary electrophoresis and laser-induced fluorescence detection.
Chuecos, S; Hernández, L; Pérez, J; Rada, P; Teneud, L; Tucci, S, 1998
)
2.06
"Gabapentin was concluded to be an effective therapeutic option for neuralgia of the IXth cranial nerve before surgery."( [Use of gabapentin in glossopharyngeal neuralgia].
Esparcia Navarro, M; García Callejo, FJ; Marco Algarra, J; Martínez Beneyto, MP; Morant Ventura, A; Talamantes Escribá, F, 1999
)
1.46
"Gabapentin is a relatively new anticonvulsant being investigated for potential use in the treatment of bipolar disorder (BD), anxiety disorders, behavioral dyscontrol, and substance use disorders."( Gabapentin: a review of published experience in the treatment of bipolar disorder and other psychiatric conditions.
Letterman, L; Markowitz, JS, 1999
)
2.47
"Gabapentin (GBP) is a new antiepileptic drug approved for clinical treatment of partial seizures in the USA. "( Rapid high-performance liquid chromatographic determination of serum gabapentin.
Jiang, Q; Li, S, 1999
)
1.98
"Gabapentin is a new, novel antiepileptic drug helpful in the management of other pain states."( Gabapentin for the treatment of dysesthetic pain after reconstructive surgery.
Otley, CC, 1999
)
2.47
"Gabapentin is an anticonvulsant medication used recently as an effective adjuvant agent for treating neuropathic pain. "( Using gabapentin to treat neuropathic pain.
Hays, H; Woodroffe, MA, 1999
)
2.23
"Gabapentin (GBP) is a antiepileptic drug (AED) indicated as adjunct therapy for treatment of partial seizures, with and without secondary generalization, in patients 12 and older with epilepsy. "( Gabapentin.
Morris, GL, 1999
)
3.19
"Gabapentin is an adjunctive drug for the treatment of resistant partial seizures. "( Antinociceptive effect of gabapentin in the formalin test.
Bhargava, VK; Dixit, R; Kaur, N, 1999
)
2.05
"Gabapentin is an anti-epileptic drug approved in the USA in December 1993 as an additional treatment for patients with crises of partial onset. "( [Monotherapy with gabapentin ++].
Padró, L; Rovira, R,
)
1.91
"Gabapentin is a new adjunctive medication to antiseizure therapies. "( Gabapentin as an adjunct to standard mood stabilizers in outpatients with mixed bipolar symptomatology.
DeMet, EM; Green, C; Maris, DE; Sokolski, KN, 1999
)
3.19
"Gabapentin is an antiepileptic agent that is indicated for use as adjunctive therapy for partial seizures. "( A case of sustained massive gabapentin overdose without serious side effects.
Radtke, RA; St Clair, EW; Verma, A, 1999
)
2.04
"Gabapentin is an anticonvulsant with an unknown mechanism of action. "( Allosteric modulation of [(3)H]gabapentin binding by ruthenium red.
Bonhaus, DW; Taylor, MT, 2000
)
2.04
"Gabapentin proved to be a significantly better analgesic than placebo, was well tolerated in the elderly population, and had a significant positive impact on several subjective and objective outcome measures."( Gabapentin: a new tool in the treatment of neuropathic pain.
Harden, RN, 1999
)
2.47
"Gabapentin is a relatively new anticonvulsant indicated for adjunctive therapy in the treatment of partial seizures, with and without secondary generalization, in adults with epilepsy. "( Anorgasmia in a patient with bipolar disorder type 1 treated with gabapentin.
Brannon, GE; Rolland, PD, 2000
)
1.99
"Gabapentin is a newer generation antiepileptic drug that is commonly used in treatment of neuropathic pain."( Use of gabapentin in the treatment of neuropathic pain.
Gidal, BE; Laird, MA, 2000
)
1.48
"Gabapentin (GBP) is a non-metabolized, non-plasma protein bound, renally excreted antiepileptic drug that is actively absorbed via the system L amino acid transporter. "( Inter- and intra-subject variability in gabapentin absorption and absolute bioavailability.
Bockbrader, HN; Gidal, BE; Kruger, S; Pitterle, M; Radulovic, LL; Rutecki, P, 2000
)
2.02
"Gabapentin is a novel anticonvulsant that may have a unique effect on voltage-dependent Ca2+ channel currents at postsynaptic dorsal horn neurons."( Gabapentin use in neuropathic pain syndromes.
Nicholson, B, 2000
)
2.47
"Gabapentin (GBP) is a new antiepileptic drug whose efficacy and tolerability have been evaluated in clinical trials, although there is little data on its use in everyday clinical practice."( [Gabapentin used in 559 patients with partial seizures. A multicenter observation study. Spanish Gabapentin Work Group].
Hernández, G; Herranz, JL; Sol, JM,
)
2.48
"Gabapentin is an antiepileptic drug of new generation that increases brain GABA levels. "( Gabapentin in the prophylaxis of migraine: a double-blind randomized placebo-controlled study.
Capuano, A; Di Trapani, G; Marra, C; Mazza, S; Mei, D,
)
3.02
"Gabapentin (GBP) is a novel antiepileptic drug (AED), currently used as add-on therapy in patients with partial seizures. "( Gabapentin-induced modulation of interictal epileptiform activity related to different vigilance levels.
Bassetti, MA; Marciani, MG; Mattia, D; Placidi, F; Romigi, A; Spanedda, F, 2000
)
3.19
"Gabapentin (GBP) is a new, well-tolerated antiepileptic drug found to be effective for painful paroxysmal symptoms (PS) in multiple sclerosis (MS). "( R3 nociceptive reflex in multiple sclerosis patients with paroxysmal symptoms treated with gabapentin.
Bramanti, P; D'Aleo, G; Di Bella, P; Rifici, C; Sessa, E,
)
1.79
"Gabapentin is a recently introduced anti-epileptic drug used as an adjuvant in partial and secondarily generalised tonic-clonic seizures. "( [Gabapentin--yet another antiepileptic agent for the treatment of neuropathic pain?].
Kamp-Jensen, M; Werner, MU, 2001
)
2.66
"Gabapentin is an effective prophylactic agent for patients with migraine. "( Efficacy of gabapentin in migraine prophylaxis.
Klapper, J; Magnus, L; Mathew, NT; Ramadan, N; Rapoport, A; Saper, J; Stacey, B; Tepper, S, 2001
)
2.13
"Gabapentin is an anticonvulsant with unclear but therapeutic effects on neurologic pain."( Oral gabapentin (neurontin) treatment of refractory genitourinary tract pain.
Chancellor, MB; Chuang, YC; Kim, JC; Lee, JY; Sasaki, K; Smith, CP, 2001
)
1.55
"Gabapentin (Neurontin) is a gamma-aminobutyric acid analogue indicated in adults for adjunctive treatment of partial seizures with or without secondary generalization. "( Single-dose gabapentin pharmacokinetics and safety in healthy infants and children.
Bockbrader, HN; Boellner, SW; Brown, RR; Haig, GM; Ouellet, D; Posvar, EL; Randinitis, EJ; Wesche, DL, 2001
)
2.13
"Gabapentin is an anticonvulsant shown to alleviate symptoms of RLS in two small studies of nonhemodialysis patients."( A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients.
Bagby, SP; Morris, CD; Thorp, ML, 2001
)
1.35
"Gabapentin is an anticonvulsant drug released in the United States in 1993 for use as adjunctive therapy in refractory partial epilepsy. "( Gabapentin and methylphenidate treatment of a preadolescent with attention deficit hyperactivity disorder and bipolar disorder.
Bailey, K; Hamrin, V, 2001
)
3.2
"Gabapentin is a gabaergic agent and therefore it can be useful in dystonia."( [Efficacy and tolerance of gabapentin in dystonia and hemifacial spasm: a pilot study].
Linazasoro Cristóbal, G,
)
1.15
"Gabapentin is an anti-epileptic drug (AED) that was approved in 1993 for the adjunct treatment of complex partial seizures (CPS) with and without generalization. "( Gabapentin: a unique anti-epileptic agent.
Dougherty, JA; Rhoney, DH, 2001
)
3.2
"Gabapentin is an anticonvulsant agent, also effective in the treatment of mood disorders and anxiety disorders. "( Treatment of alcohol withdrawal with gabapentin.
Bozikas, V; Gamvrula, K; Karavatos, A; Petrikis, P; Savvidou, I, 2002
)
2.03
"Gabapentin is an effective, well tolerated drug used as monotherapy in newly diagnosed epilepsy."( [Monotherapy using gabapentin in epilepsy].
López-Trigo, J; Sancho-Rieger, J,
)
1.9
"Gabapentin (GBP) is a new anti epileptic drug which is indicated in partial epilepsy as either monotherapy or additional therapy. "( [Titration and dosage of gabapentin].
Arroyo, S,
)
1.88
"Gabapentin (GBP) is a neutral amino acid and a GABA analog which in animal experimental models has shown a broad anticonvulsant spectrum. "( Selected CSF biochemistry and gabapentin concentrations in the CSF and plasma in patients with partial seizures after a single oral dose of gabapentin.
Ben-Menachem, E; Hedner, T; Persson, LI, 1992
)
2.01
"Gabapentin is a gamma-aminobutyric acid analogue, which has been shown to be an effective antiepileptic. "( Stability studies of gabapentin in aqueous solutions.
Chaturvedi, PR; Lodhi, SA; Nesbitt, RU; Silbering, SB; Zour, E, 1992
)
2.05
"Gabapentin is an analogue of gamma aminobutyric acid (GABA) which has anticonvulsant properties in animals. "( Gabapentin in partial epilepsy. UK Gabapentin Study Group.
, 1990
)
3.16

Effects

Gabapentin has an established role in the treatment of neuropathic pain, with evidence supporting a benefit in visceral hypersensitivity. The most common reported effects are dizziness, fatigue, drowsiness, weight gain, and peripheral edema.

Gabapentin (GBP) has been shown to reduce paired-pulse inhibition in the dentate gyrus of the urethane-anesthetized rat, which is a proconvulsant effect. Gabapentin has been used clinically as an antihyperalgesic agent to treat certain neuropathic pain states.

ExcerptReferenceRelevance
"Gabapentin has an established role in the treatment of neuropathic pain, with evidence supporting a benefit in visceral hypersensitivity. "( Gabapentin Improves Symptoms of Functional Dyspepsia in a Retrospective, Open-label Cohort Study.
Dimisko, LR; Kuo, B; McGovern, R; Reynolds, JS; Skarbinski, KF; Staller, K; Thurler, AH,
)
3.02
"Gabapentin has a similar body of evidence as other pharmacotherapeutic agents used to treat hiccups. "( Gabapentin therapy of hiccups.
Brooks, KG; Thompson, DF, 2013
)
3.28
"Gabapentin has a favorable adverse effect profile in therapeutic dosing with the most common reported effects being dizziness, fatigue, drowsiness, weight gain, and peripheral edema."( Gabapentin concentrations and postmortem distribution.
Gary, RD; Hamm, CE; McIntyre, IM, 2016
)
2.6
"Gabapentin has an antipruritus effect, which its efficacy in reducing pruritus induced by intrathecal morphine has not been well documented. "( Single dose of gabapentin for prophylaxis intrathecal morphine-induced pruritus in orthopedic surgery: a randomized controlled trial.
Chiravanich, W; Kovitwanawong, N; Oofuvong, M, 2012
)
2.17
"Gabapentin has a number of original mechanisms of action with which to account for its effects in epilepsies and in many other clinical entities."( [Gabapentin: its mechanisms of action in the year 2003].
Herranz, JL,
)
2.48
"Gabapentin has a favorable pharmacokinetic profile and is generally well tolerated."( Gabapentin.
Bruni, J, 1996
)
2.46
"Gabapentin has an established, favorable safety profile and has been shown to be effective in various animal models and human studies of chronic neuropathic pain."( Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases.
Braverman, DL; Lenrow, DA; Slipman, CW, 2001
)
1.51
"Gabapentin has been shown to reduce opioid use in head and neck cancer patients. "( Effectiveness of gabapentin in reducing opioid requirements after radiation in head and neck cancer in a single institution.
Biedermann, GB; Bollig, CA; Clark, AD; Dooley, LM; Gilley, DR; Wieser, ME, 2022
)
2.5
"Gabapentin has been historically considered a safe medication, including during pregnancy and lactation, with low reported concerns for misuse and use disorders."( Gabapentin Use During Pregnancy and Lactation With and Without Concurrent Opioid Exposure: Considerations and Future Directions.
DeLisle, A; Jansson, LM; Jones, HE,
)
2.3
"Gabapentin has been increasingly used as part of a multimodal analgesia regimen to reduce opioid use in perioperative pain management. "( Perioperative Gabapentin Use and In-Hospital Adverse Clinical Events Among Older Adults After Major Surgery.
Bateman, BT; Inouye, SK; Kim, DH; Lee, SB; Levin, R; Lie, JJ; Marcantonio, ER; Metzger, E; Park, CM, 2022
)
2.52
"Gabapentin treatment has shown promise for symptomatic improvement for visceral hyperalgesia in some patients."( Gabapentin Can Improve Irritability and Feeding Tolerance in Single Ventricle Interstage Patients: A Case Series.
Allen, CC; Bartlett, H; Canada, K; Schlueter, S; Zhang, X, 2023
)
3.07
"Gabapentin has not been shown to improve patient outcomes; however, pregabalin may decrease pain and opioid use after total joint arthroplasty."( A Case Illustrating the Practical Application of the AAOS Clinical Practice Guideline: Pharmacologic, Physical, and Cognitive Pain Alleviation for Musculoskeletal Extremity/Pelvis Surgery.
Patzkowski, JC; Patzkowski, MS, 2022
)
1.44
"Gabapentin has been adopted in Enhanced Recovery After Surgery protocols as a means to reduce opioid consumption while maintaining adequate post-operative analgesia. "( Effect of gabapentin on length of stay, opioid use, and pain scores in posterior spinal fusion for adolescent idiopathic scoliosis: a retrospective review across a multi-hospital system.
Brenn, B; Cho, R; Poon, SC; Samdani, A; Zhang, DA, 2023
)
2.76
"Gabapentin has been used as an anxiolytic in various species, but little information is available on its use in rabbits."( Behavioral and Physiologic Effects of a Single Dose of Oral Gabapentin in Rabbits (Oryctolagus cuniculus).
Burton, M; Conway, RE; Desmarchelier, M; Kendall, LV; Mama, K; Rao, S; Sadar, MJ,
)
1.09
"Gabapentin has played an integral role in this evolution of practice."( Perioperative gabapentin usage in pediatric patients: A scoping review.
Afonso, AM; Cadwell, JB; Chen, O; Hagen, J; Matsoukas, K, 2023
)
1.99
"Gabapentin has been shown to decrease postoperative pain and opioid use after spine surgery, but it has not yet been investigated as part of a multimodal pain regimen intended to decrease the perioperative use of opioids."( Multimodal pain control in adolescent posterior spinal fusion patients: a double-blind, randomized controlled trial to validate the effect of gabapentin on postoperative pain control, opioid use, and patient satisfaction.
Anderson, DE; Duletzke, NT; Halsey, MF; Pedigo, EB, 2020
)
1.48
"Gabapentin has received increased attention due to a growing number of reports of misuse and diversion. "( Descriptions of Gabapentin Misuse and Associated Behaviors among a Sample of Opioid (Mis)users in South Florida.
Buttram, ME; Kurtz, SP,
)
1.92
"Gabapentin has been reported in several cases to be effective in hiccup treatment in both the general and post-stroke populations."( Treatment of hiccups in stroke rehabilitation with gabapentin: A case series and focused clinical review.
Fan, C; Got, T; MacNeill, H; Vivas, L, 2021
)
1.59
"Gabapentin has been studied for diverse off-label indications, including alcohol use disorder (AUD)."( Gabapentin for Alcohol-Related Disorders: Critical Appraisal of the Symptom-Driven Approach.
Andrade, C, 2020
)
2.72
"Gabapentin has antihyperalgesic action, decreasing central sensitization in neuropathic pain models; this effect depends on the mobilization of endogenous pain control pathways. "( Role of the endocannabinoid system on the antihyperalgesic action of gabapentin in animal model of neuropathic pain induced by partial sciatic nerve ligation.
Buffon, AC; Heymanns, AC; Horewicz, VV; Javornik, MA; Martins, DF; Piovezan, AP; Salm, DC, 2020
)
2.24
"Gabapentin has efficacy as an add-on treatment in people with drug-resistant focal epilepsy, and seems to be fairly well-tolerated. "( Gabapentin add-on treatment for drug-resistant focal epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Panebianco, M, 2021
)
3.51
"Gabapentin has been widely used to manage post-herpetic neuralgia, peripheral neuropathy, seizure disorders, alcohol use disorder (AUD), alcohol withdrawal, and insomnia. "( Gabapentin dependence and withdrawal requiring an 18-month taper in a patient with alcohol use disorder: a case report.
Benhamou, OM; Deng, H; Lembke, A,
)
3.02
"Gabapentin has shown initial promise as an opioid-sparing medication in pain patients as well as a treatment for opioid withdrawal and liquid chriomatography/tandem mass spectrometry (LC/MS/MS) is often used for clinical monitoring. "( Development and validation of a rapid liquid chromatography/tandem mass spectrometry method to quantitate gabapentin and buprenorphine in human serum.
Hendrickson, HP; Mancino, MJ; Oliveto, A; Phillips, SJ, 2021
)
2.28
"Gabapentin has emerged as a common therapy for a diverse group of pain syndromes and neurologic conditions in adults."( Gabapentin in Infants: Critical Evaluation of a Novel Sedative/Analgesic Medication.
McPherson, C, 2021
)
2.79
"Gabapentin has been extensively prescribed off-label for psychiatric indications, with little established evidence of efficacy. "( Biological rationale and potential clinical use of gabapentin and pregabalin in bipolar disorder, insomnia and anxiety: protocol for a systematic review and meta-analysis.
Atkinson, LZ; Awad, A; Cipriani, A; Forrest, A; Geddes, JR; Harrison, PJ; Houghton, KT; Stockton, S, 2017
)
2.15
"Gabapentin misuse has been associated with drug-related harm and increased healthcare service utilization in a few studies, including a recent large-sample analysis of commercially insured enrollees in the United States (U.S.) Responding to this emerging base of evidence, a small number of U.S."( Policies to mitigate nonmedical use of prescription medications: how should emerging evidence of gabapentin misuse be addressed?
Fairman, KA; Peckham, AM; Sclar, DA, 2018
)
1.42
"Gabapentin has been shown to be effective for postoperative analgesia in a variety of operations."( Perioperative Gabapentin Improves Patient-Centered Outcomes After Inguinal Hernia Repair.
Hannon, M; Quail, J; Spence, D, 2017
)
1.54
"Gabapentin has been linked with impaired driving and opioid use, highlighting the need to more fully understand its risk profile."( A qualitative analysis of gabapentin misuse and diversion among people who use drugs in Appalachian Kentucky.
Boland, EM; Havens, JR; Lofwall, MR; Quiroz, A; Staton, M; Vickers Smith, R; Young, AM, 2018
)
1.5
"Gabapentin has been shown to be effective in reducing cough number and severity in patients with idiopathic refractory cough."( Gabapentin for Cough in Cancer.
Doberman, DJ; Feliciano, JL; Razzak, R; Smith, TJ; Waldfogel, JM,
)
2.3
"Gabapentin has an established role in the treatment of neuropathic pain, with evidence supporting a benefit in visceral hypersensitivity. "( Gabapentin Improves Symptoms of Functional Dyspepsia in a Retrospective, Open-label Cohort Study.
Dimisko, LR; Kuo, B; McGovern, R; Reynolds, JS; Skarbinski, KF; Staller, K; Thurler, AH,
)
3.02
"Gabapentinoids have been shown to both decrease postoperative pain and, secondarily, decrease opiate dependence."( Gabapentin as an Adjunct to Standard Postoperative Pain Management Protocol in Lower Extremity Surgery.
Atway, SA; Crisologo, PA; Monson, EK,
)
2.3
"Gabapentin has efficacy as an add-on treatment in people with drug-resistant focal epilepsy. "( Gabapentin add-on treatment for drug-resistant focal epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Panebianco, M; Weston, J, 2018
)
3.37
"Gabapentin has shown efficacy in the treatment of chronic neuropathic or mixed pain in adults. "( Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled t
Ceci, A; de Leeuw, TG; de Wildt, SN; Kaguelidou, F; Lundin, R; Mangiarini, L; Pasqua, OD; Tibboel, D; van der Zanden, T, 2019
)
3.4
"Gabapentin has been increasingly used in various indications in recent years. "( Therapeutic drug monitoring of gabapentin in various indications.
Johannessen Landmark, C; Johannessen, SI; Kinge, E; Larsen Burns, M; Stokke Opdal, M, 2019
)
2.24
"Gabapentin has growing evidence to support its use in the treatment of alcohol use disorder, however there is limited evidence regarding its role in the treatment of alcohol withdrawal."( Impact of Gabapentin Adjunct use with Benzodiazepines for the Treatment of Alcohol Withdrawal in a Psychiatric Hospital.
Kjome, KL; Smith, TL; Vadiei, N; Walton, AE, 2019
)
1.64
"Gabapentin has analgesic efficacy for neuropathic pain and is increasingly used in burn care. "( The Effects of Early Neuropathic Pain Control With Gabapentin on Long-Term Chronic Pain and Itch in Burn Patients.
Carrougher, GJ; Gibran, NS; Kneib, CJ; Mandell, SP; Muffley, LA; Sibbett, SH, 2019
)
2.21
"Gabapentin (GPT) has become an emerging contaminant in aquatic environments due to its wide application in medical treatment all over the world. "( A transcriptomics-based analysis of the toxicity mechanisms of gabapentin to zebrafish embryos at realistic environmental concentrations.
He, Y; Jia, D; Li, X; Xu, Y; Yu, Y; Zhang, T; Zhang, W; Zhang, Y, 2019
)
2.2
"Gabapentin has been proved to be beneficial in promoting abstinence, decreasing alcohol cravings, and improving mood and sleep quality when given at higher doses; however, data are limited regarding the efficacy and safety of using high-dose gabapentin as part of the treatment of alcohol withdrawal syndrome (AWS). "( High-Dose Gabapentin for the Treatment of Severe Alcohol Withdrawal Syndrome: A Retrospective Cohort Analysis.
Carrasquillo, L; Ibrahim, D; Levine, AR; Mueller, J; Naut, ER; Nounou, MI, 2019
)
2.36
"Gabapentinoid use has increased substantially in the past several years after initial promising data with regard to acute perioperative pain control. "( The role of gabapentinoids in acute and chronic pain after surgery.
Habib, AS; Kumar, AH, 2019
)
2.34
"Gabapentin has also been shown to induce modulate other targets including transient receptor potential channels, NMDA receptors, protein kinase C and inflammatory cytokines."( Implications and mechanism of action of gabapentin in neuropathic pain.
Bali, A; Jaggi, AS; Kukkar, A; Singh, N, 2013
)
1.38
"Gabapentin has high and saturable permeability across the BBB, but no mechanistic studies underpinning this process have been reported."( Transport of gabapentin by LAT1 (SLC7A5).
Antonyuk, S; Dickens, D; Giannoudis, A; Hasnain, SS; Owen, A; Pirmohamed, M; Rädisch, S; Webb, SD, 2013
)
1.48
"Gabapentin has a similar body of evidence as other pharmacotherapeutic agents used to treat hiccups. "( Gabapentin therapy of hiccups.
Brooks, KG; Thompson, DF, 2013
)
3.28
"Gabapentin has efficacy as an add-on treatment in people with drug-resistant partial epilepsy. "( Gabapentin add-on for drug-resistant partial epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Pulman, J, 2013
)
3.28
"Gabapentin has shown to be effective in animals and humans with acute postoperative and chronic pain. "( Gabapentin increases extracellular glutamatergic level in the locus coeruleus via astroglial glutamate transporter-dependent mechanisms.
Eisenach, JC; Hayashida, K; Severino, AL; Suto, T, 2014
)
3.29
"Gabapentin has been used for the management of post-herpetic neuralgia (PHN). "( Efficacy and safety of gabapentin 1800 mg treatment for post-herpetic neuralgia: a meta-analysis of randomized controlled trials.
Cao, H; Fan, H; Hu, X; Li, J; Shao, Y; Wang, J; Yu, W; Zhang, Q, 2014
)
2.16
"Gabapentin has been shown to disrupt the interaction of thrombospondin (TSP) with α2δ-1, an auxiliary calcium channel subunit."( Gabapentin attenuates hyperexcitability in the freeze-lesion model of developmental cortical malformation.
Andresen, L; Dulla, CG; Hampton, D; Maguire, J; Morel, L; Taylor-Weiner, A; Yang, Y, 2014
)
2.57
"Gabapentin has been shown to cause minimal to no toxicity in overdose."( A review on the efficacy and safety of gabapentin in the treatment of chronic cough.
Ryan, NM, 2015
)
1.41
"Gabapentin has shown acute postoperative analgesic effects, but the optimal dose and procedure-specific benefits vs harm have not been clarified. "( Analgesic and sedative effects of perioperative gabapentin in total knee arthroplasty: a randomized, double-blind, placebo-controlled dose-finding study.
Hansen, LT; Husted, H; Kehlet, H; Laursen, MB; Lunn, TH, 2015
)
2.12
"Gabapentin use has also been recommended for hyperemesis gravidarum and restless leg syndrome in pregnant mothers."( Neonatal Gabapentin Withdrawal Syndrome.
Bearer, CF; Carrasco, M; Rao, SC; Sundararajan, S, 2015
)
1.56
"Gabapentin has been used in the management of neuropathic pain, epilepsy and occasionally movement disorders."( Gabapentin can significantly improve dystonia severity and quality of life in children.
Gimeno, H; Kaminska, M; Lin, JP; Liow, NY; Lumsden, DE; Marianczak, J; Tomlin, S, 2016
)
3.32
"Gabapentin has a favorable adverse effect profile in therapeutic dosing with the most common reported effects being dizziness, fatigue, drowsiness, weight gain, and peripheral edema."( Gabapentin concentrations and postmortem distribution.
Gary, RD; Hamm, CE; McIntyre, IM, 2016
)
2.6
"Gabapentin has been used as an adjuvant for treatment of cancer pain. "( The research on long-term clinical effects and patients' satisfaction of gabapentin combined with oxycontin in treatment of severe cancer pain.
Chen, DL; Li, YH; Wang, ZJ; Zhu, YK, 2016
)
2.11
"Gabapentin has been used effectively to attenuate the pressor response to laryngoscopy and tracheal intubation."( Effect of oral gabapentin on the intraocular pressure and haemodynamic responses induced by tracheal intubation.
Altun, GT; Ata, F; Baykara, M; Gülhan, N; Kaya, FN; Yavascaoglu, B, 2008
)
1.42
"Gabapentin has been used for the treatment of diabetic neuropathy."( Gabapentin therapy improves heart rate variability in diabetic patients with peripheral neuropathy.
Caliskan, M; Ermis, N; Gullu, H; Kulaksizoglu, M; Muderrisoglu, H; Unsal, A,
)
2.3
"Gabapentin has been used as adjuvant in the treatment of postoperative pain with a neuropathic component. "( Review of the use of gabapentin in the control of postoperative pain.
Clivatti, J; Issy, AM; Sakata, RK,
)
1.89
"Gabapentin has been recently found to be useful for reducing acute postoperative pain when administered preoperatively. "( A single dose of preoperative gabapentin for pain reduction and requirement of morphine after total mastectomy and axillary dissection: randomized placebo-controlled double-blind trial.
Grover, VK; Mathew, PJ; Sehgal, S; Yaddanapudi, S,
)
1.86
"Gabapentin has opioid-sparing effects in adult surgical patients, but no reported studies have involved children and adolescents. "( Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial.
Berens, RJ; Czarnecki, ML; Hainsworth, KR; Lyon, RM; Nelson, TJ; Rusy, LM; Tassone, JC; Thometz, JG; Weisman, SJ, 2010
)
3.25
"Gabapentin has been successfully used for the treatment of multiple neuropathic pain syndromes such as diabetic neuropathy and postherpetic neuralgia."( Gabapentin for the treatment of cancer-related pain syndromes.
Bar Ad, V, 2010
)
2.52
"Gabapentin has been successfully used to treat cutaneous pain and pruritus in a variety of conditions."( A case of post-herpetic itch resolved with gabapentin.
Jagdeo, J; Kroshinsky, D, 2011
)
1.35
"Gabapentin has been introduced as an effective agent for post-operative pain control. "( Optimal dose of pre-incision/post-incision gabapentin for pain relief following lumbar laminectomy: a randomized study.
Khan, RH; Khan, ZH; Makarem, J; Rahimi, M, 2011
)
2.07
"Gabapentin has been used in the treatment of neuropathic pain as well as postoperative pain with good result. "( Analgesic effect of low gynaecological surgery under general anaesthesia.
Bhattacharya, D; Chakrabarti, J; Chakraborty, S; Chowdhury, L; Mandals, M, 2010
)
1.8
"The gabapentin has beneficial effect in the FBSS associated neuropathic pain. "( Beneficial response to gabapentin portraying with interval change of brain SPECT imaging in a case with failed back surgery syndrome.
Chang, ST; Lai, MH; Lu, SC; Wu, YT, 2011
)
1.24
"Gabapentin has been specifically synthesized as a potential gamma-amino-butyric-acid (GABA) mimetic with the capability to cross the blood-brain barrier."( The effect of gabapentin on gap detection and forward masking in young and old gerbils.
Gleich, O; Strutz, J,
)
1.21
"Gabapentin has demonstrated analgesic effects in some studies. "( Effects of gabapentin on postoperative pain, nausea and vomiting after abdominal hysterectomy: a double blind randomized clinical trial.
Ajori, L; Amiri, Z; Mazloomfard, MM; Nazari, L, 2012
)
2.21
"Gabapentin has demonstrated efficacy in clinical trials as a pre-emptive analgesic and in acute postoperative pain management. "( Effect of pre-emptive gabapentin on postoperative pain following lower extremity orthopaedic surgery under spinal anaesthesia.
Marashi, SH; Nadjafi, A; Panah Khahi, M; Yaghooti, AA, 2011
)
2.13
"Gabapentin has been used to treat a variety of conditions in both human and veterinary medicine, including seizures, neuropathies and chronic pain. "( Effects of intraperitoneal administration of gabapentin on the minimum alveolar concentration of isoflurane in adult male rats.
Boruta, DT; Golder, FJ; Sotgiu, G, 2012
)
2.08
"Gabapentin has been widely and successfully used in the clinic for many neuropathic pain syndromes since last decade, however its analgesic mechanisms are still elusive. "( Analgesic effect of gabapentin in a rat model for chronic constrictive injury.
Huang, YG; Liu, W; Ma, LL; Yang, N; Zuo, PP, 2011
)
2.14
"Gabapentin has an antipruritus effect, which its efficacy in reducing pruritus induced by intrathecal morphine has not been well documented. "( Single dose of gabapentin for prophylaxis intrathecal morphine-induced pruritus in orthopedic surgery: a randomized controlled trial.
Chiravanich, W; Kovitwanawong, N; Oofuvong, M, 2012
)
2.17
"Gabapentin has been shown to be effective in reducing postoperative narcotic usage, a reduction that may be associated with a reduction in opioid-induced tolerance and hyperalgesia."( The effects of gabapentin on acute opioid tolerance to remifentanil under sevoflurane anesthesia in rats.
Abreu, M; Aguado, D; Benito, J; Garcia-Fernandez, J; Gómez de Segura, IA, 2012
)
1.45
"Gabapentin has antihyperalgesic and potential anxiolytic effects. "( Effects of a single 1200-mg preoperative dose of gabapentin on anxiety and memory.
Adam, F; Bordenave, L; Chauvin, M; Sessler, DI, 2012
)
2.08
"Gabapentin has also been demonstrated to be efficacious in the treatment of vasomotor symptoms in postmenopausal women when administered three times a day."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
1.38
"Gabapentin has been reported to be useful in the management of epilepsy, neuropathic pain and post-dural puncture headache. "( Gabapentin in the treatment of post-dural puncture headache: a case series.
Cope, S; Storr, F; Wagner, Y, 2012
)
3.26
"gabapentin has marginal efficacy."( Uremic pruritus in hemodialysis patients: treatment with desloratidine versus gabapentin.
Barrón, B; Lauxmann, JE; Marquez, D; Martinatto, C; Novoa, PA; Orías, M; Peixoto, AJ; Ramonda, C; Romero, CA; Vukelic, VL, 2012
)
1.33
"Gabapentin has dose-limiting side effects that prevent some patients from achieving therapeutic plasma levels, such as somnolence (27.4%), dizziness (23.9%), and ataxia (7.1%)."( Gabapentin for once-daily treatment of post-herpetic neuralgia: a review.
Beal, B; Moeller-Bertram, T; Schilling, JM; Wallace, MS, 2012
)
2.54
"Gabapentin has shown promise in treating insomnia in adults."( Gabapentin shows promise in treating refractory insomnia in children.
Malow, BA; Robinson, AA, 2013
)
2.55
"Gabapentin has been widely used in human medicine to control acute and chronic pain. "( Long-term use of gabapentin for musculoskeletal disease and trauma in three cats.
Comerford, EJ; Iff, I; Lorenz, ND, 2013
)
2.17
"Gabapentin has some beneficial effects on certain types of neuropathic pain. "( Gabapentin in the treatment of neuropathic pain after spinal cord injury: a prospective, randomized, double-blind, crossover trial.
Chen, B; DeLisa, JA; Johnston, M; Kirshblum, S; Millis, S; Tai, Q, 2002
)
3.2
"Gabapentin has demonstrated efficacy, specifically in painful diabetic neuropathy and postherpetic neuralgia."( Use of anticonvulsants for treatment of neuropathic pain.
Backonja, MM, 2002
)
1.04
"Gabapentin (GBP) has been shown to reduce paired-pulse inhibition in the dentate gyrus of the urethane-anesthetized rat, which is a proconvulsant effect, and to shorten the afterdischarge duration, which is an antiepileptic effect. "( Modulation of the in vivo effects of gabapentin by vigabatrin and SKF89976A.
Aribi, AM; Stringer, JL, 2002
)
2.03
"Gabapentin has recently been used clinically as an antihyperalgesic agent to treat certain neuropathic pain states. "( Gabapentin markedly reduces acetic acid-induced visceral nociception.
Cui, M; Feng, Y; Willis, WD, 2003
)
3.2
"Gabapentin has a number of original mechanisms of action with which to account for its effects in epilepsies and in many other clinical entities."( [Gabapentin: its mechanisms of action in the year 2003].
Herranz, JL,
)
2.48
"Gabapentin has been known to elicit the antinociceptive effect. "( Hemodynamic effects of gabapentin in rats.
Choi, JI; Yoon, MH, 2003
)
2.07
"Gabapentin has been shown to be useful in treatment of different conditions which may be caused by increased neuronal excitability."( Treatment of chronic neuropathic pain after traumatic central cervical cord lesion with gabapentin.
Haller, H; Leblhuber, F; Schmidhammer, R; Trenkler, J, 2003
)
1.26
"Gabapentin has antihyperalgesic and antiallodynic properties but does not have significant actions as an anti-nociceptive agent."( Gabapentin in the treatment of neuropathic pain.
Bennett, MI; Simpson, KH, 2004
)
2.49
"Gabapentin has 172-->154 and 172-->136 transitions and amino-cyclohexane-propionic acid hydrate has a 172-->126 transition which can be detected in tandem MS."( Sample preparation and determination of gabapentin in venous and capillary blood using liquid chromatography-tandem mass spectrometry.
Carlsson, KC; Reubsaet, JL, 2004
)
1.31
"Gabapentin has been demonstrated to be capable of improving the cerebellar signs in cases of CCA, after single doses and after continued administration of the drug during 4 weeks."( Treatment of ataxia in cortical cerebellar atrophy with the GABAergic drug gabapentin. A preliminary study.
Benavente, I; Errea, JM; Gazulla, J; Tordesillas, CJ, 2004
)
1.28
"Gabapentin has been shown to be well tolerated and effective in the management of the pain associated with postherpetic neuralgia (PHN). "( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
3.21
"Gabapentin has been used to treat dystonias with variable results."( Dystonia induced by gabapentin.
Modrego, PJ; Pina, MA, 2005
)
1.37
"Gabapentin (Neurontin) has been successfully used in the treatment of both epilepsy and neuropathic pain. "( Gabapentin fails to alter P/Q-type Ca2+ channel-mediated synaptic transmission in the hippocampus in vitro.
Brown, JT; Randall, A, 2005
)
3.21
"Gabapentin has antihyperalgesic and anxiolytic properties. "( Preoperative gabapentin decreases anxiety and improves early functional recovery from knee surgery.
Adam, F; Chauvin, M; Guignard, B; Ménigaux, C; Sessler, DI, 2005
)
2.14
"Gabapentin (GBP) has been shown to be effective in animal models of neuropathic pain as well as in chronic pain patients."( Effects of gabapentin on spontaneous discharges and subthreshold membrane potential oscillation of type A neurons in injured DRG.
Duan, JH; Hu, SJ; Xing, JL; Yang, RH, 2005
)
1.44
"Gabapentin has been shown to provide pain relief for post-herpetic neuralgia at dosage of 1200 to 2400 mg/day. "( Starting dose of gabapentin for patients with post-herpetic neuralgia--a dose-response study.
Jean, WH; Mok, MS; Sun, WZ; Wu, CC, 2005
)
2.11
"Gabapentin has been shown to reduce elements of central sensitization in human experimental hyperalgesia. "( Gabapentin reduces rectal mechanosensitivity and increases rectal compliance in patients with diarrhoea-predominant irritable bowel syndrome.
Cho, SW; Kim, JH; Lee, KJ, 2005
)
3.21
"Gabapentin has been evaluated in the treatment of nonmalignant neuropathic pain, however, there is little direct evidence evaluating its efficacy in cancer-related neuropathic pain."( Gabapentin is effective in the treatment of cancer-related neuropathic pain: a prospective, open-label study.
A'hern, R; Broadley, K; Goller, K; Hardy, J; Riley, J; Ross, JR; Williams, J, 2005
)
3.21
"Gabapentin has been used successfully as a non-opioid analgesic adjuvant for postoperative pain management. "( Effect of oral gabapentin on postoperative epidural analgesia.
Apfel, CC; Karamanlioglu, B; Kaya, G; Pamukçu, Z; Turan, A, 2006
)
2.13
"Gabapentin has become popular as a first-line treatment for neuropathic pain because of its efficacy as an antineuropathic agent and relatively benign side-effect profile."( The mechanism of action of gabapentin in neuropathic pain.
Baillie, JK; Power, I, 2006
)
1.35
"Gabapentin has been suggested to decrease acute postoperative pain. "( Gabapentin attenuates late but not acute pain after abdominal hysterectomy.
Fassoulaki, A; Hassiakos, D; Petropoulos, G; Sarantopoulos, C; Siafaka, I; Stamatakis, E, 2006
)
3.22
"Gabapentin has no effect on immediate pain after abdominal hysterectomy but decreases pain 1 month postoperatively."( Gabapentin attenuates late but not acute pain after abdominal hysterectomy.
Fassoulaki, A; Hassiakos, D; Petropoulos, G; Sarantopoulos, C; Siafaka, I; Stamatakis, E, 2006
)
3.22
"Gabapentin has been reported to inhibit various acute and chronic pain conditions in animals and humans. "( Gabapentin activates spinal noradrenergic activity in rats and humans and reduces hypersensitivity after surgery.
Curry, R; DeGoes, S; Eisenach, JC; Hayashida, K, 2007
)
3.23
"Gabapentin, which has been used in the treatment of neuropathic pain, may be effective in the treatment of symptoms associated with LSS."( The efficiency of gabapentin therapy in patients with lumbar spinal stenosis.
Ozgönenel, B; Ozgönenel, L; Yaksi, A, 2007
)
1.39
"Gabapentin has recently been reported to be efficacious in the treatment of CCH."( The use of gabapentin in chronic cluster headache patients refractory to first-line therapy.
Arnold, G; Israel, H; Neeb, L; Reuter, U; Schuh-Hofer, S, 2007
)
1.45
"Gabapentin has demonstrated analgesic effects in clinical trials as a preemptive analgesic and in acute postoperative pain management. "( Pre-emptive gabapentin significantly reduces postoperative pain and morphine demand following lower extremity orthopaedic surgery.
Honarmand, A; Kashefi, P; Montazeri, K, 2007
)
2.16
"Gabapentin, which has been suggested as an adjuvant analgesic for neuropathic pain introduced orally, rapidly and significantly alleviated his pain and we could subsequently dispense with ketamine and mexiletine."( [Gabapentin mitigates neuropathic pain in cancer patients--a case report].
Okada, M; Shinjo, T, 2007
)
1.97
"Gabapentin has been reported to modulate serotonin release from platelets, but the effects of gabapentin on platelet activation have not been explored."( Inhibitory mechanisms of gabapentin, an antiseizure drug, on platelet aggregation.
Chou, DS; Hsiao, G; Pan, CF; Shen, MY; Sheu, JR; Wu, CJ, 2007
)
1.36
"Gabapentin has been used effectively for neuropathic pain with mild side effects. "( Gabapentin and sexual dysfunction: report of two cases.
Dalal, A; Zhou, L, 2008
)
3.23
"Gabapentin has been approved in the United States for the treatment of epilepsy and postherpetic neuralgia. "( Gabapentin as a potential option for treatment of sciatica.
Grice, GR; Mertens, MK, 2008
)
3.23
"Gabapentin has been administered to several geriatric patients with bipolar disorder and patients with dementia."( Use of gabapentin in the treatment of behavioural and psychological symptoms of dementia: a review of the evidence.
Kim, Y; Tampi, RR; Wilkins, KM, 2008
)
1.52
"Gabapentin has established efficacy in the reduction of burn-induced hyperalgesia and allodynia in animal and human experimental burn models."( Successful use of gabapentin in acute pain management following burn injury: a case series.
Cramond, T; Gray, P; Williams, B, 2008
)
1.4
"Gabapentin has been evaluated for the treatment of UP in 2 small, randomized, placebo-controlled studies, 1 pilot evaluation, and 1 index case."( Role of gabapentin in the treatment of uremic pruritus.
Gommer, J; Scates, AC; Vila, T, 2008
)
1.5
"Gabapentin (GBP) has shown antiepileptic efficacy and good tolerance in clinical trials. "( Efficacy and tolerance of long-term, high-dose gabapentin: additional observations.
Handforth, A; Treiman, DM,
)
1.83
"Gabapentin, has shown significant promise in the treatment of patients with refractory partial seizures and secondarily generalized tonic-clonic seizures."( Clinical efficacy and safety of gabapentin.
Ramsay, RE, 1994
)
1.29
"Gabapentin has come into clinical use as adjunctive therapy in the treatment of epilepsy. "( The effect of gabapentin on brain gamma-aminobutyric acid in patients with epilepsy.
Behar, KL; Lamoureux, D; Mattson, RH; Petroff, OA; Rothman, DL, 1996
)
2.1
"Gabapentin (GBP) has been shown to be effective an add-on drug for the treatment of refractory partial epilepsy. "( Gabapentin in refractory partial epilepsy--a trial in India.
Dixit, SN; Jain, S; Maheshwari, MC; Padma, MV,
)
3.02
"Gabapentin has negligible affinity for the strychnine insensitive [3H]glycine binding site."( The antiepileptic agent gabapentin (Neurontin) possesses anxiolytic-like and antinociceptive actions that are reversed by D-serine.
Ferris, P; Field, MJ; Hunter, JC; Oles, RJ; Singh, L; Williams, RG; Woodruff, GN, 1996
)
1.32
"Gabapentin has a favorable pharmacokinetic profile and is generally well tolerated."( Gabapentin.
Bruni, J, 1996
)
2.46
"Gabapentin has been accepted worldwide as a novel antiepileptic drug with a favourable tolerability profile. "( Isolated ataxia as an idiosyncratic side-effect under gabapentin.
Bittermann, HJ; Herrendorf, G; Kurth, C; Steinhoff, BJ, 1997
)
1.99
"Gabapentin has been reported to be effective for essential tremor (ET) based on open-label trials. "( Double-blind controlled trial of gabapentin in essential tremor.
Busenbark, K; Hubble, JP; Koller, WC; Lyons, K; Pahwa, A; Pahwa, R; Rienerth, JD, 1998
)
2.02
"Gabapentin has no activity at GABAA or GABAB receptors of GABA uptake carriers of brain."( Mechanisms of action of gabapentin.
Taylor, CP, 1997
)
1.33
"Gabapentin (GP) has been shown to have antihyperalgesic properties and the site of drug action is reported to be the central nervous system. "( Attenuation of formalin-induced nociceptive behaviors following local peripheral injection of gabapentin.
Carlton, SM; Zhou, S, 1998
)
1.96
"Gabapentin has desirable pharmacokinetic properties and acceptable side effects, which simplify its use."( Using gabapentin to treat neuropathic pain.
Hays, H; Woodroffe, MA, 1999
)
1.51
"Gabapentin has few drug-drug interactions, none of which is clinically limiting."( Gabapentin in the management of convulsive disorders.
McLean, MJ, 1999
)
2.47
"Gabapentin has been administered in placebo-controlled studies with a thrice daily (T.I.D.) schedule, because of its short half-life. "( Conversion from thrice daily to twice daily administration of gabapentin (GBP) in partial epilepsy: analysis of clinical efficacy and plasma levels.
Arnetoli, G; Balestrieri, F; Chiroli, S; Luceri, F; Mastio, MD; Muscas, GC, 2000
)
1.99
"Gabapentin has efficacy as an add-on treatment in patients with drug-resistant partial epilepsy. "( Gabapentin for drug-resistant partial epilepsy.
Chadwick, DW; Hutton, JL; Kadir, ZA; Marson, AG, 2000
)
3.19
"Gabapentin has emerged as a useful new tool based on the results of two large multicenter trials in models of human neuropathy."( Gabapentin: a new tool in the treatment of neuropathic pain.
Harden, RN, 1999
)
2.47
"Gabapentin has been shown to be efficacious in numerous smaller clinical studies, case reports, and chart reviews in a variety of neuropathic pain syndromes."( Gabapentin use in neuropathic pain syndromes.
Nicholson, B, 2000
)
2.47
"Gabapentin has efficacy as an add-on treatment in patients with drug-resistant partial epilepsy. "( Gabapentin add-on for drug-resistant partial epilepsy.
Chadwick, DW; Hutton, JL; Kadir, ZA; Marson, AG, 2000
)
3.19
"Gabapentin has been shown to reduce paired-pulse inhibition in the dentate gyrus of the urethane-anesthetized rat and has been shown to block calcium channels, but its not known how these possible mechanisms relate to its antiepileptic effect. "( The effects of gabapentin in the rat hippocampus are mimicked by two structural analogs, but not by nimodipine.
Stringer, JL; Taylor, CP, 2000
)
2.1
"Gabapentin has been successfully used for a variety of chronic pain conditions and therefore may be of use in the treatment of chronic headache."( Low doses of gabapentin may be helpful in the management of chronic daily headache.
Carrazana, EJ; Fragoso, YD, 2000
)
1.4
"Gabapentin, which has been approved for add-on therapy of focal seizures, is increasingly used for treatment of neuropathic pain. "( [Gabapentin therapy for pain].
Block, F, 2001
)
2.66
"Gabapentin has an established, favorable safety profile and has been shown to be effective in various animal models and human studies of chronic neuropathic pain."( Using gabapentin to treat failed back surgery syndrome caused by epidural fibrosis: A report of 2 cases.
Braverman, DL; Lenrow, DA; Slipman, CW, 2001
)
1.51
"Gabapentin (GBP) has gained wide acceptance in the treatment of pain, migraine, bipolar illness, and epilepsy. "( Gabapentin withdrawal syndrome.
Norton, JW,
)
3.02
"Gabapentin, which has been approved for add-on therapy of focal seizures, is increasingly used for treatment of neuropathic pain. "( [Gabapentin for therapy of neuropathic pain].
Block, F, 2001
)
2.66
"Gabapentin has been shown to reduce pain associated with diabetic neuropathia and postherpetic neuralgia. "( [Gabapentin in the treatment of chronic intractable pain].
Gustorff, B; Kress, HG; Nahlik, G; Spacek, A, 2002
)
2.67
"Gabapentin has been shown to markedly reduce the severity, frequency, and duration of these hot flashes."( Gabapentin for hot flashes in prostate cancer.
Jeffery, SM; Pepe, JJ; Popovich, LM; Vitagliano, G, 2002
)
2.48
"Gabapentin has been clearly demonstrated to be effective for the treatment of neuropathic pain in diabetic neuropathy and postherpetic neuralgia."( Gabapentin: pharmacology and its use in pain management.
Kam, PC; Rose, MA, 2002
)
2.48
"Gabapentin has favourable pharmacokinetic properties: lack of hepatic metabolism, no protein binding, and easy to calculate regimen for patients with renal failure. "( [Gabapentin in the treatment of epilepsy in the elderly].
Gil-Nagel, A,
)
2.48
"Gabapentin has been approved for the treatment of neuropathic pain in six European countries, New Zealand and Australia, and numerous countries in Latin America. "( Gabapentin. Pfizer.
Wheeler, G, 2002
)
3.2

Actions

Gabapentin was chosen because of its reported efficacy in a wide array of complex cranial pain syndromes. Gabapentin did, however, cause inhibition in the presence of the NMDA receptor antagonist DL-(E)-2-amino-4-methyl-5-phosphono-3-pentanoic acid (CGP 37849)

ExcerptReferenceRelevance
"Gabapentinoids also increase the risk of respiratory depression, in particular when paired with opioids."( Gabapentinoid Use in Perioperative Care and Current Controversies.
Abrecht, CR; Patel, AS; Urman, RD, 2022
)
2.89
"Gabapentinoids can cause concentration-dependent peripheral edema of early onset. "( Gabapentinoid-induced peripheral edema and acute heart failure: A translational study combining pharmacovigilance data and in vitro animal experiments.
Auffret, M; Bordy, R; Bredeloux, P; Cracowski, JL; Gras-Champel, V; Jonville-Béra, AP; Largeau, B; Lengellé, C; Maupoil, V; Pasqualin, C, 2022
)
3.61
"Gabapentin may increase the abuse liability of ALC and OXY + ALC in those with co-occurring OUD and AUD."( Gabapentin increases the abuse liability of alcohol alone and in combination with oxycodone in participants with co-occurring opioid and alcohol use disorder.
Castillo, F; Comer, SD; Evans, SM; Foltin, RW; Jones, JD; Luba, RR; Mogali, S, 2022
)
3.61
"Gabapentin did not cause adverse effects on the cardiovascular hemodynamics of young healthy cats."( Evaluation of the effects of gabapentin on the physiologic and echocardiographic variables of healthy cats: a prospective, randomized and blinded study.
da Costa, FV; de Azevedo, AF; Fadel, L; Ferronatto, JV; Franck, KR; Lopes, DJ; Nunes, LN; Spiering, AG; Trojan, MM; Veronezi, TM; Zardo, IL, 2022
)
1.73
"Gabapentin promotes neurological recovery histopathologically in peripheral nerve injury due to its neuroprotective properties. "( Effect of gabapentin on primary surgical treatment of experimental sciatic nerve injury in rats.
Bulduk, EB; Çivi, S; Durdağ, E; Kardeş, Ö; Selçuk, FK; Süner, Hİ; Tufan, K, 2018
)
2.33
"Gabapentinoids activate the LC by inhibiting the release of γ-aminobutyric acid (GABA) and inducing the release of glutamate, thereby increasing noradrenaline levels in the spinal cord."( Strategies to Treat Chronic Pain and Strengthen Impaired Descending Noradrenergic Inhibitory System.
Hayashida, KI; Obata, H, 2019
)
1.24
"Gabapentin displays non-linear drug disposition, which complicates dosing for optimal therapeutic effect. "( Pharmacokinetic/Pharmacodynamic Relationship of Gabapentin in a CFA-induced Inflammatory Hyperalgesia Rat Model.
Holm, R; Keizer, R; Kreilgaard, M; Larsen, MS; Munro, G; Mørk, A; Savic, R, 2016
)
2.13
"Gabapentin did not produce an anti-allodynic effect, whereas the morphine and gabapentin combination completely decreased allodynia behavior at 30 min post-injection, an effect that persisted until 120 min."( Anti-nociceptive synergism of morphine and gabapentin in neuropathic pain induced by chronic constriction injury.
Cortés-Arroyo, AR; De la O-Arciniega, M; Díaz-Reval, MI; Domínguez-Ramírez, AM; López-Muñoz, FJ, 2009
)
1.34
"Gabapentin did not produce a significant reduction in symptom severity compared with placebo over an eight-week period."( Gabapentin for the treatment of carpal tunnel syndrome: a randomized controlled trial.
Hui, AC; Leung, HW; Man, BL; Wong, LK; Wong, SM; Yu, E, 2011
)
3.25
"Gabapentin failed to suppress the scratching behavior induced by the intradermal injection of compound 48/80 in normal mice."( Gabapentin and pregabalin inhibit the itch-associated response induced by the repeated application of oxazolone in mice.
Manabe, H; Matsumoto, Y; Miura, H; Tsukumo, Y; Yano, H, 2011
)
2.53
"Gabapentin displays nonlinear absorption kinetics, is minimally protein bound (< 3%), has a high mean (SD) volume of distribution (50.4 [8.0] L), and is excreted via the kidneys as unchanged drug. "( The use of gabapentin for the treatment of postherpetic neuralgia.
Kennedy, DH; Singh, D, 2003
)
2.15
"Gabapentin did however produce significant dose-related reversal of tactile allodynia in the rat following a single administration."( Comparative activity of the anti-convulsants oxcarbazepine, carbamazepine, lamotrigine and gabapentin in a model of neuropathic pain in the rat and guinea-pig.
Bevan, S; Fox, A; Gentry, C; Kesingland, A; Patel, S, 2003
)
1.26
"Gabapentin appears to increase human brain GABA levels."( The effect of gabapentin on brain gamma-aminobutyric acid in patients with epilepsy.
Behar, KL; Lamoureux, D; Mattson, RH; Petroff, OA; Rothman, DL, 1996
)
1.38
"Gabapentin will also inhibit the uptake of certain excitatory amino acids in this synaptosomal preparation."( Comparison of the uptake of [3H]-gabapentin with the uptake of L-[3H]-leucine into rat brain synaptosomes.
Hill, DR; Thurlow, RJ; Woodruff, GN, 1996
)
1.3
"Gabapentin was chosen because it has properties similar to other anticonvulsant drugs and because previous studies have shown that it is well tolerated and appears to have a benign efficacy-to-toxicity ratio."( Reflex sympathetic dystrophy treated with gabapentin.
Mellick, GA; Mellick, LB, 1997
)
1.28
"Gabapentin was chosen because of its GABA-ergic effect and because previously reported studies have shown that it is well tolerated compared with other GABA-mimetic medication."( Gabapentin for relief of spasticity associated with multiple sclerosis.
Dunevsky, A; Perel, AB,
)
2.3
"Gabapentin displays efficacy against abnormal sensory processing in diabetic rats and may be of benefit for treating painful diabetic neuropathy."( Gabapentin prevents hyperalgesia during the formalin test in diabetic rats.
Calcutt, NA; Ceseña, RM, 1999
)
2.47
"Gabapentin did, however, cause inhibition in the presence of the NMDA receptor antagonist DL-(E)-2-amino-4-methyl-5-phosphono-3-pentanoic acid (CGP 37849)."( Inhibition of neuronal Ca(2+) influx by gabapentin and subsequent reduction of neurotransmitter release from rat neocortical slices.
Dooley, DJ; Fink, K; Göthert, M; Meder, W, 2000
)
1.3
"Gabapentin was chosen because of its reported efficacy in a wide array of complex cranial pain syndromes."( Gabapentin produces dose-dependent antinociception in the orofacial formalin test in the rat.
Dougherty, PM; Grabow, TS,
)
2.3

Treatment

Gabapentin treatment has shown promise for symptomatic improvement for visceral hyperalgesia in some patients. Gabapentin exposure in treatment-seeking persons with OUD appears to be quite common. Use, both medically and nonmedically, frequently occurs alongside OAMs.

ExcerptReferenceRelevance
"Gabapentin treatment for post-cesarean analgesia."( Post-cesarean gabapentin is not associated with lower opioid consumption or pain scores in women on chronic buprenorphine therapy: A 10-year retrospective cohort study.
Bauchat, JR; Ende, HB; Feng, X; Raymond, BL; Richardson, MG; Shotwell, MS; Sorabella, LL, 2022
)
2.52
"Gabapentin treatment was initiated after baseline evaluation, and the RDD and visual analog scale (VAS) score were both evaluated regularly during the 2-week study period."( Rate-Dependent Depression: A Predictor of the Therapeutic Efficacy in Treating Painful Diabetic Peripheral Neuropathy.
Calcutt, NA; Guan, Y; Lin, Z; Wang, Z; Xie, C; Zhou, X; Zhu, D; Zhu, Y, 2022
)
1.44
"Gabapentin treatment significantly improved the behavioral scores, decreased levels of phosphorylated IκB-α and cleaved caspase3, apoptosis rate, and serum IL-6 level in ICH rats."( Gabapentin Alleviates Brain Injury in Intracerebral Hemorrhage Through Suppressing Neuroinflammation and Apoptosis.
Guo, L; Li, X; Nan, C; Sun, Z; Wang, B; Yang, L; Yu, N; Zhao, Z, 2022
)
2.89
"Gabapentin treatment has shown promise for symptomatic improvement for visceral hyperalgesia in some patients."( Gabapentin Can Improve Irritability and Feeding Tolerance in Single Ventricle Interstage Patients: A Case Series.
Allen, CC; Bartlett, H; Canada, K; Schlueter, S; Zhang, X, 2023
)
3.07
"Gabapentin exposure in treatment-seeking persons with OUD appears to be quite common, and use, both medically and nonmedically, frequently occurs alongside OAMs. "( Understanding motivations and use typologies of gabapentin with opioid agonist medications.
Buttram, ME; Ellis, MS; Qureshi, R, 2023
)
2.61
"Gabapentin-treated participants were more likely to withdraw from treatment for any cause (285/539) than those treated with lamotrigine, oxcarbazepine, or topiramate pooled together (695/1317) (RR 1.13, 95% CI 1.02 to 1.25; 3 studies, 1856 participants; moderate-certainty evidence), but not carbamazepine."( Gabapentin monotherapy for epilepsy: A review.
Abakumova, T; Hoyle, CHV; Ziganshina, LE, 2023
)
3.07
"Gabapentin-treated patients received a lower number of doses of ondansetron when compared with the placebo group (6 [5-6] vs 7 [6-9], P = 0.02)."( Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial.
Fenikowski, D; Gawron, D; Komotajtys, H; Maciejewski, P; Tomaszek, L, 2020
)
1.64
"More gabapentin-treated individuals had no heavy drinking days (12 of 44 participants [27%]) compared with placebo (4 of 46 participants [9%]), a difference of 18.6% (95% CI, 3.1-34.1; P = .02; number needed to treat [NNT], 5.4), and more total abstinence (8 of 44 [18%]) compared with placebo (2 of 46 [4%]), a difference of 13.8% (95% CI, 1.0-26.7; P = .04; NNT, 6.2)."( Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial.
Anton, RF; Book, S; Bristol, E; Hoffman, M; Latham, P; Prisciandaro, J; Voronin, K, 2020
)
1.39
"Gabapentin treatment provided a 52% greater reduction in days 5 to 7 baseline adjusted Motherisk-pregnancy-unique quantification of nausea and emesis total scores than treatment with active comparator (95% confidence interval, 16-88; P=.01)."( Effect of gabapentin on hyperemesis gravidarum: a double-blind, randomized controlled trial.
Guttuso, T; Messing, S; Mullin, P; Saha, S; Shepherd, R; Strittmatter, C; Thornburg, LL; Tu, X, 2021
)
1.75
"Gabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD. "( Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder.
Basaraba, C; Bisaga, A; Brooks, DJ; Carpenter, KM; Levin, FR; Mamczur-Fuller, A; Mariani, JJ; Nunes, EV; Pavlicova, M, 2021
)
2.3
"Gabapentin treatment was well tolerated in this population of cats."( Use of single-dose oral gabapentin to attenuate fear responses in cage-trap confined community cats: a double-blind, placebo-controlled field trial.
Ferris, KK; Griffith, EH; Pankratz, KE; Sherman, BL, 2018
)
1.51
"Gabapentin treatment was also initiated in addition to artificial tear and cyclosporine drops treatments to the patients with neuropathic component and DED findings."( Is gabapentin effective in dry eye disease and neuropathic ocular pain?
Ongun, GT; Ongun, N, 2021
)
1.96
"Gabapentin treatment was able to reduce reactive gliosis, decrease neuronal loss and normalize PSA-NCAM staining in hippocampal CA-1."( Gabapentin administration reduces reactive gliosis and neurodegeneration after pilocarpine-induced status epilepticus.
Angelo, MF; Lukin, J; Ramos, AJ; Rossi, AR; Villarreal, A, 2013
)
2.55
"Gabapentin treatment yielded an improvement in pain intensity (risk ratio (RR) 1·88; 95% CI 1·35, 2·29; I(2)  = 64·8%; for 50% reduction and RR 1·43; 95% CI 1·12, 1·83; I(2)  = 0% for 30% reduction, respectively), PGIC (RR 1·49; 95% CI 1·28, 1·74; I(2)  = 0%), and CGIC (RR 1·58; 95% CI 1·29, 1·92; I(2)  = 30·9%)."( Efficacy and safety of gabapentin 1800 mg treatment for post-herpetic neuralgia: a meta-analysis of randomized controlled trials.
Cao, H; Fan, H; Hu, X; Li, J; Shao, Y; Wang, J; Yu, W; Zhang, Q, 2014
)
1.43
"Gabapentinoid treatment was associated with increased sedation, dizziness and visual disturbances, but the clinical relevance needs clarification."( Adverse effects of perioperative paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review.
Dahl, JB; Hamunen, K; Hansen, MS; Kjer, JJ; Kontinen, VK; Mathiesen, O; Nikolajsen, L; Pommergaard, HC; Rosenberg, J; Wetterslev, J, 2014
)
1.36
"Gabapentin is a viable treatment for conservatively managed CKD and ESKD patients with pruritus and/or RLS, but side effects are common. "( Efficacy and safety of gabapentin for uremic pruritus and restless legs syndrome in conservatively managed patients with chronic kidney disease.
Brennan, F; Brown, MA; Cheikh Hassan, HI; Collett, G; Josland, EA, 2015
)
2.17
"Gabapentin pretreatment potentiated the interoceptive effects of both experimenter-administered and self-administered alcohol in discrimination-trained rats."( Gabapentin potentiates sensitivity to the interoceptive effects of alcohol and increases alcohol self-administration in rats.
Besheer, J; Frisbee, S; Jaramillo, AA; Masciello, M; Randall, PA, 2016
)
2.6
"Gabapentin treatment with acceptable safety profile, improves OAB symptoms and HRQOL domains."( Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment.
Balingit, JC; Chua, ME; Esmeňa, EB; Morales, ML; See, MC, 2018
)
2.23
"Gabapentin-treated participants exhibited lower abstinence rates than placebo-treated participants; however, this difference was not significant."( Gabapentin for smoking cessation.
Croghan, IT; Ebbert, JO; Hays, JT; Schroeder, DR; Sood, A; Sood, R; Wyatt, KD, 2010
)
2.52
"Gabapentin treatment resulted in decreased VAS scores in both groups."( Efficacy of gabapentin for radiculopathy caused by lumbar spinal stenosis and lumbar disk hernia.
Kaptan, H; Kasimcan, O, 2010
)
1.46
"Gabapentin pretreatment (200  mg/kg, intravenously) reduced the infarct volume by 23% after transient focal ischemia in mice."( Gabapentin reduces infarct volume but does not suppress peri-infarct depolarizations.
Ayata, C; Eikermann-Haerter, K; Hoffmann, U; Lee, JH; Qin, T, 2011
)
2.53
"Gabapentin pre-treatment at lower doses (0.01-7.5 mg/kg) not only antagonized the depressive effect of morphine, but caused facilitation of the reflex."( Dose-dependent opposite effects of gabapentin on the depressive action of morphine on a C-fibre reflex in the rat.
Adam, F; le Bars, D; Pollin, B; Roy-Ledoux, R, 2011
)
1.37
"Gabapentin treatment ameliorated tinnitus in a rat model and improved tinnitus annoyance in humans with acoustic trauma."( The effect of gabapentin on gap detection and forward masking in young and old gerbils.
Gleich, O; Strutz, J,
)
1.21
"The gabapentin BA in the MgO treatment was significantly lower, by 32% and 39%, compared to the gabapentin alone and with omeprazole treatment, respectively."( Impact of concomitant antacid administration on gabapentin plasma exposure and oral bioavailability in healthy adult subjects.
Kawakami, J; Mino, Y; Naito, T; Umemura, K; Yagi, T, 2012
)
1.12
"Gabapentin-treated patients had less motor block when compared with control group."( Effect of oral gabapentin on postoperative epidural analgesia.
Apfel, CC; Karamanlioglu, B; Kaya, G; Pamukçu, Z; Turan, A, 2006
)
1.41
"Gabapentin's role in the treatment of chronic neuropathic pain is well known. "( Preoperative gabapentin for postoperative analgesia: a meta-analysis.
Paul, JE; Seib, RK, 2006
)
2.15
"Gabapentin pre-treatment reduced sensitivity to electrical induction of skin pain by 14%, p=0.016."( Multiple dose gabapentin attenuates cutaneous pain and central sensitisation but not muscle pain in healthy volunteers.
Segerdahl, M, 2006
)
1.42
"Gabapentin showed poor treatment retention and ineffectiveness in reducing cocaine use. "( Clinical efficacy of gabapentin versus tiagabine for reducing cocaine use among cocaine dependent methadone-treated patients.
Desai, R; Gonsai, K; González, G; Kosten, TR; Oliveto, A; Poling, J; Sofuoglu, M, 2007
)
2.1
"Gabapentin-treated patients displayed a significantly greater improvement in the BPI average pain severity score (P=0.015; estimated difference between groups at week 12=-0.92 [95% confidence interval -1.75, -0.71]). "( Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial.
Arnold, LM; Bishop, F; Goldenberg, DL; Hess, EV; Hudson, JI; Keck, PE; Lalonde, JK; Sandhu, HS; Stanford, KE; Stanford, SB; Welge, JA, 2007
)
3.23
"Gabapentin treatment resulted in an increase in the walking distance better than what was obtained with standard treatment (P = 0.001). "( The efficiency of gabapentin therapy in patients with lumbar spinal stenosis.
Ozgönenel, B; Ozgönenel, L; Yaksi, A, 2007
)
2.12
"Gabapentin is used for treatment of neuropathic pain, but its effect on different somatic pain modalities and integrative mechanisms are not completely understood. "( Effects of gabapentin on experimental somatic pain and temporal summation.
Arendt-Nielsen, L; Drewes, AM; Frøkjaer, JB; Graven-Nielsen, T; Huggins, JP; Smart, TS; Staahl, C,
)
1.96
"Gabapentin, a novel treatment for neuropathic pain states, also reduced neuronal responses, but the actions of the drug were n"( Effects of systemic carbamazepine and gabapentin on spinal neuronal responses in spinal nerve ligated rats.
Chamarette, HL; Chapman, V; Dickenson, AH; Rygh, LJ; Suzuki, R, 1998
)
1.29
"Gabapentin treatment was started at 300 mg/day and increased up to 2000 mg/day."( Clinical experience using adjunctive gabapentin in treatment-resistant bipolar mixed states.
Akiskal, H; Perugi, G; Ruffolo, G; Sartini, S; Simonini, E; Toni, C, 1999
)
1.3
"Gabapentin treatment significantly and reversibly changed the responses, consistent with the attenuation of the abnormal sensory behavior, and the attenuated responses lasted for the duration of the drug effect (up to 6 h)."( Rodent model of chronic central pain after spinal cord contusion injury and effects of gabapentin.
Hulsebosch, CE; McAdoo, DJ; Perez-Polo, JR; Taylor, CP; Westlund, KN; Xu, GY, 2000
)
1.25
"SCI gabapentin-treated rats did not display differences in total rearing time until PSD 28 and a significant difference in total activity of all measured parameters was not seen until PSD 60."( Changes in exploratory behavior as a measure of chronic central pain following spinal cord injury.
Grady, JJ; Hulsebosch, CE; Mills, CD, 2001
)
0.79
"Gabapentin treatment appeared to be effective in blocking a lactate-induced panic response but did not alter the magnitude or time course of an abnormal brain lactate response to lactate infusion in all subjects."( Brain metabolic changes during lactate-induced panic: effects of gabapentin treatment.
Dager, SR; Friedman, SD; Layton, ME, 2001
)
1.27
"Treatment with gabapentin and antidepressants should be considered in patients with chronic pruritus unresponsive to conventional treatment."( Gabapentin and oral antidepressants for chronic pruritus: a prospective cohort study evaluating efficacy and side effects in daily dermatological practice.
Kamsteeg, M; Kouwenhoven, TA; van de Kerkhof, PCM, 2023
)
2.71
"Treatment with gabapentinoids (GBs) has been shown to reduce pain, but its effects on sleep health have not been systematically evaluated."( Evaluating the impact of gabapentinoids on sleep health in patients with chronic neuropathic pain: a systematic review and meta-analysis.
Bhatia, A; Brull, R; Davidson, A; Kapustin, D; McParland, A; Singh, M; Trivedi, A, 2020
)
1.2
"Treatment with gabapentin and pantoprazole exhibited maximum antioxidant effect in comparison with monotherapy."( Combined therapy of gabapentin with pantoprazole exhibited better protective action against forestomach and pylorus ligation-induced gastric esophageal reflux disease in albino Wistar rats.
Arya, P; Kaithwas, G, 2020
)
1.22
"Treatment with gabapentin led to recovered behaviour and DH neuronal activity pattern in CFA-treated animals."( Dorsal horn disinhibition and movement-induced behaviour in a rat model of inflammatory arthritis.
Locke, S; Ribeiro-da-Silva, A; Yousefpour, N, 2021
)
0.96
"The treatment with gabapentin or LLLT significantly decreased the raised level in total cholesterol in DNP but could not decrease the elevated level of triglycerides, while LDL cholesterol decreased significantly in DNP treated with gabapentin but not affected by LLLT."( Efficiencies of Low-Level Laser Therapy (LLLT) and Gabapentin in the Management of Peripheral Neuropathy: Diabetic Neuropathy.
Abdel-Wahhab, KG; Daoud, EM; El Gendy, A; Mannaa, FA; Mourad, HH; Saber, MM, 2018
)
1.05
"Treatment with gabapentin, tricyclic antidepressants, or botulinum toxin may be helpful."( Nummular headache update.
Grosberg, BM; Robbins, MS; Schwartz, DP, 2013
)
0.73
"Treatment with gabapentin led to a prompt reduction of the symptoms."( Episodic itch in a case of spinal glioma.
Dihné, M; Lerche, H; Wolking, S, 2013
)
0.73
"Treatment with gabapentin 1800 mg/day yielded a significant reduction in PHN up to 14 weeks. "( Efficacy and safety of gabapentin 1800 mg treatment for post-herpetic neuralgia: a meta-analysis of randomized controlled trials.
Cao, H; Fan, H; Hu, X; Li, J; Shao, Y; Wang, J; Yu, W; Zhang, Q, 2014
)
1.07
"Treatment with gabapentin was initiated for OPT presumed secondary to neuro-Behçet disease."( Neuro-Behçet disease presenting with oculopalatal tremor.
Espino Barros Palau, A; Foroozan, R; Lee, AG; Morgan, ML, 2015
)
0.76
"Treatment with gabapentin achieved complete remission."( Pressure pain sensitivity map of multifocal nummular headache: a case report.
Barón, J; Carreres, A; Cuadrado, ML; Fernández-de-Las-Peñas, C; Guerrero, AL; Herrero-Velázquez, S; Madeleine, P; Rodríguez, C; Rodríguez-Valencia, E; Ruiz, M, 2015
)
0.76
"The treatment with gabapentin at an average dose of 1,135 mg for 14 weeks reduced pain in 80% of the patients (p < 0.0001)."( [Postmastectomy pain syndrome in our region: characteristics, treatment, and experience with gabapentin].
de Miguel-Jimeno, JM; Forner-Cordero, I; Matute-Tobias, B; Zabalza-Azparren, M, 2016
)
0.97
"Treatment with gabapentin, but not amitriptyline, was associated with a complete attenuation of hind paw mechanical hypersensitivity observed with indinavir treatment."( A rodent model of HIV protease inhibitor indinavir induced peripheral neuropathy.
Bennett, DLH; Calvo, M; Huang, W; Pheby, T; Rice, ASC, 2017
)
0.79
"Pre-treatment with gabapentin reduced the degree of neuronal damage induced by NMDA exposure in cultured hippocampal slices."( Protective effect of gabapentin on N-methyl-D-aspartate-induced excitotoxicity in rat hippocampal CA1 neurons.
Chang, HK; Kim, CJ; Kim, H; Kim, SE; Kim, YS; Lee, JW; Park, JH; Shin, MS; Sung, YH; Yi, JW, 2009
)
0.99
"Post-treatment, gabapentin-treated participants had less probability of drinking during the follow-up post-treatment period (p = 0.2 for 900 mg and p = 0.3 for 1200 mg) compared to the lorazepam-treated participants (p = 0.55)."( A double-blind trial of gabapentin versus lorazepam in the treatment of alcohol withdrawal.
Anton, RF; Becker, HC; Boyle, E; Malcolm, R; Myrick, H; Randall, CL; Randall, PK, 2009
)
0.99
"Treatment with gabapentin versus placebo reported better visual analogue scale (VAS) scores after one, two, three and four days; treatment with hydrocortisone plus conventional treatment showed better VAS scores than conventional treatment alone at six, 24 and 48 hours and treatment with theophylline showed a lower mean "sum of pain" when compared with placebo."( Drug therapy for treating post-dural puncture headache.
Basurto Ona, X; Bonfill Cosp, X; Martínez García, L; Solà, I, 2011
)
0.71
"Treatment with gabapentin at 800 mg attenuated the anxiety of subjects that had a decrease on the VAMS item calm-excite."( Effects of gabapentin on anxiety induced by simulated public speaking.
Barichello, T; Busnello, JV; de-Paris, F; Izquierdo, I; Kapczinski, F; Quevedo, J; Sant'Anna, MK; Vianna, MR, 2003
)
1.05
"Pretreatment with gabapentin prevented the upregulation of GFAP, S100B, and NSE in all brain regions of diabetic rats."( Novel role for gabapentin in neuroprotection of central nervous system in streptozotocine-induced diabetic rats.
Baydas, G; Donder, E; Sonkaya, E; Tuzcu, M; Yasar, A, 2005
)
1
"Pretreatment with gabapentin did not significantly alter subjective and performance effects of alcohol and did not alter alcohol craving."( The acute effects of gabapentin in combination with alcohol in heavy drinkers.
Bisaga, A; Evans, SM, 2006
)
0.98
"Pretreatment with gabapentin (50 and 100 mg/kg, i.p.) significantly improved ambulatory movements, anti-anxiety effect (decreased time latency to enter in mirror chamber, increased number of entries and duration in mirror chamber) and antioxidative activity in stressed mice (P < 0.05)."( Possible involvement of GABAergic modulation in the protective effect of gabapentin against immobilization stress-induced behavior alterations and oxidative damage in mice.
Goyal, R; Kumar, A, 2007
)
0.89
"Pretreatment with gabapentin had no effect on the spread of sensory block or the regression of motor block but was associated with lower systolic arterial blood pressure values in patients undergoing subarachnoid anesthesia with ropivacaine."( Preoperative gabapentin: the effect on ropivacaine subarachnoid block and hemodynamics.
Chatziara, V; Fassoulaki, A; Melemeni, A; Sarantopoulos, C; Zotou, M, 2008
)
1.05
"Treatment with gabapentin (50 and 100 mg/kg) significantly increased ambulatory movements, exerted anti-anxiety like effect and reduced oxidative damage in mice subjected to acute hypoxic stress."( Gabapentin attenuates acute hypoxic stress-induced behavioral alterations and oxidative damage in mice: possible involvement of GABAergic mechanism.
Goyal, R; Kumar, A, 2008
)
2.13
"Treatment with gabapentin was associated with a substantial decrease in pain, which relapsed after tapering the medication. "( Gabapentin for the treatment of dysesthetic pain after reconstructive surgery.
Otley, CC, 1999
)
2.1
"Pretreatment with gabapentin dose dependently decreased flinches and weighted pain scores in phase 2, but not phase 1, at each concentration of formalin."( Intrathecally administered gabapentin inhibits formalin-evoked nociception and the expression of Fos-like immunoreactivity in the spinal cord of the rat.
Hammond, DL; Kaneko, M; Mestre, C; Sánchez, EH, 2000
)
0.93
"Treatment with gabapentin was initiated, with good results at 6-month follow-up."( Gabapentin treatment in a child with delayed-onset hemichorea/hemiballismus.
Kothare, SV; Kulberg, AG; Pollack, P; Ravin, PD, 2000
)
2.09
"Pretreatment with gabapentin (10 mg/kg and 30 mg/kg) affected neither the expression nor the induction of sensitization to cocaine."( Effect of riluzole and gabapentin on cocaine- and methamphetamine-induced behavioral sensitization in mice.
Itzhak, Y; Martin, JL, 2000
)
0.94

Toxicity

Gabapentin is safe and effective in improving the sleep quality of patients with sensory nervous-system diseases. In patients undergoing abdominal wall reconstruction, postoperative gabapentin administration was not associated with an increase in adverse effects.

ExcerptReferenceRelevance
" No adverse maternal or fetal effects were observed in mice or rats given doses up to 1500 or 3000 mg/kg, respectively."( Developmental toxicity studies in mice, rats, and rabbits with the anticonvulsant gabapentin.
Anderson, JA; Petrere, JA, 1994
)
0.51
" Although adverse events occur in most patients receiving gabapentin as adjunctive therapy, they are transient and mild to moderate in severity."( Clinical efficacy and safety of gabapentin.
Ramsay, RE, 1994
)
0.82
" At the time of data cutoff, 30% of patients had withdrawn from the study due to lack of efficacy, and 4% due to adverse events."( The long-term safety and efficacy of gabapentin (Neurontin) as add-on therapy in drug-resistant partial epilepsy. The US Gabapentin Study Group.
, 1994
)
0.56
" It is well tolerated, with transient somnolence and dizziness being the most frequent adverse effects."( Gabapentin: pharmacokinetics, efficacy, and safety.
Beydoun, A; Sackellares, JC; Uthman, BM, 1995
)
1.73
"Standard antiepileptic drugs (AEDs) are associated with a wide variety of acute and chronic adverse events and with many interactions with each other and with non-AEDs that complicate patient management."( Overview of the safety of newer antiepileptic drugs.
Shorvon, S; Stefan, H, 1997
)
0.3
"We suggest that, in patients with mental retardation and epilepsy, involuntary movements may either occur as reversible side effects of gabapentin therapy or result from a previously undescribed adverse drug interaction with other antiepileptic agents."( Choreoathetosis as a side effect of gabapentin therapy in severely neurologically impaired patients.
Chudnow, RS; Dewey, RB; Lawson, CR, 1997
)
0.77
" One general rule that may reduce the risks of toxic drug interactions is to add medication to the patient's current regimen in modest doses and increase the dose slowly."( Mood stabilizer combinations: a review of safety and efficacy.
Freeman, MP; Stoll, AL, 1998
)
0.3
" Gabapentin is a new antiepileptic drug not appreciably metabolized by the liver in humans, and it appears to be safe and effective in the maintenance therapy of epilepsy in these patients."( Treatment of seizures in acute intermittent porphyria: safety and efficacy of gabapentin.
Brambilla, A; Erli, LC; Grandi, R; Mirabile, D; Zadra, M, 1998
)
1.44
" Two analyses of adverse events are presented: tolerability and safety."( Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study.
Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999
)
0.6
" Within these 281 patients, two mutually exclusive groups were compared (a) those reporting adverse events at only < or =1,800 mg/day (low dose); and (b) those reporting adverse events at only >1,800 mg/day (high dose)."( Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study.
Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999
)
0.6
"Gabapentin doses >1,800 mg/day were as well tolerated as doses < or =1,800 mg/day and were not associated with more adverse events."( Safety and tolerability of gabapentin as adjunctive therapy in a large, multicenter study.
Bernstein, P; Faught, RE; Holmes, GL; Magnus-Miller, L; McLean, MJ; Morrell, MJ; Privitera, MD; Rose-Legatt, A; Willmore, LJ, 1999
)
2.04
"Although gabapentin seems also to be safe in children, the efficacy in refractory partial seizures was disappointing."( Gabapentin in childhood epilepsy: a prospective evaluation of efficacy and safety.
Boenigk, HE; Borusiak, P; Korn-Merker, E, 2000
)
2.17
" It has a relatively benign side effect profile, but little data exists on massive overdoses with this agent."( A case of sustained massive gabapentin overdose without serious side effects.
Radtke, RA; St Clair, EW; Verma, A, 1999
)
0.6
" However, on rare occasions, they can progress to more severe cutaneous disorders, including Stevens-Johnson syndrome and toxic epidermal necrolysis."( Therapeutic safety monitoring: what to look for and when to look for it.
Harden, CL, 2000
)
0.31
" Serious adverse events were assessed individually."( Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom.
Mawer, GE; Sander, JW; Wong, IC, 2001
)
0.31
" The adverse events with LTG reported by this study were similar to those reported in the literature."( Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom.
Mawer, GE; Sander, JW; Wong, IC, 2001
)
0.31
" Life-threatening adverse reactions were rare."( Adverse event monitoring in lamotrigine patients: a pharmacoepidemiologic study in the United Kingdom.
Mawer, GE; Sander, JW; Wong, IC, 2001
)
0.31
" Weight gain, somnolence, nystagmus, and dizziness were the major adverse events in these patients, whereas ataxia, tremor, and diplopia were found with gabapentin in a dose higher than 1,800 mg/day."( Efficacy and safety of gabapentin as an add-on therapy in refractory partial epileptic patients.
Rungreangyingyod, L; Suthisisang, C; Towanabut, S, 2001
)
0.82
" The most frequent adverse events were dizziness (31%), fatigue (29%), somnolence (27%), headache (21%), and ataxia (20%), with no major increase seen in adverse events necessitating discontinuation as the dose of GBP was titrated upward."( AUStralian study of titration to effect profile of safety (AUS-STEPS): high-dose gabapentin (neurontin) in partial seizures.
Beran, R; Berkovic, S; Black, A; Danta, G; Dunne, J; Frasca, J; Grainger, K; Kilpatrick, C; McKenzie, R; McLaughlin, D; Schapel, G; Somerville, E, 2001
)
0.54
"We reviewed the reports in the literature on the safety, adverse effects and tolerance of GBP as treatment, used as monotherapy or associated with other drugs, in epilepsies in patients of all age groups, including children, adults and the elderly."( [Safety and tolerability of gabapentin].
Viteri, C,
)
0.43
" The commonest adverse effects seen were somnolence, fainting, ataxia, nystagmus, tremor and headache."( [Safety and tolerability of gabapentin].
Viteri, C,
)
0.43
" Mild adverse effects were seen in 62 patients (37."( [Effectiveness and safety of gabapentin in the preventive treatment of migraine].
Friera Acebal, G; Jiménez-Hernández, MD; Torrecillas Nárvaez, MD,
)
0.42
"Gabapentin can be considered an effective and safe drug in the preventive treatment of migraine."( [Effectiveness and safety of gabapentin in the preventive treatment of migraine].
Friera Acebal, G; Jiménez-Hernández, MD; Torrecillas Nárvaez, MD,
)
1.87
" It is assumed that adverse events occurring with gabapentin are dose related, their frequency and severity increasing with increasing doses."( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
2.02
"The aim of this study was to assess the dose dependence of adverse events with gabapentin by determining the relationship between increasing doses of gabapentin and the onset and/or worsening of adverse events in patients with PHN."( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
1.99
" The analysis of adverse events was based on 3 distinct groups: patients who received gabapentin <1800 mg/d, those who received gabapentin >or=1800 mg/d, and those who received placebo."( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
1.99
" The 3 most common adverse events were dizziness, somnolence, and peripheral edema."( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
1.77
" Dizziness and somnolence, the other most commonly occurring adverse events, were transient and did not occur more frequently or worsen with titration to >or=1800 mg/d."( Gabapentin: a pooled analysis of adverse events from three clinical trials in patients with postherpetic neuralgia.
Huang, S; Parsons, B; Tive, L, 2004
)
1.77
" The aim of the study was to evaluate the frequency of AED utilisation and reported adverse events, in a cohort of MS patients."( Antiepileptic medications in multiple sclerosis: adverse effects in a three-year follow-up study.
Battaglia, MA; Brichetto, G; Mancardi, GL; Messmer Uccelli, M; Solaro, C, 2005
)
0.33
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" There is also a fairly broad consensus that gabapentin is safe and well tolerated, but the side-effect profile of gabapentin has not been adequately assessed in pain populations."( Adverse effects of gabapentin and lack of anti-allodynic efficacy of amitriptyline in the streptozotocin model of painful diabetic neuropathy.
Bourin, C; Chen, P; Hogan, JB; Leet, JE; Lindner, MD; Machet, F; McElroy, JF; Stock, DA, 2006
)
0.92
" In this study we evaluated randomized, controlled trials examining the analgesic efficacy, adverse effects, and clinical value of gabapentinoids in postoperative pain."( Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety.
Hamunen, K; Kalso, E; Kontinen, VK; Tiippana, EM, 2007
)
0.8
" Gabapentin reduced opioid-related adverse effects, such as nausea, vomiting, and urinary retention (number-needed-to-treat 25, 6, and 7, respectively)."( Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety.
Hamunen, K; Kalso, E; Kontinen, VK; Tiippana, EM, 2007
)
1.51
"Gabapentinoids effectively reduce postoperative pain, opioid consumption, and opioid-related adverse effects after surgery."( Do surgical patients benefit from perioperative gabapentin/pregabalin? A systematic review of efficacy and safety.
Hamunen, K; Kalso, E; Kontinen, VK; Tiippana, EM, 2007
)
2.04
" A global improvement, especially in anxious and depressive symptomatology, was observed; no adverse events were reported."( [Efficacy and safety of gabapentin in Borderline Personality Disorder: a six-month, open-label study].
Peris, L; Ruíz, M; Szerman, N,
)
0.44
" The adverse effects of gabapentin seem to vary from person to person and should be viewed with a high degree of suspicion, especially in patients taking this drug at the beginning."( Gabapentin toxicity: an important cause of altered consciousness in patients with uraemia.
Chen, CC; Chong, CF; Hung, TY; Seow, VK; Wang, TL, 2008
)
2.1
"Gabapentin was found to be partially effective and safe in symptomatic treatment of CTS patients."( The efficacy and safety of gabapentin in carpal tunnel patients: open label trial.
Erdemoglu, AK,
)
1.87
"8%); toxic manifestations were more severe in group III than in group II."( Gabapentin toxicity in patients with chronic kidney disease: a preventable cause of morbidity.
McKian, KP; Qian, Q; Zand, L, 2010
)
1.8
" An understanding of structure-activity relationships (SARs) of chemicals can make a significant contribution to the identification of potential toxic effects early in the drug development process and aid in avoiding such problems."( Developing structure-activity relationships for the prediction of hepatotoxicity.
Fisk, L; Greene, N; Naven, RT; Note, RR; Patel, ML; Pelletier, DJ, 2010
)
0.36
" The most common adverse reactions (incidence ≥ 20%) with single-agent use are fatigue, nausea, and anorexia."( Pemetrexed-induced cellulitis: a rare toxicity in non-small cell lung cancer treatment.
Katsenos, S; Panagou, C; Psara, A, 2013
)
0.39
" After the treatment, more than 95% of the initial blue product was removed from the waste solution and the treated waste was proven to be safe for aquatic organisms, as studied in brine shrimp and guppy fishes."( "From safe source to safe sink" development of colorimetric assay for gabapentin in bulk drug and capsules using naturally derived genipin.
Dejpittayanunt, S; Kongpakwattana, K; Nuntharatanapong, N; Pathomcharoensukchai, S; Rojanarata, T; Suksaran, U; Winotapun, W, 2012
)
0.61
"Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events."( Once-daily gastroretentive gabapentin for postherpetic neuralgia: integrated efficacy, time to onset of pain relief and safety analyses of data from two phase 3, multicenter, randomized, double-blind, placebo-controlled studies.
Irving, GA; Rauck, RL; Sweeney, M; Vanhove, GF; Wallace, MS, 2013
)
0.69
" The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%)."( Once-daily gastroretentive gabapentin for postherpetic neuralgia: integrated efficacy, time to onset of pain relief and safety analyses of data from two phase 3, multicenter, randomized, double-blind, placebo-controlled studies.
Irving, GA; Rauck, RL; Sweeney, M; Vanhove, GF; Wallace, MS, 2013
)
0.69
" Safety assessments included the incidence and severity of adverse events (AEs), the occurrence of serious AEs, changes in physical and neurological examination findings, clinical laboratory assessments, and changes in weight."( Long-term safety of gastroretentive gabapentin in postherpetic neuralgia patients.
Irving, G; Jensen, MP; Rauck, R; Sweeney, M; Vanhove, GF; Wallace, M, 2013
)
0.66
" Weight loss and numbness were common adverse effects in the topiramate group."( Comparison of efficacy and safety of topiramate with gabapentin in migraine prophylaxis: randomized open label control trial.
Ahmed, S; Alam, R; Khan, M; Zafar, I; Zain, S, 2013
)
0.64
" A total of 12 subjects in the gabapentin group and 15 subjects in the amitriptyline group experienced adverse events which were of mild to moderate grades."( A comparative study of efficacy and safety of gabapentin versus amitriptyline as coanalgesics in patients receiving opioid analgesics for neuropathic pain in malignancy.
Banerjee, M; Basu, J; Bhattacharya, B; Ghosh, B; Mondal, S; Pal, S,
)
0.68
"This paper presents a new analytical method for the simultaneous determination of baclofen and gabapentin in feeds based on two modified quick, easy, cheap, effective, rugged and safe (QuEChERS) sample preparation methods and liquid chromatography tandem mass spectrometry (LC-MS/MS)."( Evaluation of two modified quick, easy, cheap, effective, rugged and safe (QuEChERS) sample preparation methods for the analysis of baclofen and gabapentin in feeds by liquid chromatography tandem mass spectrometry.
Chen, RX; Hou, XL; Lv, Y; Wu, YL; Xu, XQ; Zhu, Y, 2014
)
0.82
"Treatment of postherpetic neuralgia (PHN) is more complicated in elderly patients, and multiple daily dosing, complex titration, and high incidences of adverse events can be limiting for many pharmacological treatment options."( Safety and efficacy of once-daily gastroretentive gabapentin in patients with postherpetic neuralgia aged 75 years and over.
Gupta, A; Li, S, 2013
)
0.64
" We chose the number of patients experiencing = 50% reduction in pain and number of patient withdrawals due to adverse events (AE) as primary outcomes for efficacy and safety, respectively."( Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.
Bansal, D; Bhansali, A; Ghai, B; Gudala, K; Hota, D; Rudroju, N; Talakokkula, ST,
)
0.13
"Gabapentin was found to be most efficacious and amitriptyline to be least safe among the treatments included in the study."( Comparative efficacy and safety of six antidepressants and anticonvulsants in painful diabetic neuropathy: a network meta-analysis.
Bansal, D; Bhansali, A; Ghai, B; Gudala, K; Hota, D; Rudroju, N; Talakokkula, ST,
)
1.57
" Gabapentin misuse is possible, similar to other medications not typically considered drugs of abuse, but it should be considered safe and appropriate for use in patients with all types of SUDs, including patients who take opioid drugs."( Gabapentin for Substance Use Disorders: Is it Safe and Appropriate?
Howland, RH, 2014
)
2.76
" However, gabapentin increased the somnolence (RR 2·03; 95% CI 1·39, 2·98; I(2)  = 2%), dizziness (RR 2·68; 95% CI 1·95, 3·69; I(2)  = 15%), peripheral oedema (RR 9·10; 95% CI 3·23, 25·60; I(2)  = 2%), total adverse effects (RR 1·28; 95% CI 1·16, 1·42; I(2)  = 0%) and withdrawal due to adverse events (RR 1·51; 95% CI 1·06, 2·16; I(2)  = 6%), but these adverse effects were often mild to moderate."( Efficacy and safety of gabapentin 1800 mg treatment for post-herpetic neuralgia: a meta-analysis of randomized controlled trials.
Cao, H; Fan, H; Hu, X; Li, J; Shao, Y; Wang, J; Yu, W; Zhang, Q, 2014
)
1.12
" Gabapentin 1800 mg appeared safe in treating PHN for up to 24 weeks."( Efficacy and safety of gabapentin 1800 mg treatment for post-herpetic neuralgia: a meta-analysis of randomized controlled trials.
Cao, H; Fan, H; Hu, X; Li, J; Shao, Y; Wang, J; Yu, W; Zhang, Q, 2014
)
1.62
" Discontinuation because of adverse events was significantly greater in the duloxetine (19."( Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain.
Irving, G; Malcolm, S; Raskin, J; Risser, RC; Tanenberg, RJ, 2014
)
0.63
"Duloxetine, pregabalin and duloxetine plus gabapentin were generally safe and tolerable for the treatment of DPNP."( Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain.
Irving, G; Malcolm, S; Raskin, J; Risser, RC; Tanenberg, RJ, 2014
)
0.89
" The aim of this review was to provide an update of current knowledge of adverse events (AE) associated with the most common perioperative non-opioid analgesics: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids (GCCs), gabapentinoids and their combinations."( Adverse effects of perioperative paracetamol, NSAIDs, glucocorticoids, gabapentinoids and their combinations: a topical review.
Dahl, JB; Hamunen, K; Hansen, MS; Kjer, JJ; Kontinen, VK; Mathiesen, O; Nikolajsen, L; Pommergaard, HC; Rosenberg, J; Wetterslev, J, 2014
)
0.82
" If future pregnancy registry data confirm this positive safety profile, gabapentin therapy would likely be a safe and effective treatment for RLS during pregnancy."( Potential maternal symptomatic benefit of gabapentin and review of its safety in pregnancy.
Guttuso, T; Shaman, M; Thornburg, LL, 2014
)
0.9
" Delayed corneal reepithelialization was a common side effect of both topical anesthetics and topical NSAIDs."( Efficacy and safety of pain relief medications after photorefractive keratectomy: review of prospective randomized trials.
Faktorovich, EG; Melwani, K, 2014
)
0.4
" However, narcotics can have significant adverse effects."( Safety and tolerability of gabapentin for aneurysmal subarachnoid hemorrhage (sah) headache and meningismus.
Dhakal, LP; Freeman, WD; Hodge, DO; Mayes, M; Nagal, J; Nagel, J; Ng, LK; Richie, A, 2015
)
0.71
"GBP appears to be relatively safe and tolerable in SAH patients with headache and may be a useful narcotic-sparing agent to prevent narcotics-associated complications, such as gastrointestinal immobility, ileus, and constipation."( Safety and tolerability of gabapentin for aneurysmal subarachnoid hemorrhage (sah) headache and meningismus.
Dhakal, LP; Freeman, WD; Hodge, DO; Mayes, M; Nagal, J; Nagel, J; Ng, LK; Richie, A, 2015
)
0.71
"To characterize risk factors for occurrence of adverse events (AEs) and treatment discontinuations due to AEs for improving safety and tolerability of treatment of postherpetic neuralgia (PHN)."( Relationships Among Adverse Events, Disease Characteristics, and Demographics in Treatment of Postherpetic Neuralgia With Gastroretentive Gabapentin.
Bucior, I; Nalamachu, S; Shaparin, N; Slattum, PW, 2015
)
0.62
" Considering that GAB was found in raw drinking water, the formation of toxic PTPs during drinking water treatment with UV light might be possible."( Identification of phototransformation products of the antiepileptic drug gabapentin: Biodegradability and initial assessment of toxicity.
Herrmann, M; Kümmerer, K; Menz, J; Olsson, O, 2015
)
0.65
" Adverse event were monitored and summarized."( Efficacy and Safety of Gabapentin in Comparison to Solifenacin Succinate in Adult Overactive Bladder Treatment.
Balingit, JC; Chua, ME; Esmeňa, EB; Morales, ML; See, MC, 2018
)
0.79
" Summary effect for migraine headache days, headache frequency, at least 50% reduction in headache attacks, all-adverse events, nausea, somnolence, dizziness, withdrawal and withdrawal due to adverse events were produced by synthesizing both direct and indirect evidence."( Unveiling the relative efficacy, safety and tolerability of prophylactic medications for migraine: pairwise and network-meta analysis.
He, A; Li, C; Song, D; Zhang, L, 2017
)
0.46
" Patients' demographic and clinical characteristics, resource utilization data and adverse drug reactions (ADRs) as described in the leaflet were extracted."( Characteristics, resource utilization and safety profile of patients prescribed with neuropathic pain treatments: a real-world evidence study on general practices in Europe - the role of the lidocaine 5% medicated plaster.
Katz, P; Liedgens, H; Pegoraro, V, 2017
)
0.46
"This meta-analysis of randomized controlled trials (RCTs) was performed to compare the use of gabapentin with placebo in open hysterectomy regarding (1) the mean difference (MD) of postoperative opioid requirements; (2) the changes of visual analogue scale (VAS) scores in two groups; and (3) incidence rate of adverse effects."( Is gabapentin effective and safe in open hysterectomy? A PRISMA compliant meta-analysis of randomized controlled trials.
Han, C; Li, XD; Yu, WL, 2017
)
1.3
" They necessitate prolonged use and are associated with adverse effects and increased cost."( Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials.
AlAmri, R; Bhandari, M; Devereaux, PJ; Gilron, I; Kamath, S; Rajarathinam, M; Shanthanna, H; Thabane, L, 2017
)
0.77
"Existing evidence on the use of gabapentinoids in CLBP is limited and demonstrates significant risk of adverse effects without any demonstrated benefit."( Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials.
AlAmri, R; Bhandari, M; Devereaux, PJ; Gilron, I; Kamath, S; Rajarathinam, M; Shanthanna, H; Thabane, L, 2017
)
1.05
" It still remains unclear how much these drugs are safe during pregnancy."( The neurotoxic effects of prenatal gabapentin and oxcarbazepine exposure on newborn rats.
Ayas, B; Ercument Beyhun, N; Erisgin, Z; Nyengaard, JR; Terzi, Y, 2019
)
0.79
"3%) patients reported adverse events."( Efficacy and safety of oxycodone/naloxone as add-on therapy to gabapentin or pregabalin for the management of chemotherapy-induced peripheral neuropathy in Korea.
Jin, JY; Kang, JH; Kim, BS; Ko, YH; Kwon, JH; Park, HJ; Park, SY; Woo, IS, 2018
)
0.72
" Nine adverse drug reactions, mostly mild, nonserious, and nonpreventable, were reported."( An Evaluation of Efficacy and Safety of Commonly Prescribed Drugs and Effect of These Drugs on Quality of Sleep in Patients Suffering From Zoster-Associated Pain.
Desai, CK; Desai, MK; Kapadia, JD; Nayak, MK; Shah, BJ, 2018
)
0.48
"0001], but were more likely to experience incidence of adverse events, such as somnolence, dizziness, and peripheral edema."( A Meta-Analysis of Therapeutic Efficacy and Safety of Gabapentin in the Treatment of Postherpetic Neuralgia from Randomized Controlled Trials.
Dai, ZG; Gao, CX; Li, L; Ma, KT; Si, JQ; Wang, S; Zhang, M, 2018
)
0.73
"Myalgia and arthralgia immune-related adverse events (irAEs) in patients treated with checkpoint inhibitors (CPIs) present a clinical challenge."( Myalgia and Arthralgia Immune-related Adverse Events (irAEs) in Patients With Genitourinary Malignancies Treated With Immune Checkpoint Inhibitors.
Allman, KD; Calabrese, C; Calabrese, LH; Garcia, JA; Grivas, P; Kirchner, E; Kontzias, A; Martin, A; Ornstein, MC; Profusek, P; Rini, BI; Wood, LS, 2019
)
0.51
"We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials."( Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
"We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials."( Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
" Pharmacovigilance data from the Food and Drug Administration Adverse Event Reporting System (FAERS) provides a useful examination of adverse drug event (ADE) reporting for safety signal detection."( Reports of gabapentin and pregabalin abuse, misuse, dependence, or overdose: An analysis of the Food And Drug Administration Adverse Events Reporting System (FAERS).
Covvey, JR; Evoy, KE; Hultgren, KE; Ochs, L; Peckham, AM, 2019
)
0.9
" Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions."( Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
"Using FDA Adverse Events Reporting System reports from January 1, 2005 to December 31, 2015, we calculated pharmacovigilance signal measures (i."( Gabapentin drug misuse signals: A pharmacovigilance assessment using the FDA adverse event reporting system.
Charnigo, RJ; Havens, JR; Lofwall, MR; Sun, J; Vickers-Smith, R; Walsh, SL, 2020
)
2
" Recent evidence suggests safety concerns associated with gabapentin including adverse neurologic effects."( Safety of Gabapentin Prescribed for Any Indication in a Large Clinical Cohort of 571,718 US Veterans with and without Alcohol Use Disorder.
Bryant, KJ; Fiellin, DA; Justice, AC; Morford, KL; Rentsch, CT; Tate, JP, 2020
)
1.2
" We used Poisson regression to estimate incidence rates and relative risk (RR) of these adverse events in association with gabapentin exposure overall and stratified by age, race/ethnicity, sex, HCV, HIV, AUD, and dose."( Safety of Gabapentin Prescribed for Any Indication in a Large Clinical Cohort of 571,718 US Veterans with and without Alcohol Use Disorder.
Bryant, KJ; Fiellin, DA; Justice, AC; Morford, KL; Rentsch, CT; Tate, JP, 2020
)
1.17
" Through molecular screening targeting the C terminal region of Aβ, a region involved in the toxic properties of the peptide, we detected an FDA approved compound, gabapentin (GBP), with neuroprotective effects against Aβ toxicity."( Gabapentin Inhibits Multiple Steps in the Amyloid Beta Toxicity Cascade.
Aguayo, LG; Bascuñán, D; Bobadilla-Azócar, C; Boopathi, S; Burgos, CF; Fernández-Pérez, A; Fernández-Pérez, EJ; Figueroa, M; González, W; González-Sanmiguel, J; Riffo-Lepe, N; Vicente, B, 2020
)
2.2
" No serious adverse event occurred during the trial and the most frequent treatment-emergent adverse events involved nervous system, QT prolongation, and gastrointestinal disorders."( Efficacy and Safety of Low Doses of Trazodone in Patients Affected by Painful Diabetic Neuropathy and Treated with Gabapentin: A Randomized Controlled Pilot Study.
Calisti, F; Cattaneo, A; Comandini, A; Cruccu, G; Del Vecchio, A; Di Loreto, G; Ehler, E; Lipone, P; Nastaj, M; Palka-Kisielowska, I; Pochiero, I; Truini, A, 2020
)
0.77
" As this patient population can be more challenging because of comorbidities, the presence of polypharmacy, pharmacokinetic, and pharmacodynamic changes, it is important to evaluate the risk of any relevant adverse effects for opioids and adjuncts that can lead to higher risk of opioid toxicities."( Safety and Efficacy Considerations of Gabapentin as Adjunctive Therapy to Opioids in the Perioperative Setting for Older Adults.
Garcia, E; Reinert, JP; Veronin, M, 2020
)
0.83
"Cardiotoxicity is one of the most commonly encountered adverse effects observed alongside the therapeutic use of doxorubicin (DOX), thus curbing its therapeutic utility."( Cardio-protective impact of gabapentin against doxorubicin-induced myocardial toxicity in rats; emphasis on modulation of inflammatory-apoptotic signaling.
Amin, MN; Said, E; Samra, YA, 2021
)
0.92
"To evaluate the association between perioperative coadministration of gabapentinoids and opioids with inpatient opioid-related adverse events in surgical patients."( Association of Gabapentinoids With the Risk of Opioid-Related Adverse Events in Surgical Patients in the United States.
Bateman, BT; Bykov, K; Franklin, JM; Patorno, E; Vine, SM, 2020
)
1.14
" Secondary outcomes included respiratory complications, unspecified adverse effects of opioid use, and a composite of these 3 outcomes."( Association of Gabapentinoids With the Risk of Opioid-Related Adverse Events in Surgical Patients in the United States.
Bateman, BT; Bykov, K; Franklin, JM; Patorno, E; Vine, SM, 2020
)
0.91
"In this real-world cohort study of patients who underwent major surgery, concomitant use of gabapentinoids with opioids was associated with increased risk of opioid overdose and other opioid-related adverse events; however, the absolute risk of adverse events was low."( Association of Gabapentinoids With the Risk of Opioid-Related Adverse Events in Surgical Patients in the United States.
Bateman, BT; Bykov, K; Franklin, JM; Patorno, E; Vine, SM, 2020
)
1.13
" Secondary outcomes include pain, total opioid use, adverse health events, health related quality of life and costs."( Effectiveness, cost-effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: protocol of a placebo controlled randomised controlled trial with blinding (GAP study).
Abbadi, R; Alzetani, A; Baos, S; Casali, G; Chauhan, N; Collett, L; Culliford, L; de Jesus, SE; Edwards, M; Gibbison, B; Goddard, N; Lamb, J; McKeon, H; Molyneux, M; Pufulete, M; Rogers, CA; Stokes, EA; Wordsworth, S, 2020
)
0.81
"This SR aims to assess the effectiveness of pregabalin and gabapentin on pain and disability caused by acute sciatica and the adverse events associated with their clinical use."( A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain.
Carbonell-Sanchís, R; Díaz-Cambronero, JI; Giménez-Campos, MS; López-Briz, E; Pimenta-Fermisson-Ramos, P; Ruíz-García, V, 2022
)
1.19
"The outcomes were pain, disability and adverse events."( A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain.
Carbonell-Sanchís, R; Díaz-Cambronero, JI; Giménez-Campos, MS; López-Briz, E; Pimenta-Fermisson-Ramos, P; Ruíz-García, V, 2022
)
0.95
" To inform their safe prescribing in older adults with chronic kidney disease (CKD), we examined the 30-day risk of serious adverse events according to the prescribed starting dose."( Higher-Dose Gabapentinoids and the Risk of Adverse Events in Older Adults With CKD: A Population-Based Cohort Study.
Ahmadi, F; Blake, PG; Cowan, A; Fleet, JL; Garg, AX; Muanda, FT; Sontrop, JM; Weir, MA, 2022
)
1.1
" However, the role of gabapentin has been questioned because of concerns of adverse effects, particularly in the elderly."( Analysis of Adverse Effects of Multimodal Gabapentin in Abdominal Wall Reconstruction.
Brower, KI; Janis, JE; Joshi, GP; Sarac, BA; Schoenbrunner, AR, 2022
)
1.3
" Furthermore, even among those aged 65 years or older, postoperative gabapentin use was not significantly associated with these adverse events."( Analysis of Adverse Effects of Multimodal Gabapentin in Abdominal Wall Reconstruction.
Brower, KI; Janis, JE; Joshi, GP; Sarac, BA; Schoenbrunner, AR, 2022
)
1.22
"In patients undergoing abdominal wall reconstruction, postoperative gabapentin administration was not associated with an increase in adverse effects."( Analysis of Adverse Effects of Multimodal Gabapentin in Abdominal Wall Reconstruction.
Brower, KI; Janis, JE; Joshi, GP; Sarac, BA; Schoenbrunner, AR, 2022
)
1.22
" The results showed that, at the end of the study, duloxetine was significantly superior to gabapentin in terms of the incidence of adverse reactions (RR = 0."( Comparison of the Efficacy and Safety of Duloxetine and Gabapentin in Diabetic Peripheral Neuropathic Pain: A Meta-Analysis.
Cui, J; Jiang, L; Xiong, Y, 2022
)
1.19
"There have been several reports that switching formulations of antiseizure medications (ASMs) has been associated with a deterioration of seizure control, seizure relapse or increased adverse effects."( Analyzing excipient-related adverse events in antiseizure drug formulations.
Ionova, Y; Peterson, T; Wilson, L, 2022
)
0.72
" This study evaluated GP prescribing patterns and whether excessive dosing was associated with increased incidence of gabapentinoid-related adverse events (GRAEs)."( Gabapentinoid dosing and adverse events in patients with chronic kidney disease.
Cave, B; Hudson, JQ; Washington, K; Wells, DA; Zhu, R, 2022
)
2.37
"Appropriate dosing of GPs is particularly important to minimize the risk of adverse events in patients of older age, with a history of seizures, or concomitant antipsychotic use."( Gabapentinoid dosing and adverse events in patients with chronic kidney disease.
Cave, B; Hudson, JQ; Washington, K; Wells, DA; Zhu, R, 2022
)
2.16
"All nine drugs can relieve the pain of CPSP patients to different degrees; among them pregabalin and gabapentin have the most significant effect, and gabapentin and pregabalin also have the most adverse reactions."( Efficacy and safety of different antidepressants and anticonvulsants in central poststroke pain: A network meta-analysis and systematic review.
Chen, KY; Li, RY, 2022
)
0.94
" However, there is limited data regarding the opioid-sparing effect and adverse effect profiles of gabapentin in the bariatric surgical population."( Efficacy and Safety of Gabapentin on Postoperative Pain Management After Bariatric Surgery: A Systematic Review and Meta-Analysis.
Bayaua, NE; Bramble, RS; Harmer, CM; Mijares, M; Tubog, TD, 2023
)
1.44
" The majority of adverse events pertained to the nervous system (7 effects) or psychiatric (3 effects) disorders."( The safety and efficacy of gabapentinoids in the management of neuropathic pain: a systematic review with meta-analysis of randomised controlled trials.
Eldabe, S; Meaadi, J; Nazar, H; Obara, I, 2023
)
1.21
"Despite RCTs documenting the adverse events of gabapentionoids on the nervous system, there was no evidence of gabapentinoid use leading to addiction, suggesting an urgent need to design studies investigating their abusive potential."( The safety and efficacy of gabapentinoids in the management of neuropathic pain: a systematic review with meta-analysis of randomised controlled trials.
Eldabe, S; Meaadi, J; Nazar, H; Obara, I, 2023
)
1.42
" The outcome measures included scores: (1) for the improvement in the degree of sleep interference score; (2) for the improvement in sleep quality; (3) for the rate of poor sleep quality; (4) for the rate awakenings of >5 per night; and (5) for the incidence of adverse reactions."( Efficacy and Safety of Gabapentin in Improving Sleep Quality of Patients with Sensory Nervous System Diseases: A Meta-Analysis.
Jiang, W; Li, W; Ma, M; Shen, Y, 2023
)
1.22
" No statistically significant differences existed in the incidence of adverse reactions between the two groups."( Efficacy and Safety of Gabapentin in Improving Sleep Quality of Patients with Sensory Nervous System Diseases: A Meta-Analysis.
Jiang, W; Li, W; Ma, M; Shen, Y, 2023
)
1.22
"Gabapentin is safe and effective in improving the sleep quality of patients with sensory nervous-system diseases."( Efficacy and Safety of Gabapentin in Improving Sleep Quality of Patients with Sensory Nervous System Diseases: A Meta-Analysis.
Jiang, W; Li, W; Ma, M; Shen, Y, 2023
)
2.66

Pharmacokinetics

A sensitive validated liquid chromatography-tandem mass spectrometric method (LC-MS/MS) for gabapentin (GB) in human plasma has been developed and applied to pharmacokinetic (PK) and bioequivalence (BE) studies in human. This study examined the single-dose Pharmacokinetic profiles of Li in 13 patients receiving placebo and then steady-state gabAPentin (mean daily dose: 3,646.

ExcerptReferenceRelevance
"This paper describes the pharmacokinetic studies of 1-(aminomethyl)-cyclohexane acetic acid (gabapentin, Gö 3450, CI-945) conducted with the 14C-labelled substance following intravenous and intragastric administration to rats and dogs and oral administration to humans."( Pharmacokinetics and metabolism of gabapentin in rat, dog and man.
Kölle, EU; Vollmer, KO; von Hodenberg, A, 1986
)
0.77
"With the introduction of three new anti-epileptic drugs (AEDs) in the UK during the past 4 years as adjunctive add-on therapy, the possibility of AED pharmacokinetic interactions has become a relevant consideration."( Phenobarbitone to gabapentin: a guide to 82 years of anti-epileptic drug pharmacokinetic interactions.
Patsalos, PN, 1994
)
0.62
" The elimination half-life is approximately 5 to 9 hours."( Clinical pharmacokinetics of gabapentin.
McLean, MJ, 1994
)
0.58
" Apparent oral plasma clearance (CL/F) and renal clearance (CLR) of gabapentin decreased and maximum plasma concentration, time to reach maximum concentration, and half-life values increased as renal function diminished."( Pharmacokinetics of gabapentin in subjects with various degrees of renal function.
Blum, RA; Bockbrader, H; Busch, JA; Comstock, TJ; Keller, E; Reece, PA; Reetze, P; Schultz, RW; Sica, DA; Tuerck, D, 1994
)
0.85
" Three of the new drugs, gabapentin, topiramate and vigabatrin, are more promising on the basis of their pharmacokinetic features."( Comparative pharmacokinetics of the newer antiepileptic drugs.
Bialer, M, 1993
)
0.59
"Antiepileptic drugs (AEDs) in broad use today have a number of pharmacokinetic liabilities, including a propensity for clinically meaningful drug interactions."( Pharmacokinetic profile of topiramate in comparison with other new antiepileptic drugs.
Perucca, E, 1996
)
0.29
"Gabapentin is a new antiepileptic drug (AED) with an attractive pharmacokinetic profile."( Gabapentin: pharmacokinetics, efficacy, and safety.
Beydoun, A; Sackellares, JC; Uthman, BM, 1995
)
3.18
" The BBB influx (CL1) and efflux (CL2) permeabilities of GBP were estimated with a hybrid pharmacokinetic model assuming that transport between intra- and extracellular space was more rapid than transport across the BBB."( The simultaneous estimation of the influx and efflux blood-brain barrier permeabilities of gabapentin using a microdialysis-pharmacokinetic approach.
Wang, Y; Welty, DF, 1996
)
0.51
" All the drugs can be conveniently given as a twice daily dosage apart from gabapentin, which has a short half-life and a midday dose is needed."( Clinical pharmacokinetics of newer antiepileptic drugs. Lamotrigine, vigabatrin, gabapentin and oxcarbazepine.
Binnie, CD; Elwes, RD, 1996
)
0.75
" Calculated pharmacokinetic parameters included Cmax' Tmax' AUC and T1/2."( Effect of a high-protein meal on gabapentin pharmacokinetics.
Budde, J; Gidal, BE; Jones, JC; Lensmeyer, GL; Maly, MM; Pitterle, ME, 1996
)
0.58
"This article surveys the pharmacokinetic parameters for the new antiepileptic drugs (AEDs): felbamate, gabapentin, lamotrigine, oxcarbazepine, tiagabine, topiramate, and vigabatrin."( Pharmacokinetics of new antiepileptic drugs.
Gram, L, 1996
)
0.51
"Standard antiepileptic drugs (AEDs) have a number of pharmacokinetic shortcomings, and AEDs with more favorable profiles would be preferred."( Pharmacokinetics and interaction profile of topiramate: review and comparison with other newer antiepileptic drugs.
Johannessen, SI, 1997
)
0.3
" This study examined the single-dose pharmacokinetic profiles of Li in 13 patients receiving placebo and then steady-state gabapentin (mean daily dose: 3,646."( Gabapentin does not alter single-dose lithium pharmacokinetics.
Corá-Locatelli, G; Dunn, RT; Frye, MA; Grothe, D; Ketter, TA; Kimbrell, TA; Piscitelli, S; Post, RM; Vanderham, E, 1998
)
1.95
" GBP concentrations in plasma and urine were measured by high-performance liquid chromatography, and pharmacokinetic parameters were calculated by noncompartmental methods."( Effects of age and gender on single-dose pharmacokinetics of gabapentin.
Abel, RB; Bockbrader, HN; Boyd, RA; Sedman, AJ; Türck, D, 1999
)
0.54
" No change in maximal GBP plasma concentration (Cmax), time at which Cmax occurred (tmax), or apparent volume of distribution (V/F) with age was noted."( Effects of age and gender on single-dose pharmacokinetics of gabapentin.
Abel, RB; Bockbrader, HN; Boyd, RA; Sedman, AJ; Türck, D, 1999
)
0.54
" For all drugs that are metabolized, half-life is shortened and clearance is increased when patients receive concomitant enzyme-inducing agents such as barbiturates, phenytoin, and carbamazepine."( The clinical pharmacokinetics of the new antiepileptic drugs.
Perucca, E, 1999
)
0.3
" Orally administered GBP did not significantly alter the pharmacokinetic parameters of parenteral PT."( Effect of vigabatrin and gabapentin on phenytoin pharmacokinetics in the dog.
Al-Hassan, MI; Bawazir, SA; Matar, KM; Nicholls, PJ; Tekle, A, 2000
)
0.61
" Plots of pharmacokinetic parameters versus age suggested significant differences between younger (1 month to < 5 years) and older (> or =5 to 12 years) subjects."( Single-dose gabapentin pharmacokinetics and safety in healthy infants and children.
Bockbrader, HN; Boellner, SW; Brown, RR; Haig, GM; Ouellet, D; Posvar, EL; Randinitis, EJ; Wesche, DL, 2001
)
0.69
" Orally administered GBP did not significantly alter the pharmacokinetic parameters of parental PT."( Effect of vigabatrin and gabapentin on phynytoin pharmacokinetics in the dog.
al-Hassan, MI; Bawazir, SA; Matar, KM; Nicholls, PJ; Tekle, A,
)
0.43
" In the meantime, a review of the established pharmacokinetic and pharmacodynamic activities of these agents is the first step in defining their optimal uses and limitations in the psychiatric setting."( Pharmacokinetics of new anticonvulsants in psychiatry.
Morris, HH, 1998
)
0.3
"The pharmacokinetic properties of a drug are the primary deter-minant of the extent and duration of drug action, and influence susceptibility to clinically important drug interactions."( The ideal pharmacokinetic properties of an antiepileptic drug: how close does levetiracetam come?
Johannessen, SI; Perucca, E, 2003
)
0.32
" Pharmacokinetic parameters for gabapentin were determined by non-compartment methods using multivariate regression analysis."( Pharmacokinetics of gabapentin in paediatric patients with uncontrolled seizures.
Lo, W; Nahata, MC; Tallian, KB; Tsao, CY, 2004
)
0.93
"Data from nine patients were suitable for pharmacokinetic analysis."( Pharmacokinetics of gabapentin in paediatric patients with uncontrolled seizures.
Lo, W; Nahata, MC; Tallian, KB; Tsao, CY, 2004
)
0.65
"Human pharmacokinetic parameters are often predicted prior to clinical study from in vivo preclinical pharmacokinetic data."( Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
Jolivette, LJ; Ward, KW, 2005
)
0.33
" The pharmacokinetic parameters such as AUC(0."( Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers.
Cho, HY; Kang, HA; Lee, YB, 2006
)
0.58
" No statistically significant difference was found for tmax and t1/2 values."( Pharmacokinetics and bioequivalence evaluation of two gabapentin preparations after a single oral dose in healthy Korean volunteers.
Cho, HY; Kang, HA; Lee, YB, 2006
)
0.58
" 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
)
0.58
" The pharmacokinetic profile of GBP was examined."( The effect of MDR1 G2677T/A polymorphism on pharmacokinetics of gabapentin in healthy Korean subjects.
Cho, HY; Kang, HA; Lee, YB, 2007
)
0.58
"A sensitive validated liquid chromatography-tandem mass spectrometric method (LC-MS/MS) for gabapentin (GB) in human plasma has been developed and applied to pharmacokinetic (PK) and bioequivalence (BE) studies in human."( Validated LC-MS/MS method for quantification of gabapentin in human plasma: application to pharmacokinetic and bioequivalence studies in Korean volunteers.
Jhee, OH; Kang, JS; Kim, KH; Kim, YS; Lee, JH; Lee, JS; Lee, MH; Park, JH; Park, SH; Shaw, LM, 2007
)
0.82
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" A single dose (600 mg) of each formulation was orally administered to four beagle dogs under fasted conditions, and the pharmacokinetic parameters were calculated."( In Vitro/in vivo relationship of gabapentin from a sustained-release tablet formulation: a pharmacokinetic study in the beagle dog.
Han, SB; Jeon, JW; Lee, DS; Lee, TW; Nam, TY; Oh, TO; Park, CW; Park, ES; Park, S; Rhee, YS, 2008
)
0.63
" In contrast, levetiracetam was without affect on tiagabine or vigabatrin concentrations and co-administration with gabapentin, tiagabine or vigabatrin had no effect on levetiracetam brain concentrations, indicating the pharmacodynamic nature of interaction between these antiepileptic drugs in the mouse pentylenetetrazole model."( Pharmacodynamic and pharmacokinetic interaction profiles of levetiracetam in combination with gabapentin, tiagabine and vigabatrin in the mouse pentylenetetrazole-induced seizure model: an isobolographic analysis.
Andres-Mach, MM; Czuczwar, SJ; Dudra-Jastrzebska, M; Luszczki, JJ; Patsalos, PN; Ratnaraj, N; Sielski, M, 2009
)
0.78
" Pharmacokinetic parameters were determined with computer software."( Pharmacokinetics of oral gabapentin in greyhound dogs.
Cohen, RL; Kukanich, B, 2011
)
0.67
" Data from all subjects were used for pharmacokinetic and safety analyses unless stated otherwise."( The effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbil.
Cundy, KC; Huff, FJ; Lal, R; Luo, W; Sukbuntherng, J; Zou, J, 2010
)
0.59
" The pharmacokinetics of gabapentin delivered from this extended-release formulation allows a reduced dosing frequency while maintaining bioavailability and possibly diminishing the occurrence of adverse events attributable to a slower increase to the peak concentration compared with the immediate-release dosage form."( Pharmacokinetics of gabapentin in a novel gastric-retentive extended-release formulation: comparison with an immediate-release formulation and effect of dose escalation and food.
Chen, C; Cowles, VE; Hou, E, 2011
)
1
" After IV administration, the mean +/- SEM apparent volume of the central compartment, apparent volume of distribution at steady state, and clearance and the harmonic mean +/- jackknife pseudo-SD for terminal half-life were 90."( Pharmacokinetics of gabapentin in cats.
Ilkiw, JE; Pypendop, BH; Siao, KT, 2010
)
0.68
"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
)
0.94
"Gabapentin is being used in horses although its pharmacokinetic (PK) profile, pharmacodynamic (PD) effects and safety in the equine are not fully investigated."( Pharmacokinetic profile and behavioral effects of gabapentin in the horse.
Driessen, B; Liu, Y; McDonnell, SM; Moate, PJ; Soma, LR; Terry, RL; Uboh, CE; Van Eps, AW, 2010
)
2.06
" Plasma drug concentrations were determined over 48h post-administration by liquid chromatography/mass spectrometry followed by non-compartmental pharmacokinetic analysis."( Pharmacokinetics of oral gabapentin alone or co-administered with meloxicam in ruminant beef calves.
Coetzee, JF; Cull, CA; Kelly, LL; Kohake, LE; KuKanich, B; Mosher, RA; Mueting, SL, 2011
)
0.67
" The method was proved to be selective, sensitive, rapid and suitable for pharmacokinetic study of gabapentin in human plasma."( [LC-MS/MS method for quantification and pharmacokinetic study of gabapentin in human plasma].
He, JF; Li, FM; Qin, F; Xiong, ZL; Yu, J, 2011
)
0.82
" Plasma and milk drug concentrations were determined over 7 days postadministration by HPLC/MS followed by noncompartmental pharmacokinetic analyses."( Pharmacokinetics and milk secretion of gabapentin and meloxicam co-administered orally in Holstein-Friesian cows.
Coetzee, JF; Gehring, R; Kukanich, B; Malreddy, PR, 2013
)
0.66
" Therefore, pharmacokinetic of gabapentin is essential for patients who have to receive gabapentin 600 mg."( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
0.99
"To investigate the pharmacokinetic of gabapentin 600 mg in Thai healthy subjects."( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
0.98
" The relevant pharmacokinetic parameters were determined."( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
0.71
"The data show the pharmacokinetic parameters of gabapentin 600 mg."( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
0.96
" Pharmacokinetic sampling was conducted over a 24-hour period at the end of each study period."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.66
"The pharmacokinetic profile of gabapentin-ER may allow for once- or twice-daily dosing while maintaining bioavailability and thus efficacy."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.95
" 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
)
2.19
"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
" The differences in the dosing frequency and tolerability between G-IR and GR are mainly because of the difference in formulations and thus pharmacokinetic properties."( Pharmacokinetics, efficacy, and tolerability of a once-daily gastroretentive dosage form of gabapentin for the treatment of postherpetic neuralgia.
Chen, C; Cowles, VE; Han, CH; Sweeney, M, 2013
)
0.61
" Using plasma gabapentin concentration data obtained after administration of GEn in 12 phase 1 to 3 GEn studies in healthy adults or patients with RLS (dose range, 300-2400 mg/d), a population pharmacokinetic (PK) model was developed by nonlinear mixed-effect modeling using NONMEM."( Population pharmacokinetics and pharmacodynamics of gabapentin after administration of gabapentin enacarbil.
Cundy, KC; Lal, R; Lassauzet, ML; Luo, W; Sukbuntherng, J; Tovera, J, 2013
)
1
" In this study, we compared the pharmacokinetic parameters and effect of preemptive analgesics administered to calves subjected to dehorning with local anesthesia."( The pharmacokinetics and effects of meloxicam, gabapentin, and flunixin in postweaning dairy calves following dehorning with local anesthesia.
Allen, KA; Bergamasco, LL; Coetzee, JF; Dockweiler, JC; Edwards-Callaway, LN; Fraccaro, E; Glynn, HD; Jones, M; KuKanich, B; Lubbers, B, 2013
)
0.65
"These data suggest that diet-drug pharmacokinetic interactions may occur during co-exposure to gabapentin and mushroom constituents."( Effect of mushroom diet on pharmacokinetics of gabapentin in healthy Chinese subjects.
Goh, BC; Lee, EJ; Limenta, LM; Murray, M; Toh, DS; Wang, LZ; Yee, JY, 2014
)
0.88
"5, 3, 4, 5, 6, 8, 10, 12, 15, and 24 hours after dosing, to evaluate pharmacokinetic parameters of the single dose administration, ie, the area under the plasma concentration-time curve (AUC) from time zero to 24 hours (AUCt), AUC from time zero to infinity (AUC(inf)), the peak plasma concentration of the drug (Cmax), time needed to achieve Cmax (tmax), and the elimination half-life (t1/2)."( Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects.
Amalia, F; Putri, RS; Setiawati, E; Susanto, LW; Tjandrawinata, RR; Yunaidi, DA, 2014
)
0.65
" The differences in tmax and t1/2 values between the test and reference drug products for gabapentin were not statistically significant."( Single dose pharmacokinetic equivalence study of two gabapentin preparations in healthy subjects.
Amalia, F; Putri, RS; Setiawati, E; Susanto, LW; Tjandrawinata, RR; Yunaidi, DA, 2014
)
0.87
" Pharmacodynamic measures were limited to subject assessment of somnolence, dizziness, and nausea conducted by using a visual analog scale (VAS)."( Gabapentin enacarbil and morphine administered in combination versus alone: a double-blind, randomized, pharmacokinetic, and tolerability comparison.
Arumugham, T; Chen, C; Davy, M; Stier, B; Upward, J, 2015
)
1.86
"No significant pharmacokinetic interaction between the 2 drugs was seen in this study."( Gabapentin enacarbil and morphine administered in combination versus alone: a double-blind, randomized, pharmacokinetic, and tolerability comparison.
Arumugham, T; Chen, C; Davy, M; Stier, B; Upward, J, 2015
)
1.86
" Pharmacokinetic parameters were estimated from plasma concentration-time data using standard non-compartmental methods."( Pharmacokinetic effects of simultaneous administration of single-dose gabapentin 500 mg and zolpidem tartrate 10 mg in healthy volunteers: a randomized, open-label, crossover trial.
Furey, SA; Galitz, LA; Jayawardena, S, 2015
)
0.65
" Plasma gabapentin concentrations were estimated by noncompartmental pharmacokinetic analysis."( PHARMACOKINETIC PROPERTIES OF A SINGLE ADMINISTRATION OF ORAL GABAPENTIN IN THE GREAT HORNED OWL (BUBO VIRGINIANUS).
Coetzee, JF; Gall, A; Olds, JE; Papastavros, E; Wulf, L; Yaw, TJ; Zaffarano, BA, 2015
)
1.09
" Plasma samples were analyzed for gabapentin concentration, and pharmacokinetic parameters were calculated with both a nonlinear mixed-effect approach and a noncompartmental analysis."( Pharmacokinetics of Compounded Intravenous and Oral Gabapentin in Hispaniolan Amazon Parrots ( Amazona ventralis ).
Baine, K; Cox, S; Jones, MP; Martín-Jiménez, T, 2015
)
0.95
" Despite the well characterised pharmacodynamic interaction, little is known about possible pharmacokinetic interactions."( Population Pharmacokinetic Modelling of Morphine, Gabapentin and their Combination in the Rat.
Gabel-Jensen, C; Juul, RV; Kreilgaard, M; Lund, TM; Papathanasiou, T, 2016
)
0.69
" The combination did not lead to pharmacokinetic interactions for morphine or gabapentin but resulted in an estimated ~33% diminished morphine-3-glucuronide formation."( Population Pharmacokinetic Modelling of Morphine, Gabapentin and their Combination in the Rat.
Gabel-Jensen, C; Juul, RV; Kreilgaard, M; Lund, TM; Papathanasiou, T, 2016
)
0.92
"The finding of a lack of pharmacokinetic interaction strengthens the notion that the combination of the two drugs leads to better efficacy in pain treatment due to interaction at the pharmacodynamic level."( Population Pharmacokinetic Modelling of Morphine, Gabapentin and their Combination in the Rat.
Gabel-Jensen, C; Juul, RV; Kreilgaard, M; Lund, TM; Papathanasiou, T, 2016
)
0.69
" This was a prospective pharmacokinetic study in elderly nursing home patients (≥60 years) receiving GBP for the management of chronic pain or epilepsy from seven nursing homes."( Pharmacokinetics and Saturable Absorption of Gabapentin in Nursing Home Elderly Patients.
Ahmed, GF; Bathena, SP; Birnbaum, AK; Brundage, RC; Conway, JM; Leppik, IE; Schwartz, JB, 2017
)
0.71
" With 2-L exchanges every 2 hours, we document an apparent elimination half-life of 41."( Treatment of Gabapentin Toxicity With Peritoneal Dialysis: Assessment of Gabapentin Clearance.
Edwards, JC; Ibrahim, H; Oman, Z; Schuelke, M, 2017
)
0.82
" The purpose of this study was to quantitatively characterize the pharmacodynamic interaction between the two drugs and to identify the optimal concentration-effect relationship of the combination."( Quantification of the Pharmacodynamic Interaction of Morphine and Gabapentin Using a Response Surface Approach.
Gabel-Jensen, C; Heegaard, AM; Juul, RV; Kreilgaard, M; Lund, TM; Papathanasiou, T, 2017
)
0.69
" The ultimate aim of our research is to investigate if pharmacokinetic subpopulations exist when subjects are exposed to bioequivalent formulations."( Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs.
Burger, DM; Glerum, PJ; Maliepaard, M; Neef, C; Neely, MN; Yamada, WM; Yu, Y, 2018
)
0.71
" Pharmacokinetic analysis was based on plasma and urine data concentrations."( The role of organic cation transporter 2 inhibitor cimetidine, experimental diabetes mellitus and metformin on gabapentin pharmacokinetics in rats.
Baviera, AM; Benzi, JRL; de Moraes, NV; Stevens, JH; Yamamoto, PA, 2018
)
0.69
"No differences in pharmacokinetic parameters were observed between vehicle + GAB × cimetidine + GAB and vehicle + GAB × metformin + GAB groups."( The role of organic cation transporter 2 inhibitor cimetidine, experimental diabetes mellitus and metformin on gabapentin pharmacokinetics in rats.
Baviera, AM; Benzi, JRL; de Moraes, NV; Stevens, JH; Yamamoto, PA, 2018
)
0.69
" This is the first pharmacokinetic (PK) comparison of all three formulations using FDA-recommended doses for PHN."( Pharmacokinetics of immediate release, extended release, and gastric retentive gabapentin formulations in healthy adults
.
Aronoff, GM; Ciric, S; Lal, R; Swearingen, D, 2018
)
0.71
" Despite this common and chronic usage, clinically relevant pharmacokinetic data is lacking."( The pharmacokinetics of gabapentin in cats.
Adrian, D; Baynes, R; Lascelles, BDX; Papich, MG; Stafford, E, 2018
)
0.79
"Cats were enrolled in a serial order, non-randomized pharmacokinetic study."( The pharmacokinetics of gabapentin in cats.
Adrian, D; Baynes, R; Lascelles, BDX; Papich, MG; Stafford, E, 2018
)
0.79
"The purpose of this research was to establish an in vitro dissolution testing method to predict the oral pharmacokinetic (PK) profiles and food effects of gabapentin enacarbil formulated as wax matrix extended-release (ER) tablets in humans."( Prediction of the Oral Pharmacokinetics and Food Effects of Gabapentin Enacarbil Extended-Release Tablets Using Biorelevant Dissolution Tests.
Asai, T; Kambayashi, A; Kojima, H; Oku, N; Yamaguchi Ikeuchi, S, 2018
)
0.92
" 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
" Pharmacokinetic parameters were estimated using noncompartmental analysis."( Pharmacokinetics and pharmacodynamics of repeat dosing of gabapentin in adult horses.
Cox, S; Gold, JR; Grubb, TL; Malavasi, L; Villarino, NL, 2022
)
0.97

Compound-Compound Interactions

Measurement of total brain antiepileptic drug concentrations revealed that levetiracetam in combination with gabapentin at the fixed-ratio of 1:4 significantly elevated. Gabapentin significantly increased drug liking when given in combination with ALC and OXY + ALC (p < 0.5)

ExcerptReferenceRelevance
" In the present study, the effect of gabapentin (GBP) on seizure score and memory is evaluated when it is given alone and in combination with some antidepressants, such as sertraline (SERTR) and alprazolam (ALP)."( Effects of gabapentin and antidepressant drug combinations on convulsions and memory in mice.
Ali, A; Dua, Y; Pal, SN; Pillai, KK; Rizwan, AN,
)
0.79
"Acute gabapentin administration was well tolerated in combination with alcohol, but did not alter the effects of alcohol."( The acute effects of gabapentin in combination with alcohol in heavy drinkers.
Bisaga, A; Evans, SM, 2006
)
1.13
" Measurement of total brain antiepileptic drug concentrations revealed that levetiracetam in combination with gabapentin at the fixed-ratio of 1:4 significantly elevated (21%) total brain gabapentin concentrations."( Pharmacodynamic and pharmacokinetic interaction profiles of levetiracetam in combination with gabapentin, tiagabine and vigabatrin in the mouse pentylenetetrazole-induced seizure model: an isobolographic analysis.
Andres-Mach, MM; Czuczwar, SJ; Dudra-Jastrzebska, M; Luszczki, JJ; Patsalos, PN; Ratnaraj, N; Sielski, M, 2009
)
0.78
" We, therefore, investigated the analgesic effect of gabapentin, dexamethasone and low-dose ketamine in combination with paracetamol and ketorolac as compared with paracetamol and ketorolac alone after hip arthroplasty."( Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study.
Christensen, BV; Dahl, JB; Dierking, G; Hilsted, KL; Larsen, TK; Mathiesen, O; Rasmussen, ML, 2010
)
0.91
"Preoperative gabapentin, dexamethasone and ketamine combined with paracetamol and ketorolac reduced overall pain scores in patients after hip arthroplasty as compared with paracetamol and ketorolac alone."( Multimodal analgesia with gabapentin, ketamine and dexamethasone in combination with paracetamol and ketorolac after hip arthroplasty: a preliminary study.
Christensen, BV; Dahl, JB; Dierking, G; Hilsted, KL; Larsen, TK; Mathiesen, O; Rasmussen, ML, 2010
)
1.03
"To evaluate the effects of high-frequency electrical stimulation (HFS) in both ventral hippocampi, alone and combined with a subeffective dose of antiepileptic drugs, during the status epilepticus (SE) induced by lithium-pilocarpine (LP)."( Antiepileptic drugs combined with high-frequency electrical stimulation in the ventral hippocampus modify pilocarpine-induced status epilepticus in rats.
Alcantara-Gonzalez, D; Cuellar-Herrera, M; Neri-Bazan, L; Peña, F; Rocha, L, 2010
)
0.36
" One minute following pilocarpine injection, HFS (pulses of 60 mus width at 130 Hz at subthreshold intensities and applied during 3 h) was applied alone or combined with subeffective doses of antiepileptic drugs."( Antiepileptic drugs combined with high-frequency electrical stimulation in the ventral hippocampus modify pilocarpine-induced status epilepticus in rats.
Alcantara-Gonzalez, D; Cuellar-Herrera, M; Neri-Bazan, L; Peña, F; Rocha, L, 2010
)
0.36
" This effect was not evident when HFS was combined with phenytoin (33."( Antiepileptic drugs combined with high-frequency electrical stimulation in the ventral hippocampus modify pilocarpine-induced status epilepticus in rats.
Alcantara-Gonzalez, D; Cuellar-Herrera, M; Neri-Bazan, L; Peña, F; Rocha, L, 2010
)
0.36
" The aim of this study was to see whether low-dose gabapentin is effective in treating cancer-related neuropathic pain when combined with low-dose imipramine."( Low-dose gabapentin as useful adjuvant to opioids for neuropathic cancer pain when combined with low-dose imipramine.
Arai, YC; Arakawa, M; Hayashi, R; Kinoshita, A; Kobayashi, K; Kondo, M; Matsubara, S; Matsubara, T; Nishida, K; Nishihara, M; Shimo, K; Suetomi, K; Suzuki, C; Tohyama, Y; Ushida, T, 2010
)
1.03
"Low-dose gabapentin-antidepressant combination with opioids was effective in managing neuropathic cancer pain without severe adverse effects."( Low-dose gabapentin as useful adjuvant to opioids for neuropathic cancer pain when combined with low-dose imipramine.
Arai, YC; Arakawa, M; Hayashi, R; Kinoshita, A; Kobayashi, K; Kondo, M; Matsubara, S; Matsubara, T; Nishida, K; Nishihara, M; Shimo, K; Suetomi, K; Suzuki, C; Tohyama, Y; Ushida, T, 2010
)
1.19
"Three-phase hollow fiber microextraction technique combined with high performance liquid chromatography-ultra violet (HPLC-UV) was applied for the extraction and determination of gabapentin in biological fluids."( Hollow fiber-based liquid phase microextraction combined with high-performance liquid chromatography for the analysis of gabapentin in biological samples.
Ebrahimzadeh, H; Firozjaei, HA; Kamarei, F; Rouini, MR; Tavassoli, N; Yamini, Y, 2010
)
0.76
" This study determined the pharmacokinetics of oral (PO) gabapentin alone or in combination with meloxicam in ruminant calves."( Pharmacokinetics of oral gabapentin alone or co-administered with meloxicam in ruminant beef calves.
Coetzee, JF; Cull, CA; Kelly, LL; Kohake, LE; KuKanich, B; Mosher, RA; Mueting, SL, 2011
)
0.92
" We performed unilateral ventralis caudalis deep brain stimulation combined with stereotactic bilateral cingulotomy to maximize the effects of treatment for 3 patients with intractable post-stroke pain."( Impact of ventralis caudalis deep brain stimulation combined with stereotactic bilateral cingulotomy for treatment of post-stroke pain.
Chang, JW; Chang, WS; Kim, JP; Park, YS, 2012
)
0.38
"This study examined the pharmacokinetics and analgesic effect of oral meloxicam (MEL) administered alone or in combination with gabapentin (GABA) in an experimental bovine lameness model."( Impact of oral meloxicam administered alone or in combination with gabapentin on experimentally induced lameness in beef calves.
Anderson, DE; Coetzee, JF; Gehring, R; Kohake, LE; Kukanich, B; Mosher, RA; Robert, B; Wang, C; White, BJ, 2014
)
0.84
" Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids."( The research on long-term clinical effects and patients' satisfaction of gabapentin combined with oxycontin in treatment of severe cancer pain.
Chen, DL; Li, YH; Wang, ZJ; Zhu, YK, 2016
)
0.92
"This study investigated the clinical effects of selective dorsal root ganglion pulsed radiofrequency lesioning in combination with oral administration of gabapentin in the treatment of postherpetic neuralgia (PHN)."( Clinical observations on selective dorsal root ganglion pulsed radiofrequency lesioning combined with gabapentin in the treatment of postherpetic neuralgia.
He, X; Huang, Y; Luo, F,
)
0.54
"Our study demonstrated that radiofrequency combined with gabapentin in the treatment of PHN has a good safety and efficacy profile."( Clinical observations on selective dorsal root ganglion pulsed radiofrequency lesioning combined with gabapentin in the treatment of postherpetic neuralgia.
He, X; Huang, Y; Luo, F,
)
0.59
"To compare the therapeutic effects of continuous epidural block combined with drugs and oral drugs alone on postherpetic neuralgia (PHN)."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
" Patients in group A had epidural block combined with oral administration of gabapentin and oxycodone-acetaminophen, and patients in group B received oral gabapentin and oxycodone-acetaminophen."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.85
"Both treatments have certain effects on PHN, but epidural block combined with drug therapy is more effective, especially for patients with severe pain, early use can quickly relieve pain."( Comparison of therapeutic effects of continuous epidural nerve block combined with drugs on postherpetic neuralgia.
Dong, X; Liu, Y; Liu, Z; Yang, Q; Zhang, Z, 2021
)
0.62
"5/25, 10/100, and 30/300 and investigation of potential drug-drug interaction at a dose of 10/100."( Investigations on dose proportionality and drug-drug interaction for a fixed-dose combination of trazodone and gabapentin.
Blume, HH; Calisti, F; Cattaneo, A; Comandini, A; Del Vecchio, A; Donath, F; Dragone, P; Picollo, R; Rosignoli, MT; Ruggieri, A; Todorova-Sanjari, M; Warnke, A; Wedemeyer, RS, 2021
)
0.83
" Gabapentin significantly increased drug liking when given in combination with ALC and OXY + ALC (p < 0."( Gabapentin increases the abuse liability of alcohol alone and in combination with oxycodone in participants with co-occurring opioid and alcohol use disorder.
Castillo, F; Comer, SD; Evans, SM; Foltin, RW; Jones, JD; Luba, RR; Mogali, S, 2022
)
3.07

Bioavailability

Gabapentin ER is based on the company's proprietary AcuForm drug delivery technology. This offers improved drug absorption and bioavailability compared with the existing immediate-release formulation of gabapentin (Neurontin)

ExcerptReferenceRelevance
" The substance is well absorbed after oral administration and penetrates the blood-brain barrier."( Intestinal absorption of gabapentin in rats.
Maurer, HH; Rump, AF, 1991
)
0.58
" Gabapentin is well absorbed in rats, dogs and in humans, with maximum blood levels, reached within 1-3 h after peroral administration."( Pharmacokinetics and metabolism of gabapentin in rat, dog and man.
Kölle, EU; Vollmer, KO; von Hodenberg, A, 1986
)
1.46
" Oral bioavailability was 40% in monkeys administered 25 mg/kg, 79% in mice and rats receiving 50 mg/kg, and 80% in dogs administered 50 mg/kg."( Disposition of gabapentin (neurontin) in mice, rats, dogs, and monkeys.
Bockbrader, HN; Chang, T; DeHart, PD; Hanson, BJ; McNally, WP; Radulovic, LL; Türck, D; Vollmer, KO; von Hodenberg, A, 1995
)
0.64
" This drug is rapidly absorbed and exhibits dose-dependent bioavailability as a result of a saturable transport mechanism."( Clinical pharmacokinetics of gabapentin.
McLean, MJ, 1994
)
0.58
" However, GBP concentrations were much lower after rectal administration; therefore, we concluded that the aqueous solution was poorly absorbed rectally."( Failure of absorption of gabapentin after rectal administration.
Birnbaum, AK; Caruso, KJ; Cloyd, JC; Jones Saete, C; Kriel, RL; Ricker, BJ, 1997
)
0.6
" The following kinetic parameters were calculated: area under the concentration time curve from zero time to 24 h after the dose, AUC 0-24 h; maximal serum concentration, Cmax; time to the maximal serum concentration, Tmax; absorption rate constant, ka; elimination rate constant, beta; elimination half-time, t1/2beta."( Oral gabapentin disposition in patients with epilepsy after a high-protein meal.
Baraldo, M; Benetello, P; Fortunato, M; Furlanut, M; Pea, F; Testa, G; Tognon, A, 1997
)
0.81
" At large daily doses, oral bioavailability (F) may be improved by giving the daily dose more frequently."( Gabapentin bioavailability: effect of dose and frequency of administration in adult patients with epilepsy.
Bockbrader, HN; DeCerce, J; Gidal, BE; Gonzalez, J; Kruger, S; Pitterle, ME; Ramsay, RE; Rutecki, P, 1998
)
1.74
" After oral administration, absorption is rapid and relatively efficient for the new AEDs, the most notable exception being gabapentin, whose bioavailability decreases with increasing dosage."( The clinical pharmacokinetics of the new antiepileptic drugs.
Perucca, E, 1999
)
0.51
"Study A: 400-mg single dose, randomized, cross-over study to assess bioavailability of four different gabapentin formulations (n=20, 9 males, 11 females; mean age and weight 41 years, 75."( Inter- and intra-subject variability in gabapentin absorption and absolute bioavailability.
Bockbrader, HN; Gidal, BE; Kruger, S; Pitterle, M; Radulovic, LL; Rutecki, P, 2000
)
0.79
" Intersubject variability was approximately 30% for oral clearance and volume of distribution and was larger for the absorption rate constant and lag time."( Population pharmacokinetics of gabapentin in infants and children.
Bockbrader, HN; Garofalo, E; Ouellet, D; Shapiro, DY; Wesche, DL, 2001
)
0.6
" It is well absorbed when administered orally and displays linear kinetics up to doses of 1,800 mg/day."( [Characteristics and indications of gabapentin].
Sancho-Rieger, J, 2002
)
0.59
" It has been suggested that this transportation is capacity limited, thus decreasing GBP bioavailability at higher doses."( The absorption of gabapentin following high dose escalation.
Beran, RG; Berry, DJ; Clarke, LA; Hung, WT; Plunkeft, MJ, 2003
)
0.65
" In monkeys, oral bioavailability of gabapentin from XP13512 capsules was 84."( XP13512 [(+/-)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys.
Annamalai, T; Barrett, RW; Bu, L; Cundy, KC; De Vera, J; Estrela, J; Gallop, MA; Luo, W; Shirsat, P; Torneros, A; Yao, F; Zou, J, 2004
)
0.81
" The validated method has been successfully used to analyze human plasma samples for application in pharmacokinetic, bioavailability or bioequivalence studies."( Rapid quantification of gabapentin in human plasma by liquid chromatography/tandem mass spectrometry.
Chidambara, J; Koteshwara, M; Manoj, S; Ramakrishna, NV; Santosh, M; Sumatha, B; Varma, DP; Vishwottam, KN, 2006
)
0.64
" 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
)
1
" Oral bioavailability of gabapentin was not affected by OCTN1 genotype."( Effects of genetic variation in the novel organic cation transporter, OCTN1, on the renal clearance of gabapentin.
Brett, CM; Brown, C; Burchard, EG; Castro, RA; Giacomini, KM; Huang, Y; Mercer, R; Shah, N; Urban, TJ, 2008
)
0.86
" Gabapentin ER is based on the company's proprietary AcuForm drug delivery technology, which is part of the Gastric Retention (GR) family of technologies; this offers improved drug absorption and bioavailability compared with the existing immediate-release formulation of gabapentin (Neurontin), making gabapentin ER suitable for twice-daily dosing."( Gabapentin Extended-Release - Depomed: Gabapentin ER, Gabapentin Gastric Retention, Gabapentin GR.
, 2007
)
2.69
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
"6 h, oral bioavailability of 37% and 90%) with anti-inflammatory activity (ED 50 = 37 micromol/kg, mouse) and efficacy in pain models (thermal hyperalgesia, ED 50 = 72 micromol/kg, rat)."( Rotationally constrained 2,4-diamino-5,6-disubstituted pyrimidines: a new class of histamine H4 receptor antagonists with improved druglikeness and in vivo efficacy in pain and inflammation models.
Adair, RM; Altenbach, RJ; Bettencourt, BM; Brioni, JD; Cowart, MD; Drizin, I; Esbenshade, TA; Fix-Stenzel, SR; Honore, P; Hsieh, GC; Liu, H; Marsh, KC; McPherson, MJ; Milicic, I; Miller, TR; Sullivan, JP; Wetter, JM; Wishart, N; Witte, DG, 2008
)
0.35
" XP13512 immediate-release (up to 2800 mg single dose and 2100 mg twice daily) was well absorbed (>68%, based on urinary recovery of gabapentin), converted rapidly to gabapentin, and provided dose-proportional exposure, whereas absorption of oral gabapentin declined with increasing doses to <27% at 1200 mg."( Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin.
Canafax, DM; Cundy, KC; Luo, W; Moors, TL; Sastry, S; Zou, J, 2008
)
0.78
" Bioavailability was included in the models as a function of dose by using a hyperbolic function derived from data previously reported in the literature."( A population pharmacokinetic model of gabapentin developed in nonparametric adaptive grid and nonlinear mixed effects modeling.
Carlsson, KC; Eriksen, HO; Hoem, NO; Karlsson, MO; Moberg, ER; van de Schootbrugge, M, 2009
)
0.62
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" Mean (standard deviation) bioavailability (based on urinary recovery) of gabapentin from gabapentin enacarbil was 42."( The effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbil.
Cundy, KC; Huff, FJ; Lal, R; Luo, W; Sukbuntherng, J; Zou, J, 2010
)
0.82
" The pharmacokinetics of gabapentin delivered from this extended-release formulation allows a reduced dosing frequency while maintaining bioavailability and possibly diminishing the occurrence of adverse events attributable to a slower increase to the peak concentration compared with the immediate-release dosage form."( Pharmacokinetics of gabapentin in a novel gastric-retentive extended-release formulation: comparison with an immediate-release formulation and effect of dose escalation and food.
Chen, C; Cowles, VE; Hou, E, 2011
)
1
" 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
)
0.87
" The mean oral bioavailability of gabapentin (± SD) was 16."( Pharmacokinetic profile and behavioral effects of gabapentin in the horse.
Driessen, B; Liu, Y; McDonnell, SM; Moate, PJ; Soma, LR; Terry, RL; Uboh, CE; Van Eps, AW, 2010
)
0.89
"The pharmaceutical properties, including the physical and chemical properties, and the bioavailability are greatly influenced by their polymorphism."( [The crystalline polymorph control and selection of gabapentin with polymer heteronuclei].
Lang, MD; Ru, ML; Yang, L, 2010
)
0.61
" Oral bioavailability (BA) of gabapentin was estimated by 24-h urine collection."( Impact of concomitant antacid administration on gabapentin plasma exposure and oral bioavailability in healthy adult subjects.
Kawakami, J; Mino, Y; Naito, T; Umemura, K; Yagi, T, 2012
)
0.92
" The oral bioavailability of gabapentin displays dose-dependence."( Pharmacokinetic of gabapentin 600 mg tablet in Thai healthy subjects.
Chompootaweep, S; Khemsri, W; Prompila, N; Punyasang, W; Sayankuldilok, N; Thaworn, N; Wittayalertpanya, S, 2012
)
1
"Gabapentin exposure at steady state, as measured by AUC(24), increased with doses from 600 mg/day to 3000 mg/day, although there was a slight decrease in gabapentin's relative bioavailability with increasing dose compared with the 600 mg dose."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
2.1
"The pharmacokinetic profile of gabapentin-ER may allow for once- or twice-daily dosing while maintaining bioavailability and thus efficacy."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.95
" It includes the following aspects: 1) the mechanism of gastroretention of gabapentin GR tablets, 2) in vitro dissolution profiles of the GR and IR formulations, 3) site of absorption of gabapentin in the human intestine, 4) studies of the mechanism of gabapentin absorption using intestinal tissue preparations, 5) human PK studies to examine the effects of dose and formulations on PK profiles and the bioavailability of gabapentin at therapeutically relevant doses, and 6) efficacy and safety of gastroretentive gabapentin in patients with PHN."( The intestinal absorption mechanism of gabapentin makes it appropriate for gastroretentive delivery.
Chen, C; Cowles, VE; Sweeney, M, 2013
)
0.89
"To investigate the so-called "drift" with generic-generic drug substitution, a single-dose, four-way crossover comparative bioavailability study was performed involving 24 healthy subjects and three generic and one branded formulation of a tablet containing 800 mg gabapentin as test medication."( Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study.
Burger, D; Maliepaard, M; Neef, C; Teerenstra, S; Vanmolkot, F; Yu, Y, 2013
)
0.88
" 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
)
0.89
"Gabapentin was selected to formulate oral controlled release dry suspension because of short biological half life of 5-7 h and low bioavailability (60%)."( Nanosponge-based pediatric-controlled release dry suspension of Gabapentin for reconstitution.
Bhingole, RC; Rao, MR, 2015
)
2.1
"To formulate and evaluate controlled release dry suspension for reconstitution to increase the bioavailability and to control bitter taste of drug."( Nanosponge-based pediatric-controlled release dry suspension of Gabapentin for reconstitution.
Bhingole, RC; Rao, MR, 2015
)
0.66
" The results of in vivo studies showed increase in bioavailability of controlled release suspension by 24."( Nanosponge-based pediatric-controlled release dry suspension of Gabapentin for reconstitution.
Bhingole, RC; Rao, MR, 2015
)
0.66
"The plasma/brain ECF concentration-time profiles of gabapentin were adequately described with a two-compartment plasma model with saturable intestinal absorption rate (K m  = 44."( Pharmacokinetic/Pharmacodynamic Relationship of Gabapentin in a CFA-induced Inflammatory Hyperalgesia Rat Model.
Holm, R; Keizer, R; Kreilgaard, M; Larsen, MS; Munro, G; Mørk, A; Savic, R, 2016
)
0.94
" Dose dependencies were found for morphine absorption rate and gabapentin bioavailability."( Population Pharmacokinetic Modelling of Morphine, Gabapentin and their Combination in the Rat.
Gabel-Jensen, C; Juul, RV; Kreilgaard, M; Lund, TM; Papathanasiou, T, 2016
)
0.93
" Dose-dependent bioavailability of GBP was demonstrated, and the saturable absorption profile was described by a nonlinear hyperbolic function."( Pharmacokinetics and Saturable Absorption of Gabapentin in Nursing Home Elderly Patients.
Ahmed, GF; Bathena, SP; Birnbaum, AK; Brundage, RC; Conway, JM; Leppik, IE; Schwartz, JB, 2017
)
0.71
" A significant higher bioavailability of gabapentin administered 30min after meal, compared to fasting conditions or to dose administration 10min before meal, argued in favor of the gastro-retention of gabapentin prolonged release layer."( Multi-kinetics and site-specific release of gabapentin and flurbiprofen from oral fixed-dose combination: in vitro release and in vivo food effect.
Barchielli, M; Bettini, R; Buttini, F; Colombo, G; Colombo, P; Conti, C; Leoni, B; Loprete, L; Rossi, A; Sonvico, F, 2017
)
0.98
" For that purpose, we developed a pharmacokinetic model for gabapentin, based on data from a previously conducted bioavailability study comparing gabapentin exposure following administration of the gabapentin originator and three generic gabapentin formulations in healthy subjects."( Interchangeability of Generic Drugs: A Nonparametric Pharmacokinetic Model of Gabapentin Generic Drugs.
Burger, DM; Glerum, PJ; Maliepaard, M; Neef, C; Neely, MN; Yamada, WM; Yu, Y, 2018
)
0.95
"Gabapentin (GBP), an antiepileptic and anti-neuropathic agent, suffers from short half-life (5-7 h), has narrow absorption window, and is absorbed via carrier-mediated mechanism resulting in frequent dosing, poor compliance, and poor bioavailability (<60%)."( Gastroretentive raft liquid delivery system as a new approach to release extension for carrier-mediated drug.
Aboelwafa, AA; Abouelatta, SM; El-Gazayerly, ON, 2018
)
1.92
" The main objective of developing such systems is to increase the residence time of a specific drug in stomach; controlling its release, increasing its bioavailability and decreasing its side effects and dosing frequency."( Development of Gabapentin Expandable Gastroretentive Controlled Drug Delivery System.
Kanaze, FI; Muqedi, RH; Rimawi, IB, 2019
)
0.87
"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
" Estimated oral bioavailability was 47%."( Pharmacokinetics of oral and compounded intravenous gabapentin in Duroc swine (Sus Scrofa).
Gisclair, AT; Hampton, CE; Martin, A; Oubre, MJ; Pypendop, BH; Queiroz-Williams, P, 2021
)
0.87
" 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
)
2.26
"The absorption and bioavailability of oral gabapentin are associated with a high degree of interindividual variability."( Interindividual Variability in the Bioavailability of Gabapentin Enacarbil Extended Release in Healthy Adults: An Analysis of Data From 6 Phase I Studies.
Ellenbogen, A; Gidal, B; Lal, R, 2022
)
1.23
" The distribution of bioavailability values was assessed in all studies."( Interindividual Variability in the Bioavailability of Gabapentin Enacarbil Extended Release in Healthy Adults: An Analysis of Data From 6 Phase I Studies.
Ellenbogen, A; Gidal, B; Lal, R, 2022
)
0.97
"4 μg·h/mL, and bioavailability range: 64."( Interindividual Variability in the Bioavailability of Gabapentin Enacarbil Extended Release in Healthy Adults: An Analysis of Data From 6 Phase I Studies.
Ellenbogen, A; Gidal, B; Lal, R, 2022
)
0.97
"Oral bioavailability (F), which is evaluated by permeability and solubility, is one of the key parameters in drug discovery."( Comparison of Ussing Chamber and Caco-2 Model in Evaluation of Intestinal Absorption Mechanism of Compounds from Different BCS Classifications.
Du, H; Tian, D; Wang, T; Yang, Y; Zhang, H; Zhou, H, 2023
)
0.91

Dosage Studied

This study examines dosing patterns, therapy outcomes, healthcare utilization and costs of patients with PHN who initiate treatment with gabapentin or pregabalin. The mean daily dosage was 826 mg for gab Kapentin and 187 mg for pregABalin. Higher, open-label gab Zapentin dosing was associated with 54% and 67% reductions in hot flash frequency and composite score from baseline, respectively.

ExcerptRelevanceReference
" The GBP dosage of 900 mg appeared to be ineffective."( Double-blind study of Gabapentin in the treatment of partial seizures.
Kälviäinen, R; Riekkinen, P; Sivenius, J; Ylinen, A,
)
0.45
" However, intravenous pharmacokinetics in rats were linear over the dosage range of 4-500 mg/kg."( Disposition of gabapentin (neurontin) in mice, rats, dogs, and monkeys.
Bockbrader, HN; Chang, T; DeHart, PD; Hanson, BJ; McNally, WP; Radulovic, LL; Türck, D; Vollmer, KO; von Hodenberg, A, 1995
)
0.64
" Plasma concentrations are essentially proportional to dosages up to 1,800 mg daily, which is the highest dosage used in double-blind, placebo-controlled clinical trials."( Clinical pharmacokinetics of gabapentin.
McLean, MJ, 1994
)
0.58
" Based on pharmacokinetic considerations, it appears that the dosing regimen of gabapentin in subjects with renal impairment may be adjusted on the basis of creatinine clearance."( Pharmacokinetics of gabapentin in subjects with various degrees of renal function.
Blum, RA; Bockbrader, H; Busch, JA; Comstock, TJ; Keller, E; Reece, PA; Reetze, P; Schultz, RW; Sica, DA; Tuerck, D, 1994
)
0.84
" The primary analysis compared data for patients receiving GBP 900 mg/day with placebo; the GBP 1,200-mg/day group provided dose-response data."( Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a double-blind, placebo-controlled study. The International Gabapentin Study Group.
Anhut, H; Ashman, P; Feuerstein, TJ; Sauermann, W; Saunders, M; Schmidt, B,
)
1.57
" No dosage adjustment is necessary when GBP and CBZ or VPA are coadministered."( Lack of interaction of gabapentin with carbamazepine or valproate.
Bockbrader, HN; Chang, T; Erdman, GR; Leppik, IE; Posvar, EL; Radulovic, LL; Sedman, AJ; Uthman, BM; Wilder, BJ,
)
0.44
" Plasma [14C]GBP declined linearly after dosing while brain ISF [14C]GBP concentration peaked at approximately 1 h and then declined in parallel with plasma concentration."( Gabapentin anticonvulsant action in rats: disequilibrium with peak drug concentrations in plasma and brain microdialysate.
Schielke, GP; Taylor, CP; Vartanian, MG; Welty, DF, 1993
)
1.73
" ZNS daily dosage is 400-600 mg."( Antiepileptic drugs in development: prospects for the near future.
Leppik, IE, 1994
)
0.29
" The mean daily dosage for all 100 patients was 2107 mg, and the mean daily dosage for patients who continued gabapentin treatment was 2270 mg."( Efficacy and tolerability of gabapentin in clinical practice.
Morris, GL,
)
0.63
" GBP is also active in this population, but only the 1,800 mg/day dosage was significantly better than placebo with respect to percent responders."( Clinical efficacy of new antiepileptic drugs in refractory partial epilepsy: experience in the United States with three novel drugs.
French, JA, 1996
)
0.29
" All the drugs can be conveniently given as a twice daily dosage apart from gabapentin, which has a short half-life and a midday dose is needed."( Clinical pharmacokinetics of newer antiepileptic drugs. Lamotrigine, vigabatrin, gabapentin and oxcarbazepine.
Binnie, CD; Elwes, RD, 1996
)
0.75
" Specific indications and dosage schedules have been provided."( New antiepileptic drugs.
Brodie, MJ; Wilson, EA, 1996
)
0.29
" Group results during the controlled trial did not reach statistical significance at the dosage used."( Effectiveness of gabapentin in controlling spasticity: a quantitative study.
Graves, DE; Mueller, M; Olson, WH; Priebe, MM; Sherwood, AM, 1997
)
0.64
" Gabapentin was well tolerated by patients in both dosage groups, and no patients exited the study due to adverse events, despite rapid initiation of full dose within 24 hours."( Gabapentin monotherapy: I. An 8-day, double-blind, dose-controlled, multicenter study in hospitalized patients with refractory complex partial or secondarily generalized seizures. The US Gabapentin Study Group 88/89.
Bergey, GK; Blume, WT; Crockatt, JG; Garofalo, E; LaMoreaux, L; Leiderman, DB; Morrell, MJ; Morris, HH; Penovich, PE; Pierce, M; Rosenfeld, W, 1997
)
2.65
" Results of outcome measures, including time to exit, completion rate, and mean time on monotherapy, showed no significant differences among dosage groups."( Gabapentin monotherapy: II. A 26-week, double-blind, dose-controlled, multicenter study of conversion from polytherapy in outpatients with refractory complex partial or secondarily generalized seizures. The US Gabapentin Study Group 82/83.
Abou-Khalil, B; Beydoun, A; Cantrell, D; Fischer, J; Garofalo, E; Greiner, M; Harden, C; Hayes, A; Labar, DR; Pierce, M; Ramsay, RE; Sackellares, JC; Uthman, BM, 1997
)
1.74
" In six patients, including three taking 6000 mg daily, GBP concentrations continued to rise linearly at each dosage increment."( High dose gabapentin in refractory partial epilepsy: clinical observations in 50 patients.
Brodie, MJ; Forrest, G; Sills, GJ; Wilson, EA, 1998
)
0.7
" A 6-month multicentre, open-label study, involved addition of gabapentin to pre-existing treatment at the initial dosage of 1200 mg and subsequent adjustment between 900 and 2400 mg/day according to efficacy and tolerability."( Gabapentin add-on therapy with adaptable dosages in 610 patients with partial epilepsy: an open, observational study. The French Gabapentin Collaborative Group.
Arzimanoglou, A; Baulac, M; Cavalcanti, D; Portal, JJ; Semah, F, 1998
)
1.98
" Both effects exhibited a tendency to a U-shaped dose-response curve."( Anticonvulsant action of gabapentin during postnatal development in rats.
Haugvicová, R; Mares, P, 1997
)
0.6
"When information became available on aplastic anemia and hepatotoxicity associated with felbamate, all patients were advised to taper their felbamate dosage over approximately 2 weeks."( Increased seizure frequency associated with felbamate withdrawal in adults.
Privitera, M; Shukla, R; Welty, TE, 1998
)
0.3
" Dosage and side effects were noted."( Clinical experience using gabapentin adjunctively in patients with a history of mania or hypomania.
Knoll, J; Stegman, K; Suppes, T, 1998
)
0.6
" dosing were 38."( Gabapentin bioavailability: effect of dose and frequency of administration in adult patients with epilepsy.
Bockbrader, HN; DeCerce, J; Gidal, BE; Gonzalez, J; Kruger, S; Pitterle, ME; Ramsay, RE; Rutecki, P, 1998
)
1.74
"Based on the observations of other authors, we used this drug in dosage varying between 900 and 1,200 mg/day, in three patients with neuropathic pain, of both central and peripheral origin, and in whom the usual treatments had been unsatisfactory or could not be tolerated because of side-effects."( [Treatment of neuropathic pain with gabapentin ++].
Sánchez-Valiente, S, 1998
)
0.58
"A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo."( Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial.
Bernstein, P; Harden, N; Magnus-Miller, L; Rowbotham, M; Stacey, B, 1998
)
1.98
" Gabapentin therapy proved to be very satisfactory in relieving muscular cramps with a relatively low dosage (600 mg/day) and without any remarkable side effects."( A case of myokymia-cramp syndrome successfully treated with gabapentin.
Cardinali, P; Parisi, L; Pierelli, F; Rossi, P; Serrao, M; Tramutoli, R, 1998
)
1.45
"Gabapentin is not available in a liquid dosage form for clinical use."( Development of two stable oral suspensions for gabapentin.
Nahata, MC, 1999
)
2
" Reduction of GBP dosage may be required in elderly patients with reduced renal function."( Effects of age and gender on single-dose pharmacokinetics of gabapentin.
Abel, RB; Bockbrader, HN; Boyd, RA; Sedman, AJ; Türck, D, 1999
)
0.54
" Further studies are required to confirm this effect and to determine whether a dose-response relationship exists."( Treatment of social phobia with gabapentin: a placebo-controlled study.
Davidson, JR; Greist, JH; Janney, CA; Jefferson, JW; Katzelnick, DJ; Pande, AC; Sutherland, SM; Weisler, RH, 1999
)
0.59
" Slow dosage escalation yields good tolerability."( Lamotrigine in the treatment of bipolar depression.
Bowden, CL; Mitchell, P; Suppes, T, 1999
)
0.3
" Because dosing is often modest, cost should rarely be the overriding factor in choosing a drug for a patient with newly diagnosed epilepsy in the developed world."( Monostars: an aid to choosing an antiepileptic drug as monotherapy.
Brodie, MJ, 1999
)
0.3
" Gabapentin was titrated up to a maximal dosage of 3600 mg/day to achieve seizure control or to tolerability."( Dosing to efficacy with neurontin: the STEPS trial. Study of Titration to Effect Profile of Safety.
Morrell, MJ, 1999
)
1.21
" The gabapentin dosage was titrated to effective tolerated dose up to 2400 mg/day."( Gabapentin as adjunctive therapy for partial seizures.
Bruni, J, 1999
)
2.26
" Therefore, gabapentin dosing must be optimized on an individual basis to achieve an adequate trial of the drug and obtain the best seizure control."( Gabapentin in the management of convulsive disorders.
McLean, MJ, 1999
)
2.13
" Lamotrigine may offer a much-needed treatment alternative for bipolar depression and could be found effective for acute mania, but the need for slow dosage adjustment and the risk of rash may limit overall clinical utility."( Gabapentin and lamotrigine in bipolar disorder.
Botts, SR; Raskind, J, 1999
)
1.75
" After lamotrigine was added for better seizure control and the dosage of gabapentin was tapered, anorgasmia improved."( Improved sexual function in three men taking lamotrigine for epilepsy.
Carwile, ST; Husain, AM; Miller, PP; Radtke, RA, 2000
)
0.54
" We reported that daily dosing increased brain gamma-aminobutyric acid (GABA) in patients with epilepsy."( Effects of gabapentin on brain GABA, homocarnosine, and pyrrolidinone in epilepsy patients.
Hyder, F; Mattson, RH; Petroff, OA; Rothman, DL, 2000
)
0.7
" We report 11 MS patients with trigeminal neuralgia (TN): 6 intolerant to a therapeutic dosage of CBZ, showing serious adverse effects and subsequently treated with a combination of low-dose CBZ and gabapentin (GBP) (group 1); 5 treated with lamotrigine (LMT), showing adverse effects and subsequently treated with GBP (group 2)."( Low-dose gabapentin combined with either lamotrigine or carbamazepine can be useful therapies for trigeminal neuralgia in multiple sclerosis.
Leandri, M; Mancardi, GL; Messmer Uccelli, M; Solaro, C; Uccelli, A, 2000
)
0.91
" Study medication was to be given on a three-times-a-day dosing regimen."( Efficacy of gabapentin in migraine prophylaxis.
Klapper, J; Magnus, L; Mathew, NT; Ramadan, N; Rapoport, A; Saper, J; Stacey, B; Tepper, S, 2001
)
0.69
"Fourteen of the 18 (78%) treated for hypomania or mania had a positive response to a dosage range of 600-3,600 mg/day."( Gabapentin in the acute treatment of refractory bipolar disorder.
Altshuler, LL; Brown, ES; Denicoff, K; Frye, M; Gitlin, M; Goodman, R; Hwang, S; Keck, PE; Kupka, R; Leverich, G; McElroy, SL; Nolen, W; Post, R; Suppes, T, 1999
)
1.75
"Starting gabapentin therapy at an initial therapeutic dosage of 900 mg/day is well tolerated by patients with epilepsy and is as safe as initiating with a titration schedule over 3 days."( Rapid initiation of gabapentin: a randomized, controlled trial.
Bernstein, P; Fisher, RS; Magnus, L; Pellock, J; Penovich, PE; Sachdeo, RC, 2001
)
1.05
" Similarly, valproate combined with antipsychotics provided greater improvement in mania than antipsychotic medication alone and resulted in lower dosage of the antipsychotic medication."( Novel treatments for bipolar disorder.
Bowden, CL, 2001
)
0.31
" Optimal dosing remains unclear."( Gabapentin for treatment of behavioral and psychological symptoms of dementia.
Miller, LJ, 2001
)
1.75
" The designs and dosing regimens differed between studies."( Evidence for the use of gabapentin in the treatment of diabetic peripheral neuropathy.
Hemstreet, B; Lapointe, M, 2001
)
0.62
"A highly sensitive and specific method is proposed for the determination of vigabatrin (I) and gabapentin (II) in their dosage forms and spiked human plasma."( Spectrofluorimetric determination of vigabatrin and gabapentin in dosage forms and spiked plasma samples through derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole.
Al-Deeb, OA; Belal, F; Hassan, EM; Khalil, NY,
)
0.6
" Gabapentin was given at the daily dosage of 900 mg."( Drug-resistant cluster headache responding to gabapentin: a pilot study.
Cruccu, G; Gottlieb, A; Leandri, M; Luzzani, M, 2001
)
1.48
" Also, the dosing of the drug in children has been complicated by negative behavioral adverse effects."( Gabapentin: a unique anti-epileptic agent.
Dougherty, JA; Rhoney, DH, 2001
)
1.75
" With long-term dosing and once target doses were achieved at 4 weeks, significant elevations in GABA were observed compared with baseline for all three drugs (topiramate 46%, gabapentin 25%, lamotrigine 25%)."( Modulation of cerebral GABA by topiramate, lamotrigine, and gabapentin in healthy adults.
Faught, E; Gilliam, F; Hetherington, H; Ho, S; Kuzniecky, R; Martin, R; Pan, J, 2002
)
0.75
" There was no evidence to suggest dosing difficulties due to tolerance over the 3-year period."( Long-term use of gabapentin for treatment of pain after traumatic spinal cord injury.
Hicken, BL; Kezar, L; Ness, TJ; Putzke, JD; Richards, JS,
)
0.47
" A slow upward dose titration is recommended to reduce the incidence of serious rash, but this may delay the attainment of adequate dosage for 6 weeks."( Lamotrigine update and its use in mood disorders.
Hurley, SC, 2002
)
0.31
" The selection and dosage of antiepileptic drugs requires proper attention to special pharmacokinetic and pharmacodynamic situations that are common in older individuals."( [Gabapentin in the treatment of epilepsy in the elderly].
Gil-Nagel, A,
)
1.04
" The classic AEDs had numerous problems, ranging from inconvenient dosing schedules to frequent side effects due to active metabolites and common drug interactions; newer agents have been developed to avoid some of these pitfalls."( Pharmacokinetics of new anticonvulsants in psychiatry.
Morris, HH, 1998
)
0.3
" No significant difference was found among other pain descriptors during the gabapentin and placebo treatment, although this may have been limited by the small sample size and low maximum dosage of gabapentin."( Gabapentin in the treatment of neuropathic pain after spinal cord injury: a prospective, randomized, double-blind, crossover trial.
Chen, B; DeLisa, JA; Johnston, M; Kirshblum, S; Millis, S; Tai, Q, 2002
)
1.99
" During 2- and 6-week titration periods, respectively, GBP dosage reached 1,800 mg/day, and LTG, 150 mg/day."( Gabapentin versus lamotrigine monotherapy: a double-blind comparison in newly diagnosed epilepsy.
Anhut, H; Brodie, MJ; Chadwick, DW; Garofalo, EA; Maton, S; Messmer, SL; Murray, G; Otte, A; Sauermann, W, 2002
)
1.76
" The mean effective dosage at the end of the 6-week treatment period was 1,855 mg, although therapeutic effects were already observed at the end of week 4 (1,391 mg)."( Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study.
de la Llave, Y; Garcia-Borreguero, D; Hernandez, G; Larrosa, O; Masramon, X; Verger, K, 2002
)
0.58
" Mean dosage +/- SD at week 8 was 1270 +/- 561."( Effectiveness of adjunctive gabapentin in resistant bipolar disorder: is it due to anxious-alcohol abuse comorbidity?
Akiskal, HS; Frare, F; Moretti, L; Perugi, G; Ruffolo, G; Toni, C; Torti, C, 2002
)
0.61
" After stabilising at each dosage, a sequence of serum and saliva samples were collected within the dosage interval; GBP and co-medication concentrations were determined and the results subjected to PK modelling."( The absorption of gabapentin following high dose escalation.
Beran, RG; Berry, DJ; Clarke, LA; Hung, WT; Plunkeft, MJ, 2003
)
0.65
"The influence of age and administered daily dosage on the plasma concentrations of gabapentin (GBP) at steady state was evaluated in a group of 41 children and young adults (aged 3-30 years) receiving long-term adjunctive treatment with GBP for the management of refractory partial-onset seizures."( Plasma gabapentin concentrations in children with epilepsy: influence of age, relationship with dosage, and preliminary observations on correlation with clinical response.
Bonanni, P; Bonomi, I; Ferrari, AR; Gatti, G; Guerrini, R; Perucca, E, 2003
)
1
" Higher, open-label gabapentin dosing was associated with 54% and 67% reductions in hot flash frequency and composite score from baseline, respectively."( Gabapentin's effects on hot flashes in postmenopausal women: a randomized controlled trial.
Guttuso, T; Kieburtz, K; Kurlan, R; McDermott, MP, 2003
)
2.09
" In this study, conventional analgesics were continued at a therapeutic level, and gabapentin was administrated for an 18-day titration period followed by a 5-week maintenance period at a dosage of 1800 mg/day or the maximum tolerable dosage."( Gabapentin effect on neuropathic pain compared among patients with spinal cord injury and different durations of symptoms.
Ahn, SH; Bae, JH; Jang, SH; Lee, BS; Moon, HW; Park, HW; Sakong, J, 2003
)
1.99
"The goals of this article were to review data on the efficacy and tolerability of gabapentin in the treatment of neuropathic pain in adults and to determine the optimal dosing schedule."( Gabapentin dosing for neuropathic pain: evidence from randomized, placebo-controlled clinical trials.
Backonja, M; Glanzman, RL, 2003
)
1.99
" The recommended dosage in adults is 300 mg at bedtime on day 1,300 mg BID on day 2, and 300 mg TID on day 3, titrating up as needed to 2400 to 3600 mg/d."( The use of gabapentin for the treatment of postherpetic neuralgia.
Kennedy, DH; Singh, D, 2003
)
0.71
"The purposes of this review were to assess the gabapentin titration and dosing regimens that have been published in peer-reviewed journals, to develop dosing recommendations to maximize antiseizure efficacy without compromising tolerability, and to formulate guidelines for an adequate therapeutic assessment of gabapentin dosage efficacy."( Gabapentin dosing in the treatment of epilepsy.
Gidal, BE; McLean, MJ, 2003
)
2.02
" These were reviewed to assess the range of dosing and titration schedules reported."( Gabapentin dosing in the treatment of epilepsy.
Gidal, BE; McLean, MJ, 2003
)
1.76
" Side effects occurred around the onset of dosing and were reported in some studies to be transient."( Gabapentin dosing in the treatment of epilepsy.
Gidal, BE; McLean, MJ, 2003
)
1.76
"Based in the literature here, in most adult patients, gabapentin may be initiated at a dosage of 900 mg/d and titrated to maintenance dosages > or = 3600 mg/d."( Gabapentin dosing in the treatment of epilepsy.
Gidal, BE; McLean, MJ, 2003
)
2.01
" Patients randomized to GBP started on 1800 mg/d and could have their dosage increased stepwise to 2400 and 3600 mg/d if seizures persisted."( Serum concentrations and effects of gabapentin and vigabatrin: observations from a dose titration study.
Johannessen, SI; Larsson, S; Lindberger, M; Luhr, O; Tomson, T, 2003
)
0.59
" Although its half-life is relatively short (6 to 8 hours), its duration of action is longer than anticipated from its pharmacokinetics in plasma, and a twice-daily dosing regimen is adequate to produce the desired response."( The ideal pharmacokinetic properties of an antiepileptic drug: how close does levetiracetam come?
Johannessen, SI; Perucca, E, 2003
)
0.32
" Hill slope coefficients for the tested anticonvulsants indicate that the dose-response curve was less steep for gabapentin than for phenytoin, carbamazepine and ethosuximide."( Potent analgesic effects of anticonvulsants on peripheral thermal nociception in rats.
Jevtovic-Todorovic, V; Rastogi, AJ; Todorovic, SM, 2003
)
0.53
" This dosage produced a substantial but non-significant decrease in the incidence of postherpetic pain-related responses."( Effects of the suppression of acute herpetic pain by gabapentin and amitriptyline on the incidence of delayed postherpetic pain in mice.
Kuraishi, Y; Nojima, H; Shiraki, K; Takahata, H; Takasaki, I, 2004
)
0.57
" This was followed by a 4-week stable dosing period when the patients continued to receive maximum tolerated doses, a 2-week washout period, then a crossover of 4 weeks of medication/placebo titration, and another 4 weeks of stable dosing period."( Gabapentin is a first line drug for the treatment of neuropathic pain in spinal cord injury.
Levendoglu, F; Ogün, CO; Ogün, TC; Ozerbil, O; Ugurlu, H, 2004
)
1.77
" Rapid clearance of the drug necessitates dosing three or more times per day to maintain therapeutic levels."( XP13512 [(+/-)-1-([(alpha-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys.
Annamalai, T; Barrett, RW; Bu, L; Cundy, KC; De Vera, J; Estrela, J; Gallop, MA; Luo, W; Shirsat, P; Torneros, A; Yao, F; Zou, J, 2004
)
0.54
"5 mg/d, are reasonable initial dosages, and if symptoms do not improve within a week or two, the dosage can be doubled."( Management of hot flashes in breast cancer survivors and men with prostate cancer.
Stearns, V, 2004
)
0.32
" On Day 8, an antinociceptive dose-response curve was constructed and the 50% effective dose (ED(50)) values for morphine (given alone) were calculated for each study group."( The effects of intrathecal gabapentin on spinal morphine tolerance in the rat tail-flick and paw pressure tests.
Gilron, I; Hansen, C; Hong, M, 2004
)
0.62
" This study examined the effects of gabapentin on signs of central sensitization (brush and pinprick hyperalgesia) in a human model of capsaicin-evoked pain, using a gabapentin dosing regimen similar to that used in the clinic."( Chronic oral gabapentin reduces elements of central sensitization in human experimental hyperalgesia.
Bach, FW; Brown, J; Chizh, BA; Gottrup, H; Jensen, TS; Juhl, G; Kristensen, AD; Lai, R, 2004
)
0.97
"01), but GBP daily dosage or concomitant AEDs had no significant influence on the ratio."( Association between patient age and gabapentin serum concentration-to-dose ratio: a preliminary multivariate analysis.
Adín, J; Armijo, JA; Pena, MA; Vega-Gil, N, 2004
)
0.6
"01) difference when the highest dosage of the drug was administered."( Oral treatment with PD-0200347, an alpha2delta ligand, reduces the development of experimental osteoarthritis by inhibiting metalloproteinases and inducible nitric oxide synthase gene expression and synthesis in cartilage chondrocytes.
Boileau, C; Boily, M; Brunet, J; El-Kattan, A; Flory, C; Martel-Pelletier, J; Pelletier, JP; Schrier, D; Tardif, G, 2005
)
0.33
" Further work is required to establish the optimal dosage and to validate the methods used to quantify the response to treatment."( Gabapentin can improve postural stability and quality of life in primary orthostatic tremor.
Byrnes, ML; Edwards, DJ; Mastaglia, FL; Rodrigues, JP; Stell, R; Thickbroom, G; Walters, SE, 2005
)
1.77
"Gabapentin at a dosage of 1200 mg/d is safe and effective in treatment of epilepsy."( [Curative effect of gabapentin on refractory epilepsy].
Ding, MP; Hong, Z; Lü, CZ; Ma, GY; Pan, YF; Pan, YZ; Wang, DS; Wang, DX; Xiao, B; Zhao, QC; Zhu, GX, 2005
)
2.09
"6-fold shift in morphine's dose-response curve."( Attenuation of morphine tolerance by intrathecal gabapentin is associated with suppression of morphine-evoked excitatory amino acid release in the rat spinal cord.
Lee, MS; Lin, JA; Lin, SL; Wen, ZH; Wong, CS; Wu, CT; Yeh, CC, 2005
)
0.58
"Gabapentin has been shown to provide pain relief for post-herpetic neuralgia at dosage of 1200 to 2400 mg/day."( Starting dose of gabapentin for patients with post-herpetic neuralgia--a dose-response study.
Jean, WH; Mok, MS; Sun, WZ; Wu, CC, 2005
)
2.11
"Patients were stabilised using phenobarbitone and/or potassium bromide to produce tolerable therapeutic serum concentrations and dosed additionally with gabapentin at 35 to 50 mg/kg/d (divided twice or three times daily) for 4 months."( Improving seizure control in dogs with refractory epilepsy using gabapentin as an adjunctive agent.
Govendir, M; Malik, R; Perkins, M, 2005
)
0.76
" The method was successfully applied to the analysis of gabapentin in plasma from dosed patients for therapeutic drug monitoring."( Simple and sensitive liquid chromatographic method with fluorimetric detection for the analysis of gabapentin in human plasma.
Chung, TC; Tai, CT; Wu, HL, 2006
)
0.8
" The improved pharmacokinetic profile of pregabalin relative to gabapentin is manifested in linear and dose-independent absorption and a narrow therapeutic dosing range."( Pregabalin in neuropathic pain: a more "pharmaceutically elegant" gabapentin?
Guay, DR, 2005
)
0.8
" First, the maximally effective gabapentin dosage (600-2,700 mg/day) for each patient was determined during an initial dose-titration phase."( Blinded placebo crossover study of gabapentin in primary orthostatic tremor.
Byrnes, ML; Edwards, DJ; Mastaglia, FL; Rodrigues, JP; Stell, R; Thickbroom, GW; Walters, SE, 2006
)
0.89
" In conclusion, single or repeated dosing of gabapentin reduced cutaneous but not muscle pain in healthy volunteers."( Multiple dose gabapentin attenuates cutaneous pain and central sensitisation but not muscle pain in healthy volunteers.
Segerdahl, M, 2006
)
0.95
" Initial gabapentin dosage was 600 mg/day."( The effect of gabapentin in earlier stage of reflex sympathetic dystrophy.
Duman, I; Hazneci, B; Kalyon, TA; Tan, AK; Taşkaynatan, MA, 2007
)
1.12
" For these older drugs it has been common practice to adjust the dosage to achieve a serum drug concentration within a predefined 'therapeutic range', representing an interval where most patients are expected to show an optimal response."( Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed?
Johannessen, SI; Tomson, T, 2006
)
0.33
" We used a repeated dosing paradigm because there are precedents showing that repeated drug exposure may be necessary to demonstrate analgesia in neuropathic pain models."( Chemotherapy-evoked painful peripheral neuropathy: analgesic effects of gabapentin and effects on expression of the alpha-2-delta type-1 calcium channel subunit.
Bennett, GJ; Boroujerdi, A; Luo, ZD; Xiao, W, 2007
)
0.57
"We report the case of a woman with an apparent primary thunderclap headache which occurred frequently until she achieved a therapeutic dosage of gabapentin."( Persistent primary thunderclap headache responsive to gabapentin.
Black, DF; Garza, I, 2006
)
0.78
" There was no need to decrease of the dosage of GBP and the side effects were mild and of transitory nature."( [Efficacy, safety and effect on the quality of life of gabapentin in adult epilepsy--results of a prospective open-label quasi naturalistic Hungarian multicenter study (phase human-IV)].
Rajna, P; Szíjártó, E, 2006
)
0.58
" Thus, monitoring and dosage adjustment are required, without discontinuation of the drug."( Therapeutic management of chronic neuropathic pain: an examination of pharmacologic treatment.
Argyra, E; Moka, E; Siafaka, I; Vadalouca, A; Vrachnou, E, 2006
)
0.33
" The anticonvulsant and acute adverse effects of the combination of TPM with GBP at the fixed ratio of 1:1 were determined using the type I isobolographic analysis for nonparallel dose-response relationship curves (DRRCs)."( Isobolographic analysis of interaction between drugs with nonparallel dose-response relationship curves: a practical application.
Luszczki, JJ, 2007
)
0.34
" In contrast, the tmax and terminal half-life of gabapentin did not change after oral dosing for all treatments."( In vivo effects of glycyl-glutamate and glycyl-sarcosine on gabapentin oral absorption in rat.
Fleisher, D; Nguyen, TV; Smith, DE, 2007
)
0.84
" Individualization of dosage and avoidance of unnecessary polypharmacy are essential for safe utilization of anti-epileptic drugs."( [Epilepsy in the elderly].
Yoshino, A, 2007
)
0.34
"Gabapentin, at a maintenance dosage of 900 to 3600 mg/d for 8 weeks, or lactose placebo."( Relief of idiopathic subjective tinnitus: is gabapentin effective?
Chole, RA; Finnell, J; Piccirillo, JF; Spitznagel, E; Vlahiotis, A, 2007
)
2.04
"Adjuvants are compounds which by themselves have undesirable side-effects or low potency but in combination with opioids allow a reduction of narcotic dosing for postoperative pain control."( Useful adjuvants for postoperative pain management.
Buvanendran, A; Kroin, JS, 2007
)
0.34
" Treatment was continued for 6 days, during which the dosage was progressively decreased, and the mare was discharged."( Gabapentin for the treatment of neuropathic pain in a pregnant horse.
Davis, JL; Elce, Y; Posner, LP, 2007
)
1.78
"A rapid, sensitive and accurate high performance liquid chromatography with UV detection method was developed and validated for the quantification of gabapentin in dosage forms."( Optimization of an HPLC method for determination of gabapentin in dosage forms through derivatization with 1-fluoro-2,4-dinitrobenzene.
Jalalizadeh, H; Shafiee, A; Souri, E, 2007
)
0.79
"Both gabapentin and pregabalin are approved for the management of postherpetic neuralgia (PHN), although dosing and pharmacokinetic differences between these medications may affect their use in actual practice."( A retrospective evaluation of the use of gabapentin and pregabalin in patients with postherpetic neuralgia in usual-care settings.
Gore, M; Sadosky, A; Stacey, B; Tai, KS, 2007
)
1.12
" However, the results should not be extrapolated to other gabapentin drug products and to other tablet dosage forms."( Comparison of the stability of split and intact gabapentin tablets.
Ciavarella, AB; Faustino, PJ; Gupta, A; Khan, MA; Sayeed, VA; Volpe, DA, 2008
)
0.85
" Further well-designed trials are warranted to establish the most appropriate dosing regimen in patients on HD."( Role of gabapentin in the treatment of uremic pruritus.
Gommer, J; Scates, AC; Vila, T, 2008
)
0.78
" Therefore, conventional sustained formulations would likely result in decreased bioavailability, as the dosage form would pass through the window of absorption before the drug could be completely released."( Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in hea
Berner, B; Gordi, T; Hou, E; Kasichayanula, S, 2008
)
0.67
" Gabapentin plasma concentrations were measured in serial plasma samples collected >or=48 hours following dosing on days 1 and 8 using a validated high performance liquid chromatography/tandem mass spectrometry system with a lowest limit of quantitation of 75 ng/mL."( Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in hea
Berner, B; Gordi, T; Hou, E; Kasichayanula, S, 2008
)
1.58
" However, BID dosing resulted in apparently lower C(max) (mean ratio: 81%; CI 90%, 76%-86%) and greater C(min) values (mean ratio: 118%; CI 90%, 107%-130%), while G-ER QD dosing was associated with numerically greater C(max) (mean ratio: 116%; CI 90%, 109%-123%), and lower C(min) values (mean ratio: 52%; CI 90%, 48%-56%) compared with G-IR TID during a 24-hour dosing period."( Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in hea
Berner, B; Gordi, T; Hou, E; Kasichayanula, S, 2008
)
0.67
"This exploratory study found that in these healthy subjects, the daily exposure provided by less frequent G-ER dosing was not significantly different from same daily dose with G-IR, administered more frequently."( Pharmacokinetics of gabapentin after a single day and at steady state following the administration of gastric-retentive- extended-release and immediate-release tablets: a randomized, open-label, multiple-dose, three-way crossover, exploratory study in hea
Berner, B; Gordi, T; Hou, E; Kasichayanula, S, 2008
)
0.67
" Recommendations for future research to inform clinical practice should include cost-effectiveness studies and dose-response analysis in order to determine the schema employed and the duration of treatment."( Efficacy of pregabalin and gabapentin for neuropathic pain in spinal-cord injury: an evidence-based evaluation of the literature.
Amaniti, E; Kouvelas, D; Papazisis, G; Tzellos, TG, 2008
)
0.64
" Gabapentin and R-PIA were administered to obtain the dose-response curve and the 50% effective dose (ED(50))."( The interaction of gabapentin and N6-(2-phenylisopropyl)-adenosine R-(-)isomer (R-PIA) on mechanical allodynia in rats with a spinal nerve ligation.
Jun, IG; Park, JY, 2008
)
1.58
"In this study, a straightforward and automated pulsed flow-based procedure was developed for the chemiluminometric determination of gabapentin [1-(aminomethyl)cyclo-hexaneacetic acid], a new generation antiepileptic drug, in different formulated dosage forms."( Rapid chemiluminometric determination of gabapentin in pharmaceutical formulations exploiting pulsed-flow analysis.
Cerdà, V; Estela, JM; Lima, JL; Manera, M; Miró, M; Ribeiro, MF; Santos, JL,
)
0.6
" Log-probit analysis was used to evaluate dose-response effects and calculate the ED(50) values for gabapentin, tiagabine, and their combination at the fixed-ratio of 1:1 in the phases I and II of the formalin test in mice."( Synergistic interaction of gabapentin with tiagabine in the formalin test in mice: an isobolographic analysis.
Czuczwar, M; Czuczwar, SJ; Kolacz, A; Luszczki, JJ; Przesmycki, K, 2009
)
0.87
" XP13512 may therefore provide more predictable gabapentin exposure and decreased dosing frequency."( Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin.
Canafax, DM; Cundy, KC; Luo, W; Moors, TL; Sastry, S; Zou, J, 2008
)
0.84
" Steady-state serum concentrations of gabapentin, distributed over a dosage interval, were obtained from 16 adult patients."( A population pharmacokinetic model of gabapentin developed in nonparametric adaptive grid and nonlinear mixed effects modeling.
Carlsson, KC; Eriksen, HO; Hoem, NO; Karlsson, MO; Moberg, ER; van de Schootbrugge, M, 2009
)
0.9
" To be included in the meta-analysis, RCTs had to compare gabapentin with placebo in the treatment of hot flashes in women with natural or tamoxifen-induced menopause, regardless of the sample size, dosage used, duration of treatment, or frequency of the episodes."( Gabapentin for the treatment of hot flashes in women with natural or tamoxifen-induced menopause: a systematic review and meta-analysis.
Goulis, DG; Kouvelas, D; Toulis, KA; Tzellos, T, 2009
)
2.04
" Patients in group B who were receiving gabapentin continued this treatment up to a maximum daily dosage of 2400 mg during the observation period."( Adequacy assessment of oxycodone/paracetamol (acetaminophen) in multimodal chronic pain : a prospective observational study.
Bertini, L; Carucci, A; Gatti, A; Mammucari, M; Occhioni, R; Sabato, AF, 2009
)
0.62
"The median dosage of gabapentin was 1800 mg/daily."( The efficacy and safety of gabapentin in carpal tunnel patients: open label trial.
Erdemoglu, AK,
)
0.75
" Linear regression analysis was used to evaluate the dose-response relationships between logarithms of antiepileptic drug doses and their resultant maximum possible antinociceptive effects in the mouse hot-plate test."( Synergistic interaction of gabapentin with tiagabine in the hot-plate test in mice: an isobolographic analysis.
Czuczwar, M; Czuczwar, SJ; Kołacz, A; Luszczki, JJ; Przesmycki, K; Wojda, E,
)
0.43
" The infant continued to receive gabapentin; the dosage was increased to 10 mg/kg at bedtime after 6 days, then to 5 mg/kg in the morning and 10 mg/kg at bedtime 10 days later."( Gabapentin therapy for pain and irritability in a neurologically impaired infant.
Cox, TH; Garner, SS; Haney, AL, 2009
)
2.08
" Up to estimated 336 patients (interim analyses) with acute herpes zoster pain (VAS > 30 mm) will be randomised to one of three groups (a) semi-standardised acupuncture (168 patients); (b) gabapentine with individualised dosage between 900-3600 mg/d (84 patients); (c) sham laser acupuncture."( Acupuncture in acute herpes zoster pain therapy (ACUZoster) - design and protocol of a randomised controlled trial.
Fleckenstein, J; Hoffrogge, P; Irnich, D; Kramer, S; Lang, PM; Lehmeyer, L; Mansmann, U; Pfab, F; Ring, J; Schober, GM; Schotten, KJ; Thoma, S; Weisenseel, P, 2009
)
0.54
" Gabapentin was rapidly absorbed and eliminated in dogs, indicating that frequent dosing is needed to maintain minimum targeted plasma concentrations."( Pharmacokinetics of oral gabapentin in greyhound dogs.
Cohen, RL; Kukanich, B, 2011
)
1.58
" Its normal plasma half-life is 2 - 3 hours; dosage modifications are obligatory in renal insufficiency."( Drug-induced encephalopathy secondary to non renal dosing of common medications in Two dialysis patients.
Iloanya, PC; Nye, D; Onuigbo, MA, 2009
)
0.35
" Analysis of the log dose-response curves for oxcarbazepine or gabapentin in a presence of amitriptyline and oxcarbazepine or gabapentin applied alone, revealed a synergism in oxcarbazepine-amitriptyline and additivity in gabapentin-amitriptyline combination."( Analysis of the antinociceptive interactions in two-drug combinations of gabapentin, oxcarbazepine and amitriptyline in streptozotocin-induced diabetic mice.
Bosković, B; Micov, AM; Prostran, MS; Stepanović-Petrović, RM; Tomić, MA; Ugresić, ND; Vucković, SM, 2010
)
0.83
"Although not definitive, our findings suggest that gabapentin administered at these doses with this dosing regimen holds little promise for the treatment of tobacco dependence in a population of smokers seeking treatment."( Gabapentin for smoking cessation.
Croghan, IT; Ebbert, JO; Hays, JT; Schroeder, DR; Sood, A; Sood, R; Wyatt, KD, 2010
)
2.06
" Patients with chronic kidney disease often receive inappropriately high gabapentin dosage for their kidney function, occasioning overt toxicity; advanced age and comorbidity predispose these patients for toxicity."( Gabapentin toxicity in patients with chronic kidney disease: a preventable cause of morbidity.
McKian, KP; Qian, Q; Zand, L, 2010
)
2.03
" Other gabapentin doses or dosing regimens warrant further study."( Clinical evaluation of perioperative administration of gabapentin as an adjunct for postoperative analgesia in dogs undergoing amputation of a forelimb.
Hellyer, PW; Mich, PM; Uhrig, SR; Wagner, AE, 2010
)
1.06
"4%) with gabapentin at a dosage of 900 mg/d and in 9 patients (20."( Gabapentin in the treatment of hiccups in patients with advanced cancer: a 5-year experience.
Aielli, F; Aloisi, P; Ficorella, C; Galletti, B; Porzio, G; Verna, L, 2010
)
2.22
"The objectives of the 3 phase I studies described herein were (1) to compare the pharmacokinetics of gabapentin delivered from a novel gastric-retentive dosage form vs an immediate-release formulation, (2) to assess the dose proportionality of the gastric-retentive extended-release formulation, and (3) to determine the effect of food on the pharmacokinetics of gabapentin delivered from this formulation."( Pharmacokinetics of gabapentin in a novel gastric-retentive extended-release formulation: comparison with an immediate-release formulation and effect of dose escalation and food.
Chen, C; Cowles, VE; Hou, E, 2011
)
0.91
" These findings indicate that preoperative use of gabapentin followed by postoperative dosing for two days did not significantly affect the postoperative pain, sleep, opioid consumption or patient-perceived quality of recovery for patients undergoing cardiac surgery."( Effect of gabapentin on pain after cardiac surgery: a randomised, double-blind, placebo-controlled trial.
Cornelissen, HR; Fraser, JF; Liessmann, CD; O'Connell, L; Rapchuk, IL, 2010
)
1.02
" 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
)
0.87
" After confirmation of the established allodynia, gabapentin at 10, 30, 60 and 100μg or clonidine at 5, 15, 30 and 50μg was injected as a monotherapy in conscious rats through the intrathecal catheter to obtain the dose-response curve of %MPE (maximum possible effect) of the antiallodynic effect and its ED(50)."( Intrathecal gabapentin and clonidine synergistically inhibit allodynia in spinal nerve-ligated rats.
Asada, A; Funao, T; Mori, T; Nishikawa, K; Yamama, Y, 2010
)
0.99
" Reassessment and modulation of dosing and/or medications occurred at 3- and 6-month intervals."( An open-label comparison of nabilone and gabapentin as adjuvant therapy or monotherapy in the management of neuropathic pain in patients with peripheral neuropathy.
Bestard, JA; Toth, CC,
)
0.4
" The PWT in PSL mice was dose-dependently increased by intraperitoneal injection of gabapentin, but the anti-allodynic effects varied according to its dosing time."( Molecular basis for the dosing time-dependency of anti-allodynic effects of gabapentin in a mouse model of neuropathic pain.
Hamamura, K; Inoue, K; Koyanagi, S; Kusunose, N; Matsunaga, N; Ohdo, S; Tsuda, M; Uchida, T; Yoshida, M, 2010
)
0.81
"These findings suggest that the dosing time-dependent difference in the anti-allodynic effects of gabapentin is attributable to the circadian oscillation of α2δ-1 subunit expression in the DRG and indicate that the optimizing its dosing schedule helps to achieve rational pharmacotherapy for neuropathic pain."( Molecular basis for the dosing time-dependency of anti-allodynic effects of gabapentin in a mouse model of neuropathic pain.
Hamamura, K; Inoue, K; Koyanagi, S; Kusunose, N; Matsunaga, N; Ohdo, S; Tsuda, M; Uchida, T; Yoshida, M, 2010
)
0.81
" A therapeutic strategy and optimal dosage of medications including gabapentin should be established for the treatment of SUNCT."( [Japanese SUNCT patient responsive to gabapentin].
Imai, K; Ito, Y; Kato, T; Nishida, S; Suzuki, J; Yasuda, T, 2011
)
0.88
" This study assessed the efficacy of GEn vs placebo and compared the pharmacokinetics of gabapentin after oral dosing of GEn or gabapentin in patients with PHN."( Efficacy of gabapentin enacarbil vs placebo in patients with postherpetic neuralgia and a pharmacokinetic comparison with oral gabapentin.
Backonja, MM; Canafax, DM; Cundy, KC, 2011
)
0.97
" Gabapentin was restarted at the original dosage and the symptoms resolved within 8 hours."( Akathisia induced by gabapentin withdrawal.
Hendriks, E; Hsiung, L; See, S, 2011
)
1.6
"In 32 PHN patients being administered gabapentin, without changing the frequency of dosing, the drug was substituted with pregabalin at one-sixth dosage of gabapentin."( Replacement of gabapentin with pregabalin in postherpetic neuralgia therapy.
Hidaka, I; Ifuku, M; Inada, E; Iseki, M; Komatus, S; Morita, Y, 2011
)
0.99
"It was suggested that the analgesic action of pregabalin in PHN was six times that of gabapentin in terms of effectiveness in dosage conversion."( Replacement of gabapentin with pregabalin in postherpetic neuralgia therapy.
Hidaka, I; Ifuku, M; Inada, E; Iseki, M; Komatus, S; Morita, Y, 2011
)
0.95
" The new drug combines generic gabapentin with a polymeric delivery system allowing for extended release and is licensed to be given only as a once-daily dosing regimen."( Extended-release gabapentin in post-herpetic neuralgia.
Farquhar-Smith, P; Thomas, B, 2011
)
0.99
"Although GpER has been approved by the FDA for once-daily use in PHN, there is a relative paucity of data for both its efficacy and the optimum dosing schedule (once or twice a day)."( Extended-release gabapentin in post-herpetic neuralgia.
Farquhar-Smith, P; Thomas, B, 2011
)
0.71
"Study limitations include a short timeframe and using data from different dosage schemes for GBP and PGB."( Economic evaluation of duloxetine as a first-line treatment for painful diabetic peripheral neuropathy in Mexico.
Carlos, F; Dueñas, H; Galindo-Suárez, RM; Ramírez-Gámez, J; Ramos, E, 2012
)
0.38
" The dosage was adjusted according to the level of pain control and side-effects."( Use of single- and multi-drug regimens in the management of classic (idiopathic) trigeminal neuralgia: an 11-year experience at a single Sri Lankan institution.
Ariyawardana, A; Pallegama, R; Ranasinghe, A; Sitheeque, M, 2012
)
0.38
" They have been shown to help in reaching the desired effect when administered at drug-specific modes and at proven effective dosing throughout the perioperative period."( Non-opioid IV adjuvants in the perioperative period: pharmacological and clinical aspects of ketamine and gabapentinoids.
Weinbroum, AA, 2012
)
0.59
" These results suggest this dosing regimen of gabapentin is not efficacious in improving outcomes in patients undergoing shoulder arthroscopy under general anesthesia with an interscalene block."( Perioperative administration of gabapentin for shoulder arthroscopy: a prospective, randomized, double-blind, placebo-controlled study.
Bowen, K; Goff, J; Maye, J; Mohan, E; Osborne, L; Spence, D, 2011
)
0.91
" The objective of this paper is to report the steady-state pharmacokinetics and safety of gabapentin with different dosing regimens of gabapentin-ER in postmenopausal women with hot flashes."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.88
" C(max) generally increased with increasing dose as did C(min) and C(avg) for the various treatments in a manner that was consistent with the dosing regimen."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.66
"The pharmacokinetic profile of gabapentin-ER may allow for once- or twice-daily dosing while maintaining bioavailability and thus efficacy."( Steady-state pharmacokinetics of gabapentin after administration of a novel gastroretentive extended-release formulation in postmenopausal women with vasomotor symptoms.
Cowles, VE; Gordi, T; Hou, SY, 2012
)
0.95
" The gastroretentive once-daily formulation of gabapentin (G-GR) allows for less frequent dosing while maintaining efficacy and may also reduce adverse events (AEs) associated with high plasma concentration of gabapentin occurring during the waking hours."( Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: an overview.
Argoff, CE; Chen, C; Cowles, VE, 2012
)
0.87
" The GR technology used in G-GR resulted in a decreased dosing frequency from three times per day for the IR product to once daily in the treatment of PHN, while maintaining the same efficacy with an apparent reduced incidence of AEs common to G-IR therapy."( Clinical development of a once-daily gastroretentive formulation of gabapentin for treatment of postherpetic neuralgia: an overview.
Argoff, CE; Chen, C; Cowles, VE, 2012
)
0.61
" Once-daily dosing has been shown to provide comparable drug exposure with an identical daily dose of the immediate-release formulation when administered three times daily."( Gabapentin for once-daily treatment of post-herpetic neuralgia: a review.
Beal, B; Moeller-Bertram, T; Schilling, JM; Wallace, MS, 2012
)
1.82
" This review focuses on the ADME properties of gabapentin and illustrates how GR delivery enhances its absorption compared with IR formulations and allows once-daily dosing with the evening meal for the treatment of PHN."( The intestinal absorption mechanism of gabapentin makes it appropriate for gastroretentive delivery.
Chen, C; Cowles, VE; Sweeney, M, 2013
)
0.92
"The objective of this modeling study was to assess different dosage regimens that might be used to guide clinicians in transitioning patients from gabapentin to pregabalin therapy when such a transition is clinically warranted."( Gabapentin to pregabalin therapy transition: a pharmacokinetic simulation.
Bockbrader, HN; Budhwani, MN; Wesche, DL, 2013
)
2.03
" The effective doses, for 20%, 50%, and 80% response (ED(20), ED(50), and ED(80), respectively), of each drug were calculated using least squares linear regression analysis, and then dose-response curves were compared."( Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain.
Keyhanfar, F; Shamsi Meymandi, M, 2013
)
0.67
" No difference was observed between slopes of dose-response curves."( Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain.
Keyhanfar, F; Shamsi Meymandi, M, 2013
)
0.67
"In this animal model of visceral pain, all three drugs exhibited parallel dose-response curves."( Relative potency of pregabalin, gabapentin, and morphine in a mouse model of visceral pain.
Keyhanfar, F; Shamsi Meymandi, M, 2013
)
0.67
"PHN pain reduction after G-GR treatment can be observed as early as the second day of dosing and continues for at least 10 weeks."( Once-daily gastroretentive gabapentin for postherpetic neuralgia: integrated efficacy, time to onset of pain relief and safety analyses of data from two phase 3, multicenter, randomized, double-blind, placebo-controlled studies.
Irving, GA; Rauck, RL; Sweeney, M; Vanhove, GF; Wallace, MS, 2013
)
0.69
" This study examines dosing patterns, therapy outcomes, healthcare utilization and costs of patients with PHN who initiate treatment with gabapentin or pregabalin."( Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin.
Becker, L; Halpern, R; Johnson, P; Sweeney, M, 2013
)
0.84
" The mean daily dosage was 826 mg for gabapentin and 187 mg for pregabalin."( Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin.
Becker, L; Halpern, R; Johnson, P; Sweeney, M, 2013
)
0.91
" Suboptimal dosing and discontinuation may be associated with supplementary use of other analgesics, especially opioids."( Real-world treatment of post-herpetic neuralgia with gabapentin or pregabalin.
Becker, L; Halpern, R; Johnson, P; Sweeney, M, 2013
)
0.64
" Analyses were performed on safety data from patients who received G-GR for 10 weeks in the randomized controlled study and who then received an additional 14 weeks of G-GR, asymmetrically dosed in the current study."( Long-term safety of gastroretentive gabapentin in postherpetic neuralgia patients.
Irving, G; Jensen, MP; Rauck, R; Sweeney, M; Vanhove, GF; Wallace, M, 2013
)
0.66
" The effective dosing regimen of gabapentin IR (G-IR) for PHN is 1800 mg/day in three divided doses."( Pharmacokinetics, efficacy, and tolerability of a once-daily gastroretentive dosage form of gabapentin for the treatment of postherpetic neuralgia.
Chen, C; Cowles, VE; Han, CH; Sweeney, M, 2013
)
0.89
"67 days of study drug, with eight patients receiving a dosage of 300 mg thrice daily (TID), 24 receiving 600 mg TID, 14 receiving 800 mg TID, and seven receiving 1200 mg TID."( Gabapentin is ineffective as an analgesic adjunct in the immediate postburn period.
Eid, A; Heard, J; Horsfield, A; Kealey, P; Kral, L; Liao, J; Rosenquist, R; Wibbenmeyer, L,
)
1.57
"To demonstrate the premise of individualized dosing charts (IDCs) as a clinical-bedside decision-support tool to individualize dosage regimens for drugs in which the interpatient variability is controlled by the pharmacokinetic (PK) behavior of the patient, to calculate the optimal sampling schedule (OSS), which minimizes the number of blood samples per patient."( Validation of a novel approach for dose individualization in pharmacotherapy using gabapentin in a proof of principles study.
Anaissie, EJ; Blau, GE; Fausel, C; Laínez, JM; Orcun, S; Reklaitis, GV; Suvannasankha, A, 2013
)
0.61
" The dose amount and dosing interval must be adjusted to maximize the probability of staying within the target concentration range."( Validation of a novel approach for dose individualization in pharmacotherapy using gabapentin in a proof of principles study.
Anaissie, EJ; Blau, GE; Fausel, C; Laínez, JM; Orcun, S; Reklaitis, GV; Suvannasankha, A, 2013
)
0.61
"IDCs display the risk of a patient violating the target concentration range for any dosage regimen."( Validation of a novel approach for dose individualization in pharmacotherapy using gabapentin in a proof of principles study.
Anaissie, EJ; Blau, GE; Fausel, C; Laínez, JM; Orcun, S; Reklaitis, GV; Suvannasankha, A, 2013
)
0.61
"A dosage of 600 mg of gabapentin plus 4 mg of dexamethasone significantly reduced the 24-hour incidence of nausea and PONV."( The effect of gabapentin premedication on postoperative nausea, vomiting, and pain in patients on preoperative dexamethasone undergoing craniotomy for intracranial tumors.
Misra, S; Parthasarathi, G; Vilanilam, GC, 2013
)
1.07
" We also summarised data on adverse events from all single dosage studies and calculated risk differences (RDs) and numbers needed to harm (NNHs)."( Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults.
Chronicle, EP; Linde, M; McCrory, DC; Mulleners, WM, 2013
)
1.83
" One trial of gabapentin enacarbil (523 participants) failed to demonstrate a significant difference versus placebo or between doses for gabapentin enacarbil titrated to between 1200 mg and 3000 mg with regard to proportion of responders; there was also no evidence of a dose-response trend."( Gabapentin or pregabalin for the prophylaxis of episodic migraine in adults.
Chronicle, EP; Linde, M; McCrory, DC; Mulleners, WM, 2013
)
2.19
" Multiple dosing regimens may be beneficial in reducing acute and chronic pain; however, more robust randomized control studies are needed."( Is there a role for gabapentin in preventing or treating pain following thoracic surgery?
Frazer, S; Hunt, I; Zakkar, M, 2013
)
0.71
" Several derivatization methods have been developed and used for their determination in bulk or pharmaceutical dosage forms."( A simple high-throughput method for determination of antiepileptic analogues of γ-aminobutyric acid in pharmaceutical dosage forms using microplate fluorescence reader.
Martinc, B; Vovk, T, 2013
)
0.39
" We estimated summary risk ratios for each outcome and evaluated dose-response in regression models."( Gabapentin add-on for drug-resistant partial epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Pulman, J, 2013
)
1.83
"Mean median daily dosage over 6 months was 53."( Effectiveness of duloxetine compared with pregabalin and gabapentin in diabetic peripheral neuropathic pain: results from a German observational study.
Birklein, F; Boess, FG; Happich, M; Schacht, A; Schneider, E; Wilhelm, S; Ziegler, D, 2014
)
0.65
" The extent of liver damage at different dosage and long term treatment with GPN is not yet clear."( Chronic effect of gabapentin on liver function in adult male rats.
Abdollahi, A; Meshkibaf, MH; Miladpoor, B; Shole Var, F, 2013
)
0.72
" Time-course data for the dose-response effects were analyzed using two-way analysis of variance and the posthoc Tukey-Kramer multiple-comparison test."( Antinociceptive effects of mirtazapine, pregabalin, and gabapentin after chronic constriction injury of the infraorbital nerve in rats.
Hashimoto, R; Hosokawa, K; Mashimo, T; Nakae, A; Nakai, K, 2014
)
0.65
" However, cost-analysis is only part of the equation when treating chronic pain patients and undervalues the relationships of enhanced compliance due to single-daily dosing and stable and reliable pharmacokinetics associated with extended-duration preparations using either retentive technologies or delayed absorption strategies."( Can Chronic Pain Patients Be Adequately Treated Using Generic Pain Medications to the Exclusion of Brand-Name Ones?
Anantamongkol, U; Candido, KD; Chiweshe, J; Knezevic, NN,
)
0.13
" All patients were titrated to 1800 mg G-GR/d over 2 weeks and maintained at that dosage for 6 weeks, for 8 weeks total treatment."( Real-world experience with once-daily gabapentin for the treatment of postherpetic neuralgia (PHN).
Dunteman, ED; Kareht, S; Markley, HG; Sweeney, M, 2015
)
0.69
" It may be related with using a similar dosage of dopaminergic drugs."( Augmentation in restless legs syndrome patients in Korea.
Cho, YW; Jeon, JY; Lee, HB; Moon, HJ; Song, ML, 2015
)
0.42
" We compared dosing and side effects in 34 CKD/ESKD patients with similar patients receiving HD (n = 15)."( Efficacy and safety of gabapentin for uremic pruritus and restless legs syndrome in conservatively managed patients with chronic kidney disease.
Brennan, F; Brown, MA; Cheikh Hassan, HI; Collett, G; Josland, EA, 2015
)
0.73
" GBP dosing was rapidly escalated within days of SAH up to a median of 1,200 mg/day, with a range of 300 mg three times a day to 900 mg three times a day."( Safety and tolerability of gabapentin for aneurysmal subarachnoid hemorrhage (sah) headache and meningismus.
Dhakal, LP; Freeman, WD; Hodge, DO; Mayes, M; Nagal, J; Nagel, J; Ng, LK; Richie, A, 2015
)
0.71
" Participants were dosed with gabapentin alone (n = 39), zolpidem tartrate alone (n = 38), and the combination (gabapentin + zolpidem) (n = 38) over three treatment periods, which were separated by ≥7 days."( Pharmacokinetic effects of simultaneous administration of single-dose gabapentin 500 mg and zolpidem tartrate 10 mg in healthy volunteers: a randomized, open-label, crossover trial.
Furey, SA; Galitz, LA; Jayawardena, S, 2015
)
0.94
" Dosing information can guide treatment trials and future prospective studies."( Gabapentin for management of recurrent pain in 22 nonverbal children with severe neurological impairment: a retrospective analysis.
Hauer, JM; Solodiuk, JC, 2015
)
1.86
" Effects of orally dosed standard analgesics on CRANE were examined 48 h following bilateral CFA injection."( Complete Freund's adjuvant-induced reduction of exploratory activity in a novel environment as an objective nociceptive endpoint for sub-acute inflammatory pain model in rats.
Bannon, AW; Joshi, SK; Zhu, CZ, 2015
)
0.42
" GBP has a favorable adverse effect profile in therapeutic dosing with the most common reported effects being dizziness, fatigue, drowsiness, weight gain, and peripheral edema."( An acute gabapentin fatality: a case report with postmortem concentrations.
Cantrell, FL; Gary, RD; McIntyre, IM; Mena, O, 2015
)
0.83
" Compounded dosage forms of gabapentin are commonly used for pain management, however, the penetration and efficacy of gabapentin in these compounded topical formulations has not been fully studied."( Skin permeation and antinociception of topical gabapentin formulations.
Asbill, S; Bryson, E; Sweitzer, S,
)
0.68
"Gabapentin may have a role in the treatment of mild alcohol withdrawal, but future studies should focus on adequate dosing strategies."( The role of gabapentin in the management of alcohol withdrawal and dependence.
Hall-Flavin, D; Leung, JG; Nelson, S; Schak, KM; Schmidt, KA, 2015
)
2.24
" The best compartmental, oral model was used to simulate the concentration-time profiles resulting from different dosing scenarios."( Pharmacokinetics of Compounded Intravenous and Oral Gabapentin in Hispaniolan Amazon Parrots ( Amazona ventralis ).
Baine, K; Cox, S; Jones, MP; Martín-Jiménez, T, 2015
)
0.67
" Since, 5-HT6 antagonists improved the effectiveness of gabapentinoids, reduction in the dosage and frequency of gabapentinoids treatment may reduce the side effects."( 5-HT6 receptor antagonist attenuates the memory deficits associated with neuropathic pain and improves the efficacy of gabapentinoids.
Babu, VA; Bhyrapuneni, G; Goura, V; Jayarajan, P; Nirogi, R; Shinde, A; Yathavakilla, S, 2015
)
0.87
"Gabapentin displays non-linear drug disposition, which complicates dosing for optimal therapeutic effect."( Pharmacokinetic/Pharmacodynamic Relationship of Gabapentin in a CFA-induced Inflammatory Hyperalgesia Rat Model.
Holm, R; Keizer, R; Kreilgaard, M; Larsen, MS; Munro, G; Mørk, A; Savic, R, 2016
)
2.13
" Gabapentin has a favorable adverse effect profile in therapeutic dosing with the most common reported effects being dizziness, fatigue, drowsiness, weight gain, and peripheral edema."( Gabapentin concentrations and postmortem distribution.
Gary, RD; Hamm, CE; McIntyre, IM, 2016
)
2.79
"To evaluate efficacy, appropriate dosing regimen and safety of gabapentin on UP in hemodialysis (HD) patients."( Gabapentin: A promising therapy for uremic pruritus in hemodialysis patients: A randomized-controlled trial and review of literature.
Abdelkhalik, Z; Alkot, R; Eldesouky, F; Farag, F; Nofal, A; Nofal, E, 2016
)
2.12
" Rodent models of CIPN have been developed using a range of dosing regimens to reproduce pain-like behaviours akin to patient-reported symptoms."( Chemotherapy-induced painful neuropathy: pain-like behaviours in rodent models and their response to commonly used analgesics.
Duggett, NA; Flatters, SJL; Hopkins, HL, 2016
)
0.43
" We present an overview of dosing regimens to produce CIPN models and their phenotype of pain-like behaviours."( Chemotherapy-induced painful neuropathy: pain-like behaviours in rodent models and their response to commonly used analgesics.
Duggett, NA; Flatters, SJL; Hopkins, HL, 2016
)
0.43
"The review outlines the latest description of the most-relevant rodent models of CIPN enabling comparison between chemotherapeutics, dosing regimen, rodent strain, and sex."( Chemotherapy-induced painful neuropathy: pain-like behaviours in rodent models and their response to commonly used analgesics.
Duggett, NA; Flatters, SJL; Hopkins, HL, 2016
)
0.43
" One month later, she reported that she had self-reduced the gabapentin dosage to 300 mg once daily, after which she noticed improvement in her daytime sleepiness and fatigue and experienced one hallucination approximately one week after the dosage reduction."( Visual hallucinations associated with gabapentin use.
Derkits, ME; Parsons, KA, 2016
)
0.95
"Databases were searched for peer-reviewed papers demonstrating gabapentin misuse, characterized by taking a larger dosage than prescribed or taking gabapentin without a prescription, and diversion."( Gabapentin misuse, abuse and diversion: a systematic review.
Havens, JR; Smith, RV; Walsh, SL, 2016
)
2.12
" Dose-response curves (DRC) and isobolographic analysis were used to confirm their synergistic antihyperalgesic and anti-allodynic responses in a rat neuropathic pain model involving chronic constriction injury of the sciatic nerve and in von Frey and acetone tests."( The Antinociceptive Effects of Tramadol and/or Gabapentin on Rat Neuropathic Pain Induced by a Chronic Constriction Injury.
Corona-Ramos, JN; De la O-Arciniega, M; Déciga-Campos, M; Domínguez-Ramírez, AM; Espinosa-Juárez, JV; Jaramillo-Morales, OA; López-Muñoz, FJ; Medina-López, JR, 2016
)
0.69
"The aim of this review was to evaluate current literature for dosing recommendations for the use of antiepileptic medications in patients receiving renal replacement therapy (RRT)."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
" Micromedex® DRUGDEX as well as package inserts were used to obtain known pharmacokinetic properties and dosage adjustment recommendations in RRT if known."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
"Data regarding antiepileptic drug use in RRT are limited and mostly consist of case reports limiting our proposed dosing recommendations."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
"Additional studies are necessary before specific dosing recommendations can be made for most antiepileptic drugs in critically ill patients receiving RRT, specifically with newer agents."( Antiepileptic dosing for critically ill adult patients receiving renal replacement therapy.
Bastin, ML; Cook, AM; Oyler, DR; Smetana, KS, 2016
)
0.43
" Previous studies showed that opioids combined with gabapentin for management of cancer pain reduced the dosage of opioids."( The research on long-term clinical effects and patients' satisfaction of gabapentin combined with oxycontin in treatment of severe cancer pain.
Chen, DL; Li, YH; Wang, ZJ; Zhu, YK, 2016
)
0.92
" Therefore, in women with a uterus, it is recommended that physicians prescribe combination therapy only to treat menopausal symptoms such as vasomotor symptoms (hot flashes) and vaginal atrophy, using the smallest effective dosage for the shortest possible duration."( Hormone Therapy and Other Treatments for Symptoms of Menopause.
Crider, M; Hill, DA; Hill, SR, 2016
)
0.43
" Cyclobenzaprine specimens were equally likely to be positive whether the dose was oral or topical, although mean levels after topical dosing were approximately 13-21% those after oral dosing."( Urinary Concentrations of Topically Administered Pain Medications.
Bell, P; Glinn, MA; Harvey, A; Lickteig, AJ; Rappold, B; Recer, S; Salske, M; Stensland, J; Weber, L, 2017
)
0.46
"In this study, we evaluated the dose-response efficacy of levetiracetam (12."( Combination therapy of levetiracetam and gabapentin against nonconvulsive seizures induced by penetrating traumatic brain injury.
Cao, Y; Liao, Z; Lu, XM; Mountney, A; Shear, DA; Tortella, FC, 2017
)
0.72
" However, the two drugs manifested different dose-response profiles."( Combination therapy of levetiracetam and gabapentin against nonconvulsive seizures induced by penetrating traumatic brain injury.
Cao, Y; Liao, Z; Lu, XM; Mountney, A; Shear, DA; Tortella, FC, 2017
)
0.72
" We report on a case of a 31 year old female who presented to the emergency department with unilateral leg pain, weakness, and swelling after increasingly titrating her Gabapentin dosage over three weeks."( Radiologic Findings in Gabapentin-Induced Myositis.
Chang, DR; Coupal, TM; Munk, PL; Ouellette, HA; Pennycooke, K, 2017
)
0.96
" In addition, there was a negative correlation between the gabapentin dosage and the occurrence of nausea and vomiting."( The efficacy of gabapentin in reducing pain intensity and postoperative nausea and vomiting following laparoscopic cholecystectomy: A meta-analysis.
Dong, Y; Tan, H; Wang, L; Zhang, J, 2017
)
1.04
" Dosage regimens varied between and within doctors, particularly for the use of gabapentin and diazepam."( Oral medication prescription practices of tertiary-based specialists for dystonia in children with cerebral palsy.
Harvey, A; Reddihough, D; Scheinberg, A; Williams, K, 2018
)
0.71
" Optimal dosing and timing of perioperative gabapentin in the context of specific operations to decrease opioid use should be addressed in further research."( Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial.
Carroll, I; Clay, D; Costouros, JG; Curtin, C; Dirbas, FM; Efron, B; Goodman, S; Hah, J; Huddleston, J; Humphreys, K; Mackey, SC; Maloney, WJ; McCue, R; Ruchelli, G; Schmidt, P; Sharifzadeh, Y; Shrager, J; Trafton, J, 2018
)
1.05
" Patients will continue their current pain medication at study onset, conditional upon dosage consistency during the prior 30 days."( Pregabalin versus gabapentin in the treatment of sciatica: study protocol for a randomised, double-blind, cross-over trial (PAGPROS).
Harriss, L; Hennessy, M; Marshman, LAG; Plummer, D; Robertson, K, 2018
)
0.81
" The goal of this study was to assess the association between gabapentin dosing and adverse outcomes by obtaining estimates of the 30-day risk of hospitalization with altered mental status and mortality in older adults (mean age 76 years) in Ontario, Canada initiated on high dose (>600 mg/day; n = 34,159) compared to low dose (≤600 mg/day; n = 76,025) oral gabapentin in routine outpatient care."( Gabapentin dose and the 30-day risk of altered mental status in older adults: A retrospective population-based study.
Burneo, J; Dev, VK; Dixon, SN; Fleet, JL; Garg, AX; Kuwornu, PJ; Montero-Odasso, M, 2018
)
2.16
" Gabapentin dosing was 600 mg (<65 years) or 300 mg (>65 years)."( Does low-dose gapapentin reduce opioid use postoperatively?: A randomized controlled trial in women undergoing reconstructive pelvic surgery.
Alarab, M; Dawood, A; Lemos, N; Li, ALK; Lovatsis, D; McDermott, CD; Siddiqui, NT; Wadsworth, K, 2019
)
1.42
"GEn requires less frequent dosing compared with GBP-IR and fluctuates less with sustained gabapentin exposure throughout the day."( Pharmacokinetics of immediate release, extended release, and gastric retentive gabapentin formulations in healthy adults
.
Aronoff, GM; Ciric, S; Lal, R; Swearingen, D, 2018
)
0.93
" Moreover, GBP is a freely water-soluble drug, thus it is considered a challenging candidate to be formulated as extended release dosage form."( Gastroretentive raft liquid delivery system as a new approach to release extension for carrier-mediated drug.
Aboelwafa, AA; Abouelatta, SM; El-Gazayerly, ON, 2018
)
0.48
" When sodium channel blockers cannot reach full dosage because of side effects, an add-on treatment with lamotrigine or baclofen should be considered."( Current and Innovative Pharmacological Options to Treat Typical and Atypical Trigeminal Neuralgia.
Cruccu, G; Di Stefano, G; Truini, A, 2018
)
0.48
"To evaluate the pharmacokinetics of clinically relevant dosing regimens of gabapentin in cats."( The pharmacokinetics of gabapentin in cats.
Adrian, D; Baynes, R; Lascelles, BDX; Papich, MG; Stafford, E, 2018
)
1.02
"Repeated oral dosing of gabapentin did not alter the drug's pharmacokinetics, making dose adjustments unnecessary with long-term treatment."( The pharmacokinetics of gabapentin in cats.
Adrian, D; Baynes, R; Lascelles, BDX; Papich, MG; Stafford, E, 2018
)
1.09
" We estimated summary risk ratios (RR) for each outcome and evaluated dose-response in regression models."( Gabapentin add-on treatment for drug-resistant focal epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Panebianco, M; Weston, J, 2018
)
1.92
" As only a minority of respondents felt comfortable prescribing these drugs, more education on effective and safe dosing is needed."( Use of Systemic Treatment in Patients with Chronic Pruritus: A Survey of Dermatologists in the Netherlands.
Kamsteeg, M; Kouwenhoven, TA; van de Kerkhof, PCM, 2019
)
0.51
"Gabapentin use in posterior spinal fusion (PSF) postoperative pain management for adolescent idiopathic scoliosis (AIS) is increasingly common in order to decrease opioid use and improve pain control, though there is conflicting data on dosing and effectiveness to support this practice in real world settings."( Use of Gabapentin in Posterior Spinal Fusion is Associated With Decreased Postoperative Pain and Opioid Use in Children and Adolescents.
Buckland, AJ; Errico, TJ; Mansky, R; McLeod, L; Rosenberg, RE; Sure, A; Tishelman, J; Tracy, J; Trzcinski, S; Vasquez Montes, D; Zhou, P, 2019
)
2.41
" In patients with RLS, intake in the evening/night only was common due to nocturnal symptoms, in contrast to regular dosing regimens in epilepsy."( Therapeutic drug monitoring of gabapentin in various indications.
Johannessen Landmark, C; Johannessen, SI; Kinge, E; Larsen Burns, M; Stokke Opdal, M, 2019
)
0.8
" Challenges with applying TDM in new indications such as RLS include different dosage regimens and consequently different interpretation of serum concentrations."( Therapeutic drug monitoring of gabapentin in various indications.
Johannessen Landmark, C; Johannessen, SI; Kinge, E; Larsen Burns, M; Stokke Opdal, M, 2019
)
0.8
"Gabapentin is currently used 'off-label' in children and adolescents with chronic neuropathic pain, and reliable evidence of its effects and optimal dosing are lacking."( Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol.
Alberti, C; Bonifazi, D; Ceci, A; de Leeuw, TG; de Wildt, SN; Della Pasqua, O; Felisi, M; Kaguelidou, F; Le Roux, E; Lundin, R; Mangiarini, L; Tibboel, D, 2019
)
2.19
"28), indicating a dose-response relationship."( Pregabalin add-on for drug-resistant focal epilepsy.
Bresnahan, R; Hemming, K; Marson, AG; Panebianco, M, 2019
)
0.51
" Optimal standardized dosing and drug combination for preoperative multimodal analgesia remains to be elucidated."( Preoperative multimodal analgesia decreases 24-hour postoperative narcotic consumption in elective spinal fusion patients.
Haffner, M; Hwang, J; Klineberg, E; Migdal, C; Nathe, R; Roberto, R; Saiz, AM, 2019
)
0.51
" The main objective of developing such systems is to increase the residence time of a specific drug in stomach; controlling its release, increasing its bioavailability and decreasing its side effects and dosing frequency."( Development of Gabapentin Expandable Gastroretentive Controlled Drug Delivery System.
Kanaze, FI; Muqedi, RH; Rimawi, IB, 2019
)
0.87
" The efficacy of MMF as an immunosuppressant and long-term safety in cats of this dosage regimen is unknown."(
Abrams, G; Adolfsson, E; Agarwal, PK; Akkan, AG; Al Alhareth, NS; Alves, VGL; Armentano, R; Bahroos, E; Baig, M; Baldridge, KK; Barman, S; Bartolucci, C; Basit, A; Bertoli, SV; Bian, L; Bigatti, G; Bobenko, AI; Boix, PP; Bokulic, T; Bolink, HJ; Borowiec, J; Bulski, W; Burciaga, J; Butt, NS; Cai, AL; Campos, AM; Cao, G; Cao, Y; Čapo, I; Caruso, ML; Chao, CT; Cheatum, CM; Chelminski, K; Chen, AJW; Chen, C; Chen, CH; Chen, D; Chen, G; Chen, H; Chen, LH; Chen, R; Chen, RX; Chen, X; Cherdtrakulkiat, R; Chirvony, VS; Cho, JG; Chu, K; Ciurlino, D; Coletta, S; Contaldo, G; Crispi, F; Cui, JF; D'Esposito, M; de Biase, S; Demir, B; Deng, W; Deng, Z; Di Pinto, F; Domenech-Ximenos, B; Dong, G; Drácz, L; Du, XJ; Duan, LJ; Duan, Y; Ekendahl, D; Fan, W; Fang, L; Feng, C; Followill, DS; Foreman, SC; Fortunato, G; Frew, R; Fu, M; Gaál, V; Ganzevoort, W; Gao, DM; Gao, X; Gao, ZW; Garcia-Alvarez, A; Garza, MS; Gauthier, L; Gazzaz, ZJ; Ge, RS; Geng, Y; Genovesi, S; Geoffroy, V; Georg, D; Gigli, GL; Gong, J; Gong, Q; Groeneveld, J; Guerra, V; Guo, Q; Guo, X; Güttinger, R; Guyo, U; Haldar, J; Han, DS; Han, S; Hao, W; Hayman, A; He, D; Heidari, A; Heller, S; Ho, CT; Ho, SL; Hong, SN; Hou, YJ; Hu, D; Hu, X; Hu, ZY; Huang, JW; Huang, KC; Huang, Q; Huang, T; Hwang, JK; Izewska, J; Jablonski, CL; Jameel, T; Jeong, HK; Ji, J; Jia, Z; Jiang, W; Jiang, Y; Kalumpha, M; Kang, JH; Kazantsev, P; Kazemier, BM; Kebede, B; Khan, SA; Kiss, J; Kohen, A; Kolbenheyer, E; Konai, MM; Koniarova, I; Kornblith, E; Krawetz, RJ; Kreouzis, T; Kry, SF; Laepple, T; Lalošević, D; Lan, Y; Lawung, R; Lechner, W; Lee, KH; Lee, YH; Leonard, C; Li, C; Li, CF; Li, CM; Li, F; Li, J; Li, L; Li, S; Li, X; Li, Y; Li, YB; Li, Z; Liang, C; Lin, J; Lin, XH; Ling, M; Link, TM; Liu, HH; Liu, J; Liu, M; Liu, W; Liu, YP; Lou, H; Lu, G; Lu, M; Lun, SM; Ma, Z; Mackensen, A; Majumdar, S; Martineau, C; Martínez-Pastor, JP; McQuaid, JR; Mehrabian, H; Meng, Y; Miao, T; Miljković, D; Mo, J; Mohamed, HSH; Mohtadi, M; Mol, BWJ; Moosavi, L; Mosdósi, B; Nabu, S; Nava, E; Ni, L; Novakovic-Agopian, T; Nyamunda, BC; Nyul, Z; Önal, B; Özen, D; Özyazgan, S; Pajkrt, E; Palazon, F; Park, HW; Patai, Á; Patai, ÁV; Patzke, GR; Payette, G; Pedoia, V; Peelen, MJCS; Pellitteri, G; Peng, J; Perea, RJ; Pérez-Del-Rey, D; Popović, DJ; Popović, JK; Popović, KJ; Posecion, L; Povall, J; Prachayasittikul, S; Prachayasittikul, V; Prat-González, S; Qi, B; Qu, B; Rakshit, S; Ravelli, ACJ; Ren, ZG; Rivera, SM; Salo, P; Samaddar, S; Samper, JLA; Samy El Gendy, NM; Schmitt, N; Sekerbayev, KS; Sepúlveda-Martínez, Á; Sessolo, M; Severi, S; Sha, Y; Shen, FF; Shen, X; Shen, Y; Singh, P; Sinthupoom, N; Siri, S; Sitges, M; Slovak, JE; Solymosi, N; Song, H; Song, J; Song, M; Spingler, B; Stewart, I; Su, BL; Su, JF; Suming, L; Sun, JX; Tantimavanich, S; Tashkandi, JM; Taurbayev, TI; Tedgren, AC; Tenhunen, M; Thwaites, DI; Tibrewala, R; Tomsejm, M; Triana, CA; Vakira, FM; Valdez, M; Valente, M; Valentini, AM; Van de Winckel, A; van der Lee, R; Varga, F; Varga, M; Villarino, NF; Villemur, R; Vinatha, SP; Vincenti, A; Voskamp, BJ; Wang, B; Wang, C; Wang, H; Wang, HT; Wang, J; Wang, M; Wang, N; Wang, NC; Wang, Q; Wang, S; Wang, X; Wang, Y; Wang, Z; Wen, N; Wesolowska, P; Willis, M; Wu, C; Wu, D; Wu, L; Wu, X; Wu, Z; Xia, JM; Xia, X; Xia, Y; Xiao, J; Xiao, Y; Xie, CL; Xie, LM; Xie, S; Xing, Z; Xu, C; Xu, J; Yan, D; Yan, K; Yang, S; Yang, X; Yang, XW; Ye, M; Yin, Z; Yoon, N; Yoon, Y; Yu, H; Yu, K; Yu, ZY; Zhang, B; Zhang, GY; Zhang, H; Zhang, J; Zhang, M; Zhang, Q; Zhang, S; Zhang, W; Zhang, X; Zhang, Y; Zhang, YW; Zhang, Z; Zhao, D; Zhao, F; Zhao, P; Zhao, W; Zhao, Z; Zheng, C; Zhi, D; Zhou, C; Zhou, FY; Zhu, D; Zhu, J; Zhu, Q; Zinyama, NP; Zou, M; Zou, Z, 2019
)
0.51
" We previously reported that once daily treatment with the anti-epileptic and neuropathic pain medication, gabapentin (GBP), at low dosage (50 mg/kg) mitigates experimentally induced AD soon after injections, likely by impeding glutamatergic signaling."( Paradoxical effects of continuous high dose gabapentin treatment on autonomic dysreflexia after complete spinal cord injury.
Cox, DH; Eldahan, KC; Gollihue, JL; Patel, SP; Rabchevsky, AG; Williams, HC, 2020
)
1.03
" We hypothesized that use of a gabapentinoid on the day of THA or TKA is associated with an increased risk of postoperative pulmonary complications in a dose-response fashion compared with the risk for patients who did not receive the drug."( Dose-Dependent Association of Gabapentinoids with Pulmonary Complications After Total Hip and Knee Arthroplasties.
Bartz, RR; Bryan, WE; Ellis, AR; Fuller, M; Haines, KL; Krishnamoorthy, V; Moore, S; Ohnuma, T; Pepin, MJ; Pyati, S; Raghunathan, K; Setoguchi, S; Whittle, J, 2020
)
1.13
"Exposure to gabapentinoids at any dose on the day of THA or TKA was associated with increased odds of postoperative pulmonary complications in a dose-response fashion, with minimal effects on perioperative opioid consumption."( Dose-Dependent Association of Gabapentinoids with Pulmonary Complications After Total Hip and Knee Arthroplasties.
Bartz, RR; Bryan, WE; Ellis, AR; Fuller, M; Haines, KL; Krishnamoorthy, V; Moore, S; Ohnuma, T; Pepin, MJ; Pyati, S; Raghunathan, K; Setoguchi, S; Whittle, J, 2020
)
1.23
" Higher oral dosing and longer treatment regimens of gabapentin may be indicated for the treatment of chronic musculoskeletal pain in horses."( Efficacy of orally administered gabapentin in horses with chronic thoracic limb lameness.
Bauck, AG; Gilliam, LL; Kembel, SL; Schoonover, MJ; Taylor, JD; Young, JM, 2020
)
1.09
" Subgroup and meta-regression analyses of gabapentin dosage were performed."( Gabapentin for the treatment of hot flushes in menopause: a meta-analysis.
Kim, SN; Lee, C; Lee, H; Lee, JY; Yoon, SH, 2020
)
2.27
" Furthermore, most preclinical antiepileptogenic studies lack information needed for translation, such as dose-blood level relationship, brain target engagement, and dose-response, and many use treatment parameters that cannot be applied clinically, for example, treatment initiation before or at the time of injury and dosing higher than tolerated human equivalent dosing."( Repurposed molecules for antiepileptogenesis: Missing an opportunity to prevent epilepsy?
Bar-Klein, G; Friedman, A; Hameed, MQ; Jozwiak, S; Kaminski, RM; Klein, P; Klitgaard, H; Koepp, M; Löscher, W; Prince, DA; Rotenberg, A; Twyman, R; Vezzani, A; Wong, M, 2020
)
0.56
" Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = ."( Prospective randomized trial of interventions for vincristine-related neuropathic pain.
Anghelescu, DL; Cheng, C; Jeha, S; Pauley, J; Pei, D; Pui, CH; Sandlund, JT; Tesney, JM; Trujillo, L; Wright, BB, 2020
)
0.56
" In the meantime, gabapentin appears to be the most evidence-based widely available uremic pruritus treatment, as long as care is taken with dosing and monitoring of side-effects."( Recent advances in the treatment of uremic pruritus.
Collister, D; Rigatto, C; Trachtenberg, AJ, 2020
)
0.89
" We estimated summary risk ratios (RR) for each outcome and evaluated dose-response in regression models."( Gabapentin add-on treatment for drug-resistant focal epilepsy.
Al-Bachari, S; Hutton, JL; Marson, AG; Panebianco, M, 2021
)
2.06
"The optimal dosing of post-operative total knee arthroplasty (TKA) narcotics is unclear."( Average narcotic usage in a group of TKA patients following a modern TKA protocol.
Chapman, DM; Costales, TG; Dalury, DF; Greenwell, PH; Volkmann, MC, 2021
)
0.62
" The main analysis quantified the odds ratio (OR) between opioid overdose and each nonopioid medication dispensed in the 90 days immediately before the opioid overdose date after adjustment for prescription opioid dosage and benzodiazepine codispensing."( Coprescription of Opioids With Other Medications and Risk of Opioid Overdose.
Barnett, ML; Bykov, K; Gagne, JJ; Glynn, RJ; Khan, NF, 2021
)
0.62
"Gabapentin treatment rapidly titrated to a dosage of 3600 mg/day is associated with a reduction in the proportion of HDD per week and an increase in PDA per week in actively drinking outpatients with AUD."( Pilot randomized placebo-controlled clinical trial of high-dose gabapentin for alcohol use disorder.
Basaraba, C; Bisaga, A; Brooks, DJ; Carpenter, KM; Levin, FR; Mamczur-Fuller, A; Mariani, JJ; Nunes, EV; Pavlicova, M, 2021
)
2.3
" Exposure to certain newer ASMs, such as lamotrigine and levetiracetam, does not thus far appear to impact certain aspects of neurodevelopment, but further delineation across the different neurodevelopmental domains and dosage levels is required."( Neurodevelopmental outcomes in children exposed to newer antiseizure medications: A systematic review.
Bromley, RL; Knight, R; Wittkowski, A, 2021
)
0.62
" There were issues with adherence to medication dosage regimens and data collection."( A pilot feasibility study of gabapentin for managing pain in children with dystonic cerebral palsy.
Antolovich, G; Baker, F; Chalkiadis, G; Copeland, L; Harvey, A; McKinnon, C; Orsini, F; Rice, J; Scheinberg, A; Stewart, K; Thorley, M; Waugh, MC, 2021
)
0.91
" No significant correlation was found for gabapentin dosage and sedation score."( Hemodynamic, Echocardiographic, and Sedative Effects of Oral Gabapentin in Healthy Cats.
Allen, ME; LeBlanc, NL; Scollan, KF, 2021
)
1.13
" The analgesic effect of the dosage regimens evaluated in our study warrants further research."( Pharmacokinetics and pharmacodynamics of repeat dosing of gabapentin in adult horses.
Cox, S; Gold, JR; Grubb, TL; Malavasi, L; Villarino, NL, 2022
)
0.97
" These should be used in reduced doses, avoiding tizanidine with liver disease and reducing baclofen dosing with kidney disease."( Pharmacotherapy for Spine-Related Pain in Older Adults.
Fu, JL; Perloff, MD, 2022
)
0.72
" This study evaluated GP prescribing patterns and whether excessive dosing was associated with increased incidence of gabapentinoid-related adverse events (GRAEs)."( Gabapentinoid dosing and adverse events in patients with chronic kidney disease.
Cave, B; Hudson, JQ; Washington, K; Wells, DA; Zhu, R, 2022
)
2.37
" Patients were grouped based on whether the average daily dose prescribed was higher than recommended (inappropriately dosed, (ID)) or as recommended (appropriately dosed (AD)) for CKD stage."( Gabapentinoid dosing and adverse events in patients with chronic kidney disease.
Cave, B; Hudson, JQ; Washington, K; Wells, DA; Zhu, R, 2022
)
2.16
"Appropriate dosing of GPs is particularly important to minimize the risk of adverse events in patients of older age, with a history of seizures, or concomitant antipsychotic use."( Gabapentinoid dosing and adverse events in patients with chronic kidney disease.
Cave, B; Hudson, JQ; Washington, K; Wells, DA; Zhu, R, 2022
)
2.16
"0 % did so while also on a dosage of either buprenorphine or methadone, with 28."( Understanding motivations and use typologies of gabapentin with opioid agonist medications.
Buttram, ME; Ellis, MS; Qureshi, R, 2023
)
1.17
" Further research with more enrollment and longer study duration may help elucidate the appropriate dosing and potential associated side effects."( Case Series: Synergistic Effect of Gabapentin and Adjuvant Pregabalin in Neuropathic Pain.
Chow, SP; Donelenko, S; Stevens, S; Tran, S, 2023
)
1.19
" However, studies of real-world gabapentinoid dosing demonstrate that the recommended dose targets are frequently not met and do not consider renal insufficiency."( Characterization of Outpatient Gabapentinoid Prescribing for Pain.
A Bowman, L; Banks, C; Merrey, J; Waldfogel, JM, 2023
)
1.48
"Individual dose-response curves (DRCs) of PEA, MOR and GBP were evaluated in female mice in which intraplantar nociception was induced with 2% formalin."( N-palmitoylethanolamide synergizes the antinociception of morphine and gabapentin in the formalin test in mice.
Aguilera-Martínez, ME; Déciga-Campos, M; Espinosa-Juárez, JV; Jaramillo-Morales, OA; López-Muñoz, FJ; Ventura-Martínez, R, 2023
)
1.14
" Both the administrated dosage and the time of administration are important in the final results and latency time of retention."( The effect of gabapentin and pregabalin administration on memory in clinical and preclinical studies: a meta-analysis and systematic review.
Azizi, H; Behroozi, Z; Jafarpour, M; Janzadeh, A; Kheirandish, A; Kosari-Rad, T; Ramezni, F; Razmgir, M; Saffarpour, S, 2023
)
1.27
" They were also excluded if they lacked sufficient information about how long or at what dosage they had been using the drug."( Abuse and addiction in gabapentinoid drug users for neuropathic pain.
Aydin Özaslan, E; Kiliç, Z, 2023
)
1.22
" The optimal dosage of pregabalin and gabapentin for pain control and safety in these patients has not been well established."( Different Gabapentin and Pregabalin Dosages for Perioperative Pain Control in Patients Undergoing Spine Surgery: A Systematic Review and Network Meta-Analysis.
Bydon, M; Durrani, S; El Sammak, S; Fu, TS; Ghaith, AK; Hu, CW; Krzyz, EZ; Lin, CCJ; Lin, TY; Tsai, SHL, 2023
)
1.58
" We are most familiar with the incremental dosing strategy where a ceiling dose is eventually attained guided by efficacy and patient tolerance, after which a fixed dosing regimen is prescribed."( Comparative Descriptive Analysis of Physician Versus Patient-Directed Gabapentin Usage In Chronic Pain - A Preliminary Report.
Burns, JC; Gill, JS; Madabhushi, SV; Robinson, CL; Ruan, QZ; Simopoulos, TT, 2023
)
1.14
" Of the patients still taking gabapentin, 73% were on a fixed schedule, while 27% were on a variable dosing schedule."( Comparative Descriptive Analysis of Physician Versus Patient-Directed Gabapentin Usage In Chronic Pain - A Preliminary Report.
Burns, JC; Gill, JS; Madabhushi, SV; Robinson, CL; Ruan, QZ; Simopoulos, TT, 2023
)
1.43
" None of the patients we surveyed had been given the autonomy to adjust gabapentin doses by their providers and this could significantly reduce the proportion of patients who would be encouraged to run a variable dosing regimen."( Comparative Descriptive Analysis of Physician Versus Patient-Directed Gabapentin Usage In Chronic Pain - A Preliminary Report.
Burns, JC; Gill, JS; Madabhushi, SV; Robinson, CL; Ruan, QZ; Simopoulos, TT, 2023
)
1.38
" Based upon this pilot study, the variable dosing option may be an option for improved therapeutic efficacy or as an alternative to those whose lifestyles do not allow for fixed dosing regimens."( Comparative Descriptive Analysis of Physician Versus Patient-Directed Gabapentin Usage In Chronic Pain - A Preliminary Report.
Burns, JC; Gill, JS; Madabhushi, SV; Robinson, CL; Ruan, QZ; Simopoulos, TT, 2023
)
1.14
" Eight New Zealand White rabbits were randomly assigned to receive either oral gabapentin at a dosage of 15 mg/kg or an oral placebo, with a 1-week washout period between treatments."( Effects of gabapentin on intraocular pressure, tear production and horizontal pupil diameter in New Zealand White rabbits.
Cinar, H; Danisman, IT; Isil, A; Yanmaz, LE, 2023
)
1.53
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
anticonvulsantA drug used to prevent seizures or reduce their severity.
calcium channel blockerOne 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.
environmental contaminantAny minor or unwanted substance introduced into the environment that can have undesired effects.
xenobioticA xenobiotic (Greek, xenos "foreign"; bios "life") is a compound that is foreign to a living organism. Principal xenobiotics include: drugs, carcinogens and various compounds that have been introduced into the environment by artificial means.
[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]

Drug Classes (1)

ClassDescription
gamma-amino acidA 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 Targets (16)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
USP1 protein, partialHomo sapiens (human)Potency35.48130.031637.5844354.8130AID504865
thioredoxin glutathione reductaseSchistosoma mansoniPotency89.12510.100022.9075100.0000AID485364
aldehyde dehydrogenase 1 family, member A1Homo sapiens (human)Potency6.30960.011212.4002100.0000AID1030
thyroid stimulating hormone receptorHomo sapiens (human)Potency15.84890.001318.074339.8107AID926
regulator of G-protein signaling 4Homo sapiens (human)Potency8.42880.531815.435837.6858AID504845
EWS/FLI fusion proteinHomo sapiens (human)Potency34.18540.001310.157742.8575AID1259252; AID1259253; AID1259255; AID1259256
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency2.56450.000214.376460.0339AID720691
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency0.02240.035520.977089.1251AID504332
Bloom syndrome protein isoform 1Homo sapiens (human)Potency1,584.89000.540617.639296.1227AID2364; AID2528
ubiquitin carboxyl-terminal hydrolase 2 isoform aHomo sapiens (human)Potency14.68920.65619.452025.1189AID463106
survival motor neuron protein isoform dHomo sapiens (human)Potency1.41250.125912.234435.4813AID1458
muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Potency28.18380.00106.000935.4813AID943
lamin isoform A-delta10Homo sapiens (human)Potency14.12540.891312.067628.1838AID1487
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency0.16940.060110.745337.9330AID485368
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Voltage-dependent calcium channel subunit alpha-2/delta-1Mus musculus (house mouse)Ki0.12010.10001.64665.4000AID261154
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1449628
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (22)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (8)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (12)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (355)

Assay IDTitleYearJournalArticle
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS 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.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID242165Inhibition of [3H]leucine uptake into CHO cells by L-amino acid transporters2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein.
AID730191Antiallodynic activity in rat spinal nerve ligation model of neuropathic pain assessed as reduction of cold allodynia at 100 mg/kg, po after 3 hrs2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of 2-(arylethynyl)quinoline derivatives as mGluR5 antagonists for the treatment of neuropathic pain.
AID588209Literature-mined public compounds from Greene et al multi-species hepatotoxicity modelling dataset2010Chemical research in toxicology, Jul-19, Volume: 23, Issue:7
Developing structure-activity relationships for the prediction of hepatotoxicity.
AID499470Anti-cold allodynic activity in rat assessed as tail withdrawal latency at 60 mg/kg, ip measured within cut-off time of 15 seconds for up to 24 hrs2010Bioorganic & medicinal chemistry, Aug-15, Volume: 18, Issue:16
Synthesis and T-type calcium channel blocking activity of novel diphenylpiperazine compounds, and evaluation of in vivo analgesic activity.
AID540215Volume of distribution at steady state in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1769937Toxicity in Sprague-Dawley rat assessed as drowsiness at 100 mg/kg, po2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug 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.
AID620584Antiallodynic activity in rat spinal nerve ligation model of neuropathic pain assessed as inhibition of cold allodynia at 100 mg/kg, po after 5 hrs2011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis and biological evaluation of 4-piperidinecarboxylate and 4-piperidinecyanide derivatives for T-type calcium channel blockers.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID412174Displacement of [3H]gabapentin from alpha2-delta subunit of voltage gated calcium channel in pig brain membrane2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID286892Anti-dynamic allodynia effect in Sprague-Dawley rat SNL model assessed as latency to paw withdrawal 100 mg/kg, ip after 1.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID1597733Half life in human up to 3600 mg2019Bioorganic & medicinal chemistry letters, 08-15, Volume: 29, Issue:16
Sleep modulating agents.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1890765Antinociceptive activity in CCI surgery-neuropathic pain induced nerve injured rat model assessed as increase in mechanical ipsilateral paw withdrawal threshold at 30 mg/kg for 30 to 240 mins measured on day 142022Bioorganic & medicinal chemistry, 04-15, Volume: 60Synthesis and evaluation of dual fatty acid amide hydrolase-monoacylglycerol lipase inhibition and antinociceptive activities of 4-methylsulfonylaniline-derived semicarbazones.
AID412184Half life in rat plasma2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID1744258Analgesic activity in Sprague-Dawley rat model of paclitaxel-induced neuropathic pain assessed as reduction in cold hyperalgesia by measuring increase in paw withdrawal latency at 100 mg/kg, ip measured at 1 to 2 hrs post dosing by Von Frey assay relative2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Novel Sigma 1 Receptor Antagonists as Potential Therapeutics for Pain Management.
AID1666351Antinociceptive activity in rat model of chronic constriction injury-induced neuropathic pain assessed as inhibition of CCI-induced mechanical allodynia at 30 mg/kg, po BID administered 22 days post surgery and measured on day 1, 6 and 82020ACS medicinal chemistry letters, Sep-10, Volume: 11, Issue:9
Discovery of Vixotrigine: A Novel Use-Dependent Sodium Channel Blocker for the Treatment of Trigeminal Neuralgia.
AID646275Antinociceptive activity in rat capsaicin model of secondary mechanical hyperalgesia assessed as inhibition of tactile allodynia at 150 mg/kg, po2012Bioorganic & medicinal chemistry letters, Feb-15, Volume: 22, Issue:4
Discovery of diphenyl lactam derivatives as N-type calcium channel blockers.
AID1630259Antiallodynic activity in rat model of spinal nerve ligation-induced neuropathic pain assessed as reduction in mechanical threshold for paw withdrawal at 100 mg/kg, po administered on day 14 after ligation surgery and measured 3 to 5 hrs post dose by Von 2016Bioorganic & medicinal chemistry, 11-01, Volume: 24, Issue:21
Synthesis and evaluation of 6-pyrazoylamido-3N-substituted azabicyclo[3,1,0]hexane derivatives as T-type calcium channel inhibitors for treatment of neuropathic pain.
AID1826930Toxicity in naive Sprague-Dawley rat assessed as motor impairment at 100 mg/kg, po measured after 5 hrs by rotarod test
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1391980Analgesic activity in rat model of chronic constriction injury-induced neuropathic pain assessed as reversal of mechanical allodynia at 30 mg/kg dosed twice daily for 8 days relative to untreated control2018Bioorganic & medicinal chemistry letters, 06-01, Volume: 28, Issue:10
Discovery of {4-[4,9-bis(ethyloxy)-1-oxo-1,3-dihydro-2H-benzo[f]isoindol-2-yl]-2-fluorophenyl}acetic acid (GSK726701A), a novel EP
AID1209581Fraction unbound in Sprague-Dawley rat brain homogenates at 5 uM by equilibrium dialysis analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID263850Plasma half life in rat2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID763753Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 120 mins (Rvb = 2.9 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID540220Clearance in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID603471Antiallodynic activity in Wistar albino rat chronic constriction injury-induced neuropathic pain model assessed as reversal of spontaneous pain response measured as withdrawal duration at 100 mg/kg, ip2011European journal of medicinal chemistry, Jul, Volume: 46, Issue:7
Discovery of molecules for the treatment of neuropathic pain: synthesis, antiallodynic and antihyperalgesic activities of 5-(4-nitrophenyl)furoic-2-acid hydrazones.
AID763776Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 30 mins (Rvb = 8.9 +/- 4.6%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID763768Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 120 mins (Rvb = 4.1 +/- 2.1%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1333062Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on cold allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 1 hr relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID540230Dose normalised AUC in rat after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID1070235Toxicity in ip dosed SKH1-hrhr mouse assessed as mortality measured up to 3 hrs2014Bioorganic & medicinal chemistry, Feb-15, Volume: 22, Issue:4
Gabapentin hybrid peptides and bioconjugates.
AID1209592Dissociation constant, pKa of the basic compound by capillary electrophoresis-mass spectrometry analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID779724Analgesic activity in rat assessed reduction formalin-induced second phase pain response at 100 mg/kg, iv administered 8 mins post formalin challenge2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Discovery of (S,E)-3-(2-fluorophenyl)-N-(1-(3-(pyridin-3-yloxy)phenyl)ethyl)-acrylamide as a potent and efficacious KCNQ2 (Kv7.2) opener for the treatment of neuropathic pain.
AID620583Antiallodynic activity in rat spinal nerve ligation model of neuropathic pain assessed as suppression of mechanical allodynia at 100 mg/kg, po after 5 hrs2011Bioorganic & medicinal chemistry letters, Oct-01, Volume: 21, Issue:19
Synthesis and biological evaluation of 4-piperidinecarboxylate and 4-piperidinecyanide derivatives for T-type calcium channel blockers.
AID313146Dissociation constant, pKa of the compound2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Ca2+ channel alpha2-delta ligands for the treatment of neuropathic pain.
AID189469Antiallodynic 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 threshold2004Bioorganic & 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.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID605105Neurotoxicity in C57Bl/6j mouse assessed as inability to maintain equilibrium on rotarod up to 1000 mg/kg, po determined 1 to 3 hrs postdose by rotarod test2010Journal of medicinal chemistry, Nov-11, Volume: 53, Issue:21
Discovery of dual inducible/neuronal nitric oxide synthase (iNOS/nNOS) inhibitor development candidate 4-((2-cyclobutyl-1H-imidazo[4,5-b]pyrazin-1-yl)methyl)-7,8-difluoroquinolin-2(1H)-one (KD7332) part 2: identification of a novel, potent, and selective
AID540221Volume of distribution at steady state in human after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug 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.
AID263851AUC in rat2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID1191931Analgesic activity in rat model of spinal nerve ligation-induced neuropathic pain assessed as reduction in cold allodynia by measuring paw withdrawal in response to acetone application at 100 mg/kg, po administered on day 14 after ligation surgery and mea2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Synthesis and biological evaluation of aryl isoxazole derivatives as metabotropic glutamate receptor 1 antagonists: a potential treatment for neuropathic pain.
AID598559Displacement of [3H]Gabapentin from alpha2delta calcium channel in pig brain tissue homogenates after 45 mins by scintillation counting2011Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12
Part 1: N-alkylated glycines as potent α2δ ligands.
AID477702Displacement of [3H]gabapentin from Voltage-dependent calcium channel subunit alpha-2/delta in pig cerebral cortex by scintillation counting2010Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1
Synthesis and in vivo evaluation of 3,4-disubstituted gababutins.
AID1070230Toxicity in ip dosed SKH1-hrhr mouse assessed as change in reward licking events measured up to 3 hrs2014Bioorganic & medicinal chemistry, Feb-15, Volume: 22, Issue:4
Gabapentin hybrid peptides and bioconjugates.
AID412183Clearance in rat2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID604020Unbound drug concentration in Sprague-Dawley rat plasma administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID763758Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 30 mins (Rvb = 4.7 +/- 2.1%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID412176Anticonvulsant activity in DBA/2 mouse assessed as protection from audiogenically-induced tonic seizures at 30 mg/kg, po after 1 hr2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID286883Anti-dynamic allodynic effect in Sprague-Dawley rat CCI model assessed as latency to paw withdrawal after 2 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID461906Antinociceptive activity in formalin-treated Sprague-Dawley rat model assessed as reduction in hind paw flinches at 100 mg/kg, iv measured during 11 to 60 mins of phase 2 flinches2010Journal of medicinal chemistry, Jan-28, Volume: 53, Issue:2
Novel KCNQ2/Q3 agonists as potential therapeutics for epilepsy and neuropathic pain.
AID1333091Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on mechanical allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 5 hrs relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID499471Anti-warm allodynic activity in rat assessed as tail withdrawal latency at 60 mg/kg, ip measured within cut-off time of 15 seconds for up to 24 hrs2010Bioorganic & medicinal chemistry, Aug-15, Volume: 18, Issue:16
Synthesis and T-type calcium channel blocking activity of novel diphenylpiperazine compounds, and evaluation of in vivo analgesic activity.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID763764Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of cold allodynia at 100 mg/kg, ip after 30 mins (Rvb = 0.6 +/- 2.7%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1581193Analgesic activity in ip dosed formalin-induced nociception ICR mouse model assessed as reduction in pain behaviour by measuring less licking of formalin injected hind paw pretreated with compound 30 mins prior to formalin induction by formalin test2020Journal of medicinal chemistry, 01-09, Volume: 63, Issue:1
Discovery of Nonpungent Transient Receptor Potential Vanilloid 1 (TRPV1) Agonist as Strong Topical Analgesic.
AID286886Anti-cold allodynia effect in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal 100 mg/kg, ip after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286894Anti-dynamic allodynia effect in Sprague-Dawley rat SNL model assessed as latency to paw withdrawal 100 mg/kg, ip after 2.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID461911Analgesic activity in Sprague-Dawley rat assessed as reduction of spinal nerve ligation-induced allodynia score at 100 mg/kg, iv2010Journal of medicinal chemistry, Jan-28, Volume: 53, Issue:2
Novel KCNQ2/Q3 agonists as potential therapeutics for epilepsy and neuropathic pain.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID412177Anxiolytic activity in DBA/2 mouse assessed as restoration of punished drinking behavior at 30 mg/kg, po relative to pregabalin2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID73332Displacement of [3H]gabapentin from alpha2-delta subunit of calcium channel1999Bioorganic & medicinal chemistry letters, Aug-16, Volume: 9, Issue:16
Synthesis and biological evaluation of conformationally restricted Gabapentin analogues.
AID1498741Antiallodynic activity in ip dosed NMRI mouse model of spared nerve injury-induced mechanical allodynia assessed as pain relief administered 14 days post spared nerve injury surgery measured at 15 to 60 mins post dose by Von Frey filament assay2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
An imidazole based H-Phe-Phe-NH
AID286893Anti-dynamic allodynia effect in Sprague-Dawley rat SNL model assessed as latency to paw withdrawal 100 mg/kg, ip after 2 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID35397Binding affinity towards alpha2-delta subunit of a voltage gated calcium channel using [3H]gabapentin in human brain membrane (A710 membrane)2004Bioorganic & medicinal chemistry letters, Apr-19, Volume: 14, Issue:8
N-Acridin-9-yl-butane-1,4-diamine derivatives: high-affinity ligands of the alpha2delta subunit of voltage gated calcium channels.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1450907Analgesic activity in Sprague-Dawley rat assessed as reduction in chronic constriction injury induced hyperalgesic neuropathic pain on ligated side at 100 mg/kg/day administered via oral gavage measured upto 8 days relative to vehicle-treated control2017Journal of medicinal chemistry, 09-28, Volume: 60, Issue:18
Discovery of a para-Acetoxy-benzyl Ester Prodrug of a Hydroxamate-Based Glutamate Carboxypeptidase II Inhibitor as Oral Therapy for Neuropathic Pain.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1204478Analgesic activity in rat spinal nerve ligation model of neuropathic pain assessed as recovery from cold allodynia at 100 mg/kg, po administered on day 14 post ligation surgery measured after 1 hr relative to control2015European journal of medicinal chemistry, Jun-05, Volume: 97Discovery and biological evaluation of tetrahydrothieno[2,3-c]pyridine derivatives as selective metabotropic glutamate receptor 1 antagonists for the potential treatment of neuropathic pain.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID386817Antinociceptive efficacy in spinal nerve ligated Sprague-Dawley rat assessed as reduction of neuropathic pain in left side paw at 500 umol/kg, ip administered 30 mins before testing relative to control2008Journal of medicinal chemistry, Oct-23, Volume: 51, Issue:20
Rotationally constrained 2,4-diamino-5,6-disubstituted pyrimidines: a new class of histamine H4 receptor antagonists with improved druglikeness and in vivo efficacy in pain and inflammation models.
AID753331Analgesic activity in po dosed rat spinal nerve ligation neuropathic pain model assessed as reversal of allodynia measured at 2 to 4 hrs2013Bioorganic & medicinal chemistry letters, Jun-15, Volume: 23, Issue:12
A novel benzazepinone sodium channel blocker with oral efficacy in a rat model of neuropathic pain.
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID763754Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 60 mins (Rvb = 2.8 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID763775Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 60 mins (Rvb = 4.6 +/- 0.6%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1769904Antinociceptive activity in Sprague-Dawley rat model of chronic constriction injury-induced neuropathic pain assessed as reduction in paw withdrawal latency at 100 mg/kg, po by Von Frey test2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID1301974Antinociceptive effect in C57BL/6 mouse assessed as inhibition of spared nerve injury-induced neuropathic pain response at 100 mg/kg, ip measured after 5 to 7 days of recovery by Von Frey filament assay2016Journal of medicinal chemistry, 04-28, Volume: 59, Issue:8
Gram Scale Syntheses of (-)-Incarvillateine and Its Analogs. Discovery of Potent Analgesics for Neuropathic Pain.
AID662197Analgesic activity in Sprague-Dawley rat assessed as inhibition of formalin-induced pain at 100 mg/kg, po2012Bioorganic & medicinal chemistry letters, Jun-01, Volume: 22, Issue:11
Discovery and evaluation of selective N-type calcium channel blockers: 6-unsubstituted-1,4-dihydropyridine-5-carboxylic acid derivatives.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID286865Antihyperalgesic effects in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID604021Unbound volume of distribution in Sprague-Dawley rat brain measured per gram of brain tissue administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr b2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID763761Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of cold allodynia at 100 mg/kg, ip after 30 mins (Rvb = 4.1 +/- 1.0%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID242017Inhibition of [3H]gabapentin binding to pig brain membranes2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein.
AID1769938Toxicity in Sprague-Dawley rat assessed as dizziness at 100 mg/kg, po2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID763772Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 60 mins (Rvb = 2.9 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1602078Antibacterial activity against Staphylococcus aureus ATCC 6538 measured after overnight incubation2019European journal of medicinal chemistry, Mar-15, Volume: 166Design, synthesis and anti-bacterial studies of piperazine derivatives against drug resistant bacteria.
AID477063Displacement of [3H]gabapentin binding to voltage gated calcium channel alpha2delta from rat cerebral cortex by scintillation counting2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
Synthesis, characterization and in vitro pharmacology of novel pregabalin derivatives.
AID540216Clearance in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1498744Antiallodynic activity in NMRI mouse model of spared nerve injury-induced mechanical allodynia assessed as pain relief at 585 umol/kg, ip administered 14 days post spared nerve injury surgery measured at 60 mins post dose by Von Frey filament assay2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
An imidazole based H-Phe-Phe-NH
AID1209593Dissociation constant, pKa of the acidic compound by capillary electrophoresis-mass spectrometry analysis2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1602080Antibacterial activity against Escherichia coli ATCC 25922 measured after overnight incubation2019European journal of medicinal chemistry, Mar-15, Volume: 166Design, synthesis and anti-bacterial studies of piperazine derivatives against drug resistant bacteria.
AID286868Antihyperalgesic effects in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID286869Antihyperalgesic effects in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1581166Analgesic activity in ip dosed L5/L6 spinal nerve ligation-induced neuropathic pain Sprague-Dawley rat model assessed as increase in paw withdrawal threshold in response to von frey filament compound administered at day 14 after ligation and measured up t2020Journal of medicinal chemistry, 01-09, Volume: 63, Issue:1
Discovery of Nonpungent Transient Receptor Potential Vanilloid 1 (TRPV1) Agonist as Strong Topical Analgesic.
AID286861Effect on spontaneous pain in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286876Antihyperalgesic effects in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1 hr, ip2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID412186Volume of distribution at steady state in rat2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID349992Antiinflammatory activity against gamma carrageenan-induced paw edema in Wistar rat assessed as paw volume at 50 mg/kg, ip administered 2 to 4 hrs before carrageenan challenge relative to control2009Journal of medicinal chemistry, May-14, Volume: 52, Issue:9
Gamma-aminobutyric acid amides of nortriptyline and fluoxetine display improved pain suppressing activity.
AID286873Effect on spontaneous pain in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286898Anti-cold allodynia effect in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal 100 mg/kg, ip after 2 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID249978The ability of 30 mg/kg oral dose of compound to restore punished drinking behavior in rats expressed as percent reference activity (PRA)2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein.
AID1896195Analgesic activity in chronic constriction injury-induced mechanical pain mouse model assessed as increase in paw withdrawal latency at 60 mg/kg measured after 1 to 7 hrs2022Journal of medicinal chemistry, 12-22, Volume: 65, Issue:24
Mechanism of Action and Structure-Activity Relationship of α-Conotoxin Mr1.1 at the Human α9α10 Nicotinic Acetylcholine Receptor.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1769936Induction of motor coordination impairment in Sprague-Dawley rat at 100 mg/kg, po measured up to 180 mins by rotarod test2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID318484Analgesic activity in ip dosed rat chronic constriction injury model of mechanical allodynia2007Proceedings of the National Academy of Sciences of the United States of America, May-15, Volume: 104, Issue:20
A-803467, a potent and selective Nav1.8 sodium channel blocker, attenuates neuropathic and inflammatory pain in the rat.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID286870Effect on spontaneous pain in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID286881Anti-dynamic allodynic effect in Sprague-Dawley rat CCI model assessed as latency to paw withdrawal after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID763762Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of cold allodynia at 100 mg/kg, ip after 120 mins (Rvb = 5.4 +/- 1.9%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID763769Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 60 mins (Rvb = 1.3 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1333061Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on mechanical allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 1 hr relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID352071Anticonvulsant activity against audiogenic tonus seizures in ip dosed DBA/2 mouse epilepsy model administered 30 mins before auditory simulation2009European journal of medicinal chemistry, Mar, Volume: 44, Issue:3
Solution-phase parallel synthesis and evaluation of anticonvulsant activity of N-substituted-3,4-dihydroisoquinoline-2(1H)-carboxamides.
AID286880Anti-dynamic allodynic effect in Sprague-Dawley rat CCI model assessed as latency to paw withdrawal after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID710662Antinociceptive activity in Cav2.2 deficient mouse SNL neuropathic pain model assessed as reversal of mechanical allodynia at 30 mg/kg, po after 2 hrs2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain.
AID763773Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 30 mins (Rvb = 3.2 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID286862Effect on spontaneous pain in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID598762Displacement of [3H]gabapentin from voltage gated calcium channel alpha2delta from pig cerebral cortex by scintillation counting2011Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12
Part 2: Design, synthesis and evaluation of hydroxyproline-derived α2δ ligands.
AID753342Analgesic activity in rat spinal nerve ligation neuropathic pain model assessed as reversal of allodynia at 30 mg/kg, po measured at 2 hrs relative to control2013Bioorganic & medicinal chemistry letters, Jun-15, Volume: 23, Issue:12
A novel benzazepinone sodium channel blocker with oral efficacy in a rat model of neuropathic pain.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID763765Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 120 mins relative to control2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1488686Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on mechanical allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured up to 3 hrs2017Bioorganic & medicinal chemistry letters, 09-01, Volume: 27, Issue:17
Neuropathic pain-alleviating effects of pyrazole-conjugated arylsulfonamides as 5-HT
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID261154Displacement of [3H]L-leucine from alpha-2delta containing calcium channel in murine brain2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Structure-activity relationships of alpha-amino acid ligands for the alpha2delta subunit of voltage-gated calcium channels.
AID605101Antiallodynic activity against von Frey hair mechanically stimulated neuropathic pain in mouse Chung model of neuropathic pain assessed as attenuation of tactile allodynia at 300 mg/kg, po2010Journal of medicinal chemistry, Nov-11, Volume: 53, Issue:21
Discovery of dual inducible/neuronal nitric oxide synthase (iNOS/nNOS) inhibitor development candidate 4-((2-cyclobutyl-1H-imidazo[4,5-b]pyrazin-1-yl)methyl)-7,8-difluoroquinolin-2(1H)-one (KD7332) part 2: identification of a novel, potent, and selective
AID286899Anti-cold allodynia effect in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal 100 mg/kg, ip after 2.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID1769912Reversal of chronic constriction injury-induced mechanical allodynia in Sprague-Dawley rat model of neuropathic pain at 100 mg/kg, sc measured up to 180 mins relative to control2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1449628Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method2012Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12
Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID1744227Toxicity in Sprague-Dawley rat assessed as effect on motor coordination at 100 mg/kg, ip measured at 60 to 120 mins post treatment by rotarod test2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Novel Sigma 1 Receptor Antagonists as Potential Therapeutics for Pain Management.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1602081Antibacterial activity against Pseudomonas aeruginosa ATCC 15442 measured after overnight incubation2019European journal of medicinal chemistry, Mar-15, Volume: 166Design, synthesis and anti-bacterial studies of piperazine derivatives against drug resistant bacteria.
AID1769908Antinociceptive activity in Sprague-Dawley rat model of chronic constriction injury-induced neuropathic pain assessed as reduction in mechanical hyperalgesia 100 mg/kg, po by Von Frey test relative to control2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID1209583Unbound drug partitioning coefficient, Kp of the compound assessed as ratio of unbound concentration in Sprague-Dawley rat brain to unbound concentration in plasma2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1744255Antinociceptive activity in formalin-induced Sprague-Dawley rat model of nociceptive pain assessed as decrease in time spent on licking during late phase at 100 mg/kg, ip administered 30 mins before formalin stimulation and measured at 5 mins interval for2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Novel Sigma 1 Receptor Antagonists as Potential Therapeutics for Pain Management.
AID540217Volume of distribution at steady state in dog after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID412185AUC in rat2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID286878Antihyperalgesic effects in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2 hrs, ip2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286864Effect on spontaneous pain in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID540232Dose normalised AUC in monkey after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID710663Antinociceptive activity in Cav2.2 expressing wild type mouse SNL neuropathic pain model assessed as reversal of mechanical allodynia at 30 mg/kg, po after 2 hrs2012Journal of medicinal chemistry, Nov-26, Volume: 55, Issue:22
Aminopiperidine sulfonamide Cav2.2 channel inhibitors for the treatment of chronic pain.
AID227699Virtual screen for compounds with anticonvulsant activity2003Bioorganic & medicinal chemistry letters, Aug-18, Volume: 13, Issue:16
Topological virtual screening: a way to find new anticonvulsant drugs from chemical diversity.
AID598759Inhibition of Voltage-dependent calcium channel subunit alpha-2/delta2011Bioorganic & medicinal chemistry letters, Jun-15, Volume: 21, Issue:12
Part 3: Design and synthesis of proline-derived α2δ ligands.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID263847Potency in DBA/2 mouse anticonvulsant assay2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID286874Effect on spontaneous pain in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID412175Displacement of [3H]leucine from Large neutral amino acids transporter system L in CHO cells2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID322668Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 30 ug/kg, icv after 45 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID1498743Antiallodynic activity in NMRI mouse model of spared nerve injury-induced mechanical allodynia assessed as pain relief at 585 umol/kg, ip administered 14 days post spared nerve injury surgery measured at 30 mins post dose Von Frey filament assay2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
An imidazole based H-Phe-Phe-NH
AID263849Clearance in rat2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID750685Inhibition of voltage-dependent calcium channel subunit alpha-2/delta gabapentin binding site (unknown origin)2013European journal of medicinal chemistry, Jun, Volume: 64Augmentation of GABAergic neurotransmission by novel N-(substituted)-2-[4-(substituted)benzylidene]hydrazinecarbothioamides-a potential anticonvulsant approach.
AID331914Reversal of nerve injury-induced tactile allodynia in rat L5 spinal nerve ligation-induced nociception model at 60 mg/kg, ip2008Bioorganic & medicinal chemistry letters, May-01, Volume: 18, Issue:9
Sulfamoyl benzamides as novel CB2 cannabinoid receptor ligands.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID604022Fraction unbound in Sprague-Dawley rat plasma administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID349989Antiinflammatory activity against gamma carrageenan-induced paw edema in Wistar rat assessed as reduction in paw volume at 50 mg/kg, ip administered 2 hrs before carrageenan challenge measured after 4 hrs relative to control2009Journal of medicinal chemistry, May-14, Volume: 52, Issue:9
Gamma-aminobutyric acid amides of nortriptyline and fluoxetine display improved pain suppressing activity.
AID286896Anti-cold allodynia effect in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal 100 mg/kg, ip after 1 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID604023Ratio of total drug level in brain to plasma in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID286888Anti-cold allodynia effect in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal 100 mg/kg, ip after 2 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID540214Clearance in rat after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID763771Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 120 mins (Rvb = 1.2 +/- 0.1%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID252186Percent protection of DBA/2 mice from audiogenically induced tonic seizures at a dose of 30 mg/kg of test compound2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein.
AID1276168Antinociceptive activity in Kunming mouse model of STZ-induced diabetic neuropathy pain assessed as increase in paw withdrawal mechanical threshold at 50 mg/kg, po2015Journal of natural products, Dec-24, Volume: 78, Issue:12
Antinociceptive Grayanoids from the Roots of Rhododendron molle.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID286872Effect on spontaneous pain in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286867Antihyperalgesic effects in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID540233Dose normalised AUC in human after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID1333090Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on mechanical allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 3 hrs relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID763756Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 120 mins (Rvb = 5.3 +/- 0.5%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID605029Antinociceptive activity against formalin-induced pain in mouse assessed as attenuation of nocifensive phase 2 behaviors during phase 2 (25 to 45 mins post formalin injection) administered via oral gavage 30 mins before to formalin challenge2010Journal of medicinal chemistry, Nov-11, Volume: 53, Issue:21
Discovery of dual inducible/neuronal nitric oxide synthase (iNOS/nNOS) inhibitor development candidate 4-((2-cyclobutyl-1H-imidazo[4,5-b]pyrazin-1-yl)methyl)-7,8-difluoroquinolin-2(1H)-one (KD7332) part 2: identification of a novel, potent, and selective
AID476929Human intestinal absorption in po dosed human2010European journal of medicinal chemistry, Mar, Volume: 45, Issue:3
Neural computational prediction of oral drug absorption based on CODES 2D descriptors.
AID1204477Analgesic activity in rat spinal nerve ligation model of neuropathic pain assessed as recovery from mechanical allodynia at 100 mg/kg, po administered on day 14 post ligation surgery measured after 3 hrs relative to control2015European journal of medicinal chemistry, Jun-05, Volume: 97Discovery and biological evaluation of tetrahydrothieno[2,3-c]pyridine derivatives as selective metabotropic glutamate receptor 1 antagonists for the potential treatment of neuropathic pain.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID286889Anti-cold allodynia effect in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal 100 mg/kg, ip after 2.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID74544Tested for activation of Glutamate decarboxylase; the ratio of Vmax in the presence of activators to the Vmax in the absence of activators at a concentration of 2.5 mM.1991Journal of medicinal chemistry, Jul, Volume: 34, Issue:7
3-Alkyl-4-aminobutyric acids: the first class of anticonvulsant agents that activates L-glutamic acid decarboxylase.
AID539472Solubility of the compound at pH 7.42010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID540231Dose normalised AUC in dog after po administration2005Xenobiotica; the fate of foreign compounds in biological systems, Feb, Volume: 35, Issue:2
Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and human.
AID604024Unbound brain to plasma concentration ratio in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID286875Antihyperalgesic effects in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 0.5 hr, ip2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286897Anti-cold allodynia effect in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal 100 mg/kg, ip after 1.5 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID352070Anticonvulsant activity against audiogenic clonus seizures in ip dosed DBA/2 mouse epilepsy model administered 30 mins before auditory simulation2009European journal of medicinal chemistry, Mar, Volume: 44, Issue:3
Solution-phase parallel synthesis and evaluation of anticonvulsant activity of N-substituted-3,4-dihydroisoquinoline-2(1H)-carboxamides.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1890766Antinociceptive activity in CCI surgery-neuropathic pain induced nerve injured rat model assessed as increase in tail flick latency at 30 mg/kg for 60 to 120 mins measured on day 142022Bioorganic & medicinal chemistry, 04-15, Volume: 60Synthesis and evaluation of dual fatty acid amide hydrolase-monoacylglycerol lipase inhibition and antinociceptive activities of 4-methylsulfonylaniline-derived semicarbazones.
AID779726Analgesic activity in rat assessed reduction formalin-induced initial pain response at 100 mg/kg, iv administered 2 mins before formalin challenge2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Discovery of (S,E)-3-(2-fluorophenyl)-N-(1-(3-(pyridin-3-yloxy)phenyl)ethyl)-acrylamide as a potent and efficacious KCNQ2 (Kv7.2) opener for the treatment of neuropathic pain.
AID1602079Antibacterial activity against Bacillus subtilis ATCC 6633 measured after overnight incubation2019European journal of medicinal chemistry, Mar-15, Volume: 166Design, synthesis and anti-bacterial studies of piperazine derivatives against drug resistant bacteria.
AID1333094Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on cold allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 3 hrs relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID286887Anti-cold allodynia effect in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal 100 mg/kg, ip after 1.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID1668767Antinociceptive activity in CCI-induced C57BL/6 mouse model of neuropathic pain assessed as reduction in paw withdrawal threshold at 60 mg/kg, ip measured after 45 mins by von Frey test relative to control2020Journal of medicinal chemistry, 06-11, Volume: 63, Issue:11
Discovery of Potent, Selective, and State-Dependent Na
AID763770Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 30 mins (Rvb = 3.4 +/- 0.8%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID322667Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 30 ug/kg, icv after 30 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID286879Antihyperalgesic effects in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2.5 hrs, ip2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID454488Displacement of [3H]gabapentin from calcium channel alpha2delta in pig cerebral cortex membrane after 30 mins2010Bioorganic & medicinal chemistry letters, Jan-01, Volume: 20, Issue:1
Synthesis and in vivo evaluation of 3-substituted gababutins.
AID74542Tested for activation of Glutamate decarboxylase; the ratio of Vmax in the presence of activators to the Vmax in the absence of activators at a concentration of 1.0 mM.1991Journal of medicinal chemistry, Jul, Volume: 34, Issue:7
3-Alkyl-4-aminobutyric acids: the first class of anticonvulsant agents that activates L-glutamic acid decarboxylase.
AID263852Volume of distribution in rat2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID286860Effect on spontaneous pain in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID1233874Antinociceptive activity in Sprague-Dawley rat model of capsaicin-induced secondary mechanical hyperalgesia model assessed as attenuation of nociception at 500 uM/kg, ip administered 1 hr before behavioral testing by von Frey filaments test2015ACS medicinal chemistry letters, Jun-11, Volume: 6, Issue:6
Optimization of ADME Properties for Sulfonamides Leading to the Discovery of a T-Type Calcium Channel Blocker, ABT-639.
AID1058297Activity at rat Nav1.2 expressed in CHL1610 cells up to 300 uM at -67 to -107 mV after 2 to 3 mins by whole-cell patch-clamp assay2013Journal of medicinal chemistry, Nov-27, Volume: 56, Issue:22
Novel, broad-spectrum anticonvulsants containing a sulfamide group: pharmacological properties of (S)-N-[(6-chloro-2,3-dihydrobenzo[1,4]dioxin-2-yl)methyl]sulfamide (JNJ-26489112).
AID286890Anti-dynamic allodynia effect in Sprague-Dawley rat SNL model assessed as latency to paw withdrawal 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID313145Displacement of [3H]gabapentin from alpha2-delta calcium channel in pig brain2007Journal of medicinal chemistry, May-31, Volume: 50, Issue:11
Ca2+ channel alpha2-delta ligands for the treatment of neuropathic pain.
AID588210Human drug-induced liver injury (DILI) modelling dataset from Ekins et al2010Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 38, Issue:12
A predictive ligand-based Bayesian model for human drug-induced liver injury.
AID286863Effect on spontaneous pain in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 2 hrs2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID412182Bioavailability in rat2009Bioorganic & medicinal chemistry letters, Jan-01, Volume: 19, Issue:1
Oxadiazolone bioisosteres of pregabalin and gabapentin.
AID763774Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of spontaneous pain response at 100 mg/kg, ip after 120 mins (Rvb = 4.5 +/- 0.2%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1744256Analgesic activity in Sprague-Dawley rat model of paclitaxel-induced neuropathic pain assessed as decrease in mechanical allodynia by measuring reduction in pain threshold at 100 mg/kg, ip measured at 0.5 to 1.5 hrs by Von Frey assay relative to control2021Journal of medicinal chemistry, 01-14, Volume: 64, Issue:1
Novel Sigma 1 Receptor Antagonists as Potential Therapeutics for Pain Management.
AID322669Antihyperalgesic activity in Sprague-Dawley rat assessed as lesioned paw pressure threshold at 30 ug/kg, icv after 60 mins2008Bioorganic & medicinal chemistry, Mar-15, Volume: 16, Issue:6
Synthesis and biological evaluation of novel dimiracetam derivatives useful for the treatment of neuropathic pain.
AID1488549Anti-algetic activity in rat streptozotocin-induced neuropathic pain model assessed as reduction in heat hypersensitivity at 100 mg/kg, po measured after 1 to 5 hrs2017Bioorganic & medicinal chemistry, 09-01, Volume: 25, Issue:17
Synthesis and diabetic neuropathic pain-alleviating effects of 2N-(pyrazol-3-yl)methylbenzo[d]isothiazole-1,1-dioxide derivatives.
AID189468Antiallodynic 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 threshold2004Bioorganic & 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.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID730572Antiallodynic activity in rat spinal nerve ligation model of neuropathic pain assessed as reduction of mechanical allodynia at 100 mg/kg, po after 5 hrs2013Bioorganic & medicinal chemistry letters, Mar-01, Volume: 23, Issue:5
Synthesis and biological evaluation of 2-(arylethynyl)quinoline derivatives as mGluR5 antagonists for the treatment of neuropathic pain.
AID286884Anti-dynamic allodynic effect in Sprague-Dawley rat CCI model assessed as latency to paw withdrawal after 2.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID349990Antiinflammatory activity against gamma carrageenan-induced paw edema in Wistar rat assessed as reduction in paw volume at 50 mg/kg, ip administered 2 hrs before carrageenan challenge measured after 24 hrs relative to control2009Journal of medicinal chemistry, May-14, Volume: 52, Issue:9
Gamma-aminobutyric acid amides of nortriptyline and fluoxetine display improved pain suppressing activity.
AID349984Antiinflammatory activity against formalin-induced BALB/c mouse skin assessed as reduction in TNFalpha level at 50 mg/kg, ip2009Journal of medicinal chemistry, May-14, Volume: 52, Issue:9
Gamma-aminobutyric acid amides of nortriptyline and fluoxetine display improved pain suppressing activity.
AID763760Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of cold allodynia at 100 mg/kg, ip after 60 mins (Rvb = 2.5 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID286877Antihyperalgesic effects in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1.5 hrs, ip2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID763757Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 60 mins (Rvb = 4.9 +/- 1.0%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID603571Antiallodynic activity in Wistar albino rat chronic constriction injury-induced neuropathic pain model assessed as attenuation of cold allodynia after 1 to 2.5 hrs at 100 mg/kg, ip2011European journal of medicinal chemistry, Jul, Volume: 46, Issue:7
Discovery of molecules for the treatment of neuropathic pain: synthesis, antiallodynic and antihyperalgesic activities of 5-(4-nitrophenyl)furoic-2-acid hydrazones.
AID773771Antinociceptive activity in CD-1 mouse assessed as reduction of formalin-induced paw licking activity at 100 mg/kg, ip administered 15 mins prior to formalin-challenge measured after 5 to 30 mins2013Journal of medicinal chemistry, Oct-24, Volume: 56, Issue:20
New serotonin 5-HT1A receptor agonists endowed with antinociceptive activity in vivo.
AID604026Unbound CSF to plasma concentration ratio in human2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID386623Inhibition of 4-(4-(dimethylamino)styryl)-N-methylpyridinium uptake at human OCT1 expressed in HEK293 cells at 100 uM by confocal microscopy2008Journal of medicinal chemistry, Oct-09, Volume: 51, Issue:19
Structural requirements for drug inhibition of the liver specific human organic cation transport protein 1.
AID540218Clearance in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID1209582Unbound volume of distribution in Sprague-Dawley rat brain slices at 100 nM after 5 hrs2011Drug metabolism and disposition: the biological fate of chemicals, Mar, Volume: 39, Issue:3
Measurement of unbound drug exposure in brain: modeling of pH partitioning explains diverging results between the brain slice and brain homogenate methods.
AID1594458Analgesic activity in Sprague-Dawley rat L5/L6 spinal nerve ligation-induced neuropathic pain model assessed as reversal of mechanical allodynia by measuring increase in paw withdrawal threshold to non-noxious mechanical stimuli at 100 mg/kg, po measured 2019Bioorganic & medicinal chemistry letters, 05-15, Volume: 29, Issue:10
Structural hybridization of pyrrolidine-based T-type calcium channel inhibitors and exploration of their analgesic effects in a neuropathic pain model.
AID763766Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 60 mins (Rvb = 12.5 +/- 1.2%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID263844Displacement of [3H]gabapentin from alpha-2delta calcium channel in pig brain membrane2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID1410818Antinociceptive activity in C57Bl/6J mouse assessed as inhibition of icilin induced wet-dog shakes at 25 mg/kg, sc pretreated 1 hr before icillin addition and measured after 30 mins by wet-dog shakes assay2018Journal of medicinal chemistry, Jul-26, Volume: 61, Issue:14
Identification of a Potent Tryptophan-Based TRPM8 Antagonist With in Vivo Analgesic Activity.
AID1244173Analgesic activity in intraperitoneally dosed mouse chronic constriction injury model of neuropathic pain assessed as time of peak protection2015ACS medicinal chemistry letters, Jul-09, Volume: 6, Issue:7
Rigidified A3 Adenosine Receptor Agonists: 1-Deazaadenine Modification Maintains High in Vivo Efficacy.
AID1388345Antiallodynic activity in ddY mouse partial sciatic nerve ligation-injury model assessed as inhibition of mechanical allodynia by measuring paw withdrawal threshold in response to probing with von Frey hairs administered via iv route2018Journal of medicinal chemistry, 04-12, Volume: 61, Issue:7
Modulation of Glycine-Mediated Spinal Neurotransmission for the Treatment of Chronic Pain.
AID1594460Analgesic activity in Sprague-Dawley rat L5/L6 spinal nerve ligation-induced neuropathic pain model assessed as decrease in paw withdrawal threshold to non-noxious cold stimuli at 100 mg/kg, po measured after 5 hrs2019Bioorganic & medicinal chemistry letters, 05-15, Volume: 29, Issue:10
Structural hybridization of pyrrolidine-based T-type calcium channel inhibitors and exploration of their analgesic effects in a neuropathic pain model.
AID540219Volume of distribution at steady state in monkey after iv administration2005Journal of pharmaceutical sciences, Jul, Volume: 94, Issue:7
Extrapolation of human pharmacokinetic parameters from rat, dog, and monkey data: Molecular properties associated with extrapolative success or failure.
AID763763Antinociceptive activity in Wistar rat chronic constriction injury model assessed as reversal of cold allodynia at 100 mg/kg, ip after 60 mins (Rvb = 6.3 +/- 1.9%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID261155Potency against persistent inflammatory pain in orally dosed rat CFA model2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Structure-activity relationships of alpha-amino acid ligands for the alpha2delta subunit of voltage-gated calcium channels.
AID604025Unbound CSF to plasma concentration ratio in Sprague-Dawley rat administered in casettes of 2/3 drugs at 4 hr constant rate intravenous infusions using flow rate of 1 (ml/kg)/hr corresponding to dosage rate of 2 (umol/kg)/hr by LC-MS/MS method2009Journal of medicinal chemistry, Oct-22, Volume: 52, Issue:20
Structure-brain exposure relationships in rat and human using a novel data set of unbound drug concentrations in brain interstitial and cerebrospinal fluids.
AID763755Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of mechanical allodynia at 100 mg/kg, ip after 30 mins (Rvb = 2.9 +/- 0.3%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID74545Tested for activation of Glutamate decarboxylase; the ratio of Vmax in the presence of activators to the Vmax in the absence of activators at a concentration of 250 uM.1991Journal of medicinal chemistry, Jul, Volume: 34, Issue:7
3-Alkyl-4-aminobutyric acids: the first class of anticonvulsant agents that activates L-glutamic acid decarboxylase.
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID286895Anti-cold allodynia effect in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID286866Antihyperalgesic effects in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID261157Concentration in rat brain after 0.75 h at 100 umol/kg, po2006Bioorganic & medicinal chemistry letters, Mar-01, Volume: 16, Issue:5
Structure-activity relationships of alpha-amino acid ligands for the alpha2delta subunit of voltage-gated calcium channels.
AID286871Effect on spontaneous pain in Sprague-Dawley rat SNL model assessed as duration of paw withdrawal at 100 mg/kg, ip after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID1333095Antineuropathic pain activity in rat spinal nerve ligation model assessed as effect on cold allodynia by measuring frequency of paw withdrawal at 100 mg/kg, po measured at 5 hrs relative to control2016European journal of medicinal chemistry, Nov-10, Volume: 123Synthesis and T-type calcium channel-blocking effects of aryl(1,5-disubstituted-pyrazol-3-yl)methyl sulfonamides for neuropathic pain treatment.
AID286885Anti-cold allodynia effect in Sprague-Dawley rat CCI model assessed as duration of paw withdrawal at 100 mg/kg, ip after 0.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1762196Antiallodynic activity in Sprague-Dawley rat model of neuropathic mechanical allodynia assessed as increase in paw withdrawal threshold at 100 mg/kg, po measured at 2 to 6 hrs post last dose by von Frey test2021Journal of medicinal chemistry, 03-25, Volume: 64, Issue:6
Alkyne-Bridged α-Conotoxin Vc1.1 Potently Reverses Mechanical Allodynia in Neuropathic Pain Models.
AID471865Inhibition of rat Nav1.2 channel expressed in chinese hamster CHL1610 cells at preconditioning pulse of -107 to -67 mV up to 300 uM after 2 to 3 mins by whole-cell patch-clamp technique2009Journal of medicinal chemistry, Dec-10, Volume: 52, Issue:23
Novel, broad-spectrum anticonvulsants containing a sulfamide group: advancement of N-((benzo[b]thien-3-yl)methyl)sulfamide (JNJ-26990990) into human clinical studies.
AID1769911Reversal of chronic constriction injury-induced cold allodynia in Sprague-Dawley rat model of neuropathic pain at 100 mg/kg, po measured up to 180 mins relative to control2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID263848Oral bioavailability in rat2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID779732Analgesic activity in Sprague-Dawley rat L5/L6 spinal nerve injury Chung model of neuropathic pain assessed as reduction of von Frey hair-induced paw withdrawal threshold at 100 mg/kg, iv measured after 15 to 90 mins relative to vehicle-treated control2013Bioorganic & medicinal chemistry letters, Nov-15, Volume: 23, Issue:22
Discovery of (S,E)-3-(2-fluorophenyl)-N-(1-(3-(pyridin-3-yloxy)phenyl)ethyl)-acrylamide as a potent and efficacious KCNQ2 (Kv7.2) opener for the treatment of neuropathic pain.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID753327Neurotoxicity in rat assessed as reduction in latency time at => 30 mg/kg, po after 2 hrs by rotarod test relative to vehicle-treated control2013Bioorganic & medicinal chemistry letters, Jun-15, Volume: 23, Issue:12
A novel benzazepinone sodium channel blocker with oral efficacy in a rat model of neuropathic pain.
AID1191932Analgesic activity in rat model of spinal nerve ligation-induced neuropathic pain assessed as reduction in mechanical threshold for paw withdrawal at 100 mg/kg, po administered on day 14 after ligation surgery and measured 3 hrs post dose by Von Frey fila2015Bioorganic & medicinal chemistry letters, Mar-15, Volume: 25, Issue:6
Synthesis and biological evaluation of aryl isoxazole derivatives as metabotropic glutamate receptor 1 antagonists: a potential treatment for neuropathic pain.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1769906Antinociceptive activity in Sprague-Dawley rat model of chronic constriction injury-induced neuropathic pain assessed as reduction in thermal hyperalgesia 100 mg/kg, po by Von Frey test relative to control2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID1244172Analgesic activity in intraperitoneally dosed mouse chronic constriction injury model of neuropathic pain2015ACS medicinal chemistry letters, Jul-09, Volume: 6, Issue:7
Rigidified A3 Adenosine Receptor Agonists: 1-Deazaadenine Modification Maintains High in Vivo Efficacy.
AID1488548Anti-algetic activity in rat streptozotocin-induced neuropathic pain model assessed as reduction in mechanical allodynia at 100 mg/kg, po measured after 1 to 5 hrs2017Bioorganic & medicinal chemistry, 09-01, Volume: 25, Issue:17
Synthesis and diabetic neuropathic pain-alleviating effects of 2N-(pyrazol-3-yl)methylbenzo[d]isothiazole-1,1-dioxide derivatives.
AID763759Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of cold allodynia at 100 mg/kg, ip after 120 mins (Rvb = 1.5 +/- 0.5%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1557164Antiallodynic activity in rat model of capsaicin-induced mechanical hyperalgesia assessed as increase in paw withdrawal threshold at 100 mg/kg, ip administered 30 mins before capsaicin addition relative to control2019Bioorganic & medicinal chemistry letters, 10-01, Volume: 29, Issue:19
Design and evaluation of pyrazolopyrimidines as KCNQ channel modulators.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1070227Toxicity in mouse2014Bioorganic & medicinal chemistry, Feb-15, Volume: 22, Issue:4
Gabapentin hybrid peptides and bioconjugates.
AID286882Anti-dynamic allodynic effect in Sprague-Dawley rat CCI model assessed as latency to paw withdrawal after 1.5 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID263846Inhibition of potassium-evoked [3H]norepinephrine release from rat neocortex2006Bioorganic & medicinal chemistry letters, May-01, Volume: 16, Issue:9
Carboxylate bioisosteres of gabapentin.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1070232Oral bioavailability in cynomolgus monkey at 39 mg/kg2014Bioorganic & medicinal chemistry, Feb-15, Volume: 22, Issue:4
Gabapentin hybrid peptides and bioconjugates.
AID603472Antiallodynic activity in Wistar albino rat chronic constriction injury-induced neuropathic pain model assessed as attenuation of mechanical allodynia measured as paw withdrawal latency at 100 mg/kg, ip2011European journal of medicinal chemistry, Jul, Volume: 46, Issue:7
Discovery of molecules for the treatment of neuropathic pain: synthesis, antiallodynic and antihyperalgesic activities of 5-(4-nitrophenyl)furoic-2-acid hydrazones.
AID499469Antinociceptive activity against von Frey hair mechanically stimulated neuropathic pain in rat assessed as withdrawal threshold at 60 mg/kg, ip administered 2 weeks after surgery2010Bioorganic & medicinal chemistry, Aug-15, Volume: 18, Issue:16
Synthesis and T-type calcium channel blocking activity of novel diphenylpiperazine compounds, and evaluation of in vivo analgesic activity.
AID246002Inhibition of carrageenan-induced thermal hyperalgesia in rats 1 hr after administration of a 30 mg/kg dose of test compound2005Journal of medicinal chemistry, Apr-07, Volume: 48, Issue:7
Structure-activity relationships of pregabalin and analogues that target the alpha(2)-delta protein.
AID763767Antinociceptive activity in Wistar rat partial sciatic nerve ligation model assessed as reversal of tactile allodynia at 100 mg/kg, ip after 30 mins (Rvb = 7.7 +/- 0.7%)2013European journal of medicinal chemistry, Aug, Volume: 66Discovery of novel tetrahydro-pyrazolo [4,3-c] pyridines for the treatment of neuropathic pain: synthesis and neuropharmacology.
AID1463708Antihyperalgesic activity in mouse model of chronic constriction injury-induced cold hyperalgesia assessed as reversal of cold hyperalgesia response at 30 mg/kg, po dosed 30 mins before testing starting 5 weeks after surgery2017Bioorganic & medicinal chemistry, 10-15, Volume: 25, Issue:20
Discovery of non-zwitterionic aryl sulfonamides as Na
AID1498745Antiallodynic activity in NMRI mouse model of spared nerve injury-induced mechanical allodynia assessed as pain relief at 585 umol/kg, ip administered 14 days post spared nerve injury surgery measured at 180 mins post dose by Von Frey filament assay2018Bioorganic & medicinal chemistry letters, 08-01, Volume: 28, Issue:14
An imidazole based H-Phe-Phe-NH
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1769939Toxicity in Sprague-Dawley rat assessed as unsteadiness at 100 mg/kg, po2021Journal of medicinal chemistry, 08-12, Volume: 64, Issue:15
Discovery, Structure-Activity Relationships, and In Vivo Evaluation of Novel Aryl Amides as Brain Penetrant Adaptor Protein 2-Associated Kinase 1 (AAK1) Inhibitors for the Treatment of Neuropathic Pain.
AID678119Antinociceptive effect in Sprague-Dawley rat model of sciatic nerve constriction-induced neuropathic pain model assessed as reduction in threshold to von Frey filaments applied to affected hind paw at 30 mg/kg, sc measured 2 hrs post dose2012Bioorganic & medicinal chemistry, Sep-01, Volume: 20, Issue:17
Synthesis and biological evaluation of a fluorescent analog of phenytoin as a potential inhibitor of neuropathic pain and imaging agent.
AID286891Anti-dynamic allodynia effect in Sprague-Dawley rat SNL model assessed as latency to paw withdrawal 100 mg/kg, ip after 1 hr2007Journal of medicinal chemistry, May-17, Volume: 50, Issue:10
Discovery of 4-aminobutyric acid derivatives possessing anticonvulsant and antinociceptive activities: a hybrid pharmacophore approach.
AID349983Antiinflammatory activity against formalin-induced BALB/c mouse skin assessed as reduction in TNFalpha level at to 0.5 mg/kg, po2009Journal of medicinal chemistry, May-14, Volume: 52, Issue:9
Gamma-aminobutyric acid amides of nortriptyline and fluoxetine display improved pain suppressing activity.
AID592681Apparent permeability across human Caco2 cell membrane after 2 hrs by LC-MS/MS analysis2011Bioorganic & medicinal chemistry, Apr-15, Volume: 19, Issue:8
QSAR-based permeability model for drug-like compounds.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347411qHTS 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) Libary2020ACS 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.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS 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.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings 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.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,133)

TimeframeStudies, This Drug (%)All Drugs %
pre-19908 (0.19)18.7374
1990's461 (11.15)18.2507
2000's1427 (34.53)29.6817
2010's1622 (39.25)24.3611
2020's615 (14.88)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 156.00

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index156.00 (24.57)
Research Supply Index8.57 (2.92)
Research Growth Index6.91 (4.65)
Search Engine Demand Index294.89 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (156.00)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials767 (17.12%)5.53%
Reviews876 (19.55%)6.00%
Case Studies757 (16.89%)4.05%
Observational29 (0.65%)0.25%
Other2,052 (45.79%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (412)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Imaging Framework for Testing GABAergic/Glutamatergic Drugs in Bipolar Alcoholics [NCT03220776]Phase 254 participants (Actual)Interventional2017-08-07Completed
Comparison of Gabapentin and Metoclopramide for Treating Hyperemesis Gravidarum [NCT02163434]Phase 231 participants (Actual)Interventional2014-06-30Completed
Pregabalin vs. Gabapentin on Reducing Opioid Usage in Trauma Patients [NCT04705480]Phase 4210 participants (Anticipated)Interventional2021-04-12Recruiting
A Long-Term Study of XP13512 Versus Placebo Treatment Assessing Maintenance of Efficacy and Safety in Patients With Restless Legs Syndrome. [NCT00311363]Phase 3327 participants (Actual)Interventional2006-04-30Completed
The Role of Gabapentin in Postoperative Pain and Epithelialization After Photorefractive Keratectomy A Prospective, Randomized, Double Blinded, Placebo Controlled Study [NCT01177514]Phase 440 participants (Actual)Interventional2010-04-30Completed
An Open-Label, 52-Week Extension Study Assessing XP13512 Safety and Efficacy in Patients With Restless Legs Syndrome. [NCT00333359]Phase 3581 participants (Actual)Interventional2006-06-30Completed
A Phase 4, Randomized, Double-blind, Double-dummy, Placebo and Active-controlled, Single-dose, Five-way Crossover Study Evaluating the Abuse Potential of Three Doses of NEURONTIN® Taken Orally in Healthy, Non-drug Dependent Participants With Sedative Drug [NCT04570436]Phase 452 participants (Actual)Interventional2021-03-29Completed
Efficacy and Safety of Fixed-Dose Combination (FDC) Products Containing Trazodone and Gabapentin in Patients Affected by Painful Diabetic Neuropathy: Randomized, Controlled, Dose Finding Study. [NCT03749642]Phase 2240 participants (Actual)Interventional2018-11-22Completed
Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial [NCT01127100]Phase 4108 participants (Actual)Interventional2010-05-31Completed
Biomarker-Driven Pharmacological Treatment for Autism Spectrum Disorder [NCT05063656]Phase 440 participants (Anticipated)Interventional2022-02-04Recruiting
A Pilot Study of Gabapentin for Sleep in Critically Ill Patients [NCT04631510]Early Phase 180 participants (Anticipated)Interventional2020-12-01Active, not recruiting
The Efficacy of Gabapentine and Splint Therapy in Bruxers: a Randomized Clinical Trial [NCT01255878]20 participants (Actual)Interventional2010-03-31Completed
The Effect of Preoperative Gabapentin on the Duration of Spinal Anesthesia in Patients Undergoing Lower Limb Surgery: A Double-blind, Randomized Clinical Study [NCT05659810]Early Phase 150 participants (Actual)Interventional2022-12-26Completed
A Phase II Randomized Trial of Prophylactic Gabapentin Plus Best Supportive Care Versus Best Supportive Care Alone for Patients Receiving Induction Chemotherapy Followed by Response-Stratified Locoregional Therapy for Locoregionally-Advanced, HPV-Related [NCT03423264]Phase 246 participants (Anticipated)Interventional2018-01-22Recruiting
The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study. [NCT03867240]Phase 30 participants (Actual)Interventional2019-06-30Withdrawn(stopped due to Study initially suspended recruitment due to COVID-19. Study withdrawn due to PI leaving institution in early 2021.)
Placebo Controlled Trial Evaluating Gabapentin for the Treatment of Small Fiber Neuropathic Pain in Patients With Fabry Disease [NCT01588314]Phase 20 participants (Actual)Interventional2012-04-30Withdrawn(stopped due to No patients were enrolled. No data & no study results to report.)
Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Total Knee Arthroplasty [NCT01307202]101 participants (Actual)Interventional2007-10-31Completed
Randomized Phase III, Double-Blind, Placebo Controlled Study of Prophylactic Gabapentin for the Reduction of Radiation Therapy Induced Pain During the Treatment of Oropharyngeal Squamous Cell Carcinoma [NCT03269344]Phase 365 participants (Actual)Interventional2017-06-05Completed
The Effectiveness of a Pre-operative Single Dose Administration of Gabapentin for Management of Post-operative Pain Following Cesarean Section: a Randomised, Double-blind, Placebo-controlled, Dose-finding Study [NCT01094925]126 participants (Actual)Interventional2010-04-30Completed
Opioid-Free Shoulder Arthroplasty [NCT03540030]Phase 486 participants (Actual)Interventional2016-09-30Completed
Randomized, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Conservative Management With Medications and Physical Therapy in Patients With Cervical Radiculopathy [NCT01144923]169 participants (Actual)Interventional2010-06-30Completed
Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair [NCT03818919]Phase 2100 participants (Anticipated)Interventional2019-01-22Recruiting
GRIPP: Gabapentin for Relief of Immediate Postoperative Pain [NCT03750773]Phase 1/Phase 20 participants (Actual)Interventional2019-07-02Withdrawn(stopped due to Lack of funding)
Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial [NCT04292171]Early Phase 1219 participants (Actual)Interventional2017-05-01Completed
Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial [NCT03689114]Phase 4374 participants (Anticipated)Interventional2020-01-07Not yet recruiting
Perioperative Analgesia Using Gabapentin in Head and Neck Cancer Surgery: A Randomized Controlled Trial [NCT03682367]Phase 38 participants (Actual)Interventional2018-12-01Terminated(stopped due to Poor Recruitment)
Oral Amantadine Versus Gabapentin to Attenuate the Hemodynamic Response to Laryngoscopy and Tracheal Intubation and Their Effect on β-endorphin [NCT03172234]Phase 2/Phase 390 participants (Actual)Interventional2017-06-15Completed
Gabapentin Regimens and Their Effects on Opioid Consumption [NCT03334903]Phase 477 participants (Actual)Interventional2018-05-15Completed
Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse [NCT03123861]Phase 445 participants (Actual)Interventional2017-06-01Completed
Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain [NCT02339662]Phase 450 participants (Anticipated)Interventional2015-02-28Recruiting
Gabapentin for Bipolar & Cannabis Use Disorders [NCT03334721]Phase 223 participants (Actual)Interventional2017-10-01Completed
Effect of Milnacipran Versus Gabapentin or Combination of Both in Fibromyalgia Syndrome [NCT05384210]75 participants (Anticipated)Interventional2022-06-30Enrolling by invitation
Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial [NCT03635905]Phase 4130 participants (Actual)Interventional2017-05-26Completed
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial [NCT03080493]Phase 4121 participants (Actual)Interventional2017-03-20Completed
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper [NCT02737826]32 participants (Actual)Interventional2016-05-31Completed
Ultrasound-guided (US) Serratus Anterior Plane Block (SAPB) for Acute Rib Fractures in the Emergency Department (ED) [NCT03619785]Phase 470 participants (Anticipated)Interventional2018-11-06Recruiting
Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study [NCT03758079]Phase 414 participants (Actual)Interventional2018-06-01Completed
Pilot Study of Opioid-receptor Antagonists to Reduce Pain and Inflammation Among HIV-Infected Persons With Alcohol Problems [NCT04052139]Phase 245 participants (Actual)Interventional2021-01-25Completed
Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis [NCT02252926]Phase 270 participants (Actual)Interventional2014-09-30Completed
Gabapentin Enacarbil Post-marketing Clinical Study A Randomized, Double-blind, Placebo-controlled, Parallel-group Study in Subjects With Restless Legs Syndrome. [NCT03053427]Phase 4375 participants (Actual)Interventional2017-03-30Completed
Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial) [NCT05100160]Phase 30 participants (Actual)Interventional2021-09-15Withdrawn(stopped due to 0 patient accrual)
Primary Prophylactic Gabapentin for Taxane-Induced Arthralgia and Myalgia Syndrome in Breast Cancer Patients Undergoing Adjuvant Chemotherapy: A Randomized Controlled Trial [NCT03566394]Phase 2/Phase 346 participants (Anticipated)Interventional2018-07-02Not yet recruiting
Effect of Baclofen Treatment on Nocturnal Muscle Cramps in Patients With Lumbar Spinal Stenosis: a Randomized Clinical Trial [NCT05392361]40 participants (Actual)Interventional2022-06-09Completed
Effect of Perioperative Gabapentin on Postoperative Opioid Requirements [NCT05494385]Phase 4132 participants (Actual)Interventional2021-07-27Completed
Gabapentin Premedication to Reduce Postoperative Pain for Pediatric Tonsillectomy/Adenoidectomy: Randomized Control Trial [NCT03625011]Phase 450 participants (Anticipated)Interventional2018-07-31Recruiting
Study PXN110527: The Investigation of the Efficacy and Pharmacokinetics of XP13512 in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) Who Have Had an Inadequate Response to Gabapentin Treatment. [NCT00617461]Phase 296 participants (Actual)Interventional2008-03-31Completed
Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries [NCT02525848]Phase 2/Phase 3150 participants (Actual)Interventional2015-08-31Completed
Feasibility of Delivering Enhanced Recovery After Cardiac Surgery [NCT03859102]80 participants (Anticipated)Interventional2018-12-17Recruiting
Traditional vs. Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction [NCT03818932]Phase 2/Phase 362 participants (Actual)Interventional2019-01-22Completed
Effect of Early Use of Oxycodone During the Acute Phase of Herpes Zoster on Preventing Postherpetic Neuralgia [NCT03120962]140 participants (Anticipated)Interventional2017-05-31Not yet recruiting
Acute Effects of Gabapentin on Polysomnography Parameters and on Hypothalamic-pituitary-adrenal, Hypothalamic-pituitary-gonadal and Somatotropic Axes During Sleep in Older Men: a Randomized, Double-blind, Placebo-controlled Trial [NCT02599701]Phase 48 participants (Actual)Interventional2015-09-30Terminated(stopped due to Gabapentin increased hypopnea-apnea index in the first 8 recruited subjects.)
Oral Gabapentin Versus Placebo for Treatment of Postoperative Pain Following Photorefractive Keratectomy: A Randomized, Double-masked, Single Center, Placebo-controlled Clinical Trial [NCT00793910]106 participants (Actual)Interventional2008-07-31Completed
A Multicenter, Open-label, Single-dose Pharmacokinetic and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-severe Primary Restless Legs Syndrome [NCT02633657]Phase 10 participants (Actual)Interventional2016-01-31Withdrawn(stopped due to lack of enrollment)
A Phase Ib/II Randomized, Open Label Drug Repurposing Trial of Glutamate Signaling Inhibitors in Combination With Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma [NCT05664464]Phase 1/Phase 2120 participants (Anticipated)Interventional2023-01-01Recruiting
Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery [NCT02617121]120 participants (Anticipated)Interventional2015-11-30Not yet recruiting
Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve [NCT05921604]Phase 3100 participants (Anticipated)Interventional2023-06-30Recruiting
Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy [NCT05620641]Phase 3100 participants (Anticipated)Interventional2022-10-01Recruiting
[NCT01421264]Phase 121 participants (Actual)Interventional2011-08-31Completed
Does Gabapentin Reduce Quadriceps Muscle Weakness After Anterior Cruciate Ligament Reconstruction? A Randomised Controlled Trial [NCT03496389]Phase 2/Phase 330 participants (Anticipated)Interventional2018-07-01Not yet recruiting
Bioequivalence Study of Gabapentin 400 mg Capsule [NCT05436886]24 participants (Actual)Interventional2013-06-28Completed
Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin [NCT03149432]30 participants (Actual)Interventional2017-02-22Completed
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Proof-of-Concept Study to Evaluate the Safety and Efficacy of ROZEREM™ Taken in Combination With Gabapentin for the Treatment of Subjects With Chronic Insomnia [NCT00755508]Phase 2378 participants (Actual)Interventional2005-11-30Completed
Emergency Department-Initiated Medications for Alcohol Use Disorder [NCT05827159]Phase 3240 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial [NCT02926573]Phase 4123 participants (Actual)Interventional2016-06-24Completed
Comparison of the Efficacy and Safety of Duloxetine Augmented With Gabapentin and Duloxetine Augmented With Amitriptyline vs Duloxetine Alone in Chemotherapy -Induced Neuropathy: A Randomized Controlled Trial [NCT06091553]Phase 2160 participants (Anticipated)Interventional2023-10-20Not yet recruiting
A Multimodal Analgesic Protocol With Gabapentin Dexmedetomidine For Postoperative Pain Managment After Modified Radical Mastectomy Surgery: A Randomized Placebo-Controlled Study [NCT04976374]30 participants (Anticipated)Interventional2021-05-25Recruiting
Ultrasound Guided Continuous Suprascapular Nerve Block With Oral Gabapentin For Pain Management In Patients With Frozen Shoulder [NCT05037994]40 participants (Actual)Interventional2021-04-01Completed
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT00755417]Phase 3541 participants (Actual)Interventional2008-09-30Completed
Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery [NCT04434430]Phase 1/Phase 272 participants (Actual)Interventional2019-11-11Completed
Gabapentin Kinetic Disposition and Renal Excretion: Role of Transporters for Organic Cations and the Effect of Glycemic Control in Patients With Neuropathic Pain. [NCT03047278]Phase 429 participants (Actual)Interventional2015-11-01Completed
Premedication With Single Dose Gabapentin to Improve Patient Tolerance in ERCP: A Double-Blind Randomized Controlled Trial [NCT01143766]56 participants (Actual)Interventional2010-04-30Completed
Acupuncture and Gabapentin for Hot Flashes Among Breast Cancer Survivors [NCT01005108]Phase 2120 participants (Actual)Interventional2009-01-31Completed
Decreasing Narcotics in Advanced Pelvic Surgery: A Randomized Study [NCT02110719]Phase 4138 participants (Actual)Interventional2014-03-31Completed
Gabapentin vs. Pregabalin for Post Operative Pain in Lumbar Microdiscectomy: a Randomized Controlled Trial. [NCT02120703]Phase 378 participants (Actual)Interventional2011-02-28Completed
Phase III Study of the Use of Gabapentin and Osteopathic Manipulative Medicine to Treat Fibromyalgia [NCT01107574]Phase 341 participants (Actual)Interventional2004-04-30Completed
Randomized, Double-Blinded, Placebo-controlled Study to Evaluate the Analgesic Efficacy of Oral Clonidine and Gabapentin as Part of a Multi-modal Analgesic Regimen for Preventing Pain After Arthroscopic Shoulder or Knee Surgery [NCT01112878]Phase 40 participants (Actual)Interventional2015-06-30Withdrawn(stopped due to Several studies going on at the same time.)
A Randomized, Double Blind, Active and Placebo Controlled, 5 Way Crossover Study to Determine the Abuse Potential of Orally Administered Gabapentin Enacarbil Immediate Release Capsules in Healthy, Nondependent Recreational Drug Users With Sedative Experie [NCT06097676]Phase 486 participants (Actual)Interventional2021-09-28Completed
The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy - A Randomized, Double-blind, Placebo-controlled Trial [NCT01116583]Phase 3104 participants (Actual)Interventional2011-05-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population [NCT00666575]Phase 32,105 participants (Anticipated)Interventional2004-12-31Completed
"Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting Treatment as Prevention" [NCT05443555]Phase 2300 participants (Anticipated)Interventional2023-11-20Recruiting
The Effects of Gabapentin Premedication on Postoperative Pain,Nausea,Vomiting and Sedation in Patients Undergoing Neurosurgery [NCT02306278]122 participants (Actual)Interventional2014-12-14Completed
Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus After Orthopedics Surgery [NCT01236859]180 participants (Actual)Interventional2009-09-30Completed
A Randomized, Open-Label Study to Assess the Pain, Toxicity, and Quality of Life Effects of Adding Venlafaxine to the Pain Management Regimen for Patients Treated With Chemoradiation for Head and Neck Cancer [NCT03574792]62 participants (Actual)Interventional2018-05-03Completed
Prevention of Persistent Pain and Opioid Use in Mothers - POMS [NCT03472521]Phase 478 participants (Actual)Interventional2018-09-17Completed
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance [NCT00667108]Phase 3784 participants (Actual)Interventional2004-10-31Completed
CSP #428 - Treatment of Seizures in the Elderly Population [NCT00007670]Phase 3720 participants Interventional1998-01-31Completed
A Pilot Study Comparing the Effectiveness of an Opioid- Sparing Analgesic Regimen and an Opioid Based Regimen on Post- Operative Pain Control in Cardiac Surgery Patients (INOVA OPIOID [NCT03679013]Phase 219 participants (Actual)Interventional2019-04-19Completed
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial [NCT02944656]Phase 4114 participants (Actual)Interventional2016-12-08Completed
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery [NCT03084536]Phase 2134 participants (Actual)Interventional2017-06-07Completed
Bariatric Surgery and Pharmacokinetics Gabapentin: BAR-MEDS Gabapentin [NCT03476538]12 participants (Anticipated)Observational2016-11-02Recruiting
[NCT01250561]133 participants (Actual)Interventional2002-02-28Completed
Medication-overuse Headache (MOH): Withdrawal or Use of Preventative Medications Directly? A Randomized Multi-centre Follow-up. [NCT00159588]64 participants (Actual)Interventional2004-01-31Completed
Evaluation of Anxiolysis and Pain Associated With Retrobulbar Eye Block for Cataract Surgery : Melatonin Versus Gabapentin ( A Randomized, Double-blind, Placebo-controlled Study) [NCT01200641]Phase 1/Phase 290 participants (Actual)Interventional2010-09-30Completed
A Controlled Trial of Gabapentin in Vulvodynia: Biological Correlates of Response [NCT01301001]230 participants (Actual)Interventional2012-08-31Completed
This is a Study Exploring the Reasons Why People With Alcohol Dependence Have Sleep Disturbances, and Whether or Not a Study Medication, Gabapentin, vs. Placebo, Affects Those Sleep Patterns. [NCT01014533]59 participants (Actual)Interventional2007-05-31Completed
Comparison of Hypnotherapy Versus Gabapentin in the Treatment of Hot Flashes in Breast Cancer Survivors or Women at Risk of Developing Breast Cancer. [NCT00711529]Phase 327 participants (Actual)Interventional2008-07-31Completed
A Randomized Controlled Trial to Compare the Efficacy of Medicine Conservative Treatment and Surgical Treatment for Symptomatic Sacral Perineurial Cysts (Tarlov Cysts) and the Applied Value of Resting State Functional Magnetic Resonance Imaging (rfMRI). [NCT02595190]Phase 496 participants (Anticipated)Interventional2015-03-31Recruiting
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fed Conditions [NCT00778765]24 participants (Actual)Interventional2002-09-30Completed
Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy [NCT00800527]Phase 4110 participants (Actual)Interventional2007-11-30Completed
Analgesic Effects of Gabapentin After Scoliosis Surgery in Children [NCT00684112]Phase 335 participants (Actual)Interventional2008-05-31Completed
A Randomized Controlled Trial to Determine the Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores in Patients Having Hip and Knee Arthroplasties With Spinal Anesthesia [NCT02840240]100 participants (Actual)Interventional2016-01-31Completed
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Conditions [NCT00865423]Phase 128 participants (Actual)Interventional2001-02-28Completed
Prospective Analgesic Compound Efficacy (PACE) Study [NCT02403687]300 participants (Actual)Observational [Patient Registry]2015-06-30Completed
The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy [NCT02384187]Phase 3140 participants (Actual)Interventional2015-01-31Completed
Randomized Controlled Trial Comparing Multimodal Pain Protocol Versus Hydrocodone-Acetaminophen for Post-Operative Pain Management in Orthopaedic Surgery Patients [NCT05690282]Phase 4100 participants (Anticipated)Interventional2021-05-17Active, not recruiting
Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section [NCT02490345]Phase 113 participants (Actual)Interventional2015-10-31Completed
Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures [NCT05076110]Phase 4188 participants (Anticipated)Interventional2022-04-07Recruiting
Effect of Maintenance Gabapentin Therapy on the Rate of Premature Birth in Women With Preterm Labor After Receiving Tocolysis. [NCT02056899]Phase 14 participants (Actual)Interventional2013-06-30Completed
The Effect of Pretreated Gabapentin on Hyeralgesia Occurring in the Second Operation in Staged Bilateral Cataract Surgery [NCT02127853]Phase 470 participants (Anticipated)Interventional2014-07-31Recruiting
A Comparison of Postoperative Tramadol/Gabapentin/Ibuprofen Versus Tramadol/Placebo/Ibuprofen in Children Undergoing Tonsillectomy [NCT02076893]Phase 464 participants (Actual)Interventional2014-03-31Terminated(stopped due to Interim analysis results indicated need to recruit beyond scope of budget.)
Effects of Preoperative Gabapentin Versus Pregabalin on Shoulder Pain After Laparoscopic Cholecystectomy. A Randomized Clinical Trial [NCT03241875]Phase 490 participants (Actual)Interventional2016-12-01Completed
Randomized Comparison of Two Pre-induction Analgesia Regimens: Multimodal vs Acetaminophen in the Reduction of Post-operative Pain Following Ureteroscopy With Lithotripsy for Kidney Stones Evaluated With Text Messaging [NCT03549611]Phase 40 participants (Actual)Interventional2018-08-01Withdrawn(stopped due to elected not to proceed with the study)
Analysis of Analgesia Regimens During Concurrent Chemoradiation for Head and Neck Cancer: A Pilot Study [NCT02531906]Phase 160 participants (Actual)Interventional2015-04-24Completed
Effect of a Multimodal Pain Regimen on Pain Control, Patient Satisfaction and Narcotic Use in Orthopaedic Trauma Patients [NCT02160301]Phase 40 participants (Actual)Interventional2017-11-30Withdrawn(stopped due to Insufficient infrastructure/funding for enrollment)
A Comparative Study of Melatonin and Gabapentin as Premedication for Patients Undergoing Surgery Following Trauma [NCT05699876]70 participants (Anticipated)Interventional2023-01-15Recruiting
The Impact of Perioperative Gabapentin on Chronic Groin Pain After Inguinal Hernia Repair [NCT02419443]Phase 4100 participants (Anticipated)Interventional2011-08-31Active, not recruiting
The Use of Gabapentin for Post-Operative Pain Control and Narcotic Reduction in Scrotal Surgery [NCT04230980]Phase 374 participants (Actual)Interventional2020-07-28Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Painful Diabetic Peripheral Neuropathy [NCT00712439]Phase 2147 participants (Actual)Interventional2006-04-30Completed
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pa [NCT00904202]Phase 462 participants (Actual)Interventional2003-01-31Completed
Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study [NCT00577967]80 participants (Anticipated)Interventional2005-10-31Not yet recruiting
The Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy: A Randomized Controlled Pilot Study [NCT05609682]Early Phase 140 participants (Anticipated)Interventional2022-11-29Recruiting
A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain. [NCT00414466]Phase 2254 participants (Actual)Interventional2006-12-31Terminated(stopped due to Study closed and subject follow-up completed following analysis of blinded study data.)
Does Postoperative Gabapentin Reduce Pain, Opioid Consumption & Anxiety & Have a Positive Effect on Health Related Quality of Life After Radical Prostatectomy? [NCT00982800]Phase 460 participants (Anticipated)Interventional2007-06-30Completed
A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms [NCT05494437]Phase 2234 participants (Actual)Interventional2022-10-27Completed
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty [NCT04003350]216 participants (Actual)Interventional2017-12-21Completed
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Ranbaxy and Park:-Davis (Neurontin®) 400 mg Gabapentin Capsules in Healthy Adult Volunteers Under Fasting Conditions [NCT00778271]26 participants (Actual)Interventional2002-09-30Completed
Gabapentin in Functional Dyspepsia Refractory to Proton Pump Inhibition [NCT01052896]Phase 30 participants (Actual)Interventional2010-03-31Withdrawn(stopped due to Unable to recruit subjects - unworkable)
Vasomotor Symptoms and Cardiovascular Control [NCT02202707]0 participants (Actual)Interventional2014-05-31Withdrawn(stopped due to No funding obtained to conduct study)
Clinical Study on Chemotherapy Induced Peripheral Neuropathy: Preventive Approach Using Venlafaxine [NCT05875610]Phase 460 participants (Anticipated)Interventional2023-05-01Recruiting
Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption [NCT05301205]Early Phase 196 participants (Anticipated)Interventional2021-06-25Enrolling by invitation
Phase III Double-Blind, Placebo-Controlled Study of Gabapentin for the Prevention of Delayed CINV (Chemotherapy Induced Nausea and Vomiting) in Patients Receiving Highly Emetogenic Chemotherapy [NCT00880191]Phase 3430 participants (Actual)Interventional2009-04-30Completed
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance [NCT00666939]Phase 3773 participants (Actual)Interventional2004-10-31Completed
An Open, Multicenter Study on the Efficacy, Safety and Tolerability of Gabapentin, Titrated for Reaching an Effect for the Treatment of the Painful Diabetic Neuropathy [NCT00644748]Phase 495 participants (Actual)Interventional2003-05-31Completed
Effect of Bilateral Spinae Erector Block (ESP) and Perioperative Gabapentin on Recovery and Length of Stay in Adolescent Spinal Fusion Patients: A Retrospective Cohort Stud [NCT06096480]34 participants (Actual)Observational2023-08-01Active, not recruiting
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis [NCT02642484]Phase 3200 participants (Anticipated)Interventional2018-12-31Not yet recruiting
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness [NCT00659100]Phase 31,254 participants (Actual)Interventional2006-08-31Completed
Long-term Study - Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients [NCT02658188]Phase 3182 participants (Actual)Interventional2007-12-31Completed
Pharmacokinetic (PK) Study of ASP8825 - Evaluation of Pharmacokinetics in Patients With Impaired Renal Function and Haemodialysis [NCT02629224]Phase 118 participants (Actual)Interventional2008-02-29Completed
A 52 Weeks, Open-Label, Multicenter Study Evaluating The Efficacy And Safety Of Gabapentin As Adjunctive Therapy In Pediatric Patients Who Have Completed The 12 Weeks Treatment In Study A9451162 (NCT00603473) [NCT00620555]Phase 365 participants (Actual)Interventional2008-05-31Completed
A Limited Food Effect Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules [NCT00865631]Phase 118 participants (Actual)Interventional1999-06-30Completed
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions [NCT00864305]Phase 118 participants (Actual)Interventional1997-12-31Completed
Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain [NCT02927405]Phase 40 participants (Actual)Interventional2020-03-04Withdrawn(stopped due to Did not get the study to take off, did not recruit any subjects, and then closed the study.)
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)Observational2023-11-15Recruiting
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs [NCT04278404]5,000 participants (Anticipated)Observational2020-03-05Recruiting
Does Peri-Operative Gabapentin Reduce Chronic Post-Thoracotomy Pain? [NCT00934193]Phase 30 participants (Actual)Interventional2009-07-31Withdrawn
Treatment of Ilioinguinal Entrapment Syndrome - a Randomised Controlled Trial [NCT01020162]19 participants (Actual)Interventional1995-09-30Completed
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 4407 participants (Actual)Interventional2006-09-30Completed
Preemptive Gabapentin Administration and Perioperative Plasma Concentrations With Cardiac Bypass [NCT01022736]Phase 416 participants (Actual)Interventional2007-05-31Completed
An Open, Randomized, Crossover Study In Healthy Subjects To Assess The Bioequivalence Of Gabapentin Between Japanese Commercial Tablet And Japanese Commercial Image Liquid Formulation And The Effect Of Food On The Pharmacokinetics Of Japanese Commercial I [NCT00987779]Phase 126 participants (Actual)Interventional2009-10-31Completed
Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus Surgery [NCT03820193]Early Phase 161 participants (Actual)Interventional2019-01-22Completed
An Open-Label, Multicenter Study Evaluating, The Efficacy, Safety And Pharmacokinetics Of Gabapentin As Adjunctive Therapy In Pediatric Patients With Partial Seizures When Other Antiepileptics Do Not Provide Satisfactory Effects [NCT00603473]Phase 392 participants (Actual)Interventional2008-01-31Completed
Pharmacokinetic (PK) Study of ASP8825 - Evaluation of the Effect of Food on the Pharmacokinetics [NCT02632331]Phase 118 participants (Actual)Interventional2009-01-31Completed
The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial [NCT00573664]46 participants (Actual)Interventional2007-11-30Terminated(stopped due to Interim analysis showed a significant reduction in the pain scores)
Study RXP110908, a Polysomnography Study of GSK1838262 (XP13512) Extended Release Tablets Versus Placebo in the Treatment of Restless Legs Syndrome (RLS) and Associated Sleep Disturbance [NCT00748098]Phase 3136 participants (Actual)Interventional2008-10-31Completed
Perioperative Use of Gabapentin To Decrease Opioid Requirements in Pediatric Spinal Fusion Patients [NCT00726999]63 participants (Actual)Interventional2006-06-30Completed
A Randomized Double-Blind, Placebo-Controlled, Crossover Study To Assess The Reproducibility And The Effect Of Gabapentin On Quantitative Sensory Testing In Neuropathic Pain Patients [NCT00674687]23 participants (Actual)Interventional2004-07-31Completed
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study [NCT05064319]Phase 268 participants (Anticipated)Interventional2022-02-24Recruiting
Preoperative Gabapentin Versus Bisoprolol for Intraoperative Hemodynamic and Surgical Field Optimization During Endoscopic Sinus Surgery [NCT03850093]Phase 463 participants (Actual)Interventional2015-08-31Completed
Drug Discrimination in Methadone-Maintained Humans Study 2 [NCT00733239]Phase 115 participants (Actual)Interventional2008-08-31Completed
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Condition [NCT00778401]28 participants (Actual)Interventional2002-10-31Completed
Gabapentin in Patients at Clinical Risk for Psychosis [NCT02557945]Phase 1/Phase 29 participants (Actual)Interventional2015-08-01Terminated(stopped due to Combination of insufficient funding and lack of compelling findings)
A Multimodal Technology-assisted Intervention for the Management of Menopause After Cancer: The Menopause After Cancer Study [NCT04766229]Phase 2205 participants (Actual)Interventional2021-06-21Completed
Comparison of Analgesic Effects of Gabapentin and Paracetamol in Patients With Hand Injury [NCT04068506]Phase 468 participants (Actual)Interventional2019-09-01Completed
Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy [NCT00799149]Phase 475 participants (Actual)Interventional2006-06-30Completed
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Fasting Conditions [NCT00864058]Phase 130 participants (Actual)Interventional1998-01-31Completed
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules Under Fasting Conditions [NCT00864760]Phase 130 participants (Actual)Interventional1999-06-30Completed
A Multicenter Open-Label Extension Study to Evaluate the Efficacy and Safety of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary Restless Legs Syndrome [NCT02633683]Phase 4144 participants (Anticipated)Interventional2016-01-31Recruiting
Analgetic Effectiveness of Acupuncture When Compared to a Standardised Analgesic Regimen in the Treatment of Herpes Zoster Neuralgia [NCT00885586]Phase 468 participants (Actual)Interventional2008-11-30Completed
A Multidisciplinary, Multimodal Bundled Care Approach to Chronic Pelvic Pain [NCT05658874]Phase 380 participants (Anticipated)Interventional2022-12-01Recruiting
Drug Use Investigation Of Gabapen [NCT00567268]1,273 participants (Actual)Observational2007-08-31Completed
Gabapentin in Fibromyalgia Trial (GIFT) [NCT00057278]Phase 2/Phase 3150 participants Interventional2003-03-31Completed
Multi-centre, Double-blind, Randomized-controlled Trial to Study the Efficacy and Safety of Gabapentin to Reduce Strong Opioid Use in Treatment of Radiation-induced Pain in Head and Neck Cancer Patients During Curative Radio(Chemo)Therapy. [NCT03747562]Phase 30 participants (Actual)Interventional2019-03-01Withdrawn(stopped due to Lack of funding)
Clinical Trial of Gabapentin in the Prevention of Nausea Ond Vomiting Induced by Chemotherapy, a Randomized, Double-blind, Placebo Controled Study [NCT01052844]Phase 380 participants (Actual)Interventional2009-01-31Completed
Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study. [NCT00390013]9 participants (Actual)Interventional2007-01-31Terminated(stopped due to poor recruitment)
Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy [NCT00619983]Phase 422 participants (Actual)Interventional2008-02-29Terminated(stopped due to Study terminated due to low enrollment)
Efficacy of Preoperative Administration of Gabapentin in Managing Intraoperative and Postoperative Pain From Third Molar Extractions. [NCT04860141]Phase 498 participants (Anticipated)Interventional2021-06-16Recruiting
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions [NCT00865059]Phase 124 participants (Actual)Interventional2001-02-28Completed
Post Operative Pain in Modified Radical Mastectomy. [NCT04620720]Early Phase 151 participants (Anticipated)Interventional2020-08-01Recruiting
A Randomized, Double Blind, Placebo Controlled Study to Investigate the Effect of Donepezil and Gabapentin Combination on an Experimental Pain Model in Healthy Subjects [NCT01485185]Phase 148 participants (Actual)Interventional2011-10-11Completed
A Randomized, Double-Blind, Active- and Placebo-Controlled, Crossover Study Assessing the Effect of 600 mg Gabapentin Enacarbil on Simulated Driving in Healthy Subjects [NCT01411124]Phase 136 participants (Actual)Interventional2011-06-30Completed
Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control [NCT01014520]Phase 2120 participants (Anticipated)Interventional2009-05-31Recruiting
Multiple Doses of Gabapentin and Postoperative Morphine Consumption in Primary Hip Arthroplasty [NCT00889148]103 participants (Actual)Interventional2007-10-31Completed
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 mg In Transient Insomnia Induced By A Sleep Phase Advance [NCT00674752]Phase 3377 participants (Actual)Interventional2006-03-31Completed
Pain Reduction and Changes in Upper Limb Function Produced by Physiotherapy, Ibuprofen Arginine, Gabapentin and the Absence of Treatment, in Carpal Tunnel Syndrome [NCT04025203]Phase 480 participants (Anticipated)Interventional2019-08-01Recruiting
Stanford Accelerated Recovery Trial (START) [NCT01067144]Phase 3422 participants (Actual)Interventional2010-05-31Terminated(stopped due to Trial met futility stopping point)
Cognitive Changes Associated With Initiation of Gabapentin Treatment in Adults With Chronic Pain [NCT04106011]3 participants (Actual)Observational2020-01-10Terminated(stopped due to PI request - low enrollment)
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 4482 participants (Actual)Interventional2008-02-29Completed
A Multicenter, Double-Blind, Placebo Controlled, Parallel Group, Efficacy and Safety Evaluation of HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) in Adolescents Aged 13 to 17 Years Old With Moderate-to-Severe Primary RLS [NCT02560766]Phase 4132 participants (Anticipated)Interventional2016-02-29Recruiting
A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions [NCT00778232]22 participants (Actual)Interventional2002-10-31Completed
Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery? A Randomised, Double-blind, Placebo Controlled Trial [NCT01848119]204 participants (Actual)Interventional2013-05-31Completed
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT00777023]Phase 3565 participants (Actual)Interventional2008-10-31Completed
Population Pharmacokinetic and Pharmacodynamic Modeling of Gabapentin in Neuropathic Pain - Effect of Adjuvant Pharmacotherapy [NCT00967707]Phase 230 participants (Anticipated)Interventional2009-08-31Completed
Study PXN110748: An Efficacy and Safety Study of XP13512 Compared With a Concurrent Placebo Control in Subjects With Neuropathic Pain Associated With Post-herpetic Neuralgia (PHN) [NCT00619476]Phase 2376 participants (Actual)Interventional2008-02-29Completed
Evaluation of Lamotrigine (Lamictal® (Registered Trademark)) Monotherapy and Gabapentin (Neurontin® (Registered Trademark)) Monotherapy in the Treatment of Mood Disorders [NCT00001482]Phase 260 participants Interventional1995-05-31Completed
A Comparative Study of Oral Gabapentin, Oral Alprazolam and Intravenous Dexmedetomidine on Perioperative Anxiety and Pain During Posterior Segment Eye Surgery Under Peribulbar Block : a Randomized, Double-blind Study. [NCT04658732]Phase 145 participants (Anticipated)Interventional2020-12-01Recruiting
Gabapentin Premedication to Reduce Postoperative Nausea and Vomiting in Surgical Patient Receiving Spinal Morphine [NCT02944981]Phase 480 participants (Actual)Interventional2016-08-31Completed
A 4 Week, Parallel-Design, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Treatment of Neuroleptic-Induced Tremor: Clinical and Instrumental Ratings of Outcome. [NCT00533455]Phase 340 participants (Anticipated)Interventional2004-03-31Terminated(stopped due to Failure to recruit due to polypharmacy)
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 2421 participants (Actual)Interventional2008-03-31Completed
Effects of Pain and the Treatment of Pain With Gabapentin (900-3600 Mg) on Driving Ability, Attentional Capacity and Psychomotor Performance in Chronic Neuropathic Pain Patients [NCT00189072]Phase 424 participants Interventional2003-04-30Terminated
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of XP13512 in Patients With Restless Legs Syndrome. [NCT00365352]Phase 3325 participants (Actual)Interventional2006-08-31Completed
Gabapentin as an Adjunct to Naltrexone for Alcoholism [NCT00183196]Phase 3150 participants (Actual)Interventional2003-01-31Completed
Open Label Pilot Study of Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children [NCT01092520]Phase 10 participants (Actual)Interventional2009-07-31Withdrawn
Specified Drug Use-Results Survey of Regnite [NCT01887613]1,597 participants (Actual)Observational2012-10-01Completed
Bioequivalence Study Between Two Medications for Administration of Oral Gabapentin in 300 mg Capsules in Healthy Volunteers [NCT01738893]Phase 126 participants (Actual)Interventional2011-01-14Completed
Investigating the Effect of a Perioperative Analgesia Protocol on Postoperative Opioid Usage and Pain Control in Patients Undergoing Major Head and Neck Cancer Surgery Requiring Microvascular Free Flap Reconstruction [NCT04176419]Phase 330 participants (Anticipated)Interventional2020-01-17Active, not recruiting
Gabapentin Vs. Lorazepam in Alcohol Withdrawal [NCT00229125]Phase 2160 participants Interventional2001-07-31Completed
[NCT00209885]Phase 460 participants Interventional2005-10-31Not yet recruiting
Efficiency of Multi-Modal Anesthesia (MMA) Protocol in Pain Control and Analgesia in Patients Undergoing Posterior Lumbar Spinal Fusion Surgery [NCT05413902]Phase 4100 participants (Actual)Interventional2021-04-05Completed
Multimodal Opiate-sparing Analgesia Versus Traditional Opiate Based Analgesia After Cardiac Surgery, a Randomized Controlled Trial [NCT01966172]Phase 4180 participants (Actual)Interventional2007-03-31Completed
A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery [NCT04144933]Phase 360 participants (Anticipated)Interventional2021-05-15Recruiting
Post-marketing Clinical Study of Gabapentin Enacarbil -Non-blinded Study in Restless Legs Syndrome (RLS) Patients With Moderate Renal Impairment- [NCT01981941]Phase 419 participants (Actual)Interventional2013-11-05Completed
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy [NCT04429022]Phase 368 participants (Actual)Interventional2020-11-24Completed
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty [NCT03859024]Phase 460 participants (Actual)Interventional2019-03-22Completed
Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus [NCT00555776]Phase 270 participants (Anticipated)Interventional2007-01-31Active, not recruiting
Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study [NCT04622618]Early Phase 1150 participants (Actual)Interventional2020-09-15Completed
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy [NCT00572208]64 participants (Anticipated)Interventional2008-01-31Recruiting
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER_ Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT01080300]Phase 3600 participants (Actual)Interventional2010-08-31Completed
A Randomized, Double Blind, Active- and Placebo-Controlled, Parallel Group Safety Study Assessing Simulated Driving Performance in XP13512-(GSK1838262) Treated Patients With Restless Legs Syndrome [NCT01332318]Phase 2130 participants (Actual)Interventional2007-04-30Completed
Drug Discrimination in Methadone-Maintained Humans Study 1 [NCT00593463]Phase 140 participants (Anticipated)Interventional2006-09-30Completed
An Investigation of Post-Operative Pain Scores and Analgesic Requirements After Ambulatory Inguinal Herniorrhaphy With Pre-Operative Gabapentin Therapy [NCT00735124]Phase 2/Phase 35 participants (Actual)Interventional2008-11-06Terminated(stopped due to Changes to surgical practices led to the loss of eligible patients)
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 mg in Transient Insomnia Induced by a Sleep Phase Advance [NCT00666770]Phase 3309 participants (Actual)Interventional2004-10-31Completed
Liceo Study: A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice [NCT00855738]Phase 4111 participants (Actual)Interventional2007-05-31Completed
Randomized, Double-blind, Double-dummy, Active Controlled, Multicentre, Non-inferiority Phase-III Study to Compare Gabapentin Liquid Formulation to Tramadol in Children Experiencing Moderate to Severe Chronic Neuropathic or Mixed Pain [NCT02722603]Phase 32 participants (Actual)Interventional2018-09-12Terminated(stopped due to The study was early terminated due to insufficient recruitment)
Pain Management in Corneal Collagen Crosslinking for Keratoconus: Prospective Randomized Study [NCT02867176]Phase 425 participants (Actual)Interventional2016-01-31Completed
Does a Single Preoperative Dose of Gabapentin Reduce Postoperative Tonsillectomy Pain and Subsequent Morphine Requirement in Children? [NCT00624455]Phase 328 participants (Anticipated)Interventional2007-07-31Completed
Oral Gabapentin Versus Control in the Treatment of Carpal Tunnel Syndrome [NCT04285281]Phase 450 participants (Anticipated)Interventional2020-03-31Not yet recruiting
A Randomized, Double-Blind, 4-way Crossover, Placebo-Controlled, Single Center Trial to Evaluate the Potential Pharmacodynamic Interaction Between Gabapentin 500 mg and Ethanol in Healthy Volunteers [NCT00666796]Phase 420 participants (Actual)Interventional2005-04-30Completed
A Multicenter, Randomized Controlled Trial of the Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures [NCT02856750]Early Phase 1100 participants (Actual)Interventional2016-10-31Completed
Evaluation of Ketamine and Multi-modal Analgesics for Postoperative Analgesia, Opioid Sparing, and Early Extubation in ICU Compared With Conventional Analgesia [NCT02815111]0 participants (Actual)Observational2016-07-31Withdrawn(stopped due to Not IRB approved)
A Single Centre, Single-blind, Randomized, Two-part, 6-way Cross-over Study to Investigate the Individual Bioequivalence of Gabasandoz® Relative to Neurontin® in Healthy Volunteers. [NCT01821235]Phase 151 participants (Actual)Interventional2013-04-30Completed
Efficacy of Gabapentin in Treating Pain in Children With Severe Neurological Impairment [NCT04619862]Phase 210 participants (Anticipated)Interventional2021-05-15Recruiting
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia [NCT00335933]Phase 3378 participants (Anticipated)Interventional2006-05-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance [NCT00163046]Phase 3256 participants (Actual)Interventional2005-10-31Completed
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease [NCT03082755]Phase 4156 participants (Anticipated)Interventional2017-07-01Recruiting
Treatment for Alcohol Dependence With Gabapentin: A Double Blind Placebo Controlled Randomized Clinical Trial [NCT02771925]Phase 425 participants (Actual)Interventional2016-06-30Terminated(stopped due to Due to poor compliance of patients in the study.)
An Open Label Pharmacokinetic Study Of Gabapentin In Japanese Subjects With Renal Impairment Including Hemodialysis [NCT00584779]Phase 48 participants (Actual)Interventional2007-10-31Terminated(stopped due to See detailed description for termination reason)
Feasibility of Early Gabapentin as an Intervention for Neurorecovery [NCT05302999]Phase 442 participants (Anticipated)Interventional2022-03-14Recruiting
Efficacy and Safety of Gabapentin in Treating Overactive Bladder [NCT01486706]Phase 2/Phase 394 participants (Actual)Interventional2010-10-31Completed
Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery [NCT01489631]81 participants (Actual)Interventional2013-03-31Completed
Efficacy of Gabapentin in Alcohol Dependency Treatment: a Double-blinded Randomized Placebo-controlled Trial [NCT03274167]Phase 3112 participants (Actual)Interventional2012-01-31Completed
Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial [NCT03151746]Phase 420 participants (Actual)Interventional2018-01-14Terminated(stopped due to Insufficient enrollment)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study of the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT00511953]Phase 2108 participants (Anticipated)Interventional2007-06-30Completed
Hyperalgesia in Methadone Patients: Can it be Treated? [NCT00218374]60 participants (Actual)Interventional2006-10-31Completed
Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study. [NCT02918760]Phase 364 participants (Anticipated)Interventional2016-03-31Recruiting
The Effect of Neurontin on Pain Management in the Acutely Burned Patient [NCT01265056]53 participants (Actual)Interventional2010-02-28Completed
Efficacy of Gabapentin for Post-Covid-19 Olfactory Dysfunction [NCT05184192]Phase 250 participants (Anticipated)Interventional2022-01-10Enrolling by invitation
A Feasibility Study: Understanding and Altering Pain Expectations in Subjects With Osteoarthritis of the Knee or Hip [NCT02155257]Phase 430 participants (Actual)Interventional2014-07-31Completed
Comparison of the Effectiveness and Safety Between Tramadol 37.5 Mg/Acetaminophen 325mg And Gabapentin for The Treatment of Painful Diabetic Neuropathy: Multicenter, Randomized, Open Comparative Study [NCT00634543]Phase 4162 participants (Actual)Interventional2006-12-31Completed
The Effect of Gabapentin on Postoperataive Pain ,Morphine Sparing Effect and Preoperative Anxiety in Bariatric Surgical Patients [NCT03023501]Phase 250 participants (Actual)Interventional2014-03-31Completed
A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures [NCT05658887]Phase 4110 participants (Anticipated)Interventional2023-01-01Enrolling by invitation
"Gabapentin Reduces Opioid Use Postoperatively (GROUP Study): A Randomized Control Trial in Women Undergoing Reconstructive Pelvic Surgery" [NCT02999724]Phase 344 participants (Anticipated)Interventional2017-01-31Recruiting
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery as Part of an Enhanced Recovery After Surgery Protocol: A Randomized Prospective Single- Center Trial. [NCT02958566]Phase 480 participants (Anticipated)Interventional2017-01-31Recruiting
Comparison of Aprepitant vs. Gabapentin in the Prevention of Delayed Nausea and Vomiting [NCT00250744]Phase 2200 participants (Actual)Interventional2004-12-31Completed
Preanalgesic Effect of Gabapentin in Total Knee Repair [NCT00279487]24 participants (Actual)InterventionalCompleted
A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone [NCT00087399]Phase 3118 participants (Actual)Interventional2004-11-30Completed
"Preoperative Gabapentin and Its Effects on Postoperative Analgesia in Patients Undergoing Cosmetic Breast Surgery" [NCT05997355]100 participants (Anticipated)Interventional2023-09-01Not yet recruiting
Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study [NCT04246697]Phase 430 participants (Actual)Interventional2019-11-01Completed
A Prospective Randomized Double Blind Trial to Assess the Effect of a Single Preoperative Dose of Gabapentin on Postoperative Opioid Consumption in Patients Undergoing Rhinoplasty [NCT03498261]Phase 150 participants (Actual)Interventional2018-01-30Active, not recruiting
Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Double-Blind, Randomized Clinical Effectiveness Study. [NCT02219373]Phase 360 participants (Anticipated)Interventional2023-08-31Not yet recruiting
Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial [NCT00137735]Phase 3150 participants (Actual)Interventional2003-10-31Completed
Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study. [NCT03158376]Phase 3201 participants (Actual)Interventional2015-09-30Completed
A Post-Marketing Clinical Pharmacokinetics Study Of Gabapentin In Japanese Epileptic Subjects With Renal Impairment [NCT00785772]Phase 41 participants (Actual)Interventional2010-03-31Terminated(stopped due to See termination reason in detailed description.)
The Effect of Gabapentin on Acute Pain and PONV in Bariatric Surgical Patients [NCT00886236]62 participants (Actual)Interventional2008-02-29Completed
Imaging Biomarkers of Social Cognition and Pharmacologic Target Engagement in Autism Spectrum Disorder [NCT03589898]Early Phase 119 participants (Actual)Interventional2017-09-14Completed
Gabapentin Treatment of Cannabis Dependence [NCT00974376]Phase 2150 participants (Actual)Interventional2009-11-04Completed
A Randomised, Double-Blind, Double-Dummy, Placebo And Active Controlled, 4-Way Crossover Methodology Study To Assess The Effect Of Gabapentin, Diphenhydramine And Morphine On Cold Pain In Healthy Male Volunteers [NCT01119222]Phase 119 participants (Actual)Interventional2008-07-31Completed
Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study [NCT01263132]Phase 3104 participants (Actual)Interventional2008-02-29Completed
Traditional vs. Nonopioid Analgesia After Labral Surgery [NCT03825809]Phase 2/Phase 3100 participants (Anticipated)Interventional2019-01-22Recruiting
Gabapentin in the Prevention of Phantom Limb Pain [NCT00169013]Phase 40 participants Interventional2002-05-31Completed
The Impact of Pre-emptive Large Doses of Methylprednisolone Combined With Gabapentin on Pain Treatment and Convalescence After Total Knee Arthroplasty in Elderly: A Double-blind Randomized Study [NCT04653415]Phase 4160 participants (Actual)Interventional2019-06-01Completed
Influence of Intestinal Transporter Genetic Variants on the Bioavailability of Gabapentin [NCT00187707]30 participants (Actual)Interventional2005-09-30Completed
A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain After Inguinal Hernia Repair: a Prospective Randomized Study [NCT04700592]60 participants (Actual)Interventional2020-10-02Completed
The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study [NCT00667121]85 participants (Anticipated)Observational2011-03-16Active, not recruiting
Effectiveness and Safety of Gabapentin for the Treatment of Hot Flashes in Menopausal Women: A Randomized Controlled Trial [NCT00112138]Phase 3200 participants Interventional2004-03-31Completed
Specific Interventions for Agitation in Alzheimer's Disease [NCT00018291]0 participants Interventional2001-01-31Completed
Alcohol Research Center - Treatment and Implications [NCT00011297]Phase 2160 participants InterventionalCompleted
A Randomized Trial of Gabapentin, Estrogen and Placebo for the Treatment of Postmenopausal Hot Flashes [NCT00276081]Phase 460 participants Interventional2002-05-31Completed
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST [NCT01678586]47 participants (Actual)Interventional2012-12-31Completed
Control of Vasomotor Symptoms in Women Treated for Breast Cancer [NCT00022074]0 participants Interventional2001-07-31Completed
The Efficacy Of Gabapentin In The Management Of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double-Blind, Placebo-Controlled, Crossover Trial [NCT00027963]Phase 3100 participants (Actual)Interventional2002-02-28Completed
Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease [NCT05750875]Phase 464 participants (Actual)Interventional2022-05-01Completed
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries [NCT05533684]Early Phase 150 participants (Actual)Interventional2022-09-01Completed
A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Management of Hot Flashes in Men [NCT00028574]Phase 3223 participants (Actual)Interventional2001-12-31Completed
Study of Gabapentin for the Pruritus of Cholestasis [NCT00058890]Phase 315 participants (Actual)Interventional2000-11-30Completed
[NCT00209872]Phase 460 participants (Anticipated)Interventional2005-10-31Not yet recruiting
Randomised, Placebo Controlled, Double Blind, Parallel Group 3-Months Study of Gabapentin Efficacy in Asthma Therapy [NCT00153283]Phase 468 participants Interventional2003-09-30Completed
COMPARATION BETWEEN SPHENOPALATINE BLOCK AND MULTIMODAL CLINICAL TREATMENT IN TREATMENT OF HEADACHE AFTER DURAL PUNCTION IN PREGNANT WOMEN. [NCT04148846]45 participants (Anticipated)Interventional2019-09-20Recruiting
Use of Preoperative Gabapentin in Patients Undergoing Laparoscopic Cholecystectomy [NCT03583892]60 participants (Anticipated)Observational [Patient Registry]2018-07-01Recruiting
Efficacy of Opioid-free Anesthesia in Reducing Postoperative Respiratory Depression in Children Undergoing Tonsillectomy: a Pilot Study [NCT02987985]Phase 350 participants (Actual)Interventional2017-10-15Completed
Gabapentin Premedication for Pediatric Anterior Cruciate Ligament Reconstruction: Randomized Control Trial [NCT03417479]57 participants (Actual)Observational2015-10-09Completed
Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty, a Study of Opiate Consumption and Weight Reduction [NCT04613024]Early Phase 170 participants (Anticipated)Interventional2023-07-01Not yet recruiting
Preoperative Gabapentin for Reduction of Post-tonsillectomy Pain in Children [NCT01707420]36 participants (Actual)Interventional2012-08-31Completed
Sertraline Augmented With GABA Agents for Cocaine Dependence [NCT00654953]Phase 2102 participants (Actual)Interventional2006-01-31Completed
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage [NCT02330094]Phase 416 participants (Actual)Interventional2014-12-31Completed
Administration of Pre-Operative Gabapentin to Patients Undergoing Laparoscopy: A Prospective Double-blinded, Placebo Controlled Randomized Study [NCT02359110]Phase 4112 participants (Actual)Interventional2015-06-30Completed
Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients [NCT05510856]Phase 490 participants (Anticipated)Interventional2022-09-01Recruiting
Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery [NCT03005483]Phase 440 participants (Actual)Interventional2014-01-31Completed
The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement [NCT00236223]Phase 448 participants (Actual)Interventional2005-10-31Terminated(stopped due to Structural changes that stopped the type of operations used in the study)
Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research Database [NCT01138124]54,202 participants (Actual)Observational2010-03-31Completed
The Effect of Gabapentin on the Sensation and Impact of Tinnitus [NCT00257270]Phase 240 participants Interventional2003-08-31Completed
Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects [NCT02349477]Phase 296 participants (Actual)Interventional2014-11-30Completed
Gabapentin for the Relief of Idiopathic Subjective Tinnitus [NCT00317850]Phase 2/Phase 3160 participants Interventional2004-04-30Terminated
Randomized, Double-blind, Placebo Controlled, Superiority Phase II Study to Evaluate the Safety, Pharmacokinetic, Efficacy of Gabapentin as add-on to Morphine in Children From 3 Months to Less Than 18 Years [NCT03275012]Phase 20 participants (Actual)Interventional2017-04-04Withdrawn(stopped due to Study not started)
Randomized Controlled Trial Comparing Gabapentin and Amitriptyline for the Treatment of Neuropathic Pain in Children and Adolescents [NCT00312260]Phase 334 participants (Actual)Interventional2006-04-30Completed
Gabapentin for Cannabis Withdrawal and Use [NCT00395044]Phase 250 participants (Actual)Interventional2006-08-31Completed
Analgesic Effect of Perioperative Gabapentin in Total Knee Arthroplasty: A Randomized, Double-blind, Placebo-controlled, Dose-response Study [NCT01507363]Phase 4300 participants (Actual)Interventional2012-01-31Completed
A Randomized Controlled Pilot Trial of Gabapentin for the Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients [NCT00420771]Phase 219 participants (Actual)Interventional2007-01-31Completed
DIalysis Symptom COntrol-Restless Legs Syndrome Trial (DISCO-RLS Trial): A Randomized Controlled Trial [NCT03806530]Phase 352 participants (Actual)Interventional2019-05-01Completed
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 372 participants (Anticipated)Interventional2022-09-15Enrolling by invitation
Pregabalin Versus Gabapentin Efficacy in the Management of Neuropathic Pain Associated With Failed Back Surgery Syndrome [NCT05324761]Phase 460 participants (Actual)Interventional2022-04-25Completed
Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality [NCT05800847]Phase 4130 participants (Anticipated)Interventional2023-04-30Not yet recruiting
Hyperalgesia in Methadone-Maintained Patients: Can it be Treated? [NCT01210079]Phase 226 participants (Actual)Interventional2002-09-30Completed
A Prospective Randomized Controlled Open Label Trial of Symptom-triggered Benzodiazepine Versus Fixed-dose Gabapentin for Alcohol Withdrawal Syndrome [NCT03012815]Phase 488 participants (Actual)Interventional2017-02-01Completed
Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease [NCT01954927]Phase 290 participants (Actual)Interventional2013-10-07Completed
[NCT01744444]Phase 210 participants (Actual)Interventional2012-11-30Completed
Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain [NCT01776671]Phase 316 participants (Actual)Interventional2013-02-28Active, not recruiting
A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient [NCT03335436]Phase 40 participants (Actual)Interventional2018-04-01Withdrawn(stopped due to Lack of enrollment)
Pilot Study to Assess Tolerability and Preliminary Efficacy of a Titrated Dose of Gabapentin up to 600mg Administered at Bedtime for Insomnia Symptoms and Nighttime Vasomotor Symptoms (VMS) in Peri- and Postmenopausal Women With VMS. [NCT02040532]32 participants (Actual)Interventional2014-01-31Completed
The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache [NCT05328635]100 participants (Anticipated)Observational2021-09-01Recruiting
Effect of Gabapentin and Tizanidine on Insomnia in Chronic Pain Patients: A Randomized, Double-blind, Placebo-controlled Crossover Trial. [NCT04429347]Phase 224 participants (Anticipated)Interventional2020-07-29Enrolling by invitation
Effectiveness of Ropinirole and Gabapentin for the Treatment of Restless Legs Syndrom in Patients on Maintenance Hemodialysis: a Randomized, Blinded, Placebo-Controlled Trial [NCT03708237]Phase 23 participants (Actual)Interventional2019-02-19Terminated(stopped due to Recruitment suspended due to COVID-19 pandemic and will not resume.)
Comparison of Chlordiazepoxide and Gabapentin for Outpatient Alcohol Detoxification Treatment [NCT01573052]Phase 426 participants (Actual)Interventional2004-03-31Completed
The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial. [NCT05626998]Phase 4153 participants (Actual)Interventional2022-11-01Completed
A Prospective, Randomized Study Evaluating the Efficacy and Safety of Early Diuresis Following Colorectal Surgery [NCT02351934]Phase 4123 participants (Actual)Interventional2015-02-28Completed
Gabapentin Treatment of Benzodiazepine Dependence [NCT01893632]Phase 22 participants (Actual)Interventional2013-07-31Terminated(stopped due to Insufficient recruitment, funding terminated from sponsor)
Randomized, Open-Label Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer [NCT01533753]Phase 25 participants (Actual)Interventional2012-02-29Terminated(stopped due to Slow accrual)
Efficacy of Gabapentin in Prevention of Tourniquet Pain and Hypertension During Orif of Tibia Fracture Under General Anesthesia [NCT01441531]Early Phase 10 participants (Actual)Interventional2012-01-31Withdrawn(stopped due to Unable to recruit patient due to surgical case type. Not worth continuing study.)
A Phase II, Randomized, Placebo-controlled, Double Blind, Cross-over, Study of the Effects of Gabapentin on Chronic Irritability in Neurologically Impaired Children [NCT01675960]Phase 22 participants (Actual)Interventional2012-04-30Terminated(stopped due to unable to enroll)
Pain Control in Pediatric Posterior Spine Fusion Patients: The Effect of Gabapentin on Post-operative Opioid Use and Patient Satisfaction [NCT01977937]Phase 455 participants (Actual)Interventional2013-11-30Completed
The Effect of Gabapentin Pretreatment on Hyperalgesia in Elderly Patients Undergoing Staged Bilateral Cataract Operations [NCT03826615]64 participants (Actual)Interventional2019-02-01Completed
Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children [NCT04724252]Phase 2/Phase 360 participants (Anticipated)Interventional2021-08-23Recruiting
Special Investigation Of Gabapen For Pediatric (Regulatory Post Marketing Commitment Plan) [NCT01441401]82 participants (Actual)Observational2011-12-31Completed
Randomized, Double-blind, Comparative-effectiveness Study Comparing Epidural Steroid Injections to Gabapentin in Patients With Lumbosacral Radiculopathy [NCT01495923]145 participants (Actual)Interventional2011-12-31Completed
Predicting, Understanding, and Speeding Recovery After Total Knee Arthroplasty [NCT02685735]Phase 4350 participants (Actual)Interventional2016-06-02Terminated(stopped due to lack of continued funding support)
Pain Control With Total Knee Replacement: Does Gabapentin Affect Narcotic Usage and Functional Outcome? A Randomized Controlled Trial. [NCT01680549]Phase 450 participants (Actual)Interventional2012-09-30Completed
A Double Blind Evaluation of Flumazenil and Gabapentin for the Treatment of Alcohol Withdrawal and Relapse Prevention [NCT00262639]Phase 2/Phase 360 participants (Actual)Interventional2005-12-31Completed
Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study to Compare the Efficacy, Tolerability, and Safety of 3 Doses of Gabapentin Enacarbil (GSK1838262) With Placebo in Treatment of Moderate-to-Severe Primary RLS [NCT01668667]Phase 4501 participants (Actual)Interventional2012-06-30Completed
Randomized Single Oral Dose, Open-label, Two-way, Two-periods, Un-replicated Crossover, Bioequivalence Study to Compare Nerpentin600 mg Film Coated Tablet (Gabapentin 600 mg) Manufactured by EGPI (Egyptian Group for Pharmaceutical Industry) - Egypt for Am [NCT04805827]34 participants (Actual)Interventional2021-02-25Completed
Medication Development for Opioid and Alcohol Abuse: Laboratory Study in Humans [NCT03205423]Phase 217 participants (Actual)Interventional2017-08-01Completed
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients With Postherpetic Neuralgia [NCT00636636]Phase 3452 participants (Actual)Interventional2008-03-31Completed
Gabapentin Treatment of Alcohol Dependence [NCT00391716]Phase 2150 participants (Actual)Interventional2004-02-29Completed
Efficacy of Gabapentin as Adjuvant for Postoperative Pain in Pediatric Thoracic Surgery - a Randomized Quadruple Blind Study [NCT03393702]Phase 4104 participants (Actual)Interventional2017-05-09Completed
A Comparative Study Of Botulinum Toxin Type A Versus Conventional Oral Therapy As A Second Line Treatment Of Diabetic Neuropathy [NCT05296759]Phase 430 participants (Actual)Interventional2021-02-01Completed
Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy: a Prospective, Randomized Study. [NCT00954187]8 participants (Actual)Interventional2009-11-30Terminated(stopped due to PI left institution)
CSP #2016 - National Adaptive Trial for PTSD Related Insomnia [NCT03668041]Phase 31,224 participants (Anticipated)Interventional2021-02-25Recruiting
Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients. [NCT02052414]34 participants (Actual)Interventional2012-07-31Completed
Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management [NCT02605187]160 participants (Actual)Interventional2015-11-30Completed
ACL Repair and Multimodal Analgesia [NCT01868425]Phase 4112 participants (Actual)Interventional2013-04-30Completed
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 432 participants (Actual)Interventional2015-09-24Completed
A Phase 4 Randomized Double-blind Double-dummy Placebo & Active-controlled Single-dose Six-way Crossover Study Evaluating Abuse Potential of NEURONTIN® Taken Orally With Oxycodone HCL in Healthy Non-drug Dependent Recreational Opioid Users [NCT05319756]Phase 454 participants (Actual)Interventional2021-04-30Completed
Efficacy of Antidepressants in Chronic Back Pain [NCT00108550]Phase 2108 participants (Actual)Interventional2004-10-31Completed
Impact of Genetic Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use of the Drug [NCT02977208]Phase 466 participants (Actual)Interventional2016-09-30Completed
MAST Trial: Multi-modal Analgesic Strategies in Trauma [NCT03472469]Phase 41,561 participants (Actual)Interventional2018-04-02Completed
Impact of Gabapentin on Slow Wave Sleep in Adult Critically Ill Patient. [NCT04818450]60 participants (Actual)Interventional2021-04-19Completed
Evaluation of Initiation Time on the Efficacy of Gabapentin in Treating Neuropathic Pain in Spinal Cord Injury (SCI) [NCT04256603]Phase 427 participants (Actual)Interventional2019-08-01Completed
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery [NCT03202459]60 participants (Anticipated)Interventional2017-03-02Recruiting
Treatment of Pendular Nystagmus With Gabapentin and Memantine in Patients With Oculopalatal Tremor: a Controled Open-label Study [NCT02466191]Phase 47 participants (Actual)Interventional2015-06-30Completed
A Phase I, Double-Blind, PK, Safety, Tolerability Study of KSL + KLS-GABA vs KLS Alone in Healthy Males (Part A) Followed by a Study to Investigate the PD of KLS and KLS + GABA in Healthy Males (Part B) [NCT04802967]Phase 1140 participants (Actual)Interventional2021-02-08Completed
Prevention Effect of Pregabalin on Postherpetic Neuralgia: A Multicenter, Randomized, Double-blind, Controlled Trial [NCT03186443]Phase 3342 participants (Anticipated)Interventional2017-10-01Not yet recruiting
Effects of Gabapentin Enacarbil on Intensity of Cortical Arousal, Heart Rate, Blood Pressure and Anterior Tibialis EMG Responses Associated With PLMs During Sleep in Patients With RLS Using a Novel Computer Assisted Scoring System [NCT02424695]Phase 420 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Pre-Emptive Analgesia in Ano-Rectal Surgery [NCT02402543]90 participants (Actual)Interventional2014-06-30Completed
Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures [NCT02957097]Phase 40 participants (Actual)Interventional2019-09-30Withdrawn(stopped due to Original PI left institution and the PI who took over was not able to initiate the study so it was never started.)
To Examine the Effect of Horizant (Gabapentin Enacarbil) in Primary Restless Legs Syndrome (RLS) Patients Who Are on Dopaminergic Agents and Exhibiting Augmentation [NCT02642315]10 participants (Actual)Interventional2016-01-31Completed
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management [NCT02703259]Phase 4137 participants (Actual)Interventional2016-06-30Completed
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
Effect of Gabapentin on Postoperative Opioid Analgesic Use and Pain in Adolescents Undergoing Tonsillectomy [NCT05024825]Phase 417 participants (Actual)Interventional2017-08-04Terminated(stopped due to recruitment target not met.)
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation Disc: a Prospective, Multicentric, Randomized, Controlled, Double-blind Study [NCT04865042]Phase 4144 participants (Anticipated)Interventional2022-02-02Recruiting
Efficacy of Multimodal Analgesia Following Hip Arthroscopy [NCT03351439]100 participants (Actual)Interventional2018-04-06Completed
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia: A Randomized, Double-blinded, Placebo-controlled Study [NCT00588159]146 participants (Actual)Interventional2007-06-30Completed
Phase I/II Trial of Gabapentin Plus Ketamine for Prevention and Treatment of Acute and Chronic Pain in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation [NCT05156060]Phase 1/Phase 244 participants (Anticipated)Interventional2022-01-24Recruiting
Gabapentin for Abstinence Initiation in Alcohol Dependence [NCT01141049]Phase 2/Phase 340 participants (Actual)Interventional2010-08-31Completed
Novel Topical Therapies for the Treatment of Genital Pain [NCT02099006]Phase 2/Phase 39 participants (Actual)Interventional2013-11-30Completed
Effect of Preoperative Gabapentine for Carpal Tunnel Syndrome [NCT01632215]Phase 340 participants (Actual)Interventional2010-03-31Completed
Comparative Effectiveness of Multi-modal Pain Management Versus Standard Intra- and Post-operative Analgesia: Randomized Controlled Clinical Trial to Reduce Post-operative Pain and Opioid Use Among Patients Undergoing Lumbar Spine Surgery [NCT03088306]Early Phase 149 participants (Actual)Interventional2017-07-01Completed
The Effect of Gabapentin on Postoperative Pain: a Randomized, Double Blind, Placebo Controlled Trial [NCT01546857]Phase 434 participants (Actual)Interventional2012-03-31Terminated(stopped due to No longer able to recruit subjects due to unavailability of orthopedic surgeon.)
Improving Treatment Outcomes for Prescription Opioid Dependence [NCT02543944]Phase 2/Phase 3117 participants (Actual)Interventional2016-02-29Completed
Therapeutic Interventions For Peripheral Neuropathy/Neuropathic Pain Induced By Vincristine Treatment For Childhood Acute Lymphoblastic Leukemia (ALL) On Total XVI Protocol [NCT01506453]Phase 251 participants (Actual)Interventional2012-01-24Completed
Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain in Surgical Patients [NCT00221338]Phase 3750 participants (Actual)Interventional2006-01-31Completed
Gralise® for Spine Surgery Pain (GRASSP): A Partially Enriched, Placebo Controlled, Randomized, Double Blind, Cross-Over Trial of Gralise® for the Treatment of Post Laminectomy Pain Syndrome [NCT01764464]Phase 453 participants (Actual)Interventional2012-12-31Completed
Gabapentin Treatment of Postural Tachycardia Syndrome (PoTS): a Pilot Study [NCT04345432]10 participants (Actual)Interventional2014-01-31Completed
A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis [NCT01943435]259 participants (Actual)Interventional2013-11-20Completed
Investigation and Treatment of Ocular Motor Disorders: Cross-over Comparison of Gabapentin and Memantine as Treatment for Nystagmus [NCT00928954]10 participants (Actual)Interventional2005-02-28Completed
[NCT02074267]Phase 440 participants (Actual)Interventional2009-03-31Completed
Excessive Crying in Children With Cerebral Palsy and Communication Deficits -a Fixed-sequence, Crossover Clinical Trial [NCT04523935]Phase 4131 participants (Actual)Interventional2005-12-07Completed
Department of Anaesthesiology [NCT04491786]60 participants (Actual)Interventional2020-08-01Completed
Role of Combined Therapy of Propranolol and Gabapentin in Paroxysmal Sympathetic Hyperactivity in Traumatic Brain Injury at Emergency Intensive Care Unit [NCT05427474]Phase 390 participants (Anticipated)Interventional2022-12-01Recruiting
A Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN) [NCT00475904]Phase 2360 participants (Actual)Interventional2007-07-31Completed
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 4353 participants (Actual)Interventional2011-04-30Completed
Gabapentin for Smoking Abstinence [NCT00578552]Phase 280 participants (Actual)Interventional2007-10-31Completed
Risk of Cancer in Patients Exposed to Gabapentin in the GPRD [NCT01236053]2,323,608 participants (Actual)Observational2010-06-30Completed
Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy [NCT05172570]Phase 3120 participants (Anticipated)Interventional2021-04-06Recruiting
The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study [NCT03347916]75 participants (Anticipated)Interventional2017-01-05Recruiting
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial [NCT02725710]Phase 296 participants (Actual)Interventional2016-08-31Completed
A Randomized Double-blinded Study to Evaluate Preincisional Dextromethorphan in Patients Undergoing Total Knee Arthroplasty and Its Effect on Postoperative Opioid Use [NCT02987920]Phase 423 participants (Actual)Interventional2017-01-31Terminated(stopped due to The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol.)
The Effect of Gabapentin Used as a Preemptive to the Emergence and Development Chronic Neuropathic Pain in Patients After Spinal Cord Trauma [NCT03255330]Phase 30 participants (Actual)Interventional2017-10-31Withdrawn(stopped due to no participant enrolled)
Preemptive Oral Gabapentin Versus Tramadol on Postoperative Pain After Knee Arthroscopy Done Under Spinal Anesthesia: A Prospective Randomized Trial [NCT06112223]50 participants (Anticipated)Interventional2023-11-10Not yet recruiting
Randomized Placebo Control Trial of Perioperative Gabapentin to Reduce Total Analgesic Requirements in Patients Undergoing Radical Cystectomy [NCT02355886]Phase 2/Phase 325 participants (Actual)Interventional2015-04-22Completed
Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia [NCT03346668]Early Phase 110 participants (Actual)Interventional2016-01-28Completed
Multimodal Analgesia Versus Traditional Opiate Based Analgesia and Cardiac Surgery Outcome [NCT03521167]225 participants (Anticipated)Interventional2018-05-01Not yet recruiting
Multimodal Analgesia Effect on Post Surgical Patient [NCT04240626]Phase 460 participants (Anticipated)Interventional2021-01-20Recruiting
A Randomized Phase III Trial of Gabapentin Versus Standard of Care for Prevention and Treatment of Mucositis in Locally Advanced Head and Neck Cancer Patients Undergoing Primary or Adjuvant Chemoradiation [NCT02480114]Phase 379 participants (Actual)Interventional2015-07-31Completed
Efficacy of Gralise® for Chronic Pelvic Pain [NCT01678911]Phase 411 participants (Actual)Interventional2012-08-31Terminated(stopped due to Study ended due to difficulties in recruitment and low enrollment.)
Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of HORIZANT (Gabapentin Enacarbil) Extended-Release Tablets for the Treatment of Alcohol Use Disorder [NCT02252536]Phase 2346 participants (Actual)Interventional2015-06-30Completed
Pain Management in Head and Neck Surgery Patients [NCT03121963]Phase 40 participants (Actual)Interventional2017-11-10Withdrawn(stopped due to This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.)
Blinded, Randomized Study of Gabapentin (Neurontin®) and Gabapentin Enacarbil (Horizant™) in Restless Leg Syndrome [NCT02117076]Phase 45 participants (Actual)Interventional2014-04-30Terminated(stopped due to Recruitment unsuccessful due to overly restrictive inclusion/exclusion criteria.)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, CROSS-OVER, PLACEBO-CONTROLLED, SINGLE DOSE, CLINICAL TRIAL TO ASSESS THE NEXT-DAY RESIDUAL EFFECTS OF GABAPENTIN, DIPHENHYDRAMINE AND TRIAZOLAM ON SIMULATED DRIVING PERFORMANCE IN NORMAL VOLUNTEERS [NCT01888497]Phase 359 participants (Actual)Interventional2013-07-29Completed
Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise) [NCT01623271]5 participants (Actual)Interventional2013-05-31Terminated(stopped due to Due to limited population of research participants.)
Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies [NCT05965492]Phase 3100 participants (Anticipated)Interventional2024-02-01Not yet recruiting
Persistent Postoperative Pain Incidence With Long Term Perioperative Gabapentin Used [NCT02693821]Phase 4122 participants (Actual)Interventional2015-12-31Completed
Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy: A Randomized Controlled Trial [NCT04939987]Phase 2/Phase 30 participants (Actual)Interventional2022-08-31Withdrawn(stopped due to PI left institution and study was not transferred to new PI)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00108550 (2) [back to overview]Roland and Morris Disability Index Scores Adjusted for Time
NCT00108550 (2) [back to overview]Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time
NCT00159588 (2) [back to overview]Headache Index
NCT00159588 (2) [back to overview]Headache Days
NCT00183196 (1) [back to overview]Time to Relapse to Drinking
NCT00221338 (6) [back to overview]Median Postoperative Opioid Doses Across Study Follow up Period
NCT00221338 (6) [back to overview]Postoperative Pain Score - Postoperative Day 2
NCT00221338 (6) [back to overview]Incidence of Postoperative Delirium by Study Group
NCT00221338 (6) [back to overview]Postoperative Pain Score - Postoperative Day 1
NCT00221338 (6) [back to overview]Hospital Length of Stay
NCT00221338 (6) [back to overview]Postoperative Pain Score - Postoperative Day 3
NCT00262639 (2) [back to overview]Percent Subjects Completely Abstinent
NCT00262639 (2) [back to overview]Percent Days Abstinent
NCT00311363 (31) [back to overview]Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)
NCT00311363 (31) [back to overview]Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period
NCT00311363 (31) [back to overview]Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score
NCT00311363 (31) [back to overview]Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)
NCT00311363 (31) [back to overview]Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)
NCT00311363 (31) [back to overview]Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF
NCT00311363 (31) [back to overview]Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF
NCT00333359 (12) [back to overview]Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52
NCT00333359 (12) [back to overview]Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC
NCT00333359 (12) [back to overview]Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC
NCT00333359 (12) [back to overview]Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC
NCT00333359 (12) [back to overview]Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC
NCT00333359 (12) [back to overview]Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data
NCT00333359 (12) [back to overview]Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52
NCT00333359 (12) [back to overview]Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)
NCT00333359 (12) [back to overview]Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC
NCT00333359 (12) [back to overview]Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked
NCT00333359 (12) [back to overview]Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores
NCT00333359 (12) [back to overview]Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity
NCT00365352 (27) [back to overview]Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)
NCT00365352 (27) [back to overview]Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF
NCT00365352 (27) [back to overview]Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)
NCT00365352 (27) [back to overview]Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF
NCT00365352 (27) [back to overview]Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF
NCT00365352 (27) [back to overview]Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)
NCT00365352 (27) [back to overview]The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I
NCT00365352 (27) [back to overview]Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment
NCT00365352 (27) [back to overview]Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF
NCT00365352 (27) [back to overview]Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF
NCT00365352 (27) [back to overview]Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF
NCT00365352 (27) [back to overview]Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)
NCT00365352 (27) [back to overview]"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Total Bilirubin
NCT00385671 (48) [back to overview]Number of Participants With Treatment-Emergent Changes in Body Weight
NCT00385671 (48) [back to overview]Number of Participants With Treatment-emergent Elevated Blood Pressure
NCT00385671 (48) [back to overview]Number of Patients With Treatment-Emergent Elevated Laboratory Analytes
NCT00385671 (48) [back to overview]Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms
NCT00385671 (48) [back to overview]Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation
NCT00385671 (48) [back to overview]Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)
NCT00385671 (48) [back to overview]Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Body Weight
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Heart Rate
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score
NCT00385671 (48) [back to overview]Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score
NCT00385671 (48) [back to overview]Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks
NCT00385671 (48) [back to overview]Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks
NCT00385671 (48) [back to overview]Number of Participants With Treatment-Emergent Elevated Heart Rate
NCT00385671 (48) [back to overview]Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score
NCT00385671 (48) [back to overview]Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks
NCT00385671 (48) [back to overview]Summary of Number of Participants Who Discontinued
NCT00385671 (48) [back to overview]Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score
NCT00385671 (48) [back to overview]Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores
NCT00385671 (48) [back to overview]Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores
NCT00385671 (48) [back to overview]Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Blood Pressure
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain
NCT00385671 (48) [back to overview]Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose
NCT00385671 (48) [back to overview]Mean Change From Baseline to 12 Weeks in Hemoglobin A1C
NCT00390013 (1) [back to overview]Change From Baseline in Vulvar Pain
NCT00391716 (4) [back to overview]Sleep
NCT00391716 (4) [back to overview]Mood
NCT00391716 (4) [back to overview]Drinking
NCT00391716 (4) [back to overview]Craving
NCT00395044 (7) [back to overview]Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4
NCT00395044 (7) [back to overview]Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12
NCT00395044 (7) [back to overview]Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12
NCT00395044 (7) [back to overview]Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12
NCT00395044 (7) [back to overview]Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12
NCT00395044 (7) [back to overview]Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12
NCT00395044 (7) [back to overview]Change From Week 0 in Cannabis-related Problems on the Marijuana Problem Scale (MPS) at Week 12
NCT00414466 (3) [back to overview]Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
NCT00414466 (3) [back to overview]Number of Participants With Treatment-emergent Adverse Events
NCT00414466 (3) [back to overview]Responder Analysis Between Active Treatment and Placebo Groups.
NCT00420771 (1) [back to overview]Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back
NCT00475904 (2) [back to overview]Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
NCT00475904 (2) [back to overview]Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.
NCT00537940 (9) [back to overview]Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.
NCT00537940 (9) [back to overview]Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.
NCT00537940 (9) [back to overview]Medical Outcomes Study Sleep Scale (MOS-SS) Score.
NCT00537940 (9) [back to overview]Hospital Anxiety and Depression Scale (HADS) Score.
NCT00537940 (9) [back to overview]Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.
NCT00537940 (9) [back to overview]Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.
NCT00537940 (9) [back to overview]Percent Change From Baseline in 28-day Seizure Frequency at Week 21.
NCT00537940 (9) [back to overview]Percentage of Participants Without Seizures.
NCT00537940 (9) [back to overview]Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)
NCT00567268 (15) [back to overview]Clinical Efficacy Rate
NCT00567268 (15) [back to overview]Response Ratio (R Ratio)
NCT00567268 (15) [back to overview]Responder Rate
NCT00567268 (15) [back to overview]Percent Reduction From Baseline in Epileptic Seizure Frequency
NCT00567268 (15) [back to overview]Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
NCT00567268 (15) [back to overview]Number of Participants With Treatment-Related Adverse Events by Number of Concomitant Antiepileptic Drugs at Baseline
NCT00567268 (15) [back to overview]Number of Participants With Treatment-Related Adverse Events by Age Across 7 Categories
NCT00567268 (15) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
NCT00567268 (15) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
NCT00578552 (1) [back to overview]Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco
NCT00588159 (6) [back to overview]Average Pain Score With Coughing on Second Morning After Surgery
NCT00588159 (6) [back to overview]Average Pain Score With Coughing the First Morning Following Surgery
NCT00588159 (6) [back to overview]Opioid Consumption in First 24 Hours Postoperatively
NCT00588159 (6) [back to overview]Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively
NCT00588159 (6) [back to overview]Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively
NCT00588159 (6) [back to overview]Average Pain Score at Rest
NCT00603473 (3) [back to overview]Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures
NCT00603473 (3) [back to overview]Percent Change in Seizure Frequency (PCH)
NCT00603473 (3) [back to overview]Responder Rate
NCT00617461 (18) [back to overview]Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations
NCT00617461 (18) [back to overview]Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF
NCT00617461 (18) [back to overview]Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period
NCT00617461 (18) [back to overview]Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF
NCT00617461 (18) [back to overview]Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF
NCT00617461 (18) [back to overview]Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data
NCT00617461 (18) [back to overview]Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score
NCT00619476 (19) [back to overview]Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data
NCT00619476 (19) [back to overview]Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data
NCT00619983 (1) [back to overview]Visual Analog Scale for Pain
NCT00620555 (4) [back to overview]Response Ratio
NCT00620555 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)
NCT00620555 (4) [back to overview]Percent Change in Seizure Frequency
NCT00620555 (4) [back to overview]Responder Rate
NCT00634543 (6) [back to overview]Percentage of Participants With Pain Relief
NCT00634543 (6) [back to overview]Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43
NCT00634543 (6) [back to overview]Change From Baseline in Pain Intensity Score at Day 43
NCT00634543 (6) [back to overview]Overall Assessment of Study Medication by Participants
NCT00634543 (6) [back to overview]Overall Assessment of Study Medication by Investigator
NCT00634543 (6) [back to overview]Change From Baseline in Short Form-36 (SF-36) Score at Day 43
NCT00636636 (5) [back to overview]Clinical Global Impression of Change (CGIC)
NCT00636636 (5) [back to overview]Average Daily Sleep Interference Score
NCT00636636 (5) [back to overview]Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score
NCT00636636 (5) [back to overview]Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score
NCT00636636 (5) [back to overview]Patient Global Impression of Change (PGIC)
NCT00643760 (19) [back to overview]Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT
NCT00643760 (19) [back to overview]Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data
NCT00643760 (19) [back to overview]Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score
NCT00654953 (1) [back to overview]Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites
NCT00711529 (9) [back to overview]Hot Flash Related Daily Interference Score (HFRDIS)
NCT00711529 (9) [back to overview]Number of Daily Hot Flashes
NCT00711529 (9) [back to overview]Hot Flash Related Daily Interference Score (HFRDIS)
NCT00711529 (9) [back to overview]Hot Flash Severity Score
NCT00711529 (9) [back to overview]Hot Flash Severity Score
NCT00711529 (9) [back to overview]Number of Daily Hot Flashes
NCT00711529 (9) [back to overview]Hot Flash Related Daily Interference Score (HFRDIS)
NCT00711529 (9) [back to overview]Hot Flash Severity Score
NCT00711529 (9) [back to overview]Number of Daily Hot Flashes
NCT00726999 (4) [back to overview]Number of Ondansetron Doses Administered for Nausea
NCT00726999 (4) [back to overview]Amount of Morphine Consumed (mg/kg/hr)
NCT00726999 (4) [back to overview]Amount of Morphine Consumed (mg/kg/hr)
NCT00726999 (4) [back to overview]Amount of Morphine Consumed (mg/kg/hr)
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF
NCT00748098 (28) [back to overview]Number of PLMAI Responders at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]"Number of Participants Who Self-reported Very Satisfied or Satisfied With the Investigational Product at Week 4/10 Using LOCF"
NCT00748098 (28) [back to overview]Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF
NCT00748098 (28) [back to overview]Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10
NCT00748098 (28) [back to overview]"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"
NCT00748098 (28) [back to overview]Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.
NCT00755417 (4) [back to overview]Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
NCT00755417 (4) [back to overview]Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
NCT00755417 (4) [back to overview]Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
NCT00755417 (4) [back to overview]Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo
NCT00777023 (4) [back to overview]Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
NCT00777023 (4) [back to overview]Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
NCT00777023 (4) [back to overview]Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment
NCT00777023 (4) [back to overview]Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment
NCT00785772 (3) [back to overview]Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration
NCT00785772 (3) [back to overview]Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model
NCT00785772 (3) [back to overview]Observed Plasma Gabapentin Concentration
NCT00793910 (5) [back to overview]Level of Pain
NCT00793910 (5) [back to overview]Occurence of Use of Rescue Medication
NCT00793910 (5) [back to overview]Level of Pain
NCT00793910 (5) [back to overview]Level of Pain
NCT00793910 (5) [back to overview]Level of Pain
NCT00855738 (17) [back to overview]Time to First Seizure
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)
NCT00855738 (17) [back to overview]Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment
NCT00855738 (17) [back to overview]Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)
NCT00855738 (17) [back to overview]Percent of Participants Who Continued on Study Medication to Month 6
NCT00855738 (17) [back to overview]Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)
NCT00855738 (17) [back to overview]Percent of Participants Classified as Responders
NCT00855738 (17) [back to overview]Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)
NCT00855738 (17) [back to overview]Percent of Participants Reaching Monotherapy
NCT00855738 (17) [back to overview]Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation
NCT00855738 (17) [back to overview]Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy
NCT00855738 (17) [back to overview]Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)
NCT00855738 (17) [back to overview]Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit
NCT00855738 (17) [back to overview]Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy
NCT00855738 (17) [back to overview]Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy
NCT00880191 (7) [back to overview]Comparison of Percentage of Complete Responders
NCT00880191 (7) [back to overview]Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.
NCT00880191 (7) [back to overview]Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses
NCT00880191 (7) [back to overview]Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents
NCT00880191 (7) [back to overview]Level of Satisfaction for the Control of Nausea.
NCT00880191 (7) [back to overview]Comparison of Daily Complete Response Endpoints
NCT00880191 (7) [back to overview]Complete Response
NCT00886236 (3) [back to overview]Evaluate the Amount of Diluadid Given Postoperatively
NCT00886236 (3) [back to overview]Number of Participants Who Experience Incidence of Postoperative Nausea.
NCT00886236 (3) [back to overview]Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data
NCT00928954 (2) [back to overview]Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing
NCT00928954 (2) [back to overview]Percent Change in Median Eye Speed
NCT00974376 (1) [back to overview]Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period
NCT01014533 (3) [back to overview]Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication
NCT01014533 (3) [back to overview]Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)
NCT01014533 (3) [back to overview]Relapse to Any Drinking
NCT01052844 (2) [back to overview]Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1
NCT01052844 (2) [back to overview]Number of Patients With Complete Response During Chemotherapy Course 1
NCT01067144 (6) [back to overview]Count of Participants With Continued Pain at 6 Months
NCT01067144 (6) [back to overview]Time to Pain Resolution
NCT01067144 (6) [back to overview]Time to Opioid Cessation
NCT01067144 (6) [back to overview]Count of Participants With Continued Pain at 1 Year
NCT01067144 (6) [back to overview]Count of Participants With Continued Opioid Use at 6 Months
NCT01067144 (6) [back to overview]Count of Participants With Continued Opioid Use at 1 Year
NCT01080300 (12) [back to overview]Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period.
NCT01080300 (12) [back to overview]G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
NCT01080300 (12) [back to overview]G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
NCT01080300 (12) [back to overview]G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.
NCT01080300 (12) [back to overview]Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
NCT01080300 (12) [back to overview]Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period.
NCT01080300 (12) [back to overview]Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes
NCT01080300 (12) [back to overview]Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes
NCT01080300 (12) [back to overview]Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).
NCT01080300 (12) [back to overview]G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.
NCT01080300 (12) [back to overview]Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.
NCT01080300 (12) [back to overview]Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.
NCT01119222 (2) [back to overview]Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)
NCT01119222 (2) [back to overview]Interpolated Average Pain (0-8 Hours)
NCT01138124 (8) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01138124 (8) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01138124 (8) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01138124 (8) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01138124 (8) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01138124 (8) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01138124 (8) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01138124 (8) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01141049 (2) [back to overview]Percent Days of Abstinence From Alcohol
NCT01141049 (2) [back to overview]Percent of Heavy Drinking Days Per Week
NCT01143766 (5) [back to overview]Median Anxiety Score at Time of Discharge
NCT01143766 (5) [back to overview]Median Nausea Score at Time of Discharge
NCT01143766 (5) [back to overview]Number of Participants With Sedation-Related Adverse Events
NCT01143766 (5) [back to overview]Dosing Requirements
NCT01143766 (5) [back to overview]Median Pain Score at Time of Discharge
NCT01210079 (1) [back to overview]Change in Pain Threshold Time From Baseline to Week 5
NCT01236053 (55) [back to overview]Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions
NCT01236053 (55) [back to overview]Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin
NCT01236053 (55) [back to overview]Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin
NCT01236053 (55) [back to overview]Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin
NCT01263132 (5) [back to overview]Mean Neuropathic Pain Score at Visit 5 (Week 3)
NCT01263132 (5) [back to overview]Mean Neuropathic Pain Score at Visit 6 (Week 4)
NCT01263132 (5) [back to overview]Mean Neuropathic Pain Score at Visit 3 (Week 1)
NCT01263132 (5) [back to overview]Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire
NCT01263132 (5) [back to overview]Mean Neuropathic Pain Score at Visit 4 (Week 2)
NCT01265056 (3) [back to overview]Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)
NCT01265056 (3) [back to overview]Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups
NCT01265056 (3) [back to overview]Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)
NCT01301001 (3) [back to overview]Vulvodynia Pain
NCT01301001 (3) [back to overview]Tampon Test Pain Intensity
NCT01301001 (3) [back to overview]Coital Pain
NCT01332318 (28) [back to overview]Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score
NCT01332318 (28) [back to overview]Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14
NCT01332318 (28) [back to overview]Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14
NCT01332318 (28) [back to overview]Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item
NCT01332318 (28) [back to overview]Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score
NCT01332318 (28) [back to overview]Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality
NCT01332318 (28) [back to overview]Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items
NCT01332318 (28) [back to overview]Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14
NCT01332318 (28) [back to overview]Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)
NCT01332318 (28) [back to overview]Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score
NCT01332318 (28) [back to overview]Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score
NCT01332318 (28) [back to overview]Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14
NCT01332318 (28) [back to overview]Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14
NCT01364298 (9) [back to overview]Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)
NCT01364298 (9) [back to overview]Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale
NCT01364298 (9) [back to overview]Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration
NCT01364298 (9) [back to overview]Profile of Mood States (POMS) Score
NCT01364298 (9) [back to overview]Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84
NCT01364298 (9) [back to overview]Number of Participants With Adverse Events (AEs)
NCT01364298 (9) [back to overview]Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84
NCT01364298 (9) [back to overview]Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale
NCT01364298 (9) [back to overview]Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84
NCT01441401 (12) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure
NCT01441401 (12) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline
NCT01441401 (12) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period
NCT01441401 (12) [back to overview]Number of Participants With Key Treatment-Related Adverse Events (Aggressive Behaviors)
NCT01441401 (12) [back to overview]Number of Participants With Key Treatment-Related Adverse Events (Central Nervous System Depressant Actions)
NCT01441401 (12) [back to overview]Number of Participants With Treatment-Related Adverse Events
NCT01441401 (12) [back to overview]Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
NCT01441401 (12) [back to overview]Clinical Efficacy Rate
NCT01441401 (12) [back to overview]Reduction From Baseline in Epileptic Seizure Frequency
NCT01441401 (12) [back to overview]Responder Rate
NCT01441401 (12) [back to overview]Response Ratio (R Ratio)
NCT01441401 (12) [back to overview]Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure
NCT01495923 (11) [back to overview]Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Proceeded to Surgery Within Year of Enrollment
NCT01495923 (11) [back to overview]Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
NCT01495923 (11) [back to overview]Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
NCT01495923 (11) [back to overview]Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
NCT01495923 (11) [back to overview]Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
NCT01506453 (6) [back to overview]Daily Total Dose of Oral Morphine (mg/kg/Day).
NCT01506453 (6) [back to overview]Pain Score During the Previous 24 Hours
NCT01506453 (6) [back to overview]Pain Score During the Previous 24 Hours
NCT01506453 (6) [back to overview]Pain Scores Right Now
NCT01506453 (6) [back to overview]Pain Scores Right Now
NCT01506453 (6) [back to overview]Daily Total Dose of Oral Morphine (mg/kg/Day).
NCT01546857 (3) [back to overview]Opioid Consumption
NCT01546857 (3) [back to overview]Visual Analogue Scale for Pain
NCT01546857 (3) [back to overview]Quality of Sleep.
NCT01573052 (3) [back to overview]Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)
NCT01573052 (3) [back to overview]Epworth Sleepiness Scale (ESS)
NCT01573052 (3) [back to overview]PENN Alcohol Craving Scale
NCT01623271 (1) [back to overview]Visual Analog Scale (VAS) at Visit 3
NCT01632215 (2) [back to overview]Chronic Pain
NCT01632215 (2) [back to overview]Pain Intensity
NCT01668667 (4) [back to overview]The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment
NCT01668667 (4) [back to overview]"The Proportion of Subjects at the End of Treatment Who Are Responders With Either Much Improved or Very Much Improved on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)"
NCT01668667 (4) [back to overview]The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score
NCT01668667 (4) [back to overview]The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment
NCT01678911 (5) [back to overview]Center for Epidemiologic Studies Depression Scale
NCT01678911 (5) [back to overview]Pain Disability Index
NCT01678911 (5) [back to overview]Pain Anxiety Symptoms Scale
NCT01678911 (5) [back to overview]McGill Pain Questionnaire - Short Form
NCT01678911 (5) [back to overview]Patient Global Impression of Change
NCT01680549 (4) [back to overview]Patient Restfulness
NCT01680549 (4) [back to overview]Knee Range of Motion
NCT01680549 (4) [back to overview]Narcotics Consumption
NCT01680549 (4) [back to overview]Patient Pain Scores
NCT01707420 (3) [back to overview]Self-report Pain Score at Rest
NCT01707420 (3) [back to overview]Total Oral Analgesia Consumption
NCT01707420 (3) [back to overview]Self-report Pain Score When Swallowing
NCT01764464 (6) [back to overview]Mean Change in Patient Global Assessment (PGA)
NCT01764464 (6) [back to overview]Insomnia Severity Index (ISI)
NCT01764464 (6) [back to overview]Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)
NCT01764464 (6) [back to overview]Mean McGill Pain Questionnaire-2 (MPQ-2)
NCT01764464 (6) [back to overview]Mean Change in Numeric Rating Scale (NRS)
NCT01764464 (6) [back to overview]Mean Change in Visual Analog Scale (VAS)
NCT01868425 (12) [back to overview]Incidence of Post-Operative Pruritus
NCT01868425 (12) [back to overview]Intraoperative Medication Use: Ketorolac and Lidocaine
NCT01868425 (12) [back to overview]Number of Participants Who Received Medication for Nausea
NCT01868425 (12) [back to overview]Post-Operative Incidence of Nausea
NCT01868425 (12) [back to overview]Post-Operative Nausea Scores
NCT01868425 (12) [back to overview]Post-Operative Pruritis Score
NCT01868425 (12) [back to overview]Sedation Scale
NCT01868425 (12) [back to overview]Time to Discharge
NCT01868425 (12) [back to overview]Pain Scores During Recovery
NCT01868425 (12) [back to overview]Intraoperative Medication Use: Fentanyl
NCT01868425 (12) [back to overview]Number of Participants With Complications From the Procedure
NCT01868425 (12) [back to overview]Opioid Consumption in the Immediate Postoperative Period
NCT01888497 (3) [back to overview]Speed Deviation
NCT01888497 (3) [back to overview]Lane Exceedance
NCT01888497 (3) [back to overview]Standard Deviation of Lateral Position (SDLP)
NCT01893632 (1) [back to overview]Abstinence From Benzodiazepine Use
NCT01943435 (3) [back to overview]Sense Wear Armband
NCT01943435 (3) [back to overview]Self Paced Walking Test (SPWT)
NCT01943435 (3) [back to overview]Swiss Spinal Stenosis (SSS) Questionnaire Score
NCT01954927 (7) [back to overview]Absolute Change in Pain From Study Drug to 3 Hours Post Administration of Study Drug
NCT01954927 (7) [back to overview]Absolute Change in Pain, Study Drug to Hospital Discharge Decision
NCT01954927 (7) [back to overview]Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo
NCT01954927 (7) [back to overview]Morphine Equivalent Doses Administered From Presentation to the Point of Decision for Either Admission or Discharge to Home
NCT01954927 (7) [back to overview]Hospital Admission
NCT01954927 (7) [back to overview]Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug
NCT01954927 (7) [back to overview]Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home
NCT01977937 (2) [back to overview]Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients.
NCT01977937 (2) [back to overview]Opiate Usage in the Gabapentin Group Versus Control.
NCT02040532 (6) [back to overview]Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime
NCT02040532 (6) [back to overview]Quality of Life-Menopause Specific
NCT02040532 (6) [back to overview]Quality of Life-Overall
NCT02040532 (6) [back to overview]Severity of Insomnia
NCT02040532 (6) [back to overview]Sleep Quality and Disturbances Over Past Month
NCT02040532 (6) [back to overview]Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime
NCT02052414 (5) [back to overview]Numeric Pain Rating System (NPRS)
NCT02052414 (5) [back to overview]Patient Global Impression of Change (PGIC)
NCT02052414 (5) [back to overview]Self Reported Side Effects.
NCT02052414 (5) [back to overview]Fibromyalgia Impact Questionnaire (FIQ)
NCT02052414 (5) [back to overview]Medical Outcome Study (MOS) Sleep Questionnaires
NCT02099006 (2) [back to overview]Reduction in Tampon Test Pain
NCT02099006 (2) [back to overview]Reduction in Daily Genital Pain.
NCT02155257 (3) [back to overview]Pain Intensity Rating
NCT02155257 (3) [back to overview]Resting Pupil Diameter
NCT02155257 (3) [back to overview]Cognitive Style
NCT02163434 (6) [back to overview]Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7
NCT02163434 (6) [back to overview]Desire to Continue Therapy at Study Endpoint
NCT02163434 (6) [back to overview]Global Satisfaction of Treatment at the Study Endpoint.
NCT02163434 (6) [back to overview]Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.
NCT02163434 (6) [back to overview]Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7
NCT02163434 (6) [back to overview]Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.
NCT02252536 (14) [back to overview]Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)
NCT02252536 (14) [back to overview]Alcohol Related Consequences (ImBIBe) Score
NCT02252536 (14) [back to overview]Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)]
NCT02252536 (14) [back to overview]Weekly Mean Number of Drinks Per Week
NCT02252536 (14) [back to overview]Weekly Mean Drinks Per Drinking Day
NCT02252536 (14) [back to overview]Pittsburgh Sleep Quality Index (PSQI) Score
NCT02252536 (14) [back to overview]Percentage of Subjects With no Heavy Drinking Days (PSNHDD)
NCT02252536 (14) [back to overview]Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels
NCT02252536 (14) [back to overview]Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level
NCT02252536 (14) [back to overview]Percentage of Heavy Drinking Days Per Week
NCT02252536 (14) [back to overview]Percentage of Days Abstinent Per Week
NCT02252536 (14) [back to overview]Cigarettes Per Week Among Smokers
NCT02252536 (14) [back to overview]Beck Depression Inventory - II
NCT02252536 (14) [back to overview]Beck Anxiety Inventory (BAI) Score
NCT02330094 (3) [back to overview]Average Numeric Pain Score
NCT02330094 (3) [back to overview]Pain Control Satisfaction Questionnaire
NCT02330094 (3) [back to overview]Average Narcotic Consumption
NCT02349477 (3) [back to overview]Percent of Subjects With no Heavy Drinking Days (PSNHDD)
NCT02349477 (3) [back to overview]Number of Participants With No Drinking Days by AWS Score and Medication
NCT02349477 (3) [back to overview]Percent of Subjects With no Drinking Days (PSNDD)
NCT02351934 (6) [back to overview]Number of Participants Readmitted to Mayo Clinic Within 30-days
NCT02351934 (6) [back to overview]Time to Stool Output
NCT02351934 (6) [back to overview]Number of Participants With Acute Kidney Injury
NCT02351934 (6) [back to overview]Number of Participants With Hypokalemia
NCT02351934 (6) [back to overview]Length of Hospital Stay
NCT02351934 (6) [back to overview]Number of Participants Requiring Nasogastric Tube Placement
NCT02355886 (3) [back to overview]Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)
NCT02355886 (3) [back to overview]Patient Self-assessed Pain on Numerical Pain Scale
NCT02355886 (3) [back to overview]Length of Stay Following Radical Cystectomy
NCT02359110 (3) [back to overview]VAS (Visual Analog Scale)
NCT02359110 (3) [back to overview]NRS (Numerical Rating Scale)
NCT02359110 (3) [back to overview]Total Morphine Consumption
NCT02480114 (3) [back to overview]Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)
NCT02480114 (3) [back to overview]Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)
NCT02480114 (3) [back to overview]Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))
NCT02543944 (4) [back to overview]Detox Phase Completers
NCT02543944 (4) [back to overview]NTX Transition Initiation
NCT02543944 (4) [back to overview]Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time
NCT02543944 (4) [back to overview]Vivitrol Injection Receivers
NCT02557945 (3) [back to overview]Change in Positive, Negative, Disorganization, and General Symptoms Over Time as Measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS)/the Scale of Psychosis-Risk Symptoms (SOPS)
NCT02557945 (3) [back to overview]Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)
NCT02557945 (3) [back to overview]Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
NCT02605187 (12) [back to overview]Patient Overall Satisfaction With Postoperative Analgesia
NCT02605187 (12) [back to overview]Count of Participants Who Need Opioid Use
NCT02605187 (12) [back to overview]Count of Participants With Presence of Pruritus
NCT02605187 (12) [back to overview]Pruritus Score at 24 and 48 After Delivery
NCT02605187 (12) [back to overview]Pain Scores
NCT02605187 (12) [back to overview]Opioid Consumption in the 0-48 Hour Study Periods.
NCT02605187 (12) [back to overview]Counts of Participants Who Need Medical Treatment for Nausea
NCT02605187 (12) [back to overview]Counts of Participants With Presence of Nausea
NCT02605187 (12) [back to overview]Time to Discharge
NCT02605187 (12) [back to overview]Average Number of Vomiting Episodes After Delivery
NCT02605187 (12) [back to overview]Count of Participants Who Need Medical Treatment of Pruritus
NCT02605187 (12) [back to overview]Nausea Score Score at 24 and 48 After Delivery
NCT02642315 (2) [back to overview]Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication)
NCT02642315 (2) [back to overview]Change in Augmentation Severity From Day 0 to Day 90
NCT02685735 (6) [back to overview]Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo-- Slope
NCT02685735 (6) [back to overview]Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept
NCT02685735 (6) [back to overview]Effect Pupil Diameter, Catastrophizing-optimism Construct, and Gabapentin on Model Fit of the Trajectory of Change in Worst Daily Pain After Surgery
NCT02685735 (6) [back to overview]Tampa Scale of Kinesiophobia
NCT02685735 (6) [back to overview]Wisconsin Card Sort Task
NCT02685735 (6) [back to overview]Iowa Gambling Task
NCT02703259 (6) [back to overview]Subjective Pain at 2 Weeks Postop
NCT02703259 (6) [back to overview]Subjective Pain at 24 Hours Postoperative
NCT02703259 (6) [back to overview]Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively
NCT02703259 (6) [back to overview]Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively
NCT02703259 (6) [back to overview]Narcotic Use at 24 Hours Postop
NCT02703259 (6) [back to overview]Narcotic Use at 2 Weeks Postop
NCT02725710 (7) [back to overview]Perioperative Nausea as Measured by 100-mm VAS
NCT02725710 (7) [back to overview]Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
NCT02725710 (7) [back to overview]Number of Subjects Using Pain Medications
NCT02725710 (7) [back to overview]Perioperative Anxiety as Measured by the 100-mm VAS
NCT02725710 (7) [back to overview]Pain Score on the 100-mm VAS
NCT02725710 (7) [back to overview]Number of Subjects Experiencing Perioperative Vomiting
NCT02725710 (7) [back to overview]Number of Subjects Experiencing Side Effects
NCT02737826 (13) [back to overview]Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline
NCT02737826 (13) [back to overview]Mean Score of Subjective Opioid Withdrawal Scale (SOWS)
NCT02737826 (13) [back to overview]Mean Score Pittsburgh Sleep Quality Index
NCT02737826 (13) [back to overview]Mean Score of Current Opioid Measure (COMM)
NCT02737826 (13) [back to overview]Pain Self-report: Pain Catastrophizing Scale - Baseline
NCT02737826 (13) [back to overview]Number of Participants Who Achieve Opioid Cessation
NCT02737826 (13) [back to overview]Percentage of Patients Who Tolerate Buprenorphine Initiation
NCT02737826 (13) [back to overview]Pain Laboratory Testing: Mechanical - Baseline
NCT02737826 (13) [back to overview]Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month
NCT02737826 (13) [back to overview]Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months
NCT02737826 (13) [back to overview]Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months
NCT02737826 (13) [back to overview]Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months
NCT02737826 (13) [back to overview]Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH
NCT02926573 (4) [back to overview]Mean Pain With Coughing Score as Measured by VAS
NCT02926573 (4) [back to overview]Change in Daily Narcotic Consumption
NCT02926573 (4) [back to overview]Mean Pain With Swallowing Score as Measured by VAS
NCT02926573 (4) [back to overview]Mean Pain With Resting Score as Measured by VAS
NCT02944656 (10) [back to overview]Nausea or Vomiting at Postoperation Follow-up Assessment
NCT02944656 (10) [back to overview]Moderate Pain at Postoperation Follow-up Assessment
NCT02944656 (10) [back to overview]Number of Participants Using Pain Medication
NCT02944656 (10) [back to overview]Severe Pain at Postoperation Follow-up Assessment
NCT02944656 (10) [back to overview]Anxiety Levels
NCT02944656 (10) [back to overview]Pain at Time of Uterine Evacuation
NCT02944656 (10) [back to overview]Perioperative Nausea
NCT02944656 (10) [back to overview]Perioperative Pain Level
NCT02944656 (10) [back to overview]Perioperative Vomiting
NCT02944656 (10) [back to overview]Side Effects
NCT03012815 (8) [back to overview]Number of Participants With Delirium Tremens (DT)
NCT03012815 (8) [back to overview]Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale
NCT03012815 (8) [back to overview]Mean Total Benzodiazepine Use
NCT03012815 (8) [back to overview]Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale
NCT03012815 (8) [back to overview]Change in Sleepiness as Assessed by the Epworth Sleepiness Scale
NCT03012815 (8) [back to overview]Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale
NCT03012815 (8) [back to overview]Mean Length of Hospital Stay
NCT03012815 (8) [back to overview]Number of Participants Experiencing Seizure
NCT03053427 (9) [back to overview]Number of Participants With Adverse Events
NCT03053427 (9) [back to overview]Change From Baseline in IRLS Score at Each Time Point
NCT03053427 (9) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)
NCT03053427 (9) [back to overview]Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response
NCT03053427 (9) [back to overview]Change From Baseline in Restless Legs Syndrome (RLS) Pain Score
NCT03053427 (9) [back to overview]Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12
NCT03053427 (9) [back to overview]Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)
NCT03053427 (9) [back to overview]Change From Baseline in Athens Insomnia Scale
NCT03053427 (9) [back to overview]Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion
NCT03080493 (6) [back to overview]Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion
NCT03080493 (6) [back to overview]Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)
NCT03084536 (5) [back to overview]Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03084536 (5) [back to overview]Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
NCT03084536 (5) [back to overview]Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03084536 (5) [back to overview]Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
NCT03084536 (5) [back to overview]Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
NCT03123861 (4) [back to overview]Daily Narcotic Use
NCT03123861 (4) [back to overview]Gluteal Pain During Normal Activities
NCT03123861 (4) [back to overview]Pain During Normal Activities (Surgical Pain Scale Item 2)
NCT03123861 (4) [back to overview]Worst Pain (Surgical Pain Scale Item 4)
NCT03151746 (3) [back to overview]24 Hour Pain Burden
NCT03151746 (3) [back to overview]48 Hours Morphine Equivalents Consumed.
NCT03151746 (3) [back to overview]QOR 40 Questionnaire Scores
NCT03179345 (12) [back to overview]Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)
NCT03179345 (12) [back to overview]Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT).
NCT03179345 (12) [back to overview]"Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin®"
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS).
NCT03179345 (12) [back to overview]Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).
NCT03179345 (12) [back to overview]"Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica®"
NCT03179345 (12) [back to overview]To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Placebo.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Low Alcohol Dose.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (15mg)
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (30mg)
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.
NCT03205423 (9) [back to overview]Peak Positive Subjective Responses to High Alcohol Dose.
NCT03220776 (2) [back to overview]Prefrontal Glx Concentrations
NCT03220776 (2) [back to overview]Prefrontal GABA+ Concentrations
NCT03269344 (6) [back to overview]Change in Quality of Life From Mucositis-related Pain Measured by the Patient-Reported Oral Mucositis Symptoms (PROMS) Scale From Baseline to Follow-up
NCT03269344 (6) [back to overview]Change in Total FACT-HN Scores From Baseline to Follow-up
NCT03269344 (6) [back to overview]Feeding Tube Placement
NCT03269344 (6) [back to overview]Percent Weight Lost
NCT03269344 (6) [back to overview]Average Opioid Use, Measured in Morphine Equivalents Per Day.
NCT03269344 (6) [back to overview]Change in PRO-CTCAE Scores From Baseline to Follow-up
NCT03334721 (1) [back to overview]Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy
NCT03334903 (7) [back to overview]"VAS Score 2: How Much Pain do You Feel in Your Operative Site When Moving?"
NCT03334903 (7) [back to overview]Opioid Consumption
NCT03334903 (7) [back to overview]"VAS Score 4: How Bad is Your Nausea?"
NCT03334903 (7) [back to overview]"VAS Score 1: How Much Pain do You Feel in Your Operative Site When Resting?"
NCT03334903 (7) [back to overview]"VAS Score 3: How Well Are You Sleeping?"
NCT03334903 (7) [back to overview]Days Taking Opioids
NCT03334903 (7) [back to overview]"VAS Score 5: How Satisfied Are You With Your Pain Management?"
NCT03472469 (10) [back to overview]Number of Intensive Care Unti (ICU) Days
NCT03472469 (10) [back to overview]Number of Participants Discharged From the Hospital With an Opioid Prescription
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Numeric Rating Scale (NRS)
NCT03472469 (10) [back to overview]Pain as Assessed by Score on the Behavioral Pain Scale (BPS)
NCT03472469 (10) [back to overview]Number of Ventilator Days
NCT03472469 (10) [back to overview]Overall Costs
NCT03472469 (10) [back to overview]Opioid Use Per Day
NCT03472469 (10) [back to overview]Number of Participants With Any Opioid-related Complications
NCT03472469 (10) [back to overview]Pharmacy Costs
NCT03472469 (10) [back to overview]Number of Hospital Days
NCT03472521 (3) [back to overview]Time to Opioid Cessation as a Measure of Opioid Utilization
NCT03472521 (3) [back to overview]Pain Report
NCT03472521 (3) [back to overview]Functional Recovery
NCT03540030 (16) [back to overview]Falls
NCT03540030 (16) [back to overview]Nausea
NCT03540030 (16) [back to overview]Falls
NCT03540030 (16) [back to overview]Constipation
NCT03540030 (16) [back to overview]Constipation
NCT03540030 (16) [back to overview]Additional Post Op Pain
NCT03540030 (16) [back to overview]Simple Shoulder Test
NCT03540030 (16) [back to overview]Simple Shoulder Test
NCT03540030 (16) [back to overview]Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
NCT03540030 (16) [back to overview]Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore
NCT03540030 (16) [back to overview]Pain Satisfaction
NCT03540030 (16) [back to overview]Pain Satisfaction
NCT03540030 (16) [back to overview]Post Op Pain
NCT03540030 (16) [back to overview]Nausea
NCT03540030 (16) [back to overview]Morphine Use
NCT03540030 (16) [back to overview]ASES
NCT03679013 (3) [back to overview]Average Pain Score at 24, 48 and 72 Hours Post-operatively
NCT03679013 (3) [back to overview]Number of Participants With Ileus During Hospitalization
NCT03679013 (3) [back to overview]The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).
NCT03850093 (10) [back to overview]Changes in Surgical Field Visibility
NCT03850093 (10) [back to overview]Mean Arterial Blood Pressure Change
NCT03850093 (10) [back to overview]Surgeon Satisfaction (Categorical)
NCT03850093 (10) [back to overview]Visual Analogue Scale (VAS) for Postoperative Pain
NCT03850093 (10) [back to overview]Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure
NCT03850093 (10) [back to overview]Blood Loss
NCT03850093 (10) [back to overview]Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure
NCT03850093 (10) [back to overview]Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure
NCT03850093 (10) [back to overview]Heart Rate Change
NCT03850093 (10) [back to overview]Time to 1st Postoperative Rescue Analgesia
NCT04052139 (10) [back to overview]Change in TNF-alpha
NCT04052139 (10) [back to overview]Number of Participants With a Change in HIV Viral Load Suppression Status
NCT04052139 (10) [back to overview]Change in Past Week Pain Severity
NCT04052139 (10) [back to overview]Change in IL-1beta
NCT04052139 (10) [back to overview]Change in Percentage of Past Month Heavy Drinking Days
NCT04052139 (10) [back to overview]Change in Biomarker IL-10
NCT04052139 (10) [back to overview]Change in Biomarker IL-6
NCT04052139 (10) [back to overview]Change in CD4 Count
NCT04052139 (10) [back to overview]Change in Cold Pain Tolerance
NCT04052139 (10) [back to overview]Change in Past Week Pain Interference
NCT04230980 (2) [back to overview]Pain Score as Measured by the NRS-11 Scale
NCT04230980 (2) [back to overview]Opioid Consumption, as Measured by Number of Tablets Taken.
NCT04256603 (1) [back to overview]Neuropathic Pain
NCT04292171 (5) [back to overview]Pain Score
NCT04292171 (5) [back to overview]Pain Score 24
NCT04292171 (5) [back to overview]Pain Score at 30 Minutes Postoperative
NCT04292171 (5) [back to overview]Vomiting
NCT04292171 (5) [back to overview]Nausea
NCT04429022 (8) [back to overview]Operative Time
NCT04429022 (8) [back to overview]Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
NCT04429022 (8) [back to overview]Estimated Blood Loss
NCT04429022 (8) [back to overview]Pain Scores
NCT04429022 (8) [back to overview]Length of Stay in Hours
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
NCT04429022 (8) [back to overview]Total Opioid Pain Medications Required Through 3-24h Post op in MME
NCT04429022 (8) [back to overview]Pain Scores
NCT04570436 (18) [back to overview]AUClast of Gabapentin
NCT04570436 (18) [back to overview]Cmax of Gabapentin
NCT04570436 (18) [back to overview]Terminal Half-life of Gabapentin
NCT04570436 (18) [back to overview]Tmax of Gabapentin
NCT04570436 (18) [back to overview]"Bipolar VAS for Overall Drug Liking at 72 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Take Drug Again at 36 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Drug Liking (Time for Maximum Effect, Emax [TEmax])"
NCT04570436 (18) [back to overview]"Bipolar VAS for Drug Liking (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])"
NCT04570436 (18) [back to overview]"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."
NCT04570436 (18) [back to overview]"Unipolar VAS for High (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])"
NCT04570436 (18) [back to overview]"Bipolar VAS for Take Drug Again at 24 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Overall Drug Liking at 36 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Take Drug Again at 72 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Overall Drug Liking at 48 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Take Drug Again at 48 Hour Post Dose"
NCT04570436 (18) [back to overview]"Bipolar VAS for Overall Drug Liking at 24 Hour Post Dose"
NCT04570436 (18) [back to overview]"Unipolar VAS for High (Maximum Effect, Emax)"
NCT04570436 (18) [back to overview]"Unipolar VAS for High (Time for Maximum Effect, Emax [TEmax])"
NCT05319756 (26) [back to overview]AUClast of Oxycodone
NCT05319756 (26) [back to overview]AUClast of Gabapentin
NCT05319756 (26) [back to overview]AUCinf of Oxycodone
NCT05319756 (26) [back to overview]AUCinf of Gabapentin
NCT05319756 (26) [back to overview]"Unipolar VAS for High: Time to Maximum Effect (TEmax)"
NCT05319756 (26) [back to overview]"Unipolar VAS for High - Maximum Effect (Emax)"
NCT05319756 (26) [back to overview]"Unipolar VAS for Good Drug Effect"
NCT05319756 (26) [back to overview]"Unipolar VAS for Bad Drug Effect"
NCT05319756 (26) [back to overview]"Unipolar VAS for Any Drug Effect"
NCT05319756 (26) [back to overview]Half-life (t½) of Oxycodone
NCT05319756 (26) [back to overview]"Bipolar VAS for Take Drug Again"
NCT05319756 (26) [back to overview]"Bipolar VAS for Overall Drug Liking"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 8 Hours (AUEC8)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 4 Hours (AUEC4)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 3 Hours (AUEC3)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking - Time to Maximum Effect (TEmax)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 1 Hour (AUEC1)"
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)"
NCT05319756 (26) [back to overview]"Area Under the Effect Curve for High VAS (AUEClast)"
NCT05319756 (26) [back to overview]Tmax of Oxycodone
NCT05319756 (26) [back to overview]"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 2 Hours (AUEC2)"
NCT05319756 (26) [back to overview]Tmax of Gabapentin
NCT05319756 (26) [back to overview]Half-life (t½) of Gabapentin
NCT05319756 (26) [back to overview]Cmax of Oxycodone
NCT05319756 (26) [back to overview]Cmax of Gabapentin
NCT05319756 (26) [back to overview]"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."

Roland and Morris Disability Index Scores Adjusted for Time

"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points." (NCT00108550)
Timeframe: Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9

Interventionunits on a scale (Mean)
Placebo7.50
Gabapentin6.96

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Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time

"Self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points." (NCT00108550)
Timeframe: Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9

Interventionunits on a scale (Mean)
Placebo0.6683
Gabapentin0.6988

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Headache Index

Headache index (HI) per month calculated by the sum of products of headache days /month combined with mean daily hours with headache and mean daily headache severity on days with headache. High HI reflect high headache burden (NCT00159588)
Timeframe: 5-month follow-up

Interventionheadache index per month (Mean)
Preventive Drugs From the Start169
Abrupt Withdrawal371
Controls302

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Headache Days

Change in Headache days per month (NCT00159588)
Timeframe: 5 month

Interventiondays/month (Median)
Prophylaxis From the Start7.2
Abrupt Withdrawal4.2
Controls1.6

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Time to Relapse to Drinking

Time to relapse drinking which is 5 standard drinks perday for males and 4 standard drinks per day for females. Subjects had a minimum of 4 days of abstinence prior to being entered into the protocol. (NCT00183196)
Timeframe: 16 weeks

Interventiondays (Mean)
Naltrexone Plus Gabapentin and CBI69.9
Naltrexone Plus Placebo and CBI59.6
Placebo Plus Placebo Plus CBI57.3

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Median Postoperative Opioid Doses Across Study Follow up Period

Postoperative intravenous opioid doses converted to morphine equivalents. Median derived from total opioid doses on first, second and third postoperative days. (NCT00221338)
Timeframe: Study follow up period: postoperative days 1, 2 and 3

Interventionmorphine equivalents, mg (Median)
Gabapentin6.7
Placebo6.7

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Postoperative Pain Score - Postoperative Day 2

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable). (NCT00221338)
Timeframe: Postoperative day 2

Interventionscore on a scale (Mean)
Gabapentin3
Placebo4

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Incidence of Postoperative Delirium by Study Group

Number of subjects who developed postoperative delirium, as measured by the Confusion Assessment Method, a validated tool for assessing delirium based on DSM-III-R, on any of the first three postoperative days. (NCT00221338)
Timeframe: postoperative days 1, 2 and 3

InterventionParticipants (Count of Participants)
Gabapentin84
Placebo72

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Postoperative Pain Score - Postoperative Day 1

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable). (NCT00221338)
Timeframe: Postoperative day 1

Interventionscore on a scale (Mean)
Gabapentin4
Placebo4

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Hospital Length of Stay

(NCT00221338)
Timeframe: Typically within the first week after surgery

Interventiondays (Mean)
Gabapentin4.4
Placebo4.1

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Postoperative Pain Score - Postoperative Day 3

Postoperative pain as measured by Visual Analog Pain scale (0=no pain, 10=worst pain imaginable). (NCT00221338)
Timeframe: Postoperative day 3

Interventionscore on a scale (Mean)
Gabapentin3
Placebo3

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Percent Subjects Completely Abstinent

percent of subjects completely abstinent during the six week medication study study (NCT00262639)
Timeframe: 6 week trial

Interventionpercent of participants (Number)
Low CIWA Flumazenil/Gabapentin44
Low CIWAar Placebo19
High CIWAar Placebo33
High CIWAar Flumazenil/Gabapentin71

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Percent Days Abstinent

percent days abstinent during treatment (NCT00262639)
Timeframe: Weeks 1 to 6

Interventionpercent days (Mean)
Low CIWA Flumazenil/Gabapentin70.8
Low CIWAar Placebo86.1
High CIWAar Placebo75.9
High CIWAar Flumazenil/Gabapentin95.9

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Median Time to Onset of First RLS Symptoms Using the 24-hour RLS Symptom Record at Week 36 (DB Treatment Phase)

The 24-hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. Note: The median is not estimable with Kaplan-Meier methodology when fewer than 50% of participants experience an event; thus, no data are presented for the DB GEn 1200 mg arm. (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

Interventionhours (Median)
DB Placebo14.5

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Percentage of Participants Who Experienced a Relapse During the Double-Blind Treatment Period

"Relapse was defined as worsening of Restless Legs Syndrome (RLS) symptoms or withdrawal due to lack of efficacy during the 12-week double-blind (DB) treatment period (the period from Randomization on Visit 14 [Week 24] through the end of treatment). Worsening of symptoms was defined as an increase in the total International RLS (IRLS) Scale score by at least 6 or more points relative to the participant's score at Randomization, achieving an IRLS score of at least 15, and an assessment of much worse or very much worse on the investigator-rated Clinical Global Impression of Change (CGI-C)." (NCT00311363)
Timeframe: DB Treatment Period; Days 169 to 252 (Weeks 24 to 36)

Interventionpercentage of participants (Number)
DB Placebo22.7
DB GEn 1200 mg9.4

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Percentage of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated Clinical Global Impression of Change (CGI-C) Scale as a Dichotomous Variable at Week 36 (DB Treatment Phase) Using LOCF

"The CGI-C scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline. For this endpoint, response on the CGI-C was defined as participants with a rating of no change, (score of 4) minimally improved, (score of 3) much improved, (score of 2) or very much improved (score of 1) compared to Randomization (Week 24)." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

Interventionpercentage of participants (Number)
DB Placebo67
DB GEn 1200 mg75

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Percentage of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Week 36 (DB Treatment Phase) Using LOCF

"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response on the participant-rated CGI-I was defined as a rating of very much improved (score of 1) or much improved (score of 2) compared to Baseline of the SB phase." (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

Interventionpercentage of participants (Number)
DB Placebo79.4
DB GEn 1200 mg87.5

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Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionpoints on a scale (Mean)
RandomizationWeek 36Change from Randomization to Week 36
DB GEn 1200 mg74.670.3-4.3
DB Placebo73.361.6-11.6

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Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Quantity Domain Score of the MOS Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionhours (Mean)
RandomizationWeek 36Change from Randomization to Week 36
DB Placebo7.06.8-0.2
GEn 1200 mg7.06.9-0.1

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Change From Randomization to Week 36 (DB Treatment Phase) in the RLS Quality of Life (QoL) Overall Life-Impact Score

The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionpoints on a scale (Mean)
RandomizationWeek 36Change from Randomization to Week 36
DB GEn 1200 mg94.392.1-2.2
DB Placebo94.189.9-4.2

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Mean Change From Baseline in the IRLS Scale Total Score at Week 24 (SB Treatment Phase) Using LOCF

The IRLS Rating scale is a measure of disease severity. The scale reflects participant-reported assessment of sensory and motor features and associated sleep problems in RLS. In addition, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. Total score ranges from 0-40 points, with 40 being the most severe. (NCT00311363)
Timeframe: Days 1 to 168 (Baseline to Week 24 of SB Phase)

Interventionpoints on a scale (Mean)
BaselineWeek 24Change from Baseline to Week 24
SB GEn 1200 mg24.79.2-15.5

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Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionpoints on a scale (Mean)
RandomizationWeek 36Change from Randomization to Week 36
DB GEn 1200 mg11.012.61.5
DB Placebo11.815.53.8

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Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Ability to Function in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Randomization, ExcellentRandomization, GoodRandomization, ModerateRandomization, PoorWeek 36, ExcellentWeek 36, GoodWeek 36, ModerateWeek 36, Poor
DB GEn 1200 mg632841533283
DB Placebo534220444391

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Mean Change From Randomization to Week 36 (or End of Treatment) in the IRLS Rating Scale (IRLS) Total Score Using Last Observation Carried Forward (LOCF)

The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. LOCF: Missing data (MD) values were imputed using the last non-missing observation prior to the visit with MD; randomization visit data could be carried forward. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionpoints on a scale (Mean)
RandomizationWeek 36Mean change from Randomization to Week 36
DB GEn 1200 mg5.17.01.9
DB Placebo5.39.23.9

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Number of Participants in Each Category of the Investigator-Rated CGI-C at Week 36 (DB Treatment Phase) Using LOCF

"The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Very much improved (score of 1)Much improved (score of 2)Minimally improved (score of 3)No change (score of 4)Minimally worse (score of 5)Much worse (score of 6)Very much worse (score of 7)
DB GEn 1200 mg10315441392
DB Placebo45124414117

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Number of Participants in Each Category of the Investigator-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF

"The CGI-I scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Very Much Improved (score of 1)Much Improved (score of 2)Minimally Improved (score of 3)No change (score of 4)Minimally worse (score of 5)Much Worse (score of 6)Very Much Worse (score of 7)
SB GEn 1200 mg170782825442

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Number of Participants in Each Category of the Participant-Rated CGI-I at Week 24/End of Treatment (SB Treatment Phase) Using LOCF

"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Very Much Improved (score of 1)Much Improved (score of 2)Minimally Improved (score of 3)No Change (score of 4)Minimally Worse (score of 5)Much Worse (score of 6)Very Much Worse (score of 7)
SB GEn 1200 mg163823816702

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Number of Participants in Each Category of the Participant-Rated CGI-I Scale at Week 36 (DB Treatment Phase) Using LOCF

"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline." (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Very much improved (score of 1)Much improved (score of 2)Minimally improved (score of 3)No change (score of 4)Minimally worse (score of 5)Much worse (score of 6)Very much worse (score of 7)
DB GEn 1200 mg602446011
DB Placebo473078311

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Number of Participants With no Reported RLS Symptoms (Sx) During Each of the 4-hour Periods From the 24-hour RLS Record at Week 36 (DB Treatment Phase)

In the 24-hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hr intervals (8 AM to 12 PM, 12 to 4 PM, 4 to 8 PM, 6 to 10 PM, 8 to Midnight, Midnight to 4 AM, 4 to 8 AM) (NCT00311363)
Timeframe: Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
8 AM to 12 PM, Randomization, n=96, 958 AM to 12 PM, Week 36, n=87, 8912 PM to 4 PM, Randomization, n=96, 9512 PM to 4 PM, Week 36, n=87, 894 PM to 8 PM, Randomization, n=96, 954 PM to 8 PM, Week 36, n=87, 896 PM to 10 PM, Randomization, n=96, 956 PM to 10 PM, Week 36, n=87, 898 PM to 12 AM, Randomization, n=96, 958 PM to 12 AM, Week 36, n=87, 8912 AM to 4 AM, Randomization, n=96, 9512 AM to 4 AM, Week 36, n=87, 894 AM to 8 AM, Randomization, n=96, 954 AM to 8 AM, Week 36, n=87, 89
DB GEn 1200mg8883857868726162596179778380
DB Placebo8372857173686653624182668367

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Baseline, 0 nightsBaseline, 1-2 nightsBaseline 3-4 nightsBaseline 5-6 nightsBaseline, 7 nightsWeek 24, 0 nightsWeek 24, 1-2 nightsWeek 24, 3-4 nightsWeek 24, 5-6 nightsWeek 24, 7 nights
SB GEn 1200 mg113612215110698372446

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Number of Participants With the Indicated Post-Sleep Questionnaire (PSQ) Responses to the Question Regarding Their Overall Quality of Sleep in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Randomization, ExcellentRandomization, ReasonableRandomization, PoorWeek 36, ExcellentWeek 36, ReasonableWeek 36, Poor
DB GEn 1200 mg43467384612
DB Placebo38563295117

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Ability to Function in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Baseline, ExcellentBaseline, GoodBaseline, ModerateBaseline, PoorWeek 24, ExcellentWeek 24, GoodWeek 24, ModerateWeek 24, Poor
SB GEn 1200 mg20124141261451272910

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Randomization, 0 timesRandomization, 1-2 timesRandomization, 3-4 timesRandomization, 5 or more timesWeek 36, 0 timesWeek 36, 1-2 timesWeek 36, 3-4 timesWeek 36, 5 or more times
DB GEn 1200 mg722211682251
DB Placebo732220533572

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Nights With RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Randomization, 0 nightsRandomization, 1-2 nightsRandomization, 3-4 nightsRandomization, 5-6 nightsRandomization, 7 nightsWeek 36, 0 nightsWeek 36, 1-2 nightsWeek 36, 3-4 nightsWeek 36, 5-6 nightsWeek 36, 7 nights
DB GEn 1200 mg3836115641301267
DB Placebo4735834303017614

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Baseline, 0 hours (hr)Baseline, less than 1 hrBaseline, 1 hr to less than 2 hrBaseline, 2 hr to less than 3 hrBaseline, 3 or more hrWeek 24, 0 hrWeek 24, less than 1 hrWeek 24, 1 hr to less than 2 hrWeek 24, 2 hr to less than 3 hrWeek 24, 3 or more hr
SB GEn 1200 mg267810760401886337176

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Hours Awake Per Night Due to RLS Symptoms in the Week Prior to Measurement at Randomization and Week 36 (DB Treatment Phase) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionparticipants (Number)
Randomization, 0 hours (hr)Randomization, less than 1 hrRandomization, 1 hr to less than 2 hrRandomization, 2 hr to less than 3 hrRandomization, 3 or more hrWeek 36, 0 hrWeek 36, less than 1 hrWeek 36, 1 hr to less than 2 hrWeek 36, 2 hr to less than 3 hrWeek 36, 3 or more hr
DB GEn 1200 mg72165306817830
DB Placebo731472153241523

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Overall Quality of Sleep in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Baseline, ExcellentBaseline, ReasonableBaseline, PoorWeek 24, ExcellentWeek 24, ReasonableWeek 24, Poor
SB GEn 1200 mg39721110216445

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Mean Change From Baseline in the MOS Sleep Scale Domain, Sleep Quantity, Score at Week 24 (SB Treatment Period) Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and somnolence. The Sleep Quantity Domain score is a participant-rated estimate of the average number of hours of sleep per night over the month. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionhours (Mean)
SB GEn 1200 mg1.0

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Mean Change From Randomization to Week 36 (DB Treatment Phase) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance. (NCT00311363)
Timeframe: Randomization (Week 24) and Week 36 (or end of DB treatment)

,
Interventionpoints on a scale (Mean)
RandomizationWeek 36Change from Randomization to Week 36
DB GEn 1200 mg18.821.02.3
DB Placebo16.726.910.2

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Mean Change From Baseline in the Overall Quality of Life Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 24 (SB Treatment Phase)

The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionpoints on a scale (Mean)
SB GEn 1200 mg25.7

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Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Daytime Somnolence Domain Score of the Medical Outcomes Study (MOS) Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. Responses are recoded so that a higher score reflects more of the attribute, and then converted to a 0 to 100 scale. The daytime somnolence score is based on questions pertaining to feeling drowsy or sleepy, trouble staying awake, and taking naps > 5 minutes. For daytime somnolence, a negative value indicates an improvement. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionpoints on a scale (Mean)
SB GEn 1200 mg-21.8

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Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Adequacy Domain Score of the MOS Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. The MOS Sleep Scale sleep adequacy domain is a participant-rated measure of the adequacy of sleep over the month prior to measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with higher scores representing more adequate ratings of sleep. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionpoints on a scale (Mean)
SB GEn 1200 mg35.7

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Mean Change From Baseline to Week 24 (SB Treatment Period) in the Mean Sleep Disturbance Domain Score of the MOS Sleep Scale Using LOCF

The MOS Sleep Scale is a participant-rated non-disease-specific measure with questions relating to four areas related to sleep: quantity (number of hours slept), sleep disturbance, sleep adequacy, and daytime somnolence. . The MOS Sleep Scale sleep disturbance domain is a participant-rated measure of sleep disturbance over the month prior to the measurement. Questions are scored, and responses are converted to a 0 to 100 scale, with lower scores representing less sleep disturbance. (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionpoints on a scale (Mean)
SB GEn 1200 mg-35.3

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Number of Participants With the Indicated Post-Sleep Questionnaire Responses to the Question Regarding the Number of Awakenings During the Night Due to RLS Symptoms in the Week Prior to Measurement at Baseline and Week 24 (SB Treatment Period) Using LOCF

"The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. Participants rated overall sleep quality and their ability to function on scales ranging from excellent to poor and were asked to provide the number of nights they experienced RLS symptoms and the number of times/hours they awoke at night during the week prior to the measurement." (NCT00311363)
Timeframe: Baseline and Day 168 or Week 24/End of Treatment of SB Treatment Phase

Interventionparticipants (Number)
Baseline, 0 timesBaseline, 1-2 timesBaseline, 3-4 timesBaseline, 5 or more timesWeek 24, 0 timesWeek 24, 1-2 timesWeek 24, 3-4 timesWeek 24, 5 or more times
SB GEn 1200 mg261311134118898187

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Median Time to Onset of the First RLS Symptom Using the RLS Symptom Record at Weeks 24 and 52

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms for a 24-hour period, in 30-min increments, beginning at 8AM on the day prior to the visit. (NCT00333359)
Timeframe: Weeks 24 and 52

,,
Interventionhours (Median)
Week 24, n=127, 285, 412Week 52, n=123, 241, 364
All Participants; 1200 mg GEn18NA
Naïve; 1200 mg GEn15.5NA
Non-naïve; 1200 mg GEn20NA

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Number of Participants Classified as Responders to Treatment on the Investigator-rated Clinical Global Impressions of Improvement (CGI-I) at Each Visit Using OC

"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to the start of the study. Responders on the CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved or improved, respectively." (NCT00333359)
Timeframe: Weeks 0, 1, 4, 12, 24, 36, and 52

,,
Interventionparticipants (Number)
Week 0, n=197, 376, 573Week 1, n=185, 363, 548Week 4, n=171, 354, 525Week 12, n=150, 324, 474Week 24, n=138, 305, 443Week 36, n=132, 281, 413Week 52, n=126, 262, 388
All Participants; 1200 mg GEn384446451430401380362
Naïve; 1200 mg GEn84152143133126120115
Non-naïve; 1200 mg GEn300294308297275260247

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Number of Participants Classified as Responders to Treatment on the Participant-rated CGI-I at Each Visit Using OC

"The Participant-rated CGI-I is a self-reported measure completed by the participant, who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse. Responders on the Participant-rated CGI-I are defined as those with a score of 1 or 2, corresponding to very much improved and improved, respectively." (NCT00333359)
Timeframe: Weeks 0, 1, 4, 12, 24, 36, and 52

,,
Interventionparticipants (Number)
Week 0, n=197, 376, 573Week 1, n=182, 351, 533Week 4, n=171, 348, 519Week 12, n=148, 318, 466Week 24, n=133, 300, 433Week 36, n=129, 276, 405Week 52, n=122, 247, 369
All Participants; 1200 mg GEn390406442414392367334
Naïve; 1200 mg GEn86145143131117115107
Non-naïve; 1200 mg GEn304261299283275252227

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Number of Participants in Each Category of the Investigator-rated CGI-I by Visit Using OC

"The CGI-I is a widely used tool designed to allow clinicians to rate the severity of illness and the change over time based on a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study." (NCT00333359)
Timeframe: Weeks 0, 1, and 52

,,
Interventionparticipants (Number)
Week 0, Very much improved, n=197, 376, 573Week 0, Much improved, n=197, 376, 573Week 0, Minimally improved, n=197, 376, 573Week 0, No change, n=197, 376, 573Week 0, Minimally worse, n=197, 376, 573Week 0, Much worse, n=197, 376, 573Week 0, Very much worse, n=197, 376, 573Week 1, Very much improved, n=185, 363, 548Week 1, Much improved, n=185, 363, 548Week 1, Minimally improved, n=185, 363, 548Week 1, No change, n=185, 363, 548Week 1, Minimally worse, n=185, 363, 548Week 1, Much worse, n=185, 363, 548Week 1, Very much worse, n=185, 363, 548Week 52, Very much improved, n=126, 262, 388Week 52, Much improved, n=126, 262, 388Week 52, Minimally improved, n=126, 262, 388Week 52, No change, n=126, 262, 388Week 52, Minimally worse, n=126, 262, 388Week 52, Much worse, n=126, 262, 388Week 52, Very much worse, n=126, 262, 388
All Participants; 1200 mg GEn23015484919412372096829320259103168011
Naïve; 1200 mg GEn384647559208270284010724374000
Non-naïve; 1200 mg GEn192108373602115513940253101876094011

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Number of Participants in Each Category of the Participant-rated CGI-I by Visit Using OC

"The Participant-rated CGI-I is a self-reported measure completed by the participant who rates the change from the start of the study in the severity of their illness using a seven-point rating scale, with a score of 1 being very much improved, 2 being much improved, 3 being minimally improved, 4 being no change, 5 being minimally worse, 6 being much worse, and 7 being very much worse compared to the start of the study." (NCT00333359)
Timeframe: Weeks 0, 1, and 52

,,
Interventionparticipants (Number)
Week 0, Very much improved, n=197, 376, 573Week 0, Much improved, n=197, 376, 573Week 0, Minimally improved, =197, 376, 573Week 0, No change, n=197, 376, 573Week 0, Minimally worse, n=197, 376, 573Week 0, Much worse, n=197, 376, 573Week 0, Very much worse, n=197, 376, 573Week 1, Very much improved, n=182, 351, 533Week 1, Much improved, n=182, 351, 533Week 1, Minimally improved, n=182, 351, 533Week 1, No change, n=182, 351, 533Week 1, Minimally worse, n=182, 351, 533Week 1, Much worse, n=182, 351, 533Week 1, Very much worse, n=182, 351, 533Week 52, Very much improved, n=122, 247, 369Week 52, Much improved, n=122, 247, 369Week 52, Minimally improved, n=122, 247, 369Week 52, No change, n=122, 247, 369Week 52, Minimally worse, n=122, 247, 369Week 52, Much worse, n=122, 247, 369Week 52, Very much worse, n=122, 247, 369
All Participants; 1200 mg GEn23315782791462262144773279225777248012
Naïve; 1200 mg GEn3947475085191542941218027113001
Non-naïve; 1200 mg GEn194110352961117190482867117750135011

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Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Week 52 Using OC Data

In the 24-Hour RLS Record (diary), participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12PM, 12 to 4PM, 4 to 8PM, 6 to 10PM, 8 to 12 Midnight, Midnight to 4AM, 4 to 8AM). (NCT00333359)
Timeframe: Week 52

,,
Interventionparticipants (Number)
8 AM to 12 PM, n=123, 241, 36412 PM to 4 PM, n=122, 240, 3624 PM to 8 PM, n=122, 240, 3626 PM to 10 PM, n=122, 241, 3638 PM to 12 AM, n=122, 241, 36312 AM to 4 AM, n=123, 241, 3644 AM to 8 AM, n=123, 241, 364
All Participants; 1200 mg GEn330322272255237293318
Naïve; 1200 mg GEn10610688807598104
Non-naïve; 1200 mg GEn224216184175162195214

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Overall Quality of Life (QoL) Impact Score of the RLS Quality of Life Questionnaire at Weeks 24 and 52

The RLS QoL is an 18-item scale assessing the impact of RLS on daily life, emotional well-being, social and work life. Responses range from 1 (not at all/never) to 5 (a lot/all of the time). Ten items contribute to a single summary score, the Overall Life Impact, which is standardized to range from 0-100, with lower scores representing better QoL. (NCT00333359)
Timeframe: Weeks 24 and 52

,,
Interventionpoints on a scale (Mean)
Week 24, n=164, 328, 492Week 52, n=121, 264, 385
All Participants; 1200 mg GEn90.792.0
Naïve; 1200 mg GEn89.892.0
Non-naïve; 1200 mg GEn91.192.0

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Change From Baseline in the International Restless Legs Syndrome Rating Scale (IRLS) at Week 52 Using Observed Case (OC)

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the Week 52 value minus the baseline value. Change scores with higher value represents greater improvement in RLS symptoms. (NCT00333359)
Timeframe: Baseline and Week 52

Interventionpoints on a scale (Mean)
Naïve; 1200 mg GEn-16.3
Non-naïve; 1200 mg GEn-17.0
All Participants; 1200 mg GEn-16.8

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Change From Baseline in the IRLS Rating Scale Score at Each Visit Using OC

The IRLS rating scale is a measure of RLS disease severity. The score reflects participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Also, items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score on the IRLS ranges from 0 to 40, with higher values representing more severe RLS symptoms. Change from baseline was calculated as the value at each visit minus the baseline value. Change scores with higher values represent greater improvement in RLS symptoms. (NCT00333359)
Timeframe: Weeks 0, 1, 4, 12, 24, and 36

,,
Interventionpoints on a scale (Mean)
Week 0, n=197, 376, 573Week 1, n=186, 360, 546Week 4, n=174, 352, 526Week 12, n=150, 322, 472Week 24, n=139, 305, 444Week 36, n=130, 281, 411
All Participants; 1200 mg GEn-12.8-14.2-15.7-16.1-16.4-16.7
Naïve; 1200 mg GEn-9.4-15.6-15.6-15.8-16.2-16.8
Non-naïve; 1200 mg GEn-14.6-13.5-15.8-16.3-16.5-16.6

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Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Items: Hours of Work Missed Due to RLS, Hours of Work Missed Due to Other Reason, and Hours Actually Worked

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 24/52 minus the observed value at baseline. Absenteeism is recorded as the number of hours missed from work. W, Week; hr, hour. (NCT00333359)
Timeframe: Baseline and Weeks 24 and 52

,,
Interventionhours (Mean)
W24, hr missed due to RLS, n=108, 199, 307W24, hr missed for other reason, n=108, 199, 307HW24, hr actually worked, n=108, 199, 307W52, hr missed due to RLS, n=82, 175, 257W52, hr missed other reason, n=82, 175, 257W52, hr actually worked, n=82, 175, 257
All Participants; 1200 mg GEn-0.1-0.81.90.2-1.01.5
Naïve; 1200 mg GEn-0.1-1.80.80.10.50.0
Non-naïve; 1200 mg GEn-0.1-0.22.50.2-1.82.2

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Mean Change From Baseline at Week 24 and Week 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Summary Scores

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Each summary score is expressed as a percentage and ranges from 0 to 100, with higher scores indicating more work missed; a negative change from baseline indicates less work missed. Change = the observed value at the current visit minus the observed value at Week 0. Change is calculated only for participants who had a value at both the current visit and at Week 0. (NCT00333359)
Timeframe: Baseline and Weeks 24 and 52

,,
Interventionpercent change (Mean)
Week 24, Work Time Missed, n=108, 199, 307Week 24, Impairment While Working, n=101, 185, 286Week 24, Overall Work Impairment, n=101, 185, 286Week 24, Daily Activity Impairment, n=158,309,467Week 52, Work Time Missed, n=82, 175, 257Week 52, Impairment While Working n=78, 170, 248Week 52, Overall Work Impairment, n=78, 170, 248Week 52, Daily Activity Impairment, n=117,261,378
All Participants; 1200 mg GEn0.0-4.2-4.1-6.30.6-3.3-3.3-6.3
Naïve; 1200 mg GEn-0.2-7.6-7.6-10.3-0.2-8.7-8.9-11.5
Non-naïve; 1200 mg GEn0.1-2.3-2.2-4.31.0-0.9-0.8-3.9

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Mean Change From Baseline at Weeks 24 and 52 in Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) Individual Item: RLS Affected Productivity

The WPAI:SHP estimates work productivity and social activities lost over the past week due to RLS symptoms. Change is calculated as the observed value at Week 52 minus the observed value at baseline. Productivity affected while working is estimated on a 0 (no effect) to 10 scale (completely preventing productivity). (NCT00333359)
Timeframe: Baseline and Weeks 24 and 52

,,
Interventionpoints on a scale (Mean)
Week 24, n=101, 185, 286Week 52, n=78, 170, 248
All Participants; 1200 mg GEn-0.4-0.3
Naïve; 1200 mg GEn-0.8-0.9
Non-naïve; 1200 mg GEn-0.2-0.1

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Number of Participants Experiencing No RLS Symptoms in Each of the Seven 4-hour Periods From the 24-hour RLS Record at Week 12 (End of Treatment)

RLS severity ratings were summarized in 6 non-overlapping 4-hour periods beginning at 8 AM. A 4-hour period from 6 PM to 10 PM was also prospectively included to reflect the time frame when the most participants would experience their first symptoms of the day. (NCT00365352)
Timeframe: Week 12

,,
Interventionparticipants (Number)
8 AM to 12 PM12 PM to 4 PM4 PM to 8 PM6 PM to 10 PM8 PM to 12 AM12 AM to 4 AM4 AM to 8 AM
GEn (XP13512/GSK1838262) 1200 mg74696155486772
GEn (XP13512/GSK1838262) 600 mg85746855497479
Placebo52514539273856

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Number of Participants Classified as Responders With at Least 30% and 50% Improvement in the Average Daily RLS Pain Score Using LOCF

"The Mean Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits A Responder is a participant with a score of much improved or very much improved on the investigator rated CGI I Scale at the end of treatment (Week 12 using LOCF)." (NCT00365352)
Timeframe: Week 12

,,
Interventionparticipants (Number)
> or equal to 30% response> or equal to 50% response
GEn (XP13512/GSK1838262) 1200 mg7666
GEn (XP13512/GSK1838262) 600 mg7562
Placebo4841

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Number of Participants Classified as Responders to Treatment Based on the Participant-Rated CGI of Improvement at Week 1 and Week 12 (End of Treatment)

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 1 and Week 12

,,
Interventionparticipants (Number)
Responders at the End of Treatment (Week 12)Responders at the End of One Week
GEn (XP13512/GSK1838262) 1200 mg8352
GEn (XP13512/GSK1838262) 600 mg9055
Placebo4620

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Number of Participants Classified as Investigator-rated CGI-I Scale Responders at Week 12 by RLS Treatment History Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Basline and Week 12

,,
Interventionparticipants (Number)
No RLS Treatment HistoryTreatment terminatedTreatment within 1 month of study start
GEn (XP13512/GSK1838262) 1200 mg571315
GEn (XP13512/GSK1838262) 600 mg54918
Placebo26511

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Mean Change in the IRLS Rating Scale Total Score From Baseline at Week 12 by RLS Treatment History Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

,,
Interventionscores on a scale (Mean)
No RLS Treatment HistoryTreatment terminatedTreatment within 1 month of study start
GEn (XP13512/GSK1838262) 1200 mg-12.5-17.1-12.1
GEn (XP13512/GSK1838262) 600 mg-13.7-12.4-14.6
Placebo-8.8-13.3-10.7

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Change From Baseline in the IRLS Rating Scale Total Score at Week 12 by Baseline RLS Rating Scale Total Score Category (Baseline RLS Severity) Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and Week 12

,,
Interventionscores on a scale (Mean)
IRLS Total Score < 17.5IRLS Total Score 17.5 to < 22.5IRLS Total Score 22.5 to < 27.5IRLS Total Score >= 27.5
GEn (XP13512/GSK1838262) 1200 mg-7.9-8.8-15.5-19.6
GEn (XP13512/GSK1838262) 600 mg-8.9-11.9-15.1-18.2
Placebo-6.3-8.5-9.6-13.3

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Time to Onset of the First RLS Symptom From the 24-hour RLS Record Obtained at the End of Treatment (Week 12)

The time to onset of the first RLS symptoms from the 24-hour RLS Record is defined as the length of time from the start of the 24-hour assessment period (8:00 AM) to the time when 50% of participants experienced their first symptom. (NCT00365352)
Timeframe: Week 12

Interventionhours (Median)
Placebo12.8
GEn (XP13512/GSK1838262) 600 mg13.5
GEn (XP13512/GSK1838262) 1200 mg13.8

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The Time to Onset of the First Response to Treatment on the IRLS Rating Scale Total Score and the Investigator-rated CGI-I

The Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved. The median time to onset is estimated using the product-limit estimation method. (NCT00365352)
Timeframe: Baseline (Day 1) to End of Treatment (Week 12)

Interventionweeks (Median)
PlaceboNA
GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally4.1
GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day2.1

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Number of Total Responders to Treatment Based on the Investigator-Rated CGI of Improvement at the End of One Week of Treatment

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: End of Week 1

Interventionresponders (Number)
Placebo26
GEn (XP13512/GSK1838262) 600 mg54
GEn (XP13512/GSK1838262) 1200 mg59

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Number of Participants With a Rating of Excellent for the Overall Quality of Sleep in Past Week Measured by the Post-Sleep Questionnaire (PSQ) at the End of Treatment (Week 12) Using LOCF

"The Post-Sleep Questionnaire (PSQ) was designed to evaluate overall sleep quality, ability to function, and RLS symptoms' interference with sleep over the past week. Participants were asked to rate overall sleep quality (as either Excellent, Reasonable, or Poor), ability to function, number of nights with RLS symptoms, number of nights awakened by RLS symptoms, and the number of hours spent awake due to RLS symptoms over the past week." (NCT00365352)
Timeframe: End of Treatment (Week 12)

Interventionparticipants (Number)
Placebo14
GEn (XP13512/GSK1838262) 600 mg24
GEn (XP13512/GSK1838262) 1200 mg30

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Number of Participants Who Indicated on the Mood Assessment That Their Mood Was Much Improved or Very Much Improved at Week 12 (End of Treatment) Using LOCF

The Mood Assessment is a non-disease-specific question surveying global change in a participant's overall mood. Participants were asked to rate their overall change in mood since the start of the study by choosing a score in a range from 1 (Very Much Improved) to 7 (Very Much Worse). The assessment was completed at Day 1 and the ends of Weeks 4, 8, and 12 or (Early Termination). (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo19
GEn (XP13512/GSK1838262) 600 mg35
GEn (XP13512/GSK1838262) 1200 mg39

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Number of Participants Classsified as Responders on the Investigator-rated CGI-I Scale at Week 12 Using LOCF

"The CGI-I scale is a standardized tool that is widely used in psychopharmacologic trials. For the CGI-I, the investigator was asked to rate the participant's overall change in RLS symptoms from Baseline. Scores ranged from 1 (very much improved) to 7 (very much worse). Participants who were much improved (score of 2) or very much improved on the CGI-I scale at the end of treatment (Week 12) are classified as Responders." (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo43
GEn (XP13512/GSK1838262) 600 mg83

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Change From Baseline to the End of Week 1 in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and the End of Week 1

Interventionscores on a scale (Mean)
Placebo-6.0
GEn (XP13512/GSK1838262) 600 mg-9.8
GEn (XP13512/GSK1838262) 1200 mg-8.7

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Change From Baseline to the End of Treatment in Average Daily Wake Time (Minutes) After Sleep Onset Using LOCF

Average daily wake time after sleep onset was derived from the Pittsburgh Sleep Diary (PghSD) as the mean of non-missing total hours awake during the night after falling asleep over the 7 days before each visit. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionminutes (Mean)
Placebo-12.5
GEn (XP13512/GSK1838262) 600 mg-16.4
GEn (XP13512/GSK1838262) 1200 mg-18.5

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Change From Baseline to the End of Treatment in Average Daily Total Sleep Time (Hours) Using LOCF

Average daily total sleep time was derived from the Pittsburgh Sleep Diary (PghSD; an instrument with separate components to be completed [self-reported] at bedtime and waketime) as the mean of non-missing total sleep time over the 7 days before each visit, where total sleep time = [(wake up time - lights out time) - time to fall asleep - time awake during the night] in hours. The change was calculated as the end of treatment (Week 12) value minus the Baseline value. (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionhours (Mean)
Placebo0.6
GEn (XP13512/GSK1838262) 600 mg0.7
GEn (XP13512/GSK1838262) 1200 mg1.0

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Change From Baseline to the End of Treatment (Week 12) in the IRLS Rating Scale Total Score Using LOCF

The IRLS Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline (Day 1) and End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-9.8
GEn (XP13512/GSK1838262) 600 mg-13.8

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Change From Baseline in the Sleep Disturbance Score, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep disturbance domain ranged from 1 to 100, with a high score indicating greater impairment of sleep. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-17.0
GEn (XP13512/GSK1838262) 600 mg-29.5
GEn (XP13512/GSK1838262) 1200 mg-30.7

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Change From Baseline in the Overall Life-Impact Score of the RLS Quality of Life (QoL) Questionnaire at Week 12 Using LOCF

The Restless Legs Syndrome Quality of Life (RLS-QoL) questionnaire is a disease-specific, participant-rated questionnaire that assesses the impact of RLS on daily life, emotional well-being, social life, and work life of the participants. The RLS-QoL Questionnaire is presented on a 0 (lowest possible score) to 100 (highest possible score) scale. It was completed at Day 1 and at the end of Weeks 4, 8, and 12 (or Early Termination). (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo14.5
GEn (XP13512/GSK1838262) 600 mg19.3
GEn (XP13512/GSK1838262) 1200 mg20.4

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Number of Participants Who Had an Onset of Response to Treatment at the End of Week 1 Based Upon the IRLS Rating Scale Total Score and the Investigator-rated CGI-I Using LOCF

"The IRLS Rating scale is a measure of RLS disease severity. Items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. Response was defined by an IRLS Rating Scale total score at the end of Week 1 < 15 and at least a 6-point reduction from the participant's Baseline score and an investigator-rated CGI-I response of much improved or very much improved." (NCT00365352)
Timeframe: End of Week 1

Interventionparticipants (Number)
Placebo13
GEn (XP13512/GSK1838262) 600 mg36
GEn (XP13512/GSK1838262) 1200 mg40

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Change From Baseline in the Profile of Mood State (POMS) Scale at Week 12 Using LOCF

"The Profile of Mood States (POMS) Brief Form contains 30 adjectives; each participant is asked to rate the degree to which each adjective describes themselves based on how they felt during the past week including the date on which the adjective was rated. The possible ratings range from 0 (Not all all) to 4 (Extremely). The Total Mood Disturbance Score (range of 0 to 120) is obtained by summing the values of six domains. Higher scores indicate a more negative mood disturbance. The POMS was completed at Baseline (Day 1), and at the end of Weeks 4, 8, and 12 (or Early Termination)." (NCT00365352)
Timeframe: Baseline to End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-7.3
GEn (XP13512/GSK1838262) 600 mg-10.9
GEn (XP13512/GSK1838262) 1200 mg-11.5

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Change From Baseline in the Daytime Somnolence Score, an Item on the Medical Outcomes Study (MOS) Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the daytime somnolence domain ranged from 1 to 100, with a high score indicating greater daytime somnolence. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-9.7
GEn (XP13512/GSK1838262) 600 mg-9.8
GEn (XP13512/GSK1838262) 1200 mg-16.1

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Change From Baseline in the Average Daily RLS Pain Score to Week 12 for Participants With a Baseline Pain Score of at Least 4 Using LOCF

The Average Daily RLS pain was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-2.3
GEn (XP13512/GSK1838262) 600 mg-3.5
GEn (XP13512/GSK1838262) 1200 mg-3.5

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Change From Baseline in the Average Daily RLS Pain Score at the End of Treatment (Week 12) for Participants With Pain at Baseline or the End of Week 12 Using LOCF

The Daily RLS pain score was assessed by participants reporting whether they experienced any pain associated with RLS in the last 24 hours and rating their pain levels on an 11-point numerical rating scale, with 0 being no pain and 10 the most intense pain imaginable. The assessment was performed for 7 days prior to Baseline and pre-defined study visits. The change from baseline was calculated as the End of Treatment (Week 12) value minus the Baseline (Day 1) value. (NCT00365352)
Timeframe: Baseline and End of Treatment (Week 12)

Interventionscores on a scale (Mean)
Placebo-1.7
GEn (XP13512/GSK1838262) 600 mg-2.5
GEn (XP13512/GSK1838262) 1200 mg-2.6

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Change From Baseline in Sleep Quantity, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep quantity domain were measured in time (number of hours of sleep each night). The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Baseline and Week 12

Interventionhours (Mean)
Placebo0.3
GEn (XP13512/GSK1838262) 600 mg0.6
GEn (XP13512/GSK1838262) 1200 mg0.8

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Change From Baseline in Sleep Adequacy, an Item on the MOS Sleep Scale, at Week 12 Using LOCF

"The MOS Sleep Scale measures most constructs of sleep. The scale has a battery of questions to measure specific aspects of sleep in participants with co-morbidities. The four domains scored from the MOS Sleep Scale were sleep disturbance,' sleep quantity,' sleep adequacy, and daytime somnolence. The scores of the sleep adequacy domain ranged from 1 to 100, with a high score indicating greater adequacy. The assessment was completed at Baseline (Day 1) and end of Weeks, 4, 8, and 12 (or end of Treatment)." (NCT00365352)
Timeframe: Basline and Week 12

Interventionscores on a scale (Mean)
Placebo13.6
GEn (XP13512/GSK1838262) 600 mg29.1
GEn (XP13512/GSK1838262) 1200 mg27.7

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Change From Baseline in IRLS Rating Scale Total Score at Week 12 Using Last Observation Carried Forward (LOCF)

The International Restless Legs Syndrome (IRLS) Rating scale is a measure of RLS disease severity. The scale reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT00365352)
Timeframe: Baseline and Week 12

Interventionscores on a scale (Mean)
Placebo-9.8
GEn (XP13512/GSK1838262) 1200 mg-13.0

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"Number of Participants With a Score of Much Improved or Very Much Improved on the Investigator-rated CGI-I Scale (Response) at (Week 12) Using LOCF"

"The investigator -rated Clinical Global Impression of Improvement (CGI-I) scale is an assessment designed to allow investigators to rate the change of a participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, a score of 2 being much improved, a score of 3 being minimally improved, a score of 4 being no change, a score of 5 being minimally improved,a score of 6 being much worse, and a score of 7 being very much worse. Participants with a response of much improved or very much improved were classified as responders." (NCT00365352)
Timeframe: Week 12

Interventionparticipants (Number)
Placebo43
GEn (XP13512/GSK1838262) 1200 mg86

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Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels

Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos (NCT00385671)
Timeframe: baseline, 12 weeks

,,
Interventionunits/liter (Mean)
baseline, AST, n=119, n=121, n=118change, AST, n=119, n=121, n=118baseline, ALT, n=120, n=122, n=120change, ALT, n=120, n=122, n=120baseline, GGT, n=121, n=123, n=120change, GGT, n=121, n=123, n=120baseline, AlkPhos, n=121, n=123, n=120change, AlkPhos, n=121, n=123, n=120
Duloxetine22.84-0.5225.04-0.1634.29-3.0383.740.55
Gabapentin + Duloxetine23.42-0.4824.390.0343.93-2.5582.181.78
Pregabalin22.551.1223.88-0.1340.801.1784.972.80

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Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)

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

,,
Interventionunits on a scale (Least Squares Mean)
GTS, n=122, n=119, n=118QOS, n=121, n=118, n=118AFS, n=122, n=118, n=118BFW, n=124, n=115, n=118
Duloxetine17.407.398.1421.04
Gabapentin + Duloxetine14.759.6411.8614.33
Pregabalin10.969.3210.0219.67

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Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

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

,,
Interventionunits on a scale (Least Squares Mean)
total, n=122, n=126, n=128cognitive toxicity, n=126, n=129, n=128somatomotor 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

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Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

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

,,
Interventionunits on a scale (Least Squares Mean)
male, total; n=62, n=67, n=66female, total; n=39; n=42, n=43male, pleasure; n=64, n=67, n=69female, pleasure; n=40, n=42, n=43male, desire/frequency; n=65, n=67, n=69female, desire/frequency; n=42, n=42, n=43male, desire/interest; n=65, n=67, n=70female, desire/interest; n=42, n=42, n=45male, arousal; n=65, n=67, n=70female, arousal; n=40, n=42, n=45male, orgasm; n=64, n=67, n=69female, orgasm; n=40, n=42, n=43
Duloxetine0.481.12-0.060.470.060.26-0.190.340.520.070.18-0.05
Gabapentin + Duloxetine1.29-0.610.13-0.090.160.300.050.010.52-0.300.17-0.85
Pregabalin-0.53-0.010.080.15-0.020.21-0.27-0.170.17-0.11-0.390.31

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Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3

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

,,
Interventionunits on a scale (Least Squares Mean)
TotalItem 1Item 2Item 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

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Mean Change From Baseline to 12 Weeks in Total Bilirubin

(NCT00385671)
Timeframe: baseline, 12 weeks

,,
Interventionmicromole/liter (Mean)
baselinechange
Duloxetine8.07-0.28
Gabapentin + Duloxetine8.23-0.42
Pregabalin8.43-0.51

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Number of Participants With Treatment-Emergent Changes in Body Weight

"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

,,
Interventionparticipants (Number)
highlow
Duloxetine110
Gabapentin + Duloxetine38
Pregabalin62

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Number of Participants With Treatment-emergent Elevated Blood Pressure

"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

,,
Interventionparticipants (Number)
diastolic, n=94, n=98, n=100systolic, n=42, n=39, n=56
Duloxetine1215
Gabapentin + Duloxetine1316
Pregabalin1120

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Number of Patients With Treatment-Emergent Elevated Laboratory Analytes

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

,,
Interventionparticipants (Number)
AST, n=113, n=116, n=109ALT, n=111, n=104, n=110TBili, n=119, n=121, n=116GGT, n=102, n=105, n=96FPG, n=33, n=30, n=36HbA1C, n=17, n=18, n=29AlkPhos, n=112, n=114, n=113
Duloxetine66061123
Gabapentin + Duloxetine4100618104
Pregabalin4322764

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Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms

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

Interventioncoefficient (Number)
Direct Treatment EffectIndirect Treatment EffectTotal Treatment Effect
Ordinary Coefficient-0.4490.014-0.435

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Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation

(NCT00385671)
Timeframe: baseline through 12 weeks

,,
Interventionparticipants (Number)
NauseaPeripheral OedemaInsomniaSomnolenceAnxietyDizzinessDysuriaHeadacheHyperhidrosisSedationAllergic OedemaAnorgasmiaIncreased Blood CreatineIncreased Blood GlucoseBruxismCerebrovascular AccidentChest DiscomfortDepressionDermatitisDiarrhoeaDry mouthEnterovirus InfectionFatigueGeneralized OedemaFacial HypoaesthesiaLacunar InfarctionLoss of ConsciousnessLymphomaMental ImpairmentMuscular WeaknessMyoclonusPollakiuriaPulomnary EmbolismRashSleep DisorderUrticariaVomiting
Duloxetine4042102210010011011010100010001000101
Gabapentin + Duloxetine4000120011001000100101000001010111000
Pregabalin0501000001100100000000011100100000010

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Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine6.02-2.58
Gabapentin + Duloxetine5.74-2.40
Pregabalin5.74-2.12

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Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)

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

,,
Interventionunits on a scale (Least Squares Mean)
de novo, baselinede novo, week 1de novo, week 2de novo, week 3de novo, week 4de novo, week 5de novo, week 6de novo, week 7de novo, week 8de novo, week 9de novo, week 10de novo, week 11de novo, week 12prior use, baselineprior use, week 1prior use, week 2prior use, week 3prior use, week 4prior use, week 5prior use, week 6prior use, week 7prior use, week 8prior use, week 9prior use, week 10prior use, week 11prior use, week 12
Duloxetine5.39-0.71-1.22-1.83-2.35-2.65-2.64-2.73-2.78-2.89-2.86-2.98-3.085.99-0.48-0.99-1.32-1.61-1.95-2.03-2.14-2.16-2.38-2.45-2.46-2.46
Gabapentin + Duloxetine5.49-0.38-1.10-1.62-1.67-1.81-1.88-2.07-2.06-2.10-1.92-2.09-2.105.92-0.65-1.28-1.68-1.75-1.96-1.98-2.17-2.31-2.37-2.44-2.41-2.53
Pregabalin5.24-0.22-0.39-0.71-0.84-0.95-1.09-1.08-1.26-1.21-1.42-1.48-1.625.91-0.30-0.70-1.18-1.64-1.72-1.92-1.93-1.89-2.04-2.14-2.27-2.39

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Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score

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

Interventionunits on a scale (Least Squares Mean)
Pregabalin-2.57
Duloxetine-3.13
Gabapentin + Duloxetine-2.54

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Mean Change From Baseline to 12 Weeks in Body Weight

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

Interventionkilogram (Least Squares Mean)
Pregabalin1.00
Duloxetine-2.39
Gabapentin + Duloxetine-1.06

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Mean Change From Baseline to 12 Weeks in Heart Rate

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

Interventionbeats per minute (Least Squares Mean)
Pregabalin-1.30
Duloxetine0.80
Gabapentin + Duloxetine1.05

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Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin

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

Interventionunits on a scale (Least Squares Mean)
Gabapentin + Duloxetine-2.39
Duloxetine-2.62

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Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine

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

Interventionunits on a scale (Least Squares Mean)
Pregabalin-2.12
Duloxetine-2.62

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Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity

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

Interventionunits on a scale (Least Squares Mean)
Pregabalin-2.30
Duloxetine-2.71
Gabapentin + Duloxetine-2.49

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Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score

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

Interventionunits on a scale (Least Squares Mean)
Pregabalin-2.59
Duloxetine-3.08
Gabapentin + Duloxetine-2.86

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Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score

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

Interventiondays (Median)
Pregabalin35.0
Duloxetine28.0
Gabapentin + Duloxetine28.0

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Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks

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

Interventionparticipants (Number)
Pregabalin65
Duloxetine68
Gabapentin + Duloxetine72

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Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks

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

Interventionparticipants (Number)
Pregabalin59
Duloxetine64
Gabapentin + Duloxetine68

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Number of Participants With Treatment-Emergent Elevated Heart Rate

Elevated heart rate: >=100 beats per minute (bpm) + an increase of >=10 bpm if baseline <100 bpm. (NCT00385671)
Timeframe: baseline through 12 weeks

Interventionparticipants (Number)
Pregabalin2
Duloxetine9
Gabapentin + Duloxetine6

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Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score

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

Interventionparticipants (Number)
Pregabalin48
Duloxetine50
Gabapentin + Duloxetine47

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Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks

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

Interventionunits on a scale (Mean)
Pregabalin3.03
Duloxetine3.01
Gabapentin + Duloxetine2.83

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Summary of Number of Participants Who Discontinued

Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow. (NCT00385671)
Timeframe: baseline through 12 weeks

Interventionparticipants (Number)
Pregabalin38
Duloxetine51
Gabapentin + Duloxetine36

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Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score

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

Interventiondays (Median)
Pregabalin56.0
Duloxetine35.0
Gabapentin + Duloxetine28.0

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Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores

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

,,
Interventionparticipants (Number)
better, total; n=122, n=126, n=128same, total; n=122, n=126, n=128worse, total; n=122, n=126, n=128better, cognitive toxicity; n=126, n=129, n=128same, cognitive toxicity; n=126, n=129, n=128worse, cognitive toxicity; n=126, n=129, n=128better, somatomotor toxicity; n=122, n=126, n=129same, somatomotor toxicity; n=122, n=126, n=129worse, somatomotor toxicity; n=122, n=126, n=129
Duloxetine8453780643741933
Gabapentin + Duloxetine8643882541741936
Pregabalin6884675942601547

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Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores

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

,,
Interventionparticipants (Number)
male, total, better; n=62, n=67, n=66male, total, same; n=62, n=67, n=66male, total, worse; n=62, n=67, n=66female, total, better; n=39, n=42, n=43female, total, same; n=39, n=42, n=43female, total, worse; n=39, n=42, n=43male, pleasure, better; n=64, n=67, n=69male, pleasure, same; n=64, n=67, n=69male, pleasure, worse; n=64, n=67, n=69female, pleasure, better; n=40, n=42, n=43female, pleasure, same; n=40, n=42, n=43female, pleasure, worse; n=40, n=42, n=43male, desire/frequency, better; n=65, n=67, n=69male, desire/frequency, same; n=65, n=67, n=69male, desire/frequency, worse; n=65, n=67, n=69female, desire/frequency, better; n=42, n=42, n=43female, desire/frequency, same; n=42, n=42, n=43female, desire/frequency, worse; n=42, n=42, n=43male, desire/interest, better; n=65, n=67, n=70male, desire/interest, same; n=65, n=67, n=70male, desire/interest, worse; n=65, n=67, n=70female, desire/interest, better; n=42, n=42, n=45female, desire/interest, same; n=42, n=42, n=45female, desire/interest, worse; n=42, n=42, n=45male, arousal, better; n=65, n=67, n=70male, arousal, same; n=65, n=67, n=70male, arousal, worse; n=65, n=67, n=70female, arousal, better; n=40, n=42, n=45female, arousal, same; n=40, n=42, n=45female, arousal, worse; n=40, n=42, n=45male, orgasm, better; n=64, n=67, n=69male, orgasm, same; n=64, n=67, n=69male, orgasm, worse; n=64, n=67, n=69female, orgasm, better; n=40, n=42, n=43female, orgasm, same; n=40, n=42, n=43female, orgasm, worse; n=40, n=42, n=43
Duloxetine26932235141140161621520291812219181930181410242914181014183118171312
Gabapentin + Duloxetine31112418718213216632524232212247261727161712233314151614172923111616
Pregabalin249291352113391210237123617112110201926131217202817111415122923151312

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Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure

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

,,
Interventionparticipants (Number)
Increased blood creatinineIncreased blood glucose
Duloxetine00
Gabapentin + Duloxetine10
Pregabalin01

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Mean Change From Baseline to 12 Weeks in Blood Pressure

Least-squares means represent adjustment due to baseline severity and investigative site. (NCT00385671)
Timeframe: baseline through 12 weeks

,,
Interventionmillimeter mercury (Least Squares Mean)
DiastolicSystolic
Duloxetine2.24-3.08
Gabapentin + Duloxetine-0.79-2.08
Pregabalin0.18-3.31

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.63-2.09
Gabapentin + Duloxetine5.02-2.33
Pregabalin4.38-1.82

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.08-1.85
Gabapentin + Duloxetine4.10-1.43
Pregabalin3.42-1.46

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.98-1.86
Gabapentin + Duloxetine5.15-1.88
Pregabalin4.61-1.63

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine3.08-1.27
Gabapentin + Duloxetine3.29-1.17
Pregabalin2.96-0.97

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.97-2.12
Gabapentin + Duloxetine5.40-2.50
Pregabalin4.91-2.29

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine5.52-2.56
Gabapentin + Duloxetine5.79-2.09
Pregabalin5.25-1.88

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine5.03-2.38
Gabapentin + Duloxetine5.03-1.86
Pregabalin4.24-1.51

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.61-2.00
Gabapentin + Duloxetine4.83-1.90
Pregabalin4.25-1.62

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine5.65-2.44
Gabapentin + Duloxetine5.75-2.29
Pregabalin5.53-1.80

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.18-1.55
Gabapentin + Duloxetine4.07-1.54
Pregabalin4.23-1.27

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine5.03-2.24
Gabapentin + Duloxetine5.36-2.19
Pregabalin4.98-1.77

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Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine6.87-3.02
Gabapentin + Duloxetine7.00-2.64
Pregabalin6.73-2.34

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Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale

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

,,
Interventionparticipants (Number)
hours worked, greater, n=86, n=90, n=83hours worked, same, n=86, n=90, n=83hours worked, lower, n=86, n=90, n=83hours volunteered, greater, n=86, n=91, n=82hours volunteered, same, n=86, n=91, n=82hours volunteered, lower, n=86, n=91, n=82psychiatric visits, greater, n=92, n=93, n=90psychiatric visits, same, n=92, n=93, n=90psychiatric visits, lower, n=92, n=93, n=90outpatient group visits, greater, n=91, n=92, n=91outpatient group visits, same, n=91, n=92, n=91outpatient group visits, lower, n=91, n=92, n=91outpatient ind. visits, greater, n=91, n=88, n=90outpatient ind. visits, same, n=91, n=88, n=90outpatient ind. visits, lower, n=91, n=88, n=90days of partial care, greater, n=93, n=95, n=90days of partial care, same, n=93, n=95, n=90days of partial care, lower, n=93, n=95, n=90nights of partial care, greater, n=92, n=95, n=91nights of partial care, same, n=92, n=95, n=91nights of partial care, lower, n=92, n=95, n=91ER visits-psychiatric, greater, n=93, n=94, n=91ER visits-psychiatric, same, n=93, n=94, n=91ER visits-psychiatric, lower, n=93, n=94, n=91ER visits-nonpsychiatric, greater,n=91, n=95, n=88ER visits-nonpsychiatric, same,n=91, n=95, n=88ER visits-nonpsychiatric, lower,n=91, n=95, n=88phone mental health, greater,n=94, n=95, n=90phone mental health, same,n=94, n=95, n=90phone mental health, lower,n=94, n=95, n=90nonpsychiatric visits, greater, n=89, n=94, n=83nonpsychiatric visits, same, n=89, n=94, n=83nonpsychiatric visits, lower, n=89, n=94, n=83unpaid care, greater, n=84, n=87, n=86unpaid care, same, n=84, n=87, n=86unpaid care, lower, n=84, n=87, n=86missed work caregiver, greater, n=6, n=9, n=5missed work caregiver, same, n=6, n=9, n=5missed work caregiver, lower, n=6, n=9, n=5paid care, greater, n=60, n=58, n=58paid care, same, n=60, n=58, n=58paid care, less, n=60, n=58, n=58
Duloxetine12661287760912092018431940194009404856193120462808700810580
Gabapentin + Duloxetine135911106662844189148152871289009104786287118452008510500580
Pregabalin106511766132882090138442910191009123835192124442128200600600

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Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)

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

,,
Interventionunits on a scale (Least Squares Mean)
baselinechange
Duloxetine4.47-1.16
Gabapentin + Duloxetine4.40-1.13
Pregabalin4.27-1.06

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Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose

(NCT00385671)
Timeframe: baseline, 12 weeks

,,
Interventionmillimole/liter (Mean)
baselinechange
Duloxetine8.450.19
Gabapentin + Duloxetine7.990.67
Pregabalin8.240.16

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Mean Change From Baseline to 12 Weeks in Hemoglobin A1C

(NCT00385671)
Timeframe: baseline, 12 weeks

,,
Interventionpercent (Mean)
baselinechange
Duloxetine7.51-0.01
Gabapentin + Duloxetine7.160.07
Pregabalin7.57-0.12

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Change From Baseline in Vulvar Pain

change in vulvar pain following gabapentin compared to placebo - will evaluate the efficacy of gabapentin to decrease vulvar pain compared to placebo. end of 1st treatment (after 8 weeks) and end of 2nd treatment (after 19 weeks). Pain was assessed using ordinal scale (0-10): 0 = no pain, 10 = most severe pain. (NCT00390013)
Timeframe: 19 weeks

Interventionunits on a scale (Mean)
Gabapentin-1.3
Placebo-1.3

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Sleep

The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups. (NCT00391716)
Timeframe: 12-week

Interventionunits on a scale (Mean)
Gabapentin 900mg Daily4.04
Gabapentin 1800mg Daily3.24
Placebo Daily4.50

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Mood

Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups. (NCT00391716)
Timeframe: 12-week

Interventionunits on a scale (Mean)
Gabapentin 900mg Daily5.08
Gabapentin 1800mg Daily3.62
Placebo Daily5.40

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Drinking

Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men). (NCT00391716)
Timeframe: 12-week

Interventionparticipants (Number)
Gabapentin 900mg Daily6
Gabapentin 1800mg Daily8
Placebo Daily2

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Craving

Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups. (NCT00391716)
Timeframe: 12-week

Interventionunits on a scale (Mean)
Gabapentin 900mg Daily33.66
Gabapentin 1800mg Daily32.31
Placebo Daily34.27

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Change From Baseline in Cognitive Functioning Using the Delis-Kaplan Executive Function System (D-KEFS) at Week 4

The D-KEFS is a testing battery designed to measure executive functioning, a critical component of participating in cognitive behavioral therapy used to treat marijuana dependence. Data were obtained from the D-KEFS test instruments completed at baseline and week 4, which included the Trail Making Test, Verbal Fluency Test, and Color-Word Interference Test. Scaled scores range from 1 (worst) to 19 (best). Change = (Week 4 score - Week 0 score). Positive values indicate increased executive functioning. (NCT00395044)
Timeframe: Week 0 and Week 4

Interventionscores on a scale (Mean)
Gabapentin.28
Placebo-.20

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Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 12

Urinary THC/Cr ratio, also known as CN-THCCOOH (creatinine normalized tetrahydrocannabinol carboxylic acid), is a highly sensitive and specific quantitative analytic procedure to determine current marijuana metabolite levels in the urine as well as new marijuana use or abstinence. Gas chromatography-mass spectrometric levels of 11-nor-9-carboxy-9-THC (THC-COOH), the primary marijuana metabolite, are normalized to the urine creatinine (CN) concentration to reduce the variability of drug measurement attributable to urine dilution. Negative values indicate decreased use. (NCT00395044)
Timeframe: Week 0 and Week 12

Interventionng/ml (Mean)
Gabapentin-966.00
Placebo-532.81

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Change From Week 0 in Craving on the Marijuana Withdrawal Checklist Marijuana Craving Question at Week 12

The Marijuana Craving question of the Marijuana Withdrawal Checklist assesses severity of craving to smoke marijuana. The craving question is rated on a scale of 0-3 where 0=best outcome (no symptoms) and 3=worst outcome (severe symptoms). Change = (Week 12 score - Week 0 score). (NCT00395044)
Timeframe: Week 0 and Week 12

Interventionunits on a scale (Mean)
Gabapentin-1.55
Placebo-1.46

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Change From Week 0 in Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at Week 12

The MWC is an instrument to assess the severity of frequently reported cannabis withdrawal symptoms. Each question on the measure is recorded as a severity rating between 0-3: 0=best outcome; 3=worst outcome. The severity rating of each question was averaged to obtain a single marijuana withdrawal severity score. Change = (Week 12 score - Week 0 score). (NCT00395044)
Timeframe: Week 0 and Week 12

Interventionunits on a scale (Mean)
Gabapentin1.42
Placebo2.12

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Change in Sleep Quality on the Pittsburgh Sleep Quality Index (PSQI) at Week 12

The PSQI is an instrument to assess subjective sleep quality and disturbance. The range on the measure is from 0-21: 0=best outcome; 21=worst outcome. Change = (Week 12 score - Week 0 score). (NCT00395044)
Timeframe: Week 0 and Week 12

Interventionunits on a scale (Mean)
Gabapentin-4.27
Placebo-1.72

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Change From Week 0 in Mood on the Beck Depression Inventory (BDI-II) at Week 12

The BDI-II is a self-rating of severity of depressive symptoms. The Total score range on the BDI-II is from 0-63; 0=best outcome; 63=worst outcome. Change = (Week 12 score - Week 0 score). (NCT00395044)
Timeframe: Week 0 and Week 12

Interventionunits on a scale (Mean)
Gabapentin3.71
Placebo5.22

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Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.

Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain. (NCT00414466)
Timeframe: Baseline and Post-randomization Day 22

InterventionScores on a scale (Mean)
1 Placebo0.48
2 Gabapentin Low0.40
3 Gabapentin Medium0.10
4 Gabapentin High-0.02

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Number of Participants With Treatment-emergent Adverse Events

Evaluation of adverse event profiles between placebo and active treatment groups. (NCT00414466)
Timeframe: Randomization to Post-randomization Day 29 (includes dose reduction)

InterventionParticipants (Number)
1 Placebo40
2 Gabapentin Low32
3 Gabapentin Medium37
4 Gabapentin High36

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Responder Analysis Between Active Treatment and Placebo Groups.

Responders were subjects that reported at least a 30% decrease in average daily pain scores between baseline and Day 22. (NCT00414466)
Timeframe: Baseline to Post-randomization Day 22

InterventionParticipants (Number)
1 Placebo4
2 Gabapentin Low4
3 Gabapentin Medium1
4 Gabapentin High2

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Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back

Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back (NCT00420771)
Timeframe: data collected during 8 weeks of trial or length of participation

Interventionmilligrams/day (Mean)
Active Medication4.0
Placebo2.3

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Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin

Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain. (NCT00475904)
Timeframe: baseline to 28 Days

Interventionunits on a scale (Least Squares Mean)
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules2.424
Gabapentin Capsules, Placebo Cream2.471
Placebo Cream and Capsules1.877

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Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.

Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain. (NCT00475904)
Timeframe: baseline and 28 days

Interventionunits on a scale (Mean)
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules2.424
Gabapentin Capsules, Placebo Cream2.471
Placebo Cream and Capsules1.877

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Percentage of Participants With 75% Reduction From Baseline in 28-day Seizure Rate at Week 21.

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

,
InterventionPercentage of participants (Number)
All Partial Seizure (n=238, 240)Simple Partial (n=87, 88)Complex Partial (n=161, 158)SGTC (n=112, 114)
Gabapentin34.233.036.143.9
Pregabalin33.636.837.338.4

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Percentage of Participants With 50% Reduction From Baseline in 28-day Seizure Rate at Week 21.

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

,
InterventionPercentage of participants (Number)
All Partial Seizure (n=238, 240)Simple Partial (n=87, 88)Complex Partial (n=161, 158)SGTC (n=112, 114)
Gabapentin58.353.455.160.5
Pregabalin56.355.256.550.9

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Medical Outcomes Study Sleep Scale (MOS-SS) Score.

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

,
InterventionUnits 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)
Gabapentin26.4328.0919.617.5963.6729.3128.1525.3126.1218.208.7764.5329.9827.54
Pregabalin29.6829.2823.647.5661.3032.2931.6024.9928.0716.268.7963.8732.0427.88

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Hospital Anxiety and Depression Scale (HADS) Score.

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

,
InterventionUnits 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)
Gabapentin7.60-0.835.65-0.42
Pregabalin7.82-0.925.94-0.59

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Change From Baseline in the 28-day Secondarily Generalized Tonic-clonic (SGTC) Seizure Frequency at Week 21.

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

,
Interventionpercentage of all partial seizure/28days (Mean)
Baseline (n=114, 114)Change from Baseline at Double Blind (n=104, 98)
Gabapentin59.60-2.17
Pregabalin56.531.59

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Reduction in Proportion of the 28-day SGTC Seizure Rate Over the Total Partial Seizure Rate at Week 21.

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

Interventionpercentage of responders (Number)
Pregabalin30.8
Gabapentin39.8

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Percent Change From Baseline in 28-day Seizure Frequency at Week 21.

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

Interventionpercent change (Median)
Pregabalin-58.65
Gabapentin-57.43

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Percentage of Participants Without Seizures.

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

,
Interventionpercentage of participants (Number)
All Partial Seizure (n=189, 182)Simple Partial (n=74, 66)Complex Partial (n=126, 123)SGTC (n=95, 91)
Gabapentin34.136.440.742.9
Pregabalin30.729.737.346.3

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Percentage of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) Score.

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

,
Interventionpercentage of participants (Number)
Baseline (n=238, 240)Week 21 (n=212, 210)
Gabapentin58.858.6
Pregabalin49.251.4

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Number of Participants Who Responded to Treatment With Gabapentin by Baseline Creatinine Clearance

Participants who responded to the treatment with gabapentin were counted by the baseline creatinine clearance (CLcr) across 6 categories to assess whether the baseline CLcr was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
CLcr >=60 mL/Min284
CLcr >=30 and <60 mL/Min28
CLcr >=15 and <30 mL/Min4
CLcr >=5 and <15 mL/Min1
Unkown322

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Number of Participants Who Responded to Treatment With Gabapentin by Age Across 7 Categories

Participants who responded to the treatment with gabapentin were counted by age across 7 categories to assess whether the age was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
Age <15 Years93
Age >=15 and <25 Years91
Age >=25 and <35 Years102
Age >=35 and <45 Years113
Age >=45 and <55 Years64
Age >=55 and <65 Years82
Age >=65 Years94

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Number of Participants Who Responded to Treatment With Gabapentin by Age (<65 Versus >=65 Years)

Participants who responded to the treatment with gabapentin were counted by age (<65 vs. >=65 years) to assess whether the age was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
Age <65 Years545
Age >=65 Years94

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Clinical Efficacy Rate

Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded for the periods during the previous 4 weeks from the treatment start date, and that from the end date of observation (12 weeks after the treatment start date, or date of which treatment was terminated before reaching 12 weeks). Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable. (NCT00567268)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Gabapentin 200, 300, 400 mg Tablets61.1

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Response Ratio (R Ratio)

Response Ratio (R Ratio) was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: R Ratio= (T-B) / (T+B). R Ratio was within the range of -1 to +1, and a negative value represented a reduction in the frequency of seizure. (NCT00567268)
Timeframe: 12 weeks

InterventionRatio (Mean)
Gabapentin 200, 300, 400 mg Tablets-0.410

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Responder Rate

Responder rate, which was defined as the percentage of participants whose R ratio was -0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of -0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more. (NCT00567268)
Timeframe: 12 weeks

InterventionPercentage of participants (Number)
Gabapentin 200, 300, 400 mg Tablets55.0

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Percent Reduction From Baseline in Epileptic Seizure Frequency

Percent reduction from the baseline in epileptic seizure frequency, was calculated by the following formula, where B represented the frequency of epileptic seizures during 4 weeks before gabapentin treatment, whereas T represented the frequency of epileptic seizures during 4 weeks at the end of observation period of gabapentin treatment: Reduction from the baseline in epileptic seizure frequency (%) = [(T-B)/B] X 100. (NCT00567268)
Timeframe: 12 weeks

InterventionPercentage (Mean)
Gabapentin 200, 300, 400 mg Tablets-34.0

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Number of Participants Who Responded to Treatment With Gabapentin by Severity of Partial Epileptic Seizure

Participants who responded to the treatment with gabapentin were counted by the severity of partial epileptic seizure (mild, moderate and severe) to assess whether the severity of partial epileptic seizure was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
Mild150
Moderate363
Severe118

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Number of Participants Who Responded to Treatment With Gabapentin by Presence or Absence of Non-Drug Therapy

Participants who responded to the treatment with gabapentin were counted by the presence or absence of non-drug therapy to assess whether the non-drug therapy was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
Presence of Non-Drug Therapy34
Absence of Non-Drug Therapy605

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Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline

Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
No Concomitant Antiepileptic Drug32
One Concomitant Antiepileptic Drug295
Two Concomitant Antiepileptic Drugs190
Three Concomitant Antiepileptic Drugs98
Four or More Concomitant Antiepileptic Drugs24

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Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure

Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 vs. >8 episodes) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy. (NCT00567268)
Timeframe: 12 weeks

Interventionparticipants (Number)
<=8 Episodes432
>8 Episodes166
Unknown41

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Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco

"Point prevalence tobacco abstinence was adjudicated if the following conditions were met: (a) self-reported tobacco abstinence for the previous 7 days with a negative response to the question Have you used any type of tobacco, even a puff, in the past 7 days? and (b) Expired Carbon Monoxide equal or less then 8 parts per million." (NCT00578552)
Timeframe: 12 weeks following start of medication

Interventionparticipants (Number)
Placebo5
Gabapentin - 1800 mg /Day4
Gabapentin - 2700 mg/Day0

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Average Pain Score With Coughing on Second Morning After Surgery

Numeric rating scale pain score with coughing on second morning after surgery, range 0-10. (NCT00588159)
Timeframe: Second morning after surgery

InterventionUnites on a scale (Mean)
Gabapentin Preoperatively5.0
Active Placebo5.1

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Average Pain Score With Coughing the First Morning Following Surgery

Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10. (NCT00588159)
Timeframe: First morning following surgery

InterventionUnits on a scale (Mean)
Gabapentin Preoperatively5.2
Active Placebo5.0

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Opioid Consumption in First 24 Hours Postoperatively

(NCT00588159)
Timeframe: 24 hours

Interventionmg (Mean)
Gabapentin Preoperatively111.9
Active Placebo118.1

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Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively

Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively (NCT00588159)
Timeframe: 48 hours postoperatively

Interventionmg (Mean)
Gabapentin Preoperatively114.4
Active Placebo121.6

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Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively

Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively. (NCT00588159)
Timeframe: 3 months postoperatively

InterventionParticipants (Number)
Gabapentin Preoperatively37
Active Placebo38

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Average Pain Score at Rest

Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine. (NCT00588159)
Timeframe: 48 hours

InterventionUnits on a scale (Mean)
Gabapentin Preoperatively3.1
Active Placebo2.9

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Response Ratio of Gabapentin in Japanese Pediatric Patients With Partial Seizures

The Response Ratio calculated by the following equation was assessed as the primary endpoint: R Ratio = (T-B) / (T+B) where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period. (NCT00603473)
Timeframe: 12 weeks

Interventionratio (Mean)
Gabapentin-0.158

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Percent Change in Seizure Frequency (PCH)

PCH calculated by the following equation was assessed as secondary endpoint: PCH = 100 (T-B) / B where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 12-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period. (NCT00603473)
Timeframe: 12 weeks

InterventionPercent Change (Median)
Gabapentin-24.4

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Responder Rate

Responder Rate was defined as the percentage of subjects with a 50% or greater reduction in the seizure frequency per 28 days for the 12-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period. (NCT00603473)
Timeframe: 12 weeks

InterventionPercentage of Subjects (Mean)
Gabapentin19.8

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Mean Gabapentin Steady-State (ss) Average, Minimum and Maximum Concentrations

"Steady-state average (Cave, ss), maximum (Cmax, ss), and minimum (Cmin,ss) plasma concentration of gabapentin in each participant were estimated using the gabapentin plasma concentration data and with the aid of a population pharmacokinetic model. Dispersion is represented by the fifth to ninety-fifth percentile, though labeled as Full Range. A total of 10 blood samples were collected per participant over the Baseline, Period 1, and Period 2 at various timepoints during the dosing interval. Plasma concentration of gabapentin in these samples was measured." (NCT00617461)
Timeframe: A total of 10 blood samples (2 samples at each visit) were collected per participant at Baseline, and the Week 1 and Week 4 visits for each period

,,
Interventionmicrograms per milliliter (Geometric Mean)
Cave,ssCmin, ssCmax, ss
Gabapentin 1800 mg6.84.37.4
GEn 1200 mg4.13.05.1
GEn 3600 mg12.49.215.2

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Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) at the Last Week of Each Treatment Period Using LOCF Data

"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 Data are summarized by dose, independent of treatment period." (NCT00617461)
Timeframe: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionparticipants (Number)
GEn 1200 mg17
GEn 3600 mg28

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Change From Baseline in the Mean Night-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

Night-time worst pain is defined as the participant's assessment of their worst pain intensity between going to bed and rising in the morning. Participants recorded night-time worst pain in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for primary endpoint. Change from baseline = the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-0.97
GEn 3600 mg-1.33

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Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data by Period

Baseline and end of treatment scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (end of treatment). Percent reduction from baseline was calculated as the [(end of treatment 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. Data are summarized by period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

,,,
Interventionparticipants (Number)
0% or more10% or more20% or more30% or more40% or more50% or more60% or more70% or more80% or more90% or more100%
GEn 1200 mg in First Intervention Period382619139710000
GEn 1200 mg in Second Intervention Period302520158854110
GEn 3600 mg in First Intervention Period3423191310530000
GEn 3600 mg in Second Intervention Period37262319161185222

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Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Using LOCF Data

"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. Data are summarized by dose, independent of treatment period." (NCT00617461)
Timeframe: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionparticipants (Number)
GEn 1200 mg15
GEn 3600 mg18

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Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

"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. Data are summarized by dose within each treatment period." (NCT00617461)
Timeframe: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionparticipants (Number)
GEn 1200 mg in First Intervention Period6
GEn 3600 mg in First Intervention Period11
GEn 1200 mg in Second Intervention Period11
GEn 3600 mg in Second Intervention Period17

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Change From Baseline in the Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at the Last Week of Each Treatment Period Using LOCF

The BPI assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact to 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 scores range from 0 to 10 (0=no impact to 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. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of treatment)

,
Interventionpoints on a scale (Least Squares Mean)
Brief Pain Inventory Severity of PainBrief Pain Inventory Interference of Pain
GEn 1200 mg-1.17-0.82
GEn 3600 mg-1.63-1.57

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Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

Baseline and end of treatment (EOT) scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization (Baseline) and the 7 days prior to the last on-treatment completed diary (EOT). Percent reduction from baseline was calculated as the [(EOT score minus 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. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

,
Interventionparticipants (Number)
0% or more10% or more20% or more30% or more40% or more50% or more60% or more70% or more80% or more90% or more100%
GEn 1200 mg68513928171564110
GEn 3600 mg714942322616115222

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Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using Last Observation Carried Forward (LOCF) Data

Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants rated their API over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (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 end of treatment minus baseline. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-1.18
GEn 3600 mg-1.47

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Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data for Each Treatment Period

Baseline and end of treatment 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 last 7 days on treatment within each period (end of treatment). Participants used a hand-held diary to rate their average pain intensity over the preceding 24 hours, using an 11-point 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. The by period summary is provided as a sensitivity analysis for the primary analysis. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Mean)
GEn 1200 mg in First Intervention Period-1.11
GEn 3600 mg in First Intervention Period-1.09
GEn 1200 mg in Second Intervention Period-1.29
GEn 3600 mg in Second Interevention Period-1.92

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Change From Baseline in the Mean Current (Evening) Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

"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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period." (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-1.10
GEn 3600 mg-1.39

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Change From Baseline in the Mean Current Morning Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF

"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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period." (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-1.11
GEn 3600 mg-1.46

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Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at the Last Week of Each Treatment Period

Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commercial Tylenol) during treatment and multiplying that by 500 mg. Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionmilligrams (Least Squares Mean)
GEn 1200 mg-68.18
GEn 3600 mg-71.26

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Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF Data

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 end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-1.17
GEn 3600 mg-1.48

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Change From Baseline in the Mean Day-time Worst Pain Intensity Score at the Last Week of Each Treatment Period Using LOCF Data

Day-time worst pain is defined as the participant's assessment of their worst pain intensity between rising in the morning and going to bed at night. Day-time worst pain was recorded in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-1.17
GEn 3600 mg-1.50

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Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at the Last Week of Each Treatment Period Using LOCF

Night-time is defined as the time between going to bed in the evening and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-0.92
GEn 3600 mg-1.21

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Change From Baseline in the Mean Sleep Interference Score at the Last Week of Each Treatment Period Using LOCF Data

Participants assessed sleep interference due to pain on a daily basis using the 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and end of treatment scores are as defined for the primary endpoint. Change from baseline is calculated as the end of treatment score minus the baseline score. An ANCOVA with baseline value, BMI, grouped center as covariates was used. Data are summarized by dose, independent of treatment period. (NCT00617461)
Timeframe: Baseline and End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionpoints on a scale (Least Squares Mean)
GEn 1200 mg-0.97
GEn 3600 mg-1.23

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Number of Participants Who Are Responders on the Clinical Global Impression of Change (CGIC) Questionnaire at the Last Week of Each Treatment Period Presented by Period Using LOCF Data

"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. Data are summarized by dose within each treatment period." (NCT00617461)
Timeframe: End of Treatment (Weeks 4 and 9, representing the last week of each treatment period)

Interventionparticipants (Number)
GEn 1200 mg in First Intervention Period5
GEn 3600 mg in First Intervention Period8
GEn 1200 mg in Second Intervention Period10
GEn 3600 mg in Second Intervention Period10

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Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at the End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data

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 average pain intensity over the preceding 24 hours, using an 11-point PI-Numerical Rating Scale (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 EOMT score minus Baseline score. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.66
GEn 1200 mg/Day-2.47
GEn 2400 mg/Day-2.36
GEn 3600 mg/Day-2.72

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Change From Baseline in the Mean Current Evening Pain Intensity Score at EOMT Using LOCF Data

"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." (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.45
GEn 1200 mg/Day-2.45
GEn 2400 mg/Day-2.24
GEn 3600 mg/Day-2.69

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Change From Baseline in the Mean Current Morning Pain Intensity Score at EOMT Using LOCF Data

"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." (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.34
GEn 1200 mg/Day-2.29
GEn 2400 mg/Day-2.13
GEn 3600 mg/Day-2.41

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Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data

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 wss calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.65
GEn 1200 mg/Day-2.35
GEn 2400 mg/Day-2.44
GEn 3600 mg/Day-2.50

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Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionparticipants (Number)
>=0 reducation 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 baseline100% reduction from baseline
GEn 1200 mg/Day94837157504434251796
GEn 2400 mg/Day71615548392814181293
GEn 3600 mg/Day847065524637312419127
Placebo796250403222159831

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Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionpoints on a scale (Least Squares Mean)
Brief Pain Inventory Severity of PainBrief Pain Inventory Interference of Pain
GEn 1200 mg/Day-2.4-2.2
GEn 2400 mg/Day-2.4-2.2
GEn 3600 mg/Day-2.5-2.3
Placebo-1.8-2.0

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Change From Baseline in Quality of Life as Assessed by the SF-36 at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionpoints on a scale (Least Squares Mean)
SF-36 Physical Component Summary ScoreSF-36 Mental Component Summary Score
GEn 1200 mg/Day4.35.1
GEn 2400 mg/Day4.44.5
GEn 3600 mg/Day4.95.8
Placebo3.33.2

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Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionpoints on a scale (Least Squares Mean)
NPS 10 ScoreNPS 8 ScoreNPS Non-Allodynic ScoreNPS 4 Score
GEn 1200 mg/Day-22.78-22.23-22.58-24.37
GEn 2400 mg/Day-24.02-23.77-24.18-26.08
GEn 3600 mg/Day-25.2-24.49-24.54-26.55
Placebo-17.17-17.05-16.87-18.25

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Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionpoints on a scale (Least Squares Mean)
SF-MPQ Total ScoreSF-MPQ Sensory ScoreSF-MPQ Affective Score
GEn 1200 mg/Day-8.35-6.07-2.27
GEn 2400 mg/Day-7.45-5.43-2.08
GEn 3600 mg/Day-8.15-6.13-1.99
Placebo-6.08-4.51-1.58

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Change From Baseline in Emotional Functioning as Assessed by the POMS-B at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

,,,
Interventionpoints on a scale (Least Squares Mean)
Tension/Anxiety Domain ScoreDepression/Rejection Domain ScoreAnger/Hostility Domain ScoreVigor/Activity Domain ScoreFatigue/Inertia Domain ScoreConfusion/Bewilderment Domain Score
GEn 1200 mg/Day-1.8-1.5-2.00.8-1.9-0.5
GEn 2400 mg/Day-2.0-1.9-2.40.5-2.4-1.0
GEn 3600 mg/Day-2.0-1.7-1.71.4-2.5-0.5
Placebo-1.6-1.4-1.60.4-1.4-0.7

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Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score

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 the first day of event minus the 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. (NCT00619476)
Timeframe: Anytime post-baseline until date of last dose of study medication (up to Week 13)

Interventiondays (Median)
Placebo49
GEn 1200 mg/Day27
GEn 2400 mg/Day10
GEn 3600 mg/Day10

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Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data

"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 Week13/Withdrawal visit." (NCT00619476)
Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionparticipants (Number)
Placebo24
GEn 1200 mg/Day45
GEn 2400 mg/Day35
GEn 3600 mg/Day39

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Change From Baseline in Dynamic Allodynia at EOMT Using LOCF Data

Dynamic allodynia (pain in response to a standardized light touch stimulus, a foam brush applied with light pressure to the site of maximum pain) was assessed by 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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-2.29
GEn 1200 mg/Day-1.97
GEn 2400 mg/Day-2.16
GEn 3600 mg/Day-2.25

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Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data

"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 Week13/Withdrawal visit." (NCT00619476)
Timeframe: EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionparticipants (Number)
Placebo21
GEn 1200 mg/Day38
GEn 2400 mg/Day34
GEn 3600 mg/Day33

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Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data

Participants assessed sleep interference due to pain on a daily basis using the 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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-2.04
GEn 1200 mg/Day-2.72
GEn 2400 mg/Day-2.58
GEn 3600 mg/Day-2.78

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Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data

Night-time worst pain is defined as the participant'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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.76
GEn 1200 mg/Day-2.49
GEn 2400 mg/Day-2.65
GEn 3600 mg/Day-2.71

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Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data

Day-time worst pain is defined as the participant'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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.74
GEn 1200 mg/Day-2.61
GEn 2400 mg/Day-2.41
GEn 3600 mg/Day-2.82

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Change From Baseline in the Mean Day-time Average Pain Intensity(API) Score at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit)

Interventionpoints on a scale (Least Squares Mean)
Placebo-1.59
GEn 1200 mg/Day-2.47
GEn 2400 mg/Day-2.23
GEn 3600 mg/Day-2.67

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Change From Baseline in the Mean Daily Dose in Milligrams of Rescue Medication at EOMT Using LOCF Data

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. (NCT00619476)
Timeframe: Baseline and EOMT (Week 13 or early withdrawal)

Interventionmilligrams (Least Squares Mean)
Placebo-41.00
GEn 1200 mg/Day-289.94
GEn 2400 mg/Day-260.03
GEn 3600 mg/Day-266.21

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Visual Analog Scale for Pain

"The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as No pain at all and on the right as The worst pain imaginable. The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone)." (NCT00619983)
Timeframe: Study completion (16 weeks)

,,,
Interventionunits on a scale (Median)
Baseilne ( weeks)Test drug alone (6 weeks)Drug plus gabapentin (6 weeks)Gabapentin alone (2 weeks)
Donepezil3.34.12.92.2
Donepezil + Duloxetine5.85.23.94.3
Duloxetine6.42.92.73.0
Placebo4.93.94.14.1

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Response Ratio

The Response Ratio calculated by the following equation : Response Ratio = (T minus B) divided by (T plus B), where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473). (NCT00620555)
Timeframe: Up to 52 weeks

InterventionRatio (Mean)
Week 1 to 8 (n=65)Week 9 to 16 (n=60)Week 17 to 24 (n=58)Week 25 to 36 (n=54)Week 37 to 52 (n=47)
Gabapentin-0.263-0.256-0.300-0.280-0.327

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Number of Participants With Treatment-Emergent Adverse Events (All Causalities and Treatment-Related)

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. Severe AEs: those which interferes significantly with participant's usual function. An AE resulting in any of the following outcomes, was considered to be a serious adverse event: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. (NCT00620555)
Timeframe: up to 53 weeks

InterventionParticipants (Number)
All-causality adverse events (AEs)Treatment-related AEsAll-causality serious AEsTreatment-related serious AEsAll-causality severe AEsTreatment-related severe AEsDiscontinuation due to all-causality AEsDiscontinuation due to treatment-related AEsDose reduction due to all-causality AEsDose reduction due to treatment-related AEs
Gabapentin581320104222

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Percent Change in Seizure Frequency

Percent change in seizure frequency (PCH) was calculated as follows: PCH = 100*(T minus B) divided by B, where T is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 52-week treatment period, and B is seizure frequency per 28 days (i.e., the number of seizures per 28 days) calculated from the total number of seizures for the 6-week baseline period of the previous study A9451162 (NCT00603473). (NCT00620555)
Timeframe: Up to 52 weeks

InterventionPercent change (Median)
Week 1 to 8 (n=65)Week 9 to 16 (n=60)Week 17 to 24 (n=58)Week 25 to 36 (n=54)Week 37 to 52 (n=47)
Gabapentin-34.2-33.0-42.0-41.6-49.2

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Responder Rate

Responder Rate was defined as the percentage of subjects with a 50 percent or greater reduction in the seizure frequency per 28 days for the 52-week treatment period in comparison with the frequency per 28 days for the 6-week baseline period of the previous study A9451162 (NCT00603473). (NCT00620555)
Timeframe: Up to 52 weeks

InterventionPercentage of participants (Number)
Week 1 to 8 (n=65)Week 9 to 16 (n=60)Week 17 to 24 (n=58)Week 25 to 36 (n=54)Week 37 to 52 (n=47)
Gabapentin35.440.039.740.746.8

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Percentage of Participants With Pain Relief

Pain relief was assessed on a scale ranging from -1 to 4, where -1=became worse, 0=no change, 1=relieved a little, 2=relieved moderately, 3=relieved a lot and 4=completely resolved. (NCT00634543)
Timeframe: Day 15, Day 29 and Day 43

,
InterventionPercentage of Participants (Number)
Day 15: Became worseDay 15: No changeDay 15: Relieved a littleDay 15: Relieved moderatelyDay 15: Relieved a lotDay 15: Completely resolvedDay 29: Became worseDay 29: No changeDay 29: Relieved a littleDay 29: Relieved moderatelyDay 29: Relieved a lotDay 29: Completely resolvedDay 43: Became worseDay 43: No changeDay 43: Relieved a littleDay 43: Relieved moderatelyDay 43: Relieved a lotDay 43: Completely resolved
Gabapentin4.014.534.221.126.30.01.310.529.014.544.70.01.311.825.015.842.14.0
Tramadol Hydrochloride/ Acetaminophen1.412.731.026.826.81.44.29.925.421.138.01.42.87.022.519.746.51.4

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Change From Baseline in Brief Pain Inventory (BPI) Score at Day 43

The BPI is a questionnaire designed to assess the severity and impact of pain on quality of life. Pain severity score is caculated by sum of all severity items (pain worst, pain least, pain average and pain now) divided by pain now. Total score for pain severity ranges from 0=no pain to 10=extreme pain. Pain interference score was calculated by sum of all interference items (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) score. Total score for pain interference ranges from 0=no interference to 70= interferes completely. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
Baseline: Pain severity score (n=68, 73)Change at Day 43: Pain severity score (n=60, 60)Baseline: Pain interference score (n=71, 76)Change at Day 43:Pain interference score(n=63, 68)
Gabapentin4.90.129.8-8.8
Tramadol Hydrochloride/ Acetaminophen4.50.130.2-11.0

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Change From Baseline in Pain Intensity Score at Day 43

Pain intensity was assessed on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
BaselineChange at Day 43
Gabapentin6.302.76
Tramadol Hydrochloride/ Acetaminophen6.653.15

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Overall Assessment of Study Medication by Participants

Overall assessment of study medication was done by participants. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good. (NCT00634543)
Timeframe: Day 43

,
InterventionPercentage of participants (Number)
BadNo changeGoodVery good
Gabapentin12.529.241.716.7
Tramadol Hydrochloride/ Acetaminophen4.529.950.814.9

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Overall Assessment of Study Medication by Investigator

Overall assessment of study medication was done by Investigator. Assessment was made on a scale of -2 to 2 where, -2=very bad, -1=bad, 0=no change, 1= good and 2=very good. (NCT00634543)
Timeframe: Day 43

,
InterventionPercentage of participants (Number)
BadNo changeGoodVery good
Gabapentin2.830.651.415.3
Tramadol Hydrochloride/ Acetaminophen031.350.817.9

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Change From Baseline in Short Form-36 (SF-36) Score at Day 43

The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health and mental health. Physical health includes physical functioning, role limitations due to physical health, pain and general health. Mantal health includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. (NCT00634543)
Timeframe: Baseline and Day 43

,
InterventionUnits on a scale (Mean)
Baseline: Phiysical functioning (n=71,76)Change at Day 43: Physical functioning (n=63, 68))Baseline: Physical role limitation (n=71,76)Change at Day 43:Physical role limitation(n=62,68)Baseline: Pain (n=71,76)Change at Day 43: Pain (n=63, 68)Baseline: General health (n=71,76)Change at Day 43: General health (n=63, 68)Baseline: Emotional role limitation (n=71,76)Change at Day43:Emotional role limitation(n=63,68)Baseline: Energy/Fatigue (n=71,76)Change at Day 43: Energy/Fatigue (n=63, 68)Baseline: Emotional well-being (n=71,76)Change at Day 43: Emotional well being (n=63, 68)Baseline: Social functioning (n=71,76)Change at Dya 43: Social functioning (n=63, 68)
Gabapentin60.63.249.310.750.810.440.34.450.418.142.610.061.47.072.25.5
Tramadol Hydrochloride/ Acetaminophen56.33.242.313.749.315.638.04.646.912.739.45.757.25.368.39.9

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Clinical Global Impression of Change (CGIC)

"Investigator assessment of patient's overall PHN symptoms at end of treatment period (Week 10) compared to overall PHN symptoms at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)." (NCT00636636)
Timeframe: 10 weeks

InterventionParticipants (Number)
G-ER97
Placebo78

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Average Daily Sleep Interference Score

Assessed on 11-point numeric rating scale (where 0 = pain does not interfere with sleep, 10 = pain completely interferes with sleep); evaluated from daily sleep entry in electronic diary. Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily sleep interference score from baseline to final week of treatment period (Week 10). (NCT00636636)
Timeframe: 10 weeks

InterventionScores on a scale (Least Squares Mean)
G-ER-2.30
Placebo-1.59

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Mean Change in Baseline Observation Carried Forward (BOCF) Average Daily Pain Score

Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in baseline observation carried forward (BOCF) average daily pain score from baseline to the final week of efficacy treatment period (Week 10). (NCT00636636)
Timeframe: 10 weeks

InterventionScores on a scale (Least Squares Mean)
G-ER-2.12
Placebo-1.63

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Mean Change in Last Observation Carried Forward (LOCF) Average Daily Pain Score

Average daily pain scored on 11-point numerical rating scale (where 0 = no pain, 10 = worst possible pain). Results presented as least squares (LS) mean change in last observation carried forward (LOCF) average daily pain score from baseline to final week of efficacy treatment period (Week 10). (NCT00636636)
Timeframe: 10 weeks

InterventionScores on a scale (Least Squares Mean)
G-ER-2.40
Placebo-1.85

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Patient Global Impression of Change (PGIC)

"Patient self-assessment of how much pain had changed at end of treatment period (Week 10) compared to pain at baseline; scored on 7-point numerical rating scale (where 1 = very much improved, 7 = very much worse). Results presented as number of participants categorized at end of treatment (Week 10) as very much improved (score = 1) or much improved (score = 2)." (NCT00636636)
Timeframe: 10 weeks

InterventionParticipants (Number)
G-ER94
Placebo77

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Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data

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)

,,,,
Interventionscores on a scale (Least Squares Mean)
Tension/Anxiety Domain ScoreDepression/Rejection Domain ScoreAnger/Hostility Domain ScoreVigor/Activity Domain ScoreFatigue/Inertia Domain ScoreConfusion/Bewilderment Domain Score
GEn 1200 mg/Day-0.6-0.2-0.8-0.1-0.50.2
GEn 2400 mg/Day-0.7-0.6-0.50.1-1.1-0.1
GEn 3600 mg/Day-0.9-0.3-0.30.7-1.10.0
PGB 300 mg/Day-0.30.4-0.3-0.4-0.1-0.2
Placebo-1.0-0.5-0.50.6-0.8-0.3

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Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data

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)

,,,,
Interventionscores on a scale (Least Squares Mean)
SF-MPQ Total ScoreSF-MPQ Sensory ScoreSF-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

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Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data

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)

,,,,
Interventionscores on a scale (Least Squares Mean)
NPS 10 ScoreNPS 8 ScoreNPS Non-Allodynic ScoreNPS 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

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Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data

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)

,,,,
Interventionscores on a scale (Least Squares Mean)
SF-36 Physical Component Summary ScoreSF-36 Mental Component Summary Score
GEn 1200 mg/Day3.50.4
GEn 2400 mg/Day3.71.5
GEn 3600 mg/Day4.61.6
PGB 300 mg/Day3.70.7
Placebo3.12.5

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Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data

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

,,,,
Interventionscores on a scale (Least Squares Mean)
Brief Pain Inventory Severity of PainBrief 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

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Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data

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)

,,,,
Interventionparticipants (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 baseline100% reduction from baseline
GEn 1200 mg/Day55433631282621171154
GEn 2400 mg/Day504234251915116521
GEn 3600 mg/Day101917866554641251785
PGB 300 mg/Day55423628201495433
Placebo103867357463526151143

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Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data

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)

Interventionscores 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

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Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT

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)

Interventionscores 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

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Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data

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)

Interventionscores 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

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Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data

"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)

Interventionscores 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

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Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data

"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)

Interventionscores 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

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Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data

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)

Interventionmilligrams (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

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Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data

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)

Interventionscores 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

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Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data

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)

Interventionscores 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

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Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data

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)

Interventionscores 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

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Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data

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)

Interventionscores 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

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Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data

"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)

Interventionparticipants (Number)
Placebo39
GEn 1200 mg/Day20
GEn 2400 mg/Day22
GEn 3600 mg/Day50
PGB 300 mg/Day17

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Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data

"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)

Interventionparticipants (Number)
Placebo46
GEn 1200 mg/Day22
GEn 2400 mg/Day24
GEn 3600 mg/Day53
PGB 300 mg/Day62

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Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score

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)

Interventiondays (Median)
Placebo24
GEn 1200 mg/Day25
GEn 2400 mg/Day22
GEn 3600 mg/Day15
PGB 300 mg/Day29

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Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites

Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine. (NCT00654953)
Timeframe: 70 days

InterventionDays to relapse (two consec coc+ urines) (Mean)
Placebo19.93
Sertraline23.38
Sertraline Plus Gabapentin17.27

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Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). One woman in the hypnotherapy arm and 3 women in the gabapentin arm stopped keeping their diary before the 8 week mark." (NCT00711529)
Timeframe: Week 8

Interventiondaily hot flashes (Median)
Hypnotherapy1
Gabapentin3

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Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 4

Interventionunits on a scale (severity score) (Median)
Hypnotherapy6.5
Gabapentin4

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Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Baseline

Interventionunits on a scale (severity score) (Median)
Hypnotherapy10
Gabapentin7.5

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Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). Of the 13 women randomized to the hypnotherapy arm, 2 women were ineligible and therefore not included in analysis. Two women were unable to initiate treatment and did not submit diaries. An additional two women completed treatment but lost their diaries, leaving 7 diaries for analysis at baseline. Of the 14 randomized to receive gabapentin, 6 dropped out of the study and did not submit diaries." (NCT00711529)
Timeframe: Baseline

Interventiondaily hot flashes (Median)
Hypnotherapy5
Gabapentin4.5

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Hot Flash Severity Score

The patients kept daily hot flash diaries, including the total number of hot flashes they characterized as mild, moderate,severe and very severe. Hot flash severity scores were calculated by assigning one point to each mild hot flash, two points for each moderate hot flash, three points for each severe hot flash and four points for each very severe hot flash. The hot flash severity score for a 24 hour period was the sum of these scores. The score was calculated for each day in the diary. For each subject, median scores were calculated for each week (7 day period) of participation. The median hot flash severity score for the first week was considered the baseline. The median hot flash severity score for the fourth week is considered the week 4 time point. The median hot flash severity score for the eighth week is considered the week 8 time point. The median result for the group was then calculated at each of the timepoints. (NCT00711529)
Timeframe: Week 8

Interventionunits on a scale (severity score) (Median)
Hypnotherapy1.5
Gabapentin5

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Number of Daily Hot Flashes

"Patients kept daily diaries of their hot flashes. The absolute number of hot flashes in a 24 hour period is number of daily hot flashes. The median number was calculated for each week of data. The median number of daily hot flashes for the first week (7 days) of participation is used as baseline. The median number of daily hot flashes for the fourth week (over 7 day interval) is reported for the week four time point. The median number of daily hot flashes for the eighth week (over 7 day interval) is reported for the week eight time point (study completion). A total of 15 diaries were submitted (7 hypnotherapy, 8 gabapentin). One person in each arm stopped recording in her diary before the 4 week mark." (NCT00711529)
Timeframe: Week 4

Interventiondaily hot flashes (Median)
Hypnotherapy4
Gabapentin4

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Number of Ondansetron Doses Administered for Nausea

The number of doses of Ondansetron given for nausea to participants in both groups. (NCT00726999)
Timeframe: First 10 days after surgery

Interventiondoses of medication administered (Median)
Gabapentin Group2.0
Placebo Group2.0

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Amount of Morphine Consumed (mg/kg/hr)

Patients are taken to the PARU immediately after surgery, and typically remain for a period of 1 hour. (NCT00726999)
Timeframe: PARU (Postanesthesia Recovery Unit - participants typically remain in PARU for 1 hour)

Interventionmg/kg/h (Mean)
Gabapentin/Morphine0.064
Placebo/Morphine0.044

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Amount of Morphine Consumed (mg/kg/hr)

(NCT00726999)
Timeframe: Day 2

Interventionmg/kg/h (Mean)
Gabapentin/Morphine0.047
Placebo/Morphine0.036

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Amount of Morphine Consumed (mg/kg/hr)

(NCT00726999)
Timeframe: Day 1

Interventionmg/kg/h (Mean)
Gabapentin/Morphine0.055
Placebo/Morphine0.046

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Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the REM Sleep Stage at Week 4/10

Percentage of stage REM sleep time was defined as the time spent in stage REM sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionpercentage of total sleep time (Least Squares Mean)
Placebo-0.49
GEn 1200 mg-0.71

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Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N3 Sleep Stage at Week 4/10

Percentage of stage N3 sleep time was defined as the time spent in stage N3 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionpercentage of total sleep time (Least Squares Mean)
Placebo0.57
GEn 1200 mg2.62

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Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N2 Sleep Stage at Week 4/10

Percentage of stage N2 sleep time was defined as the time spent in stage N2 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionpercentage of total sleep time (Least Squares Mean)
Placebo0.16
GEn 1200 mg0.64

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Adjusted Mean Change From Baseline in the Percentage of Total Sleep Time Spent in the N1 Sleep Stage at Week 4/10 Using LOCF

Percentage of stage N1 sleep time was defined as the time spent in stage N1 sleep divided by total sleep time. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionpercentage of total sleep time (Least Squares Mean)
Placebo-0.23
GEn 1200 mg-2.55

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Adjusted Mean Change From Baseline in the Number of Awakenings Measured Objectively by Polysomnography at Week 4/10 Using LOCF

The number of awakenings was measured by PSG and is defined as the number of wake periods lasting at least 1 minute. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionawakenings (Least Squares Mean)
Placebo-0.56
GEn 1200 mg-3.04

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Adjusted Mean Change From Baseline in the Item 4 (Sleep Disturbance) Scores of the IRLS Rating Scale at Week 4/10 Using LOCF

"The IRLS is a measure of RLS disease severity. Item 4 of the IRLS evaluates RLS-related sleep impairment. It asks: In the past week, how severe was your sleep disturbance due to your RLS symptoms?. The item is participant rated using a 5-point scale, where 0 is the absence of any sleep disturbance and 4 is very severe disturbance. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects." (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo-1.47
GEn 1200 mg-2.27

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Adjusted Mean Change From Baseline in the International Restless Legs Rating Scale (IRLS) Total Score at Week 4/10 Using LOCF

The IRLS is a measure of RLS disease severity. Ten items (individually scored from 0 to 4) are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total scale score is a sum of all of the individual item scores and ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo-8.42
GEn 1200 mg-14.99

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Adjusted Mean Change From Baseline in the Clinical Global Impression of Illness - Severity (CGI-S) Score at Week 4/10 Using LOCF

The CGI-S scale allows the investigator to rate the severity of participants' illness considering their total clinical experience with the participant population being studied and based on all information available at the time of rating. The scale is rated from 1-7 (1=Normal, not at all ill; 7=Among the most extremely ill patients). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo-1.18
GEn 1200 mg-2.43

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Adjusted Mean Change From Baseline in Sleep Quality at Week 4/10 as Measured by the Subjective Post Sleep Diary (SPSD) Using LOCF

Each day upon awakening, participants rated their overall sleep quality for the previous night on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to sleep quality was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo0.85
GEn 1200 mg1.95

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Adjusted Mean Change From Baseline in Periodic Limb Movements Causing Awakening (PLMAWI) at Week 4/10 as Measured by Polysomnography Using LOCF

PLMAWI is defined as the number of PLMs (involuntary leg movements) that caused participants to wake up per hour of sleep. It is calculated by dividing the number of PLMs causing awakening by the total number of hours of sleep. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionnumber of PLMs/total hours of sleep (Least Squares Mean)
Placebo-0.08
GEn 1200 mg-0.22

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Number of PLMAI Responders at Week 4/10 Using LOCF

PLMAI is defined as the number of PLMs associated with arousal per hour of sleep. Participants with <=5 PLMAI were evaluated as responders. (NCT00748098)
Timeframe: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionparticipants (Number)
Placebo44
GEn 1200 mg64

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"Number of Participants Who Self-reported Very Satisfied or Satisfied With the Investigational Product at Week 4/10 Using LOCF"

"Participant satisfaction with RLS medication was captured on a seven-point ordinal scale. The scale asked Overall, how satisfied are you with the medication you received for the treatment of your RLS symptoms during the study. The participant responses ranged from 1 (Very satisfied) to 7 (Very dissatisfied). A satisfied response was scored a 2." (NCT00748098)
Timeframe: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

,
Interventionparticipants (Number)
Very SatisfiedSatisfied
GEn 1200 mg3835
Placebo2223

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Number of Participants Who Responded Affirmatively to Each of the 4 Items of the Participant-completed Patient Global Impression of Therapy at Week 4/10 Using LOCF

"Each participant completed the participant-completed Patient Global Impression questionnaire at the end of each Treatment Period (Weeks 4 and 10) or Early Withdrawal. This instrument was developed to capture a participant's subjective assessment of therapy and is composed of the following 4 questions with dichotomous (Yes or No) responses: Helped me sleep, Helped me fall asleep faster, Helped me sleep longer, and Helped me get a better night's sleep." (NCT00748098)
Timeframe: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

,
Interventionparticipants (Number)
Helped me sleepHelped me fall asleep fasterHelped me sleep longerHelped me get a better night's sleep
GEn 1200 mg95778089
Placebo53393150

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Adjusted Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF

PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionlimb movements per hour (Least Squares Mean)
Placebo-1.52
GEn 1200 mg-4.59

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Number of Participants With no Self-reported Awakenings (SPSD) Due to RLS at Week 4/10 Using LOCF

Each day upon awakening, participants recorded, using the SPSD, the number of awakenings due to RLS they experienced the previous night. Number of awakenings was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. (NCT00748098)
Timeframe: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionparticipants (Number)
Placebo68
GEn 1200 mg87

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Mean Change From Baseline in the Total Time Spent in Stage N3 Sleep Time at Week 4/10 Measured by PSG Using LOCF

Stage N3 is referred to as deep sleep; it is very difficult to wake a participant in this stage of sleep. In deep sleep, there is no eye movement or muscle activity. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo2.89
GEn 1200 mg15.02

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Adjusted Mean Change From Baseline in Wake Time During Sleep (WTDS) at Week 4/10 Measured by Polysomnography (PSG) (Sleep Study) Using Last Observation Carried Forward (LOCF)

"PSG is a comprehensive recording of the bio-physiological changes that occur during sleep. It is also known as a sleep study that monitors participants as they sleep or try to sleep. WTDS, defined as the total amount of time spent awake after falling asleep until the last awakening, was measured by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects." (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo-6.02
GEn 1200 mg-32.02

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Adjusted Mean Change From Baseline in Time Spent in the REM (Rapid Eye Movement) Sleep Stage at Week 4/10 as Measured by Polysomnography Using LOCF

In REM sleep, a participant's breathing becomes more rapid, irregular, and shallow; eyes jerk rapidly; and limb muscles are temporarily paralyzed. Brain waves during this stage increase to levels experienced when a person is awake. This is the stage when most dreams occur. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo-1.21
GEn 1200 mg4.22

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Adjusted Mean Change From Baseline in Time Spent in the N2 Sleep Stage as Measured by Polysomnography at Week 4/10 Using LOCF

In stage N2 of sleep, eye movement stops and brain waves become slower, with only an occasional burst of rapid brain waves. Participants may also experience spontaneous periods of muscle tone mixed with periods of muscle relaxation. During this stage, muscular activity, and conscious awareness of the external environment disappears. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo2.78
GEn 1200 mg22.95

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Adjusted Mean Change From Baseline in Time Spent in N1 Sleep as Measured by Polysomnography at Week 4/10 Using LOCF

"Stage N1 is considered light sleep, during which participants drift in and out of sleep and can be awakened easily. In this stage, the eyes move slowly and muscle activity slows. This stage is sometimes referred to as somnolence or drowsy sleep. Sudden twitches and hypnic jerks may be associated with the onset of sleep during N1. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects." (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo-0.95
GEn 1200 mg-6.19

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Adjusted Mean Change From Baseline in the Wake After Sleep Onset (WASO) Measured by Polysomnography (PSG) at Week 4/10 Using LOCF.

Wake After Sleep Onset (WASO) is defined as the total amount of time spent awake after falling asleep until the end of PSG recording. This endpoint is measured objectively by PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo-3.76
GEn 1200 mg-32.24

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Adjusted Mean Change From Baseline in the Total Sleep Time Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Total sleep time is the number of minutes participants slept on average during the 8-hour polysomnography. Scoring of PSG data to yield measure of total sleep time was conducted at a central site in the United States. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes (Least Squares Mean)
Placebo3.62
GEn 1200 mg36.32

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Adjusted Mean Change From Baseline in the Suggested Immobilization Test (SIT) PLM Index at Week 4/10

During the SIT, participants sat in bed with legs extended for 1 hour and were asked to rate their leg discomfort on a 100 millimeters visual analog scale every 5 minutes (score of 0-100, 0=none, higher numbers indicate more discomfort) and PLMs were assessed. The SIT-PLM Index is defined as the number of PLMs per hour during the SIT. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionnumber of PLMs per hour (Least Squares Mean)
Placebo-3.73
GEn 1200 mg-30.52

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Adjusted Mean Change From Baseline in the Self-reported Number of Hours Spent Awake During the Night (SPSD) Due to RLS at Week 4/10 Using LOCF

Each day upon awakening, participants recorded, using the SPSD, the total number of hours spent awake the previous night due to RLS. Response to number of hours awake was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionhours (Least Squares Mean)
Placebo-0.45
GEn 1200 mg-0.56

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Adjusted Mean Change From Baseline in the Sleep Efficiency Measured by Polysomnography (PSG) at Week 4/10 Using LOCF

Sleep efficiency is a percentage that is calculated by dividing total sleep time by the amount of time the participant was in bed during the PSG. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effect. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionminutes/hour (Least Squares Mean)
Placebo0.76
GEn 1200 mg7.57

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Adjusted Mean Change From Baseline in the SIT MDS (Mean Leg Discomfort Score), Mean of Scores From 0 to 60 Minutes, at Week 4/10

During the SIT, participants sat in bed with legs extended for 1 hour and rated their leg discomfort on a visual analog scale every 5 minutes (range 0-100, 0=none, higher numbers indicate more discomfort). The SIT MDS is the average rating of leg discomfort during the specified time frame. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. Only results from SITs performed before a PSG assessment and of at least 60 minutes in length are included in the analysis. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo-8.57
GEn 1200 mg-21.24

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"Number of Participants Who Were Defined as Clinical Global Impression of Illness (CGI-I) Scale Responders at Week 4/10 Using LOCF"

"The CGI-I scale allows the investigator to rate the participant's global improvement or worsening compared with the condition at baseline (i.e., Day 1), and whether or not the change is thought to be due to treatment with study medication. The scale is rated from 1-7 (1=Very much improved to 7=Very much worse). Participants with a score of 1 (Very much improved) or 2 (Much improved) are considered to be responders." (NCT00748098)
Timeframe: Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionparticipants (Number)
Placebo46
GEn 1200 mg91

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Adjusted Mean Change From Baseline in Participant's Ratings of Feeling Rested Upon Awakening as Measured by the Subjective Post Sleep Diary (SPSD) at Week 4/10 Using LOCF.

Each day upon awakening, participants rated how rested they felt upon awakening on an 11-point scale (0=poor to 10=excellent) using the SPSD. Response to feeling rested upon awakening was calculated for each visit by averaging the last 7 available diary days. Only participants with at least 4 days of diary data available (not in consecutive order) at any visit were included in the analysis. Change from baseline was calculated as the Week 4 and Week 10 values minus the baseline value. Mean change from baseline was adjusted for treatment, pooled center, and period effects. (NCT00748098)
Timeframe: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10)

Interventionscores on a scale (Least Squares Mean)
Placebo0.83
GEn 1200 mg1.68

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Change From Baseline in Average Daily Frequency of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo

Change from baseline in average daily frequency of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. (NCT00755417)
Timeframe: Form baseline to 12 weeks

InterventionModerate or severe hot flashes (Least Squares Mean)
G-ER 1200 mg-7.4
G-ER 1800 mg-7.4
Sugar Pill-6.9

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Change From Baseline in Average Daily Severity Score of Hot Flashes After 12 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo

Change from baseline in average daily severity score of moderate to severe hot flashes after 12 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale were 1=Mild, 2=Moderate, and 3=Severe. (NCT00755417)
Timeframe: From baseline to 12 weeks

InterventionScore on a numerical scale (Least Squares Mean)
G-ER 1200 mg-0.7
G-ER 1800 mg-0.7
Sugar Pill-0.5

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Change From Baseline in Average Daily Severity Score of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo

Change from baseline in average daily severity score of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. Severity score is on a 3-point scale where 1=Mild, 2=Moderate, and 3=Severe. (NCT00755417)
Timeframe: From baseline to 4 weeks

InterventionScore on a numerical scale (Least Squares Mean)
G-ER 1200 mg-0.5
G-ER 1800 mg-0.6
Sugar Pill-0.3

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Change From Baseline in Average Daily Frequency of Hot Flashes After 4 Weeks of Treatment With Daily Doses of G-ER 1200 mg or G-ER 1800 mg Compared to Placebo

Change from baseline in average daily frequency of moderate to severe hot flashes after 4 weeks of treatment with stable daily doses of G-ER 1200 mg or G-ER 1800 mg compared with placebo, using last observation carried forward (LOCF) method of imputation for missing data in intent-to-treat (ITT) population. (NCT00755417)
Timeframe: From baseline to 4 weeks

InterventionModerate or severe hot flashes (Least Squares Mean)
G-ER 1200 mg-6.8
G-ER 1800 mg-7.3
Sugar Pill-5.8

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Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 12 Weeks of Treatment

"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe." (NCT00777023)
Timeframe: At baseline and 12 weeks of treatment

InterventionUnits on a scale (Least Squares Mean)
G-ER 1200 mg-0.8
G-ER 1800 mg-0.8
Sugar Pill-0.5

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Change From Baseline in Average Daily Severity Score of Moderate or Severe Hot Flashes After 4 Weeks of Treatment

"Mean change from baseline in average daily severity score of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis.~Severity of hot flashes is scored on a scale of 1 to 3 where 1=mild, 2=moderate, 3=severe." (NCT00777023)
Timeframe: At baseline and 4 weeks of treatment

InterventionUnits on a scale (Least Squares Mean)
G-ER 1200 mg-0.5
G-ER 1800 mg-0.6
Sugar Pill-0.4

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Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 4 Weeks of Treatment

Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 4 of treatment relative to placebo; last observation carried forward (LOCF) analysis (NCT00777023)
Timeframe: At baseline and 4 weeks of treatment

InterventionHot flashes (Least Squares Mean)
G-ER 1200 mg-7.0
G-ER 1800 mg-6.9
Sugar Pill-5.4

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Change From Baseline in Average Daily Frequency of Moderate or Severe Hot Flashes After 12 Weeks of Treatment

Mean change from baseline in average daily number of moderate or severe hot flashes at stable dose week (SDW) 12 of treatment relative to placebo; last observation carried forward (LOCF) analysis (NCT00777023)
Timeframe: At baseline and 12 weeks of treatment

InterventionHot flashes (Least Squares Mean)
G-ER 1200 mg-7.7
G-ER 1800 mg-7.3
Sugar Pill-6.2

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Ratio of Observed Plasma Gabapentin Concentration to Individual Predicted Plasma Gabapentin Concentration

Ratio of observed plasma gabapentin concentration to individual predicted plasma gabapentin concentration were calculated on Day 8 and Day 15, respectively. (NCT00785772)
Timeframe: Days 8 and 15

InterventionRatio (Number)
Day 8Day 15
Gabapentin1.151.37

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Ratio of Observed Plasma Gabapentin Concentration to Predicted Plasma Gabapentin Concentration Based on Population Pharmacokinetics Model

Ratio of observed plasma gabapentin concentration to predicted plasma gabapentin concentration based on population pharmacokinetics model were calculated on Day 8 and Day 15, respectively. (NCT00785772)
Timeframe: Days 8 and 15

InterventionRatio (Number)
Day 8Day 15
Gabapentin2.162.59

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Observed Plasma Gabapentin Concentration

Plasma gabapentin concentrations were measured on Day 8 and Day 15 (NCT00785772)
Timeframe: Days 8 and 15

Interventionµg/mL (Mean)
Day 8Day 15
Gabapentin38.4044.64

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Level of Pain

level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) (NCT00793910)
Timeframe: 4 days postoperatively

Interventionunits on a scale (Mean)
Gabapentin1.30
Placebo1.86

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Occurence of Use of Rescue Medication

Occurrence of use of either ketorolac eyedrops(Acular) or oxycodone-acetaminophen tablet (Percocet), or both was measured (NCT00793910)
Timeframe: 2 hours to 4 days postoperatively

Intervention# of times rescue meds were used (Mean)
Gabapentin7.54
Placebo7.15

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Level of Pain

level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) (NCT00793910)
Timeframe: 3 days postoperatively

Interventionunits on a scale (Mean)
Gabapentin2.09
Placebo2.58

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Level of Pain

level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) (NCT00793910)
Timeframe: day 1 postoperatively

Interventionunits on a scale (Mean)
Gabapentin3.00
Placebo4.00

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Level of Pain

level of pain was measured using the Visual Analog Scale (VAS)ranging from 0 (none) to 10 (worst possible pain) (NCT00793910)
Timeframe: 2 hours postoperatively

Interventionunits on a scale (Mean)
Gabapentin3.85
Placebo4.09

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Time to First Seizure

Number of days to first seizure after baseline. (NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)

Interventiondays (Mean)
All Antiepileptic Drugs35.9

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Change From Baseline to Month 6 in the Hospital Anxiety and Depression Scale (HADS)

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

Interventionscores on scale (Mean)
DepressionAnxiety
All Antiepileptic Drugs-0.5-0.6

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Change From Baseline to Month 6 in Quality of Life 10 Domains (QOLIE-10)

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

Interventionscores on scale (Mean)
EnergyEmotions (mood)Daily activitiesMental functionMedication effects (physical/ mental)Worry about seizures (impact of seizures)Overall quality of life
All Antiepileptic Drugs0.40.70.61.2-1.19.03.8

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Percent of Participants With Reduction in Number of Seizures >=25% and >=75% During the Last 3 Months of Treatment

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)

Interventionpercent of participants (Number)
Month 3: >=25%Month 3: >=75%Month 6: >= 25%Month 6: >=75%
All Antiepileptic Drugs86.727.886.754.4

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Percent of Participants Indicating Optimal Sleep on the Optimal Sleep Subscale: Medical Outcomes Study Sleep Scale (MOS-SS)

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

Interventionpercent of participants (Number)
BaselineMonth 6
All Antiepileptic Drugs56.565.7

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Percent of Participants Who Continued on Study Medication to Month 6

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

Interventionpercent of participants (Number)
All Antiepileptic Drugs97.1

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Change From Baseline to Months 3 and 6 in Health Condition: Euro Quality of Life Scale (EQ-5D) Visual Analog Scale (VAS)

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

Interventionscores on scale (Mean)
Month 3Month 6
All Antiepileptic Drugs-0.41.2

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Percent of Participants Classified as Responders

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)

Interventionpercent of participants (Number)
Month 3Month 6
All Antiepileptic Drugs76.780.0

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Change in Sleep Disturbances From Baseline to Month 6: Medical Outcomes Study Sleep Scale (MOS-SS)

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

Interventionscores on scale (Mean)
Sleep disturbanceSnoringAwake short of breathQuantityAdequacySomnolenceSleep problems (summary 6)Sleep problems (summary 9)
All Antiepileptic Drugs-1.70.01.10.22.80.6-0.9-0.9

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Percent of Participants Reaching Monotherapy

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)

Interventionpercent of partipants (Number)
All Antiepileptic Drugs2.9

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Percent of Seizure-free Participants During the Last 3 Months Before Discontinuation

(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent of participants (Number)
Month 3Month 6
All Antiepileptic Drugs10.020.0

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Percent Change From Baseline in the Median Number of Seizures During the Last 3 Months of Treatment

(NCT00855738)
Timeframe: Baseline, Month 3, Month 6 (last 3 months of treatment)

Interventionpercent change (Median)
All Antiepileptic Drugs-75.0

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Change From Baseline to Month 6 in Total Number of Days Hospitalized Because of Epilepsy

Numerical assessment of change in total number of days hospitalized because of epilepsy during the study. (NCT00855738)
Timeframe: Baseline to Month 6

InterventionDays (Mean)
All Antiepileptic Drugs-8.0

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Percent of Participants That Reduced, Maintained and Increased Their Doses of New Antiepileptic Drugs (AED)

(NCT00855738)
Timeframe: Baseline to Month 6 (or end of treatment)

Interventionpercent of participants (Number)
ReducedMaintainedIncreased
All Antiepileptic Drugs0.968.530.6

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Percent of Participants With Cessation of Occupation, Requirement of Caregiver, or Admission to Intensive Care Unit

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

Interventionpercent of participants (Number)
Stopped Usual OccupationRequired Informal CaregiverRequired Admission to ICU
All Antiepileptic Drugs16.26.60.0

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Percent of Participants That Reduced, Maintained and Increased the Doses of the Initial Treatment Administered in Monotherapy

(NCT00855738)
Timeframe: Baseline through Month 6 (or end of treatment)

Interventionpercent of participants (Number)
ReducedMaintainedIncreased
All Antiepileptic Drugs0.0100.00.0

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Change From Baseline to Month 6 in Visits to a Specialist or the Emergency Room Because of Epilepsy

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

Interventionvisits (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

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Comparison of Percentage of Complete Responders

Complete response being defined as no emetic episodes and no use of rescue therapy for days 2 through 6. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder. (NCT00880191)
Timeframe: Days 2 through 6

,
Interventionpercentage of participants (Number)
Response Days 2-6: NoResponse Days 2-6: Yes
Gabapentin53.146.9
Placebo59.240.8

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Comparison of Percentages of Complete Responders on Day 1, vs. Days 1 Through 6 vs. Days 2 Through 6.

The percentages of complete responders on day 1, vs. days 1 through 6 vs. days 2 through 6 will be compared between arms. Complete response being defined as no emetic episodes and no use of rescue therapy. If a patient does not complete the study or does not provide complete data, they will be assumed to be a non-responder. (NCT00880191)
Timeframe: Days 1 through 6

,
Interventionpercentage of participants (Number)
Response Day 1: NoResponse Day 1: YesResponse Day 1-6: NoResponse Day 1-6: YesResponse Day 2-6: NoResponse Day 2-6: Yes
Gabapentin32.467.660.439.662.337.7
Placebo33.566.563.636.46535

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Comparison of Sum of the Daily Distress Questions as Well as the Individual Daily Responses

The sum of the daily distress questions as well as the individual daily responses from the Nausea and Vomiting Diary (NVD) on a 0-10 scale (Lower score is better) will be compared. (NCT00880191)
Timeframe: Days 1 through 6

,
Interventionunits on a scale (Mean)
NVD Nausea Distress Day 1NVD Nausea Distress Day 2NVD Nausea Distress Day 3NVD Nausea Distress Day 4NVD Nausea Distress Day 5NVD Nausea Distress Day 6NVD Nausea Distress Sum Days 1-6
Gabapentin1.10.90.90.70.90.85.1
Placebo1.21.11.21.11.10.96.4

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Comparison of the Percentage of Patients Experiencing Emetic Episodes and the Percentage Needing Rescue Agents

The percentage of patients experiencing emetic episodes and the percentage needing rescue agents was compared between groups. (NCT00880191)
Timeframe: Days1 through 6

,
Interventionpercentage of participants (Number)
Rescue Agent Status: NoRescue Agent Status: YesEmetic Status: NoEmetic Status: Yes
Gabapentin55457030
Placebo47537030

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Level of Satisfaction for the Control of Nausea.

Level of satisfaction for the control of nausea with the mean severity of nausea over the six days in the diary (on a 0 - 10 scale, higher the better) as well as the nausea subscale on the Functional Living Index - Emesis (FLIE) questionnaire ( 1-7 scale, lower the better) (NCT00880191)
Timeframe: Days 1 through 6

,
Interventionunits on a scale (Mean)
Satisfaction Nausea Control (0-10 scale)FLIE Nausea Subscale Day 6
Gabapentin8.32.8
Placebo8.12.9

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Comparison of Daily Complete Response Endpoints

Daily complete response is defined as no emetic episodes and no use of rescue therapy. (NCT00880191)
Timeframe: Days 1 through 6

,
Interventionpercentage of participants (Number)
Response Day 1: NoResponse Day 1: YesResponse Day 2: NoResponse Day 2: YesResponse Day 3: NoResponse Day 3: YesResponse Day 4: NoResponse Day 4: YesResponse Day 5: NoResponse Day 5: YesResponse Day 6: NoResponse Day 6: Yes
Gabapentin32.467.626.673.422.277.819.380.732.967.128.072.0
Placebo33.566.536.463.634.565.530.169.934.066.031.668.4

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Complete Response

The primary analysis described above was repeated using a slightly different alternate definition of complete response: no emetic episodes, no more than a mean of 2.5 on the nausea numeric analogue scale (0 - 10 (As bad as it could be)), and no rescue agents. (NCT00880191)
Timeframe: Days 2-6

,
Interventionpercentage of participants (Number)
Response Days 2-6: NoResponse Days 2-6: Yes
Gabapentin5644
Placebo60.739.3

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Evaluate the Amount of Diluadid Given Postoperatively

The amount of intraoperative and postoperative opioids used will be collected and analyzed for the three different arms. (NCT00886236)
Timeframe: 120 hours

Interventionml (Mean)
1 Preoperative Gabapentin Liquid11.035
2 Preoperative and Postoperative Gabapentin Liquid8.7
3 Preoperative and Postoperative Placebo Liquid12.4

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Number of Participants Who Experience Incidence of Postoperative Nausea.

(NCT00886236)
Timeframe: 120 hours

InterventionParticipants (Count of Participants)
1 Preoperative Gabapentin Liquid12
2 Preoperative and Postoperative Gabapentin Liquid11
3 Preoperative and Postoperative Placebo Liquid12

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Evaluate Incidence of Respiratory Depression as Evidenced by Pulse Oximetry Data

(NCT00886236)
Timeframe: 48 hours

Intervention% oxygen saturation (Mean)
1 Preoperative Gabapentin Liquid93
2 Preoperative and Postoperative Gabapentin Liquid94
3 Preoperative and Postoperative Placebo Liquid95

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Change in logMAR Visual Acuity of Each Eye, Measured During Far or Near Viewing

(NCT00928954)
Timeframe: After 2 weeks of therapy, for both drugs

,
InterventionlogMAR (Number)
Participant 1, Right EyeParticipant 1, Left EyeParticipant 2, Right EyeParticipant 2, Left EyeParticipant 3, RIght EyeParticipant 3, Left EyePatricipant 4, RIght EyeParticipant 4, Left EyeParticipant 5, Right EyeParticpant 5, Left EyeParticpant 6, RIght EyeParticpant 6, Left EyeParticpant 7, Right EyeParticpant 7, Left EyeParticipant 8, Right EyeParticipant 8, Left EyeParticpant 9, Right EyeParticipant 9, Left EyeParticipant 10, Right EyeParticipant 10. Left Eye
Gabapentin00.20.10.2-0.1NA0.30.10.100.40.2-0.10.10.1000-0.10.1
Memantine0.10.20.20-0.2NA-0.10.10.20.100.20.10.100.1000.30.2

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Percent Change in Median Eye Speed

Median eye speed during attempted visual fixation by each eye (NCT00928954)
Timeframe: After 2 weeks of therapy, for both drugs

,
InterventionPercent change (Number)
Participant 1, Right EyeParticipant 1, Left EyeParticipant 2, Right EyeParticipant 2, Left EyeParticipant 3, RIght EyeParticipant 3, Left EyePatricipant 4, RIght EyeParticipant 4, Left EyeParticipant 5, Right EyeParticpant 5, Left EyeParticpant 6, RIght EyeParticpant 6, Left EyeParticpant 7, Right EyeParticpant 7, Left EyeParticipant 8, Right EyeParticipant 8, Left EyeParticpant 9, Right EyeParticipant 9, Left EyeParticipant 10, Right EyeParticipant 10. Left Eye
Gabapentin-59.1-69.8-19.9-19.8-53.5-41.3-72.8-76.6-56.6-42.0-26.0-25.949.526.5-0.9-0.7-39.5-44.1159104.4
Memantine-21.5-35.1-26.0-35.5-44.6-40.2-8.611.4-35.5-26.5-44.8-29.5-29.0-24.1-60.4-24.82.2-19.4-80.6-79.3

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Percentage of Negative Urinary Drug Screens (UDS) for Cannabis at 12 Weeks Following Administration of Gabapentin or Placebo During the Double Blind Period

Express Results Integrated Multi-Drug Screen Cups were used to obtain a semi-quantitative urine drug screen for delta-9-THC. Submitted UDS would yield a positive result when the concentration of THC-COOH in urine exceeded 50 ng/mL. Specimens were collected weekly. Two analytical approaches were used: one where any missed UDS test was assumed positive (i.e intent-to-treat (ITT)) and another where missed UDS were considered missing at random (MAR). (NCT00974376)
Timeframe: 12 weeks

,
Interventionpercentage of negative UDS (Mean)
% Negative UDS ITT% Negative UDS Observed
Gabapentin 1200mg/Day11.2212.48
Placebo8.009.93

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Wake Time After Sleep Onset (WASO) Measured in Sleep Laboratory Recordings Pre- and Post- Study Medication

Wake time after sleep onset (WASO) (number of minutes awake throughout the night after initial sleep onset) (NCT01014533)
Timeframe: 1 week

,
Interventionminutes (Mean)
pre-interventionpost-intervention
Gabapentin26.514.2
Placebo16.721.9

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Percentage of Total Sleep Time in Stage 2 Sleep Pre- and Post-study Medication (Stage 2 Percent)

Electrophysiological measures of sleep stages: percent of total sleep time in stage 2 sleep (NCT01014533)
Timeframe: 1 week

,
Interventionpercentage of total sleep time (Mean)
Stage 2 % pre-interventionStage 2 % post-intervention
Gabapentin53.859.6
Placebo51.350.2

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Relapse to Any Drinking

Relapse to any drinking is counted as participants who drank any beverage alcohol from end of sleep laboratory study (night 10) to twelve weeks later (NCT01014533)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Placebo13
Gabapentin14

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Number of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1

Complete response during delayed-onset phase was defined as the absence of any episode of nausea or vomiting and no use of rescue medication when occurring during the period from days 2 through 5 after chemotherapy (NCT01052844)
Timeframe: 6 days

Interventionparticipants (Number)
Control Group21
Gabapentin29

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Number of Patients With Complete Response During Chemotherapy Course 1

The CR was defined as no emetic episodes and no nausea episodes from day 1 to day 5 (0-120h) (NCT01052844)
Timeframe: 5 days

Interventionparticipants (Number)
Control Group17
Gabapentin26

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Count of Participants With Continued Pain at 6 Months

"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)." (NCT01067144)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Control37
Gabapentin42

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Time to Pain Resolution

"Time to pain resolution was defined as 5 consecutive reports of 0 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery." (NCT01067144)
Timeframe: Up to 2 years

Interventiondays (Median)
Control73
Gabapentin84

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Time to Opioid Cessation

Time to opioid cessation was defined as 5 consecutive reports of no opioid use. Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery. (NCT01067144)
Timeframe: Up to 2 years

Interventiondays (Median)
Control32
Gabapentin25

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Count of Participants With Continued Pain at 1 Year

"Continued pain was defined as a report of at least 1 average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain (0 = no pain) and higher scores corresponding to more pain)." (NCT01067144)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Control18
Gabapentin21

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Count of Participants With Continued Opioid Use at 6 Months

Continued opioid use was defined as any report of any continued opioid use at Month 6. (NCT01067144)
Timeframe: Month 6

InterventionParticipants (Count of Participants)
Control4
Gabapentin5

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Count of Participants With Continued Opioid Use at 1 Year

Continued opioid use was defined as any report of any continued opioid use at Year 1. (NCT01067144)
Timeframe: Year 1

InterventionParticipants (Count of Participants)
Control3
Gabapentin4

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Changes From Baseline in Quality of Life Scores, Measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL) to Weeks, 4, 12, 24 of the Efficacy Treatment Period.

"4 sub-categories each scored individually: Minimum value = 1, maximum value = 8.~Overall summary score was mean of the 4 sub-category scores (minimum = 1 and maximum = 8).~Lower scores indicate better outcome (ie, less severity)" (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

,
Interventionscores on a scale (Least Squares Mean)
Baseline LOCF MENQOL score at Week 4Baseline LOCF MENQOL score at Week 12Baseline LOCF MENQOL score at Week 24
G-ER 1800 mg-0.91-1.01-1.01
Sugar Pill-0.71-0.87-0.96

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G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.

"G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 24 of the efficacy treatment period compared with Baseline." (NCT01080300)
Timeframe: Baseline, Week 24

Interventionscores on a scale (Least Squares Mean)
G-ER 1800 mg-0.86
Sugar Pill-0.64

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G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Severity Score of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.

"G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily severity score of moderate to severe hot flashes in post menopausal women (score defined as Mild (1), Moderate (2), and Severe (3)) at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline." (NCT01080300)
Timeframe: Baseline, Week 4, and Week 12

,
Interventionscores on a scale (Least Squares Mean)
Baseline LOCF Average Daily Severity at Week 4Baseline LOCF Average Daily Severity at Week 12
G-ER 1800 mg-0.42-0.65
Sugar Pill-0.22-0.46

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G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Weeks 4 & 12 of the Efficacy Treatment Period, Compared With Baseline.

G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 4 of the efficacy treatment period compared with Baseline and at Week 12 of the efficacy treatment period compared with Baseline. (NCT01080300)
Timeframe: Baseline, Week 4, and Week 12

,
Interventionhot flashes (Least Squares Mean)
Baseline LOCF Average Daily Frequency at Week 4Baseline LOCF Average Daily Frequency at Week 12
G-ER 1800 mg-6.72-7.64
Sugar Pill-5.01-6.50

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Patient Global Impression of Change (PGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

"Proportion of patients who were categorized as very much or much improved for PGIC at Week 12 and Week 24. Scale range is 6 categories: minimum value = very much worse to maximum value = very much improved." (NCT01080300)
Timeframe: Week 12 and Week 24

,
InterventionParticipants (Count of Participants)
Baseline LOCF Proportion at Week 12Baseline LOCF Proportion at Week 24
G-ER 1800 mg173156
Sugar Pill130114

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Changes From Baseline in Sleep Quality Scores, Measured by the Insomnia Severity Index (ISI) to Week 4, Week 12, and Week 24 of the Efficacy Treatment Period.

Insomnia Severity Index (ISI) scored on 4-point Likert-scales ('0' not at all - '4' extremely) for 7 sub-categories. Final score is sum of each sub-category generating a total sleep quality score (0-28). Minimum value = 0, maximum value = 28 (Lower scores indicate better outcome (ie, less severity)). (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

,
Interventionscores on a scale (Least Squares Mean)
Change from Baseline to Week 4: LOCF ISI ratingChange from Baseline to Week 12: LOCF ISI ratingChange from Baseline to Week 24: LOCF ISI rating
G-ER 1800 mg-6.47-7.02-6.71
Sugar Pill-4.13-5.17-4.95

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Percent of Patients With 75% or Greater Reduction in Average Daily Frequency of Moderate to Severe Hot Flashes

(NCT01080300)
Timeframe: Baseline, Week 12, and Week 24

,
InterventionParticipants (Count of Participants)
Baseline LOCF Proportion at Week 12Baseline LOCF Proportion at Week 24
G-ER 1800 mg125146
Sugar Pill101122

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Percent of Patients With 75% or Greater Reduction in Average Daily Severity Score of Moderate to Severe Hot Flashes

(NCT01080300)
Timeframe: Baseline, Week 12, and Week 24

,
InterventionParticipants (Count of Participants)
Baseline LOCF Average Daily Score at Week 12Baseline LOCF Average Daily Score at Week 24
G-ER 1800 mg4862
Sugar Pill3648

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Safety of G-ER Measuring Columbia-Suicide Severity Rating Scale (C-SSRS).

"Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects were classified as 0=no suicidal ideation or 1=suicidal ideation. Outcome Measure is number of participants with or without suicidal ideation.~Higher counts without suicidal ideation = better outcome." (NCT01080300)
Timeframe: Week 4, Week 12, Week 24/Early Termination, Week 28

InterventionParticipants (Count of Participants)
Patients Taking C-SSRS at Week 472302449Patients Taking C-SSRS at Week 472302448Patients Taking C-SSRS at Week 1272302448Patients Taking C-SSRS at Week 1272302449Patients Taking C-SSRS at Week 24/EarlyTermination72302448Patients Taking C-SSRS at Week 24/EarlyTermination72302449Patients Taking C-SSRS at Week 2872302448Patients Taking C-SSRS at Week 2872302449
Without Suicidal IdeationWith Suicidal Ideation
Gabapentin Extended Release260
Placebo257
Placebo0
Gabapentin Extended Release224
Placebo215
Gabapentin Extended Release0
Placebo1
Gabapentin Extended Release271
Placebo266
Gabapentin Extended Release1
Gabapentin Extended Release256
Placebo243

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G-ER at 1800mg Daily Compared With Placebo in Reducing the Average Daily Frequency of Moderate to Severe Hot Flashes at Week 24 of the Efficacy Treatment Period, Compared With Baseline.

G-ER dosed at 1800mg daily(600mg AM, 1200mg PM), compared with placebo in reducing the average daily frequency of moderate to severe hot flashes in post menopausal women at Week 24 of the efficacy treatment period compared with Baseline. (NCT01080300)
Timeframe: Baseline, Week 24

Interventionhot flashes (Least Squares Mean)
G-ER 1800 mg-8.99
Sugar Pill-7.91

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Change From Baseline to Weeks 4, Week 12, and Week 24 in Average Daily Sleep Interference Score.

Sleep Interference Score Range: Minimum value = 0, maximum value = 10 Lower scores indicate better outcome (ie, less interference) (NCT01080300)
Timeframe: Baseline, Week 4, Week 12, and Week 24

,
Interventionunits on a scale (Least Squares Mean)
Change from Baseline to Week 4: LOCF daily ratingChange from Baseline to Week 12: LOCF daily ratingChange from Baseline to Week 24: LOCF daily rating
G-ER 1800 mg-2.67-3.09-3.15
Sugar Pill-1.31-2.17-2.20

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Clinical Global Impression of Change (CGIC) Scales at Weeks 12 and 24 of the Efficacy Treatment Period.

"Proportion of patients who were categorized as very much or much improved in CGIC at Week 12 and Week 24. Scale range is 6 categories: minimum value = very much worse to maximum value = very much improved." (NCT01080300)
Timeframe: Week 12 and Week 24

,
InterventionParticipants (Count of Participants)
Baseline LOCF Proportion at Week 12Baseline LOCF Proportion at Week 24
G-ER 1800 mg173159
Sugar Pill122124

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Average Pain (0-120 Seconds): Cold Pain Test Visual Analog Scale (VAS)

"Area under the cold pain test Visual Analog Scale (VAS) time curve (AUCcpt 0 to 120 seconds [sec]) averaged over the 120 sec for each time point assessed. Participant adjusted 100 millimeter (mm) electronic VAS with range of no pain (0) to maximum pain (100) at the anchor endpoints of the scale and moderate pain at the midpoint. Pain reported while non-dominant hand was placed in thermostatically controlled water bath at 2±1°C for a maximum of 120 sec." (NCT01119222)
Timeframe: Pre-dose, 1, 1.5, 2, 4, and 8 hours post-dose

,,,
Interventionmm (Mean)
Pre-dose1 hour1.5 hours2 hours4 hours8 hours
Diphenhydramine45.045.142.340.544.243.8
Gabapentin45.241.939.440.441.944.7
Morphine45.528.626.125.634.736.7
Placebo44.938.440.239.544.344.2

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Interpolated Average Pain (0-8 Hours)

Interpolated average pain (0 to 8 hours): area under the curve (AUC) of average pain (0 to 120 seconds) recorded at each of the time points taken over 8 hour time period divided by 8. (NCT01119222)
Timeframe: Pre-dose to 8 hours post-dose

Interventionhours (Least Squares Mean)
Gabpentin42.2
Morphine33.4
Diphenhydramine43.6
Placebo42.8

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases309328141431251347
Controls2977383799129883444752

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Ever (without 2 year lag)Never (without 2 year lag)Ever (with 2 year lag)Never (with 2 year lag)
Cases563093243125
Controls2532977314329883

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases309330121431251437
Controls2977399649029883484946

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Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases194991761968553
Controls1888045635818970242626

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Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.55 months), Tertile 2 (1.56 - 6.44 months), and Tertile 3 (6.45 - 78.36 months). Tertile's with 2 year lag: Tertile 1 (0.01 - 1.78 months), Tertile 2 (1.79 - 7.20 months), and Tertile 3 (7.21 - 64.13 months). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases1949151071968634
Controls1888044675518970233122

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Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (without 2 year lag)Never (without 2 year lag)Ever (with 2 year lag)Never (with 2 year lag)
Cases321949131968
Controls166188807618970

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Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident renal cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions),Tertile 2 (3-8 prescriptions), and Tertile 3 (9-218 prescriptions). Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-10 prescriptions),Tertile 3 (11-191 prescriptions). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases1949161151968643
Controls1888058555318970272821

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: Without 2 year lag = Gabapentin exposure from cohort entry to index date. With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Tertile's without 2 year lag: Tertile 1 (0.01 - 33.6 grams), Tertile 2 (33.7 - 185.0 grams), and Tertile 3 (185.1 - 7500.2 grams). Tertile's with 2 year lag: Tertile 1 (0.01 - 39.0 grams), Tertile 2 (39.1 - 210.0 grams), and Tertile 3 (210.1 - 5623.8 grams). (NCT01138124)
Timeframe: The case index date (ID) was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control ID was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)
Cases309328141431251176
Controls2977388749129883464750

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Percent Days of Abstinence From Alcohol

During the course of 8 weeks the medication aims to determine whether it is effective in reducing alcohol consumption, and promoting abstinence in alcohol-dependent patients. (NCT01141049)
Timeframe: assessed for up to 8 weeks, presented at week 8 of trial

Interventionpercent of days abstinent (Mean)
Gabapentin50
Placebo27.5

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Percent of Heavy Drinking Days Per Week

percent of heavy drinking days as defined as 5 drinks per day for males and 4 drinks per day for females over the course of a study week. (NCT01141049)
Timeframe: assesed over 8 weeks, presented for week 8 of trial

Interventionpercent of heavy drinking days (Mean)
Gabapentin22.5
Placebo53.9

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Median Anxiety Score at Time of Discharge

Assess the effect of a single 900mg dose of gabapentin on anxiety at time of discharge, measured by a visual analog scale ranging from 0 (worst anxiety) to 100 (no anxiety). (NCT01143766)
Timeframe: At time of discharge post-procedure

Interventionunits on a scale (Median)
Standard Sedation99
Gapabentin98

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Median Nausea Score at Time of Discharge

Assess the effect of a single 900mg dose of gabapentin on nausea at time of discharge, measured by a visual analog scale ranging from 0 (worst nausea) to 100 (no nausea). (NCT01143766)
Timeframe: At time of discharge post-procedure

Interventionunits on a scale (Median)
Standard Sedation99
Gapabentin95

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Dosing Requirements

Assess the effect of a single 900mg dose of gabapentin pre- ERCP on intra and post procedure narcotic/sedative requirements. (NCT01143766)
Timeframe: At time of discharge post-procedure

InterventionTOTAL DOSE OF MEPERIDINE, mg (Median)
Standard Sedation100
Gapabentin100

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Median Pain Score at Time of Discharge

Assess the effect of a single 900mg dose of gabapentin on pain at time of discharge, measured by a visual analog scale ranging from 0 (worst pain) to 100 (no pain). (NCT01143766)
Timeframe: At time of discharge post-procedure

Interventionunits on a scale (Median)
Standard Sedation80
Gapabentin95

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Change in Pain Threshold Time From Baseline to Week 5

Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor. (NCT01210079)
Timeframe: baseline, 5 weeks

Interventionseconds (Mean)
Gabapentin2.95
Placebo-3.49

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Number of All-Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident All-cancer Patients178334319216269177409781413535
Matched Controls for Incident All-cancer Patients17044432739164521231698480528530334152

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Number of All-Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident All-cancer Patients178334157642517740930115976
Matched Controls for Incident All-cancer Patients17044431217463197169848024991207549

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Number of All-Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incidence of all cancers. Gabapentin Exposure Description: Without 2 year lag = Gabapentin prescription from cohort entry to index date. With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). (NCT01236053)
Timeframe: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident All-cancer Patients8041783341729177409
Matched Controls for Incident All-cancer Patients65071704443124701698480

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Number of All-Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident All-cancer Patients178334258269277177409620587522
Matched Controls for Incident All-cancer Patients17044432175216321691698480421341044153

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Number of All-Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incidence of all cancers. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident All-cancer Patients178334269268267177409640585504
Matched Controls for Incident All-cancer Patients17044432222211821671698480443838824150

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Number of Penile Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR/95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Penile Cancer Patients147100147100
Matched Controls for Incident Penile Cancer Patients13941011390132

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Number of Renal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Renal Cancer Patients12634321257564
Matched Controls for Incident Renal Cancer Patients1211415191912060324035

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Number of Renal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Renal Cancer Patients12633331257546
Matched Controls for Incident Renal Cancer Patients1211416221512060324431

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Number of Renal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Renal Cancer Patients91263151257
Matched Controls for Incident Renal Cancer Patients531211410712060

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Number of Renal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Renal Cancer Patients12632001257442
Matched Controls for Incident Renal Cancer Patients12114621120601673

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Number of Renal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident renal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident renal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Renal Cancer Patients12634231257636
Matched Controls for Incident Renal Cancer Patients1211421151712060462932

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Number of Stomach Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Stomach Cancer Patients18720321864364
Matched Controls for Incident Stomach Cancer Patients1778322212717733463143

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Number of Stomach Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.3-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 m.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Stomach Cancer Patients18720231864445
Matched Controls for Incident Stomach Cancer Patients1778324143217733443046

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Number of Stomach Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Stomach Cancer Patients51872131864
Matched Controls for Incident Stomach Cancer Patients70177832017733

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Number of Stomach Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident stomach cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Stomach Cancer Patients18722111864321
Matched Controls for Incident Stomach Cancer Patients17783158417733331911

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Pancreatic Cancer Patients2135965212015812
Matched Controls for Incident Pancreatic Cancer Patients2029633223120222564559

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Number of Anal Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Anal Cancer Patients208211207302
Matched Controls for Incident Anal Cancer Patients20611322052735

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Number of Breast Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Cases1946838243419390753267
Controls188199306182237187532577355460

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Number of Anal Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57 -105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Anal Cancer Patients208211207302
Matched Controls for Incident Anal Cancer Patients20611232052555

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Number of Anal Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident Anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Anal Cancer Patients42085207
Matched Controls for Incident Anal Cancer Patients62061152052

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Number of Anal Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident anal cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Anal Cancer Patients208000207200
Matched Controls for Incident Anal Cancer Patients20611112052311

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Number of Anal Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident anal cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident anal cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Anal Cancer Patients208211207302
Matched Controls for Incident Anal Cancer Patients20611232052735

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Number of Bladder Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bladder Cancer Patients4585645456714109
Matched Controls for Incident Bladder Cancer Patients434155251414326011210384

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Number of Bladder Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bladder Cancer Patients45855464567121110
Matched Controls for Incident Bladder Cancer Patients434155152414326011210087

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Number of Bladder Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Bladder Cancer Patients154585334567
Matched Controls for Incident Bladder Cancer Patients1444341529943260

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Number of Bladder Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Bladder Cancer Patients45852004567621
Matched Controls for Incident Bladder Cancer Patients43415217343260522410

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Number of Bladder Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident bladder cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident bladder cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bladder Cancer Patients45856364567131010
Matched Controls for Incident Bladder Cancer Patients43415683541432601387190

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Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bone/Joint Cancer Patients300000299100
Matched Controls for Incident Bone/Joint Cancer Patients29254602916838

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Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bone/Joint Cancer Patients300000299100
Matched Controls for Incident Bone/Joint Cancer Patients29254152916559

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Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Bone/Joint Cancer Patients03001299
Matched Controls for Incident Bone/Joint Cancer Patients102925192916

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Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident bone/joint cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Bone/Joint Cancer Patients300000299000
Matched Controls for Incident Bone/Joint Cancer Patients29253002916510

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Number of Bone/Joint Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident bone/joint cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident bone/joint cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Bone/Joint Cancer Patients300000299100
Matched Controls for Incident Bone/Joint Cancer Patients29254242916748

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Number of Breast Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Breast Cancer Patients1946831303519390664464
Matched Controls for Incident Breast Cancer Patients188199254225246187532493423476

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Number of Breast Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Breast Cancer Patients1946829323519390585264
Matched Controls for Incident Breast Cancer Patients188199245247233187532465473454

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Number of Breast Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Breast Cancer Patients961946817419390
Matched Controls for Incident Breast Cancer Patients7251881991392187532

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Number of Breast Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident breast cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident breast cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Breast Cancer Patients19468209219390462410
Matched Controls for Incident Breast Cancer Patients188199131542718753229113354

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Number of Stomach Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident stomach cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip]), T 2 (3-7 prescrip), T 3 (8-298 prescrip). Tertiles without 2 yr lag: T 1 (1-2 prescrip), T 2 (3-7 prescrip), and T 3 (8-388 prescrip). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident stomach cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Stomach Cancer Patients18720231864373
Matched Controls for Incident Stomach Cancer Patients1778329103117733551946

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Number of Lung Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 9600.0 grams). Tertile's without 2 year lag: Tertile 1 (0.1 - 30.0 grams), Tertile 2 (30.1 - 189.0 grams), and Tertile 3 (189.1 - 11610.0 grams). (NCT01236053)
Timeframe: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Lung Cancer Patients1080021161810700625637
Matched Controls for Incident Lung Cancer Patients102434139120143102053288224271

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Number of Lung Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Lung Cancer Patients1080021151910700674840
Matched Controls for Incident Lung Cancer Patients102434131130141102053267247269

[back to top]

Number of Lung Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Lung Cancer Patients551080015510700
Matched Controls for Incident Lung Cancer Patients402102434783102053

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Number of Lung Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Lung Cancer Patients1080010411070021114
Matched Controls for Incident Lung Cancer Patients102434752461020531677733

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Number of Lung Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident lung cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident lung cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Lung Cancer Patients1080024131810700813242
Matched Controls for Incident Lung Cancer Patients102434160105137102053327186270

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Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Other Nervous System Cancer Patients3800036011
Matched Controls for Incident ONS Cancer Patients380000379010

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Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 yr lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Other Nervous System Cancer Patients3800036011
Matched Controls for Incident ONS Cancer Patients380000379010

[back to top]

Number of Other Nervous System (ONS) Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident ONS cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (1-2 prescriptions [prescrip.]), T 2 (3-7 prescrip.), T 3 (8-298 prescrip.). Tertiles without 2 yr lag: T 1 (1-2 prescrip.), T 2 (3-7 prescrip.), and T 3 (8-388 prescrip.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was same as for case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Other Nervous System Cancer Patients3800036011
Matched Controls for Incident ONS Cancer Patients380000379010

[back to top]

Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. Inestimable OR and 95% CI when no gabapentin-exposed cancer cases or no gabapentin-exposed controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his cohort entry was the same as case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Other Nervous System Cancer Patients038236
Matched Controls for Incident ONS Cancer Patients03801379

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Number of Other Nervous System Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident other nervous system cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident other nervous system cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was same as for case

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Other Nervous System Cancer Patients3800036100
Matched Controls for Incident ONS Cancer Patients380000379000

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.56 months), and Tertile 3 (5.57 - 105.82 months). Tertile's without 2 year lag: Tertile 1 (0.01 - 1.38 months), Tertile 2 (1.39 - 5.72 months), and Tertile 3 (5.73 - 123.70 months). (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Pancreatic Cancer Patients21351127212015515
Matched Controls for Incident Pancreatic Cancer Patients2029628273120222534364

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Pancreatic Cancer Patients202135352120
Matched Controls for Incident Pancreatic Cancer Patients862029616020222

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Pancreatic Cancer Patients21355212120721
Matched Controls for Incident Pancreatic Cancer Patients2029618622022246236

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Number of Pancreatic Cancer Cases and Matched Controls With the Indicated Number of Gabapentin Prescriptions

Incident pancreatic cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. Tertile's with 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), Tertile 3 (8-298 prescriptions). Tertiles without 2 year lag: Tertile 1 (1-2 prescriptions), Tertile 2 (3-7 prescriptions), and Tertile 3 (8-388 prescriptions). (NCT01236053)
Timeframe: The case index date was the date of incident pancreatic cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Pancreatic Cancer Patients21351226212017414
Matched Controls for Incident Pancreatic Cancer Patients2029634223020222623068

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Number of Penile Cancer Cases and Matched Controls With the Indicated Cumulative Dose of Gabapentin

Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.1-30.0 grams [g]), T 2 (30.1-189.0 g), and T 3 (189.1-9600.0 g). Tertiles without 2 yr lag: T 1 (0.1-30.0 g), T 2 (30.1-189.0 g), and T 3 (189.1-11610.0 g). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Penile Cancer Patients147100147100
Matched Controls for Incident Penile Cancer Patients13941011390123

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Number of Penile Cancer Cases and Matched Controls With the Indicated Duration of Exposure to Gabapentin

Incident penile cancer. Gabapentin (Gaba.) Exposure Description: With 2 year (yr) lag=Gaba. exposure from cohort entry to 2 yr prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 yr lag=Gaba. exposure from cohort entry to index date. Tertiles (T) with 2 yr lag: T 1 (0.01-1.38 months [mo.]), T 2 (1.39-5.56 mo.), and T 3 (5.57-105.82 mo.). Tertiles without 2 yr lag: T 1 (0.01-1.38 mo.), T 2 (1.39-5.72 mo.), and T 3 (5.73-123.70 mo.). Inestimable OR and 95% CI when no gaba.-exposed cancer cases or controls at the exposure level. (NCT01236053)
Timeframe: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)Tertile 1 (with 2 year lag)Tertile 2 (with 2 year lag)Tertile 3 (with 2 year lag)Never (without 2 year lag)Tertile 1 (without 2 year lag)Tertile 2 (without 2 year lag)Tertile 3 (without 2 year lag)
Incident Penile Cancer Patients147100147100
Matched Controls for Incident Penile Cancer Patients13941011390132

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Number of Penile Cancer Cases and Matched Controls With the Indicated Exposure to Gabapentin

Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin prescription from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin prescription from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Ever (with 2 year lag)Never (with 2 year lag)Ever (without 2 year lag)Never (without 2 year lag)
Incident Penile Cancer Patients11471147
Matched Controls for Incident Penile Cancer Patients2139461390

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Number of Penile Cancer Cases and Matched Controls With the Indicated Long Duration of Exposure to Gabapentin

Incident penile cancer. Gabapentin Exposure Description: With 2 year lag = Gabapentin exposure from cohort entry to 2 years prior to index date (to control for prediagnostic prescribing for pain symptoms possibly related to cancer). Without 2 year lag = Gabapentin exposure from cohort entry to index date. (NCT01236053)
Timeframe: The case index date was the date of incident penile cancer diagnosis ascertained in the GPRD study cohort 1995-2008. The matched control index date was the date at which the follow-up time from his/her cohort entry was the same as that for the case.

,
Interventionparticipants (Number)
Never (with 2 year lag)> 1 year (with 2 year lag)> 2 year (with 2 year lag)> 3 year (with 2 year lag)Never (without 2 year lag)> 1 year (without 2 year lag)> 2 year (without 2 year lag)> 3 year (without 2 year lag)
Incident Penile Cancer Patients147000147000
Matched Controls for Incident Penile Cancer Patients13941001390111

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Mean Neuropathic Pain Score at Visit 5 (Week 3)

Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. (NCT01263132)
Timeframe: Visit 5 (Week 3)

InterventionUnits on a Scale (Mean)
Gabapentin33.74
MF0434 + Gabapentin24.86

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Mean Neuropathic Pain Score at Visit 6 (Week 4)

Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. (NCT01263132)
Timeframe: Visit 6 (Week 4)

InterventionUnits on a Scale (Mean)
Gabapentin22.08
MF0434 + Gabapentin17.29

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Mean Neuropathic Pain Score at Visit 3 (Week 1)

Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. (NCT01263132)
Timeframe: Visit 3 (Week 1)

InterventionUnits on a Scale (Mean)
Gabapentin51.00
MF0434 + Gabapentin50.70

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Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire

SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status. (NCT01263132)
Timeframe: Visit 2 (Baseline) to Visit 6 (Week 4)

,
InterventionUnits on a Scale (Mean)
Baseline (Visit 2): General SF-36 QoL IndexWeek 1 (Visit 3): General SF-36 QoL IndexWeek 2 (Visit 4): General SF-36 QoL IndexWeek 3 (Visit 5): General SF-36 QoL IndexWeek 4 (Visit 6): General SF-36 QoL Index
Gabapentin53.04465.77969.53173.05878.869
MF0434 + Gabapentin56.50765.61074.37078.07582.331

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Mean Neuropathic Pain Score at Visit 4 (Week 2)

Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain. (NCT01263132)
Timeframe: Visit 4 (Week 2)

InterventionUnits on a Scale (Mean)
Gabapentin41.24
MF0434 + Gabapentin36.94

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Difference in Psychological Outcomes on the Sickness Inventory Profile (SIP)

The sickness inventory profile (SIP) is a behaviorally based measure of health status. Scores range from 0-68 with higher numbers indicating worse outcomes. The study report total SIP score. The higher the score the worse the function. (NCT01265056)
Timeframe: First Clinic Follow Up After Discharge

Interventionunits on a scale (Mean)
Placebo34.9
Gabapentin36.0

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Psychological Functioning as Evaluated by the Brief Symptom Inventory (BSI) Between Treatment and Placebo Groups

The Brief Symptom Inventory 18 (BSI 18) is designed with reliability in mind. The BSI 18 assessment gathers patient-reported data to help measure psychological distress and psychiatric disorders in medical and community populations. As the latest in an integrated series of test instruments that include the SCL-90-R®, BSI® (53 questions), and DPRS® instruments, the BSI 18 test offers a more effective, easy-to-administer tool to help support clinical decision-making and monitor progress throughout treatment. BSI-18 measures three dimensions with 6 questions a piece (somatization , depression , anxiety) and overall psychological distress scores (Global severity index, GSI). Each of the 18 items range from a score of 0-4; total score ranges from 0-72 with higher scores indicating worse function. The GSI score is calculated as the mean of the three subscales. The study reported the GSI score. Higher score is worse. (NCT01265056)
Timeframe: First Clinic Follow Up After Discharge

Interventionunits on a scale (Mean)
Placebo9
Gabapentin7.3

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Opioid Consumption Between the Treatment and the Control Groups (Morphine Equivalents)

(NCT01265056)
Timeframe: From time of enrollment to 2 weeks after being discharged

Interventionmorphine equivalents (Mean)
Placebo7.0
Gabapentin6.7

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Vulvodynia Pain

Overall vulvodynia pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). Pain was assessed daily during the last week of treatment. Daily scores were averaged. (NCT01301001)
Timeframe: Week 6 for each treatment arm

Interventionunits on a scale (Mean)
Placebo2.88
Gabapentin2.71

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Tampon Test Pain Intensity

Tampon pain on a 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever). One tampon was inserted each week. Tampon pain was assessed during last week of maintenance phase (7 days). (NCT01301001)
Timeframe: Week 6 for each treatment arm

Interventionunits on a scale (Mean)
Placebo4.29
Gabapentin3.96

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Coital Pain

Coital pain on an 11-point Numeric Rating Scale (0 = no pain at all; 10 = worse pain ever), assessed after each sexual intercourse event. The number of sexual intercourse events was averaged during final week of each treatment arm. (NCT01301001)
Timeframe: Week 6 of each treatment arm

Interventionunits on a scale (Mean)
Placebo3.97
Gabapentin3.85

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Number of Participants With no Reported RLS Symptoms During Each of the 4-hour Periods From the 24-hour RLS Record at Day 14

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-minute increments. The period was divided into 7 four-hour intervals (8 AM to 12 PM, 12 PM to 4 PM, 4 PM to 8 PM, 6 PM to 10 PM, 8 PM to 12 Midnight, Midnight to 4 AM, and 4 AM to 8 AM). (NCT01332318)
Timeframe: Day 14

,,
Interventionparticipants (Number)
8 AM to 12 PM12 PM to 4 PM4 PM to 8 PM6 PM to 10 PM8 PM to 12 AM12 AM to 4 AM4 AM to 8 AM
GEn 1200 mg and DPH Placebo21201918131723
GEn 1800 mg and DPH Placebo27232623182426
GEn Placebo and DPH37353627182439

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Token Motor Task Test Score

Participants were given 100 plastic tokens and asked to place them in a container, 2 at a time, as quickly as possible for 60 seconds. The number of tokens correctly placed in the container was the Token Motor Task score (range: 0-100). The BAC was conducted prior to each simulated driving test. The Token Motor Task scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -6.95 to 3.35, with higher scaled scores indicating better cognition. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.4-0.00.4
GEn 1800 mg and DPH Placebo0.2-0.20.1
GEn Placebo and DPH 50 mg on Day 160.30.20.4
GEn Placebo and DPH Placebo0.20.40.4

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Composite Score

The BAC was designed as a comprehensive measure of cognitive function, including 6 individual tests: Verbal Memory Recall, Digit Sequencing, Token Motor Task, Verbal Fluency, Symbol Coding, and Tower of London. The composite/total BAC score is calculated by scoring each individual test, comparing each score to a healthy control sample (matched for sex and age category) to create z-scores, summing the z-scores, and rescaling the sum. The composite score range is -2127.8 to 1878.8, with higher scores indicating better cognition. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo5.33.49.1
GEn 1800 mg and DPH Placebo5.30.27.1
GEn Placebo and DPH 50 mg on Day 167.04.810.7
GEn Placebo and DPH Placebo4.64.87.2

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Number of Participants With the Indicated Post Sleep Questionnaire (PSQ) Responses at Day 14

The PSQ is designed to evaluate sleep quality, ability to function, and the degree to which RLS symptoms interfere with sleep. (NCT01332318)
Timeframe: Day 14

,,
Interventionparticipants (Number)
Sleep Quality: ExcellentSleep Quality: ReasonableSleep Quality: PoorAbility to Function: ExcellentAbility to Function: GoodAbility to Function: ModerateAbility to Function: Poor0 Nights with RLS Symptoms1-2 Nights with RLS Symptoms3-4 Nights with RLS Symptoms5-6 Nights with RLS Symptoms7 Nights with RLS Symptoms0 Awakenings/Night due to RLS1-2 Wakenings/Night due to RLS3-4 Awakenings/Night due to RLS5+ Awakenings/Night due to RLS0 Hours Awake/Night due to RLS<1 Hour Awake/Night due to RLS1-<2 Hours Awake/Night due to RLS2-<3 Hours Awake/Night due to RLS3+ Hours Awake/Night due to RLS
GEn 1200 mg and DPH Placebo5185617508761671821234010
GEn 1800 mg and DPH Placebo1417211184010983382311310020
GEn Placebo and DPH93121832201812171311104182533320

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Number of Participants Who Responded to Treatment Based on Scores on the Participant-Rated CGI-I at Day 14

"The participant-rated CGI-I is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse. Response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale)." (NCT01332318)
Timeframe: Day 14

Interventionparticipants (Number)
GEn Placebo and DPH23
GEn 1200 mg and DPH Placebo20
GEn 1800 mg and DPH Placebo23

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Percentage of Participants With no Reported RLS Symptoms During the 24-hour RLS Record at Day 14

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. (NCT01332318)
Timeframe: Day 14

Interventionpercentage of participants (Number)
GEn Placebo and DPH9.84
GEn 1200 mg and DPH Placebo35.71
GEn 1800 mg and DPH Placebo42.42

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Change From Baseline (Day -1) to Day 14 (Evening) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Lane Position Variability (LPV)

Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 14 (in the evening) or Day 15 (in the morning after GEn dosed at 5 PM) mean LPV over the 1-hour drive minus the Baseline (Day -1 or Day 1) mean LPV over the 1-hour drive. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14 and 15

,,,
Interventionfeet (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=32, 28, 31, 27
GEn 1200 mg and DPH Placebo0.170.13
GEn 1800 mg and DPH Placebo-0.010.02
GEn Placebo and DPH 50 mg on Day 16-0.08-0.10
GEn Placebo and DPH Placebo-0.06-0.01

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Brake Reaction Time

Brake reaction time was assessed as the time it took for each participant to move their foot off the accelerator and onto the brake pedal after the appearance of a stop sign on the simulation screen. Change from baseline was calculated as the Day 14, 15, or 16 mean reaction time minus the Baseline (Days -1 and 1) mean reaction time. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionseconds (Mean)
Day 14, n=33, 25, 32, 27Day 15, n=32, 25, 30, 25Day 16, n=30, 28, 33, 27
GEn 1200 mg and DPH Placebo-0.07-0.03-0.05
GEn 1800 mg and DPH Placebo-0.03-0.01-0.03
GEn Placebo and DPH 50 mg on Day 16-0.04-0.05-0.03
GEn Placebo and DPH Placebo-0.04-0.00-0.04

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Lane Position

Lane position was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall average lane position was calculated as the Day 14 (in the evening), 15 (in the morning after GEn dosed at 5 PM), or 16 (assessment at Tmax of GEn and DPH) mean lane position over the 1-hour drive minus the Baseline (Days -1 and 1) mean lane position over the 1-hour drive. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionfeet (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=32, 28, 31, 27Day 16, n=30, 28, 33, 28
GEn 1200 mg and DPH Placebo-0.020.120.13
GEn 1800 mg and DPH Placebo0.030.040.14
GEn Placebo and DPH 50 mg on Day 160.080.040.08
GEn Placebo and DPH Placebo0.050.010.17

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Average Speed

Participants were instructed to maintain a speed of 55 miles per hour during the driving assessment. Change from baseline in overall average speed was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed over the 1-hour drive. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionmiles per hour (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=32, 28, 31, 27Day 16, n=30, 28, 33, 28
GEn 1200 mg and DPH Placebo0.660.330.90
GEn 1800 mg and DPH Placebo0.420.300.92
GEn Placebo and DPH 50 mg on Day 160.120.370.84
GEn Placebo and DPH Placebo1.240.751.70

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in Overall Speed Variability

Speed variability was defined as the standard deviation of the speed (measured in miles per hour). Participants were instructed to maintain a speed of 55 miles per hour during the test drive. Change from baseline in overall speed variability was calculated as the Day 14 (in the evening), 15 (in the morning), or 16 (at Tmax of GEn and DPH) mean speed variability over the 1-hour drive minus the Baseline (Days -1 and 1) mean speed variability over the 1-hour drive. (NCT01332318)
Timeframe: Baseline (Day -1) and Days 14 and 16; baseline (Day 1) and Day 15

,,,
Interventionmiles per hour (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=32, 28, 31, 27Day 16, n=30, 28, 33, 28
GEn 1200 mg and DPH Placebo-0.190.43-0.12
GEn 1800 mg and DPH Placebo-0.32-0.070.23
GEn Placebo and DPH 50 mg on Day 16-0.47-0.33-0.08
GEn Placebo and DPH Placebo-0.22-0.26-0.54

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Alertness Visual Analog Scale (VAS) Score

"Alertness VAS was completed immediately before and after each simulated driving assessment. Participants indicated their alertness by marking a vertical line on a horizontal scale anchored by responses extremely sleepy and extremely alert. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point the participant marked. Scores ranged from 0-100 mm, with higher scores indicating more alertness and lower scores indicating more sleepiness. Change score was calculated as the Day 14, 15, or 16 VAS score minus the Baseline VAS score." (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionmillimeters (Mean)
Day 14; Pre-Drive, n=33, 28, 32, 28Day 14; Post-Drive, n=33, 28, 32, 28Day 14; Post-Pre Drive Difference, n=33,28,32,28Day 15; Pre-Drive, n=33, 27, 33, 28Day 15; Post-Drive, n=33, 27, 32, 27Day 15; Post-Pre Drive Difference, n=33,27,32,27Day 16; Pre-Drive, n=32, 28, 33, 28Day 16; Post-Drive, n=31, 28, 33, 28Day 16; Post-Pre Drive Difference, n=31,28,33,28
GEn 1200 mg and DPH Placebo-2.63.25.90.2-6.1-6.30.8-3.6-4.5
GEn 1800 mg and DPH Placebo-3.53.34.97.24.8-2.2-8.8-7.51.3
GEn Placebo and DPH 50 mg on Day 16-3.1-3.00.10.4-3.1-3.7-11.8-14.0-2.3
GEn Placebo and DPH Placebo4.57.73.11.5-3.2-4.76.314.37.7

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Total Sleep Time Item

The PghSD assessed a participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning after dose), and 16 (at Tmax)value minus the Baseline (Days -1 and 1) value. Total sleep time is expressed in hours. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,
Interventionhours (Mean)
Day 14, n=59, 26, 33Day 15, n=60, 28, 33Day 16, n=59, 26, 33
GEn 1200 mg and DPH Placebo0.20.20.3
GEn 1800 mg and DPH Placebo1.00.30.4
GEn Placebo and DPH0.3-0.20.5

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Median Time to Onset of a Participant's First RLS Symptoms Using the 24-hour RLS Symptom Record at Day 14

The 24-Hour RLS Record is a diary in which participants report the presence and severity of RLS symptoms (none, mild, moderate, or severe) for a 24-hour period, in 30-min increments beginning at 8AM on the day prior to the visit. For Arms 2 and 3, upper limits of the confidence intervals are not available, as they are beyond the 24-hour time frame. (NCT01332318)
Timeframe: Day 14

Interventionparticipants (Median)
GEn Placebo and DPH7.0
GEn 1200 mg and DPH Placebo14.3
GEn 1800 mg and DPH Placebo15.5

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Digit Sequencing Score (DSS)

Participants (par.) were presented with sets of numbers of increasing length and asked to tell the experimenter the numbers in order from lowest to highest. The task has 7 levels; the first level had 2 digits in the set (e.g., 5, 2); the second level had 3 digits in the set, etc. The number of times the par. correctly arranged the numbers was recorded as the score for each level. The DSS is the sum of the 7 level scores (range: 0-28). The scaled test score was calculated as indicated for the Verbal Memory Test and ranges from -6.68 to 2.73; higher scaled scores indicate better cognition. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.20.30.4
GEn 1800 mg and DPH Placebo0.4-0.20.5
GEn Placebo and DPH 50 mg on Day 160.30.10.7
GEn Placebo and DPH Placebo0.30.20.3

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Change From Baseline (Day -1) in Overall Lane Position Variability (LPV) on Day 16 (Tmax)

Lane position variability (LPV) was defined as the standard deviation of lane position, and was measured from the center line of the 26 foot wide 2-lane paved road to the center of the vehicle. Change from baseline in overall LPV was calculated as the Day 16 mean LPV over the 1-hour drive minus the Baseline mean LPV over the 1-hour drive. The Day 16 measurement is at the time of maximum concentration (Tmax) for both GEn and DPH. (NCT01332318)
Timeframe: Baseline (Day -1) and Day 16

Interventionfeet (Least Squares Mean)
GEn Placebo and DPH Placebo-0.10
GEn 1200 mg and DPH Placebo0.15
GEn 1800 mg and DPH Placebo0.15
GEn Placebo and DPH 50 mg on Day 160.16

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Fluency Test Score

Verbal Fluency included one semantic fluency and two letter fluency tasks. Participants were given 60 seconds to name as many words as possible within a given semantic category (supermarket items), and in two separate trials, participants were given 60 seconds to generate as many words as possible that began with a given letter. The total number of words from all of the 3 trials was the Verbal Fluency score (range: 0-150). The scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -5 to 10.83; higher scaled scores indicate better cognition. (NCT01332318)
Timeframe: Baseline (Days -1 and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.50.10.7
GEn 1800 mg and DPH Placebo0.40.20.4
GEn Placebo and DPH 50 mg on Day 160.60.40.9
GEn Placebo and DPH Placebo0.20.40.7

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Verbal Memory Test Score

Participants were presented with 15 words and asked to recall as many as possible; the procedure was repeated 5 times. The total number of words recalled correctly across the 5 administrations of the list was the participant's Verbal Memory Recall score (range: 0-75). The scaled test score was calculated as ((BAC component raw test score - healthy control sample test mean)/healthy control sample test standard deviation); a healthy control sample was matched to the participant's sex and age category. The scaled test score range is -7.37 to 4.86; higher scaled scores indicate better cognition. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.10.1-0.1
GEn 1800 mg and DPH Placebo0.2-0.00.1
GEn Placebo and DPH 50 mg on Day 160.10.10.0
GEn Placebo and DPH Placebo0.10.2-0.2

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Symbol Coding Test Score

Participants were given a list of numbers (numerals 1-9) that were each associated with a unique symbol. Participants decoded a list of 110 symbols as quickly as possible in 90 seconds. The total number of symbols correctly decoded was the Symbol Coding Score (range: 0-110). The Symbol Coding scaled test score was calculated as indicated for the Verbal Memory Test. Change from baseline was calculated as the Day composite score minus the Baseline composite score. The scaled test score range is -7 to 10.08, with higher scaled scores indicating better cognition. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.60.51.4
GEn 1800 mg and DPH Placebo0.5-0.01.0
GEn Placebo and DPH 50 mg on Day 160.60.41.3
GEn Placebo and DPH Placebo0.60.51.3

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Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Brief Assessment of Cognition (BAC) Scaled Tower of London (TOL) Score

Participants (par.) were asked to look at 2 pictures simultaneously; each picture showed 3 different colored balls arranged on 3 pegs. Par. were to estimate the number of times the balls in 1 picture would have to be moved to make the arrangement of balls identical to that of the second picture. Par. were allowed 20 seconds to respond to each pair of pictures. The number of correct items was the TOL Score (range: 0-22). The TOL scaled test score was calculated as indicated for the Verbal Memory Test. The scaled test score range is -7.53 to 2.76; higher scaled scores indicate better cognition. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,,
Interventionscores on a scale (Mean)
Day 14, n=33, 28, 33, 28Day 15, n=33, 28, 33, 28Day 16, n=32, 28, 33, 28
GEn 1200 mg and DPH Placebo0.20.30.5
GEn 1800 mg and DPH Placebo0.30.40.5
GEn Placebo and DPH 50 mg on Day 160.50.50.6
GEn Placebo and DPH Placebo0.30.20.1

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Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) in the Pittsburgh Sleep Diary (PghSD) Sleep Quality

"The PghSD assessed a participant's previous night's sleep. Sleep quality was assessed using a Visual Analogue Scale (VAS). Participants indicated their sleep quality by marking a vertical line on a horizontal scale anchored by responses very bad and very good. VAS score was determined by measuring the distance in millimeters (mm) from the left hand end of the line to the point that the participant marked. Scores ranged from 0 to 100 mm with higher scores indicating better sleep quality and lower scores indicating worse sleep quality." (NCT01332318)
Timeframe: Baseline (Day -1and 1) and Days 14, 15, and 16

,,
Interventionmillimeters (Mean)
Day 14, n=61, 28, 33Day 15, n=61, 28, 33Day 16, n=59, 28, 33
GEn 1200 mg and DPH Placebo29.924.627.4
GEn 1800 mg and DPH Placebo35.118.016.7
GEn Placebo and DPH21.211.820.7

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Mean Change From Baseline (Day -1) to Day 14 (Evening) and Day 16 (at Tmax) and Change From Baseline (Day 1) to Day 15 (Morning After Dose) on the Pittsburgh Sleep Diary (PghSD) Sleep Onset Items

The PghSD assessed participant's previous night's sleep. Change from baseline was calculated as the Day 14 (in the evening), 15 (in the morning), and 16 (at Tmax of GEn and DPH) value minus the Baseline (Days -1 and 1) value. Latency to sleep onset (time to fall asleep) and wake time after sleep onset are expressed in minutes. (NCT01332318)
Timeframe: Baseline (Days -1and 1) and Days 14, 15, and 16

,,
Interventionminutes (Mean)
Day 14; Latency to Sleep Onset, n=61, 28, 33Day 14; Wake Time After Sleep Onset, n=59, 26, 33Day 15; Latency to Sleep Onset n=61, 28, 33Day 15; Wake Time After Sleep Onset, n=60, 28, 33Day 16; Latency to Sleep Onset, n=60, 28, 23Day 16; Wake Time After Sleep Onset, n=59, 26, 33
GEn 1200 mg and DPH Placebo-3.2-23.3-14.9-30.8-3.3-26.3
GEn 1800 mg and DPH Placebo-25.7-26.9-35.8-14.8-19.3-9.9
GEn Placebo and DPH-8.1-14.0-8.74.9-17.3-15.8

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Number of Participants in Each Category of the Investigator-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14

"The CGI scale is a widely used tool designed to allow clinicians to rate the severity of illness and the change of the disease severity over time based on a seven-point rating scale, with a score of 1 being very much improved and a score of 7 being very much worse compared to baseline." (NCT01332318)
Timeframe: Day 14

,,
Interventionparticipants (Number)
Very Much Improved, score of 1Much Improved, score of 2Minimally Improved, score of 3No Change, score of 4Minimally Worse, score of 5Much Worse, score of 6Very Much Worse, score of 7
GEn 1200 mg and DPH Placebo10774000
GEn 1800 mg and DPH Placebo15864000
GEn Placebo and DPH7151915410

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Number of Participants With the Indicated Number of Simulated Crashes on Days 14 (Evening), 15 (Morning After Dose), and 16 (Tmax)

A simulated crash was defined as a collision with an oncoming car or obstacle (e.g., tree) or when the distance to the center line was greater than 18 feet on either side of the road. (NCT01332318)
Timeframe: Days 14, 15, and 16

,,,
Interventionparticipants (Number)
Day 14; 1 Crash, n=33, 28, 33, 28Day 14; 2 Crashes, n=33, 28, 33, 28Day 14; 3 Crashes, n=33, 28, 33, 28Day 14; 4 Crashes, n=33, 28, 33, 28Day 14; 5 Crashes, n=33, 28, 33, 28Day 14; 13 Crashes, n=33, 28, 33, 28Day 15; 1 Crash, n=33, 28, 31, 28Day 15; 2 Crashes, n=33, 28, 31, 28Day 15; 4 Crashes, n=33, 28, 31, 28Day 15; 13 Crashes, n=33, 28, 31, 28Day 16; 1 Crash, n=30, 28, 33, 28Day 16; 3 Crashes, n=30, 28, 33, 28Day 16; 4 Crashes, n=30, 28, 33, 28Day 16; 5 Crashes, n=30, 28, 33, 28Day 16; 13 Crashes, n=30, 28, 33, 28Day 16; 17 Crashes, n=30, 28, 33, 28
GEn 1200 mg and DPH Placebo1201114321511001
GEn 1800 mg and DPH Placebo0010001000320010
GEn Placebo and DPH 50 mg on Day 161000000000200100
GEn Placebo and DPH Placebo2200001000000000

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Change From Baseline (Day -1) to Day 14 (Evening) in the Epworth Sleepiness Scale (ESS) Total Score

"The Epworth Sleepiness Scale (ESS) is a questionnaire designed to evaluate daytime sleepiness. Participants were asked to rate how likely they were to doze or fall asleep during 8 activities on a scale of 0 (would never do) to 3 (high chance of dozing). The total score ranges from 0-24, with a score greater than 10 representing excessive daytime sleepiness (an increased chance of dozing). Change from baseline was calculated as the Day 14 total score minus the Baseline total score." (NCT01332318)
Timeframe: Baseline (Day -1) and Day 14

Interventionscores on a scale (Mean)
GEn Placebo and DPH Placebo-2.6
GEn 1200 mg and DPH Placebo-2.3
GEn 1800 mg and DPH Placebo-2.4
GEn Placebo and DPH 50 mg on Day 16-2.4

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Mean Change From Baseline (Day -1) at Day 14 in the International Restless Legs Syndrome (IRLS) Rating Scale Total Score

The IRLS Rating scale is a measure of RLS disease severity and reflects the participant-reported assessment of primary sensory and motor features and associated sleep problems in RLS. Items are included that assess the impact of symptoms on participants' mood, daily life, and activities. The total score ranges from 0-40 points, with 40 being the most severe. The scale assesses symptoms over the week prior to measurement. (NCT01332318)
Timeframe: Baseline (Day -1) and Day 14

Interventionscores on a scale (Mean)
GEn Placebo and DPH-7.6
GEn 1200 mg and DPH Placebo-12.4
GEn 1800 mg and DPH Placebo-13.1

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Number of Participants in Each Category of the Participant-Rated Clinician Global Impression of Improvement (CGI-I) Scale at Day 14

"The participant-rated CGI-I scale is a self-rated assessment designed to allow participants to rate the change of their disease severity over time based on a seven-point scale, with a score of 1 being very much improved and a score of 7 being very much worse." (NCT01332318)
Timeframe: Day 14

,,
Interventionparticipants (Number)
Very Much Improved, score of 1Much Improved, score of 2Minimally Improved, score of 3No Change, score of 4Minimally Worse, score of 5Much Worse, score of 6Very Much Worse, score of 7
GEn 1200 mg and DPH Placebo91133200
GEn 1800 mg and DPH Placebo14964000
GEn Placebo and DPH7161417520

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Number of Participants Who Responded to Treatment Based on Scores on the Investigator-Rated CGI-I at Day 14

"The investigator-rated CGI-I is a clinician-rated assessment designed to allow clinicians to rate the change of their participant's disease severity over time based on a seven-point scale, with a score of 1 being very much improved, and a score of 7 being very much worse compared to baseline. For this endpoint, response was defined as a rating of very much improved or much improved (score of 1 or 2 on the scale) compared to baseline." (NCT01332318)
Timeframe: Day 14

Interventionparticipants (Number)
GEn Placebo and DPH22
GEn 1200 mg and DPH Placebo17
GEn 1800 mg and DPH Placebo23

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Percentage of Participants With at Least 30 and 50 Percent (%) Improvement in Numeric Pain Intensity Scale (NPIS) From Baseline at Day 84 (Week 12)

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)

,
Interventionpercentage of participants (Number)
At least 30% improvementAt least 50% improvement
Gabapentin/B-complex76.966.0
Pregabalin85.472.4

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Number of Participants With Various Health Conditions Based on Global Impression of Patient Change (GIPC) Scale

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)

,
Interventionparticipants (Number)
Health: extremely improvedHealth: much improvedHealth: minimally improved
Gabapentin/B-complex627310
Pregabalin476510

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Sleep Evaluation: Number of Participants Who Fell Asleep in Pre-specified Time Duration

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)

,
Interventionparticipants (Number)
0 to 15 minutes16 to 30 minutes31 to 45 minutes46 to 60 minutesGreater than 60 minutes
Gabapentin/B-complex85331388
Pregabalin72331242

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Profile of Mood States (POMS) Score

"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)

Interventionunits on a scale (Mean)
Gabapentin/B-complex1.3
Pregabalin3.4

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Change From Baseline in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score at Day 84

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)

,
Interventionunits on a scale (Mean)
Baseline (n=147, 123)Change at Day 84 (n=146, 122)
Gabapentin/B-complex16.28.082
Pregabalin15.86.967

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Number of Participants With Adverse Events (AEs)

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)

Interventionparticipants (Number)
Gabapentin/B-complex80
Pregabalin93

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Change From Baseline in Visual Analogue Scale (VAS) Score at Day 84

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)

,
Interventioncentimeter (Mean)
Baseline (n=147, 123)Change at Day 84 (n=146, 122)
Gabapentin/B-complex7.04.182
Pregabalin7.14.529

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Number of Participants With Various Health Conditions Based on Clinical Global Impression of Change (CGIC) Scale

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)

,
Interventionparticipants (Number)
Health: extremely improvedHealth: much improvedHealth: minimally improved
Gabapentin/B-complex557911
Pregabalin47696

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Change From Baseline in Average Numeric Pain Intensity Scale (NPIS) Score at Day 84

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)

,
Interventionunits on a scale (Mean)
Baseline (n=147, 123)Change at Day 84 (n=146, 122)
Gabapentin/B-complex6.73.905
Pregabalin6.84.260

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Number of Participants Who Responded to Treatment With Gabapentin by Baseline Severity of Epileptic Seizure

Participants who responded to the treatment with gabapentin were counted by the baseline severity of epileptic seizure (mild, moderate and severe) to assess whether the baseline severity of epileptic seizure was a factor affecting the treatment efficacy. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionParticipants (Number)
Mild6
Moderate15
Severe6
Unknown1

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Number of Participants Who Responded to Treatment With Gabapentin by Number of Concomitant Antiepileptic Drugs at Baseline

Participants who responded to the treatment with gabapentin were counted by the number of concomitant epileptic drugs at baseline across 5 categories (no drug, 1 drug, 2 drugs, 3 drugs, and 4 or more drugs) to assess whether the number of concomitant epileptic drugs at baseline was a factor affecting the treatment efficacy. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionParticipants (Number)
No Concomitant Antiepileptic Drug1
One Concomitant Antiepileptic Drug13
Two Concomitant Antiepileptic Drugs7
Three Concomitant Antiepileptic Drugs4
Four or More Concomitant Antiepileptic Drugs3

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Number of Participants Who Responded to Treatment With Gabapentin by Treatment Period

Participants who responded to the treatment with gabapentin were counted by the treatment period (non-long term [less than 1 year] or long term [1 year or more]) to assess whether the treatment period with gabapentin was a factor affecting the treatment efficacy. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionParticipants (Number)
Non-Long Term2
Long Term26

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Clinical Efficacy Rate

Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical efficacy over the total number of efficacy analysis population, was presented along with the corresponding exact 2-sided 95% CI. For the basis of efficacy evaluation, frequencies of epileptic seizure were recorded during the previous 4 weeks from the treatment start date, and that from the end date of assessment period. Clinical efficacy was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionPercentage of participants (Number)
Week 12 (n = 73)Week 52 (n = 52)Week 104 (n = 14)End of assessment period (n = 66)
Gabapentin Tablets/Syrup56.257.764.342.4

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Reduction From Baseline in Epileptic Seizure Frequency

Reduction from baseline in epileptic seizure frequency was defined by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: Reduction from baseline in epileptic seizure frequency (%) = [(T-B) / B] X 100. The median percentages were presented along with the corresponding minimum and maximum percentages. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionPercentage (Median)
Week 12 (n = 72)Week 52 (n = 56)Week 104 (n = 16)End of assessment period (n = 73)
Gabapentin Tablets/Syrup-25.0-49.0-60.0-47.9

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Responder Rate

Responder rate, which was defined as the percentage of participants whose R ratio was - 0.333 or less, was presented along with the corresponding exact 2-sided 95% CI. R ratio of - 0.333 or less corresponded to the decrease of epileptic seizure frequency by 50% or more. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionPercentage of participants (Number)
Week 12 (n = 72)Week 52 (n = 56)Week 104 (n = 16)End of assessment period (n = 73)
Gabapentin Tablets/Syrup43.150.062.549.3

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Response Ratio (R Ratio)

R Ratio was calculated by the following formula, where B represented the baseline frequency of epileptic seizures during the previous 4 weeks from the treatment start date, whereas T represented the frequency of epileptic seizures during the previous 4 weeks from the end of assessment period: R Ratio = (T - B) / (T + B). R Ratio is within the range of -1 to +1, and a negative value represents a reduction in the frequency of seizure. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionRatio (Mean)
Week 12 (n = 72)Week 52 (n = 56)Week 104 (n = 16)End of assessment period (n = 73)
Gabapentin Tablets/Syrup-0.332-0.409-0.456-0.369

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Number of Participants Who Responded to Treatment With Gabapentin by Baseline Frequency of Epileptic Seizure

Participants who responded to the treatment with gabapentin were counted by the baseline frequency of epileptic seizure (<=8 versus >8 episodes/per 4 weeks) to assess whether the baseline frequency of epileptic seizure was a factor affecting the treatment efficacy. (NCT01441401)
Timeframe: MAX 104 weeks

InterventionParticipants (Number)
<=8 Episodes15
>8 Episodes11
Unknown2

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Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale

This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 1 month from the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection5.1
Gabapentin5.4

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Proceeded to Surgery Within Year of Enrollment

This is a measure of participants that proceeded to surgery within a year of enrollment (NCT01495923)
Timeframe: Measured within the year of enrollment in the study

InterventionParticipants (Count of Participants)
Epidural Steroid Injection9
Gabapentin10

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Worst Leg Pain at 1 Month Measured Using the Numeric Pain Scale

This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 1 month from the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection4.9
Gabapentin5.8

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Average Leg Pain at 3 Months Measured Using the Numeric Pain Scale

This outcome measure compares the average leg pain at baseline to the average leg pain 3 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 3 months from the start of treatment

Interventionunits on a scale (Mean)
Gabapentin Group3.7
Epidural Steroid3.4

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Average Back Pain at 1 Month Measured Using the Numeric Pain Scale

This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 1 month fromt he start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection3.5
Gabapentin3.6

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Average Leg Pain at 1 Month Measured Using the Numeric Pain Scale

This outcome measure compares the average leg pain at baseline to the average leg pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 1 month after the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection3.3
Gabapentin3.7

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Worst Leg Pain at 3 Months Measured Using the Numeric Pain Scale

This outcome measure compares the worst leg pain at baseline to the worst leg pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 3 months from the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection5.2
Gabapentin5.5

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Average Back Pain at 3 Months Measured Using the Numeric Pain Scale

This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 3 months from the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection3.9
Gabapentin3.7

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Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale

This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The epidural steroid injection group is compared to the gabapentin group. (NCT01495923)
Timeframe: 3 months after the start of treatment

Interventionunits on a scale (Mean)
Epidural Steroid Injection5.6
Gabapentin5.6

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Daily Total Dose of Oral Morphine (mg/kg/Day).

The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar. (NCT01506453)
Timeframe: Daily beginning day 1 for a maximum of 21 days.

Interventionmg/kg/day (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14Day 15Day 16Day 17Day 18Day 19Day 20Day 21
Gabapentin0.382670.436850.372810.403840.376620.456790.509610.507670.492340.443920.509810.577980.681830.530280.559390.376430.388370.650130.845861.123580.14981

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Pain Scores Right Now

A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. (NCT01506453)
Timeframe: Daily beginning day 1 through a maximum of 21 days.

Interventionscore on a scale 0-10 (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14Day 15Day 16Day 17Day 18Day 19Day 20
Gabapentin1.640002.000001.880001.920001.640001.400002.200001.320001.480001.160001.160001.217391.043480.826090.909091.294120.400001.454551.000001.33333

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Pain Scores Right Now

A score ranging from 0 to 10, measured by age appropriate validated pain scale. Because there was only one patient during day 21 time point for this treatment group, the mean and standard deviation could not be calculated. Infants and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain.The scale information for the FLACC and FPS-R scales are similar. (NCT01506453)
Timeframe: Daily beginning day 1 through a maximum of 21 days.

Interventionscore on a scale 0-10 (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14Day 15Day 16Day 17Day 18Day 19Day 20Day 21
Placebo1.695651.166670.750000.833331.000000.791670.916670.565220.869570.391300.826091.000000.695650.521740.608700.312500.214290.25000000

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Daily Total Dose of Oral Morphine (mg/kg/Day).

The response to therapy will be measured by pain intensity scores and daily use of morphine doses for breakthrough pain as described in the study objectives. Daily assessments will continue during treatment with the study drug (gabapentin or placebo) irrespective of patient response to study treatment. and toddlers (less than age 4 years) or other children who cannot self report, use the FLACC Scale Score each component as a subscore (face, legs, activity, cry, consolability) Total subscores to determine FLACC score Older children (ages 4 to 7 years) who can self-report, use the Faces Pain Scale-Revised (FPS-R) Ages >7 years, Self report using a numeric scale 0-10 without reference to Faces Pain Scale-Revised (FPS-R) Pain score 0 means no pain and 10 means worst pain. The scale information for the FLACC and FPS-R scales are similar. (NCT01506453)
Timeframe: Daily beginning day 1 for a maximum of 21 days.

Interventionmg/kg/day (Mean)
Day 1Day 2Day 3Day 4Day 5Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14Day 15Day 16Day 17Day 18Day 19Day 20
Placebo0.274330.318160.279610.353430.379200.439720.371810.381880.345240.346600.299370.400900.459330.349570.367310.484810.549600.136050.141230.15108

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Opioid Consumption

Patient Controlled Analgesia use over 48 hours reported in Morphine equivalent dosage. (NCT01546857)
Timeframe: 48 hours post operatively

Interventionmg (Mean)
Placebo11.88
Gabapentin11.02

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Visual Analogue Scale for Pain

Severity of pain measure on a scale from zero to ten. Zero no pain to ten severe pain. (NCT01546857)
Timeframe: 48 hours post operatively

Interventionunits on a scale (Mean)
Placebo5.15
Gabapentin4.38

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Quality of Sleep.

A questionnaire was administered asking participants about the quality of their sleep on the night of surgery asked on postoperative day 1, and on the first postoperative night ( POD 2) . Scored on a scale of zero to 3. Zero meaning poor postoperative sleep and 3 indicating better postoperative sleep. (NCT01546857)
Timeframe: Night of surgery (POD 1) and Postoperative Day 2.(POD 2)

,
Interventionunits on a scale (Mean)
POD 1POD 2
Gabapentin1.2350.647
Placebo1.3331

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Clinical Institute Withdrawal Assessment-Alcohol (Revised)(CIWA-Ar)

CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Many previously publications suggest a total score of 8-10 is severe enough to warrant medication treatment. Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity (NCT01573052)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Chlordiazepoxide3.29
Gabapentin4.33

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Epworth Sleepiness Scale (ESS)

ESS is an 8 item-scale and scores range between 0 and 24. The higher the score implies more daytime sleepiness. (NCT01573052)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Chlordiazepoxide6.35
Gabapentin2.65

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PENN Alcohol Craving Scale

PENN is a 5 item self-rated scale of alcohol craving. Scores range from 0 (little craving for alcohol) to 30 (irresistable urge to drink alcohol) (NCT01573052)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Chlordiazepoxide16.78
Gabapentin10.74

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Visual Analog Scale (VAS) at Visit 3

Subjects rated their pain using the VAS at visit 3, which was the last day of their maintenance phase. After this visit, subjects begin to taper the gralise. The VAS is subject reported on a scale of 0-10 with 0 being no pain and 10 being the worst pain they can imagine. Results reported are an average of the 3 subjects who completed visit 3. (NCT01623271)
Timeframe: At visit 3

Interventionunits on the VAS (Mean)
CRPS I Pain Subjects3.67

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Chronic Pain

"Numerical score from 0 to 10 scale:~Minimum value= zero (means no pain) and Maximum value= 10 (more intense pain)" (NCT01632215)
Timeframe: 6 months

,
Interventionpoints (Mean)
30 minutes after surgery1 hour after surgery2h after2 weeks after1 month after3 months after6 months after
Preoperative Gabapentine,5.52.40.33.63.21.81.3
Sugar Pill6.93.40.64.63.61.61.2

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Pain Intensity

Numerical score from 0 to 10; zero means no pain and 10 is the more intense pain (NCT01632215)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Preoperative Gabapentine,0.3
Sugar Pill0.4

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The Dose-response Relationship of Change From Baseline in IRLS Rating Scale Total Score at End of Treatment

"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~This model only includes treatment in the model. Least squares mean is used for analysis." (NCT01668667)
Timeframe: Baseline, 12 Weeks

Interventionunits on a scale (Least Squares Mean)
GSK1838262 600 mg-12.1
GSK1838262 450 mg-12.7
GSK1838262 300 mg-11.3
GSK1838262 Placebo Match-9.8

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"The Proportion of Subjects at the End of Treatment Who Are Responders With Either Much Improved or Very Much Improved on the Investigator-rated Clinical Global Impression of Improvement (CGI-I)"

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), on the scale. Higher score = more affected. Number of subjects responding to treatment at Week 12 with respect to dose level. CGI-I Responders = subjects who reported CGI-I scores of very much improved or much improved. (NCT01668667)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
GSK1838262 600 mg67
GSK1838262 450 mg67
GSK1838262 300 mg68
GSK1838262 Placebo Match50

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The Change From Baseline to the End of Treatment in the International Restless Legs Syndrome (IRLS) Rating Scale Score

"International Restless Legs Syndrome Rating Scale: Very severe=31-40, Severe=21-30, Moderate=11-20, Mild=1-10, None=0.~Change from Baseline = LOCF value at current visit - value at Baseline (the last nonmissing assessment before the first dose of study medication). A negative treatment difference indicates a benefit relative to placebo.~The change from baseline data is analyzed using an ANCOVA model with treatment and pooled site as the main effects and the baseline IRLS Rating Scale total score as a covariate." (NCT01668667)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Mean)
GSK1838262 600 mg-12.50
GSK1838262 450 mg-12.54
GSK1838262 300 mg-11.48
GSK1838262 Placebo Match-9.93

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The Dose-response Relationship for Investigator-rated CGI-I Scale at End of Treatment

(NCT01668667)
Timeframe: 12 Weeks

,,,
Interventionpercentage of participants (Number)
ResponderNon-Responder
GSK1838262 300 mg6832
GSK1838262 450 mg6733
GSK1838262 600 mg6733
GSK1838262 Placebo Match5050

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Center for Epidemiologic Studies Depression Scale

The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression. (NCT01678911)
Timeframe: 4 visits over 15 week period

,
Interventionunits on a scale (Mean)
change after intervention 1change after intervention 2
Gralise Then Placebo-10
Placebo Then Gralise4.57

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Pain Disability Index

The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability. (NCT01678911)
Timeframe: 4 visits over an 8 week period

,
Interventionunits on a scale (Mean)
change after intervention 1change after intervention 2
Gralise Then Placebo1014
Placebo Then Gralise4.819

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Pain Anxiety Symptoms Scale

The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety. (NCT01678911)
Timeframe: 4 Visits over an 8 week period

,
Interventionunits on the PASS scale (Mean)
mean change after intervention 1mean change after intervention 2
Gralise Then Placebo-4-5
Placebo Then Gralise-5.89.0

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McGill Pain Questionnaire - Short Form

The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain). (NCT01678911)
Timeframe: 4 Visits over a 15 week period

,
Interventionunits on a scale (Mean)
change from baseline after intervention 1change from baseline after intervention 2
Gralise Then Placebo.04.41
Placebo Then Gralise-0.341.05

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Patient Global Impression of Change

Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse. (NCT01678911)
Timeframe: 4 Visits over 15 weeks

,
Interventionparticipants (Number)
improved after intervention 1no change after intervention 1worse after intervention 1improved after intervention 2no change after intervention 2worse after intervention 2
Gralise Then Placebo010001
Placebo Then Gralise301110

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Patient Restfulness

Percentage of self reported patient restfulness was recorded on postoperative days 0, 1 and 2. (NCT01680549)
Timeframe: 3 days

,
InterventionPercent(%) of participants (Number)
Day 0Day 1Day 2
Gabapentin55.075.065.0
Placebo35.352.958.5

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Knee Range of Motion

Patient knee range of motion was assessed on postoperative days 0, 1 and 2. (NCT01680549)
Timeframe: 3 days

,
InterventionDegrees (Mean)
Day 0Day 1Day 2
Gabapentin57.8562.7465.94
Placebo53.1266.8167.47

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Narcotics Consumption

Narcotics consumption was recorded on postoperative days 0, 1, and 2. (NCT01680549)
Timeframe: 3 days

,
InterventionMorphine dose equivalents (Mean)
Day 0Day 1Day 2
Gabapentin4.1611.5311.61
Placebo7.4025.0221.62

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Patient Pain Scores

"Patient's pain assessed by the Visual Analog Scale (VAS - Units on a scale) on postoperative days 0, 1 and 2.~Scale range: 0-100 Higher Values = More Pain" (NCT01680549)
Timeframe: 3 days

,
Interventionunits on a scale- VAS (Mean)
Day 0Day 1Day 2
Gabapentin40.046.339.6
Placebo33.634.938.0

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Self-report Pain Score at Rest

Self-report pain scores at rest, using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0.5 to 36 hours post op. (NCT01707420)
Timeframe: Up to 36 hours

,
Interventionscore on a scale (Mean)
0.5 hours1.0 hours1.5 hours4 hours8 hours12 hours24 hours36 hours
Gabapentin Group5.334.334.003.463.912.693.041.95
Placebo Group5.085.803.603.002.714.204.614.00

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Total Oral Analgesia Consumption

Total mean oral analgesic requirement (cumulative hydrocodone dose (mg/kg)) at nine time points between 0 and 36 hrs post operatively. (NCT01707420)
Timeframe: Up to 36 hours

,
Interventioncumulative hydrocodone (mg/kg) (Mean)
cumulative hydrocodone (mg/kg) at 36hcumulative hydrocodone (mg/kg) at 24hcumulative hydrocodone (mg/kg) at 12hcumulative hydrocodone (mg/kg) at 8hcumulative hydrocodone (mg/kg) at 4hcumulative hydrocodone (mg/kg) at 1.5hcumulative hydrocodone (mg/kg) at 1hcumulative hydrocodone (mg/kg) at 0.5hcumulative hydrocodone (mg/kg) at 0h
Gabapentin Group0.2240.1930.1650.1320.1090.0870.0870.0680.011
Placebo Group0.2280.2000.1710.1570.1350.1270.1210.1070.079

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Self-report Pain Score When Swallowing

Self-report pain scores when swallowing using Bieri Faces Scale-Revised. The Bieri Faces Scale-Revised is a patient-reported measure in which patients indicate their pain level by selecting a face with an expression corresponding to their level of pain. Scores range from 0 to 10, with higher scores indicating worse pain. Pain was assessed at eight time points ranging from 0 to 36 hours post op. (NCT01707420)
Timeframe: Up to 36 hours

,
Interventionscore on a scale (Mean)
0.5 Hours1 Hours1.5 Hours4 Hours8 Hours12 Hours24 Hours36 Hours
Gabapentin Group6.474.785.404.305.303.865.463.70
Placebo Group5.426.005.504.274.004.805.655.13

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Mean Change in Patient Global Assessment (PGA)

Subjects will be asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA is measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor. (NCT01764464)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Gralise-0.04
Placebo-0.00

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Insomnia Severity Index (ISI)

The ISI has 7 questions with each question ranging from 0-4 for a total of 28 points with higher scores indicating more severe insomnia. (NCT01764464)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Gralise16.81
Placebo18.40

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Mean Change in Modified Brief Pain Inventory- Short Form (mBPI-sf)

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 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). The scale ranges from 0 to 70. Higher scores indicate worse outcome. (NCT01764464)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Gralise-0.07
Placebo-0.07

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Mean McGill Pain Questionnaire-2 (MPQ-2)

The McGill Pain questionnaire is 22 questions where patient rate their pain symptoms with each question scaled 0-10 for a total 220 points where a higher score indicates worse outcome. (NCT01764464)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Gralise2.97
Placebo3.13

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Mean Change in Numeric Rating Scale (NRS)

Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable). (NCT01764464)
Timeframe: baseline to 6 weeks

Interventionunits on a scale (Least Squares Mean)
Gralise-0.56
Placebo-0.54

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Mean Change in Visual Analog Scale (VAS)

The VAS asks 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. (NCT01764464)
Timeframe: baseline to 6 weeks

Interventionmm (Least Squares Mean)
Gralise-0.47
Placebo0.31

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Incidence of Post-Operative Pruritus

Pruritus in recovery and through the first 24 hours post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Number of patients with pruritis OR to dischargeNumber of patients with pruritis discharge to 24 h
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine813
Placebo Pills and Injectables1019

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Intraoperative Medication Use: Ketorolac and Lidocaine

All participants received standard induction medications. (NCT01868425)
Timeframe: From induction until arrival in post anesthesia care unit.

,
Interventionmg (Mean)
Intraoperative KetorolacIntraoperative Lidocaine
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine15.071.5
Placebo Pills and Injectables14.765.6

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Number of Participants Who Received Medication for Nausea

Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Anti-Nausea Medication Before DischargeAnti-Nausea Medication after Discharge
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine86
Placebo Pills and Injectables73

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Post-Operative Incidence of Nausea

Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
InterventionParticipants (Count of Participants)
Nausea Post op to dischargeNausea - discharge to 24 hour
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine1624
Placebo Pills and Injectables1223

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Post-Operative Nausea Scores

Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible). (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
Post Operative (recovery room)24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine1.22.2
Placebo Pills and Injectables0.71.6

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Post-Operative Pruritis Score

Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
Post Operative (recovery room)24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine0.40.7
Placebo Pills and Injectables0.71.2

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Sedation Scale

Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake. (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionscore on a scale (Mean)
1 hour post-op in Recovery Room24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine5.04.2
Placebo Pills and Injectables4.64.3

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Time to Discharge

Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). (NCT01868425)
Timeframe: Up to 24 hours following surgery

,
Interventionminutes (Mean)
Discharge from Recovery RoomDischarge from Outpatient Center
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine64.8132.1
Placebo Pills and Injectables61.4123.6

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Pain Scores During Recovery

Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain. (NCT01868425)
Timeframe: up to 24 hours postoperatively

,
Interventionscore on a scale (Mean)
Lowest Score Upon Arrival to Recovery RoomHighest Score Upon Arrival to Recovery Room1 hour post-op24 hours post-op
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine2.34.83.42.4
Placebo Pills and Injectables3.05.53.82.6

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Intraoperative Medication Use: Fentanyl

All participants received standard induction medications. (NCT01868425)
Timeframe: From induction until arrival in post anesthesia care unit.

Interventionmcg (Mean)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine125
Placebo Pills and Injectables128

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Number of Participants With Complications From the Procedure

(NCT01868425)
Timeframe: Up to 24 hours following surgery

InterventionParticipants (Count of Participants)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine0
Placebo Pills and Injectables0

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Opioid Consumption in the Immediate Postoperative Period

"This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The immediate postoperative period covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours." (NCT01868425)
Timeframe: Up to 10 hours

Interventionmorphine mg equivalents (Mean)
Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine12.0
Placebo Pills and Injectables14.4

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Speed Deviation

Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Standard deviation of speed was reported in the outcome measure. (NCT01888497)
Timeframe: 7.25 hours post dose

Interventionmeters per second (m/sec) (Mean)
Placebo0.9
Gabapentin0.9
Diphenhydramine Citrate1.0
Triazolam1.3

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Lane Exceedance

Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). Mean lanes excursed/exceeded was reported in the outcome measure. (NCT01888497)
Timeframe: 7.25 hours post-dose

Interventionlanes exceeded (Mean)
Placebo37.8
Gabapentin46.7
Diphenhydramine Citrate52.4
Triazolam147.7

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Standard Deviation of Lateral Position (SDLP)

Driving performance assessment for the participants were measured by simulated driving test using Cognitive Research Corporation Driving Simulator (CRCDS-MiniSim). The assessment was performed after 45 minutes of awakening from approximately 6.5 hours of sleep on testing day (after 7.25 hours of study drug administration). SDLP was used to assess driver's ability to track their lane and was the standard deviation of lane positions through the entire drive. (NCT01888497)
Timeframe: 7.25 hours post-dose

Interventioncentimeter (cm) (Mean)
Placebo33.2
Gabapentin34.2
Diphenhydramine Citrate35.4
Triazolam47.4

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Abstinence From Benzodiazepine Use

Achievement of two weeks abstinence from benzodiazepine use at end of trial (NCT01893632)
Timeframe: last two weeks of 12 week trial

InterventionParticipants (Count of Participants)
Gabapentin0
Placebo0

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Sense Wear Armband

Our secondary aim was to measure the change in physical activity between baseline and 8 weeks using the Sense Wear armband (SWA). The outcome measure was the average number of minutes spent daily performing physical activities >1.5 metabolic equivalents (METs).The SWA is a small device that collects information from multiple sensors: a triaxial accelerometer, heat flux, skin temperature, and galvanic signal. The information is integrated and processed by software using proprietary algorithms utilizing subjects' demographic characteristics (gender, age, height, and weight) to provide minute-by-minute estimates of physical activity. The SWA has shown good reliability and validity. The research participants in our study will wear the SWA for a week before and after they complete the treatment interventions. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).

Interventionminutes per day (Mean)
Medical Care-23.1
Group Exercise4.3
Manual Therapy and Exercise-6.0

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Self Paced Walking Test (SPWT)

Our primary aim also included a performance-based outcome measure, which was the distance walked during the SPWT. The analysis was a comparison of between-group changes in SPWT between baseline and 8 weeks. The Self-Paced Walking Test (SPWT) is a validated objective measure of a patient's walking capacity, which is performed on a level walking surface. The patient is instructed to walk at their own pace and to stop when the symptoms are troublesome enough that s/he needs to sit down to rest. The total time and total distance walked are measured by the research assistant. Our unit of measure was the total distance walked, expressed in meters. (NCT01943435)
Timeframe: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).

Interventionmeters (Mean)
Medical Care130.5
Group Exercise219.2
Manual Therapy and Exercise267.8

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Swiss Spinal Stenosis (SSS) Questionnaire Score

Our primary aim included a primary outcome measure of self-reported pain/function, which was the change in SSS total score between baseline and 8 weeks. The Swiss Spinal Stenosis Questionnaire (SSS) is a validated 12-item condition-specific instrument for patients with lumbar spinal stenosis. It provides a patient self-report measure of pain and physical function. Higher scores represent worse symptoms and less physical function. The 12-item SSS total score range is 12-55. For our analysis, we compared the change in the 12-item Total score from baseline to 8 weeks. (NCT01943435)
Timeframe: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).

Interventionunits on a scale (Mean)
Medical Care-2.0
Group Exercise-1.7
Manual Therapy and Exercise-4.1

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Absolute Change in Pain From Study Drug to 3 Hours Post Administration of Study Drug

To compare the change in pain score from time of administration of study drug to assessment at 3 hours post administration of study drug in the gabapentin vs. placebo groups. (0=no pain and 10=worst possible pain) (NCT01954927)
Timeframe: Study drug administration to 3-hours post study drug administration

Interventionscore on a scale (Median)
Gabapentin0
Placebo0.5

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Absolute Change in Pain, Study Drug to Hospital Discharge Decision

To compare the change in pain score from time of administration of study drug to the point of decision for either admission or discharge to home, in the gabapentin and placebo groups. (0=no pain and 10=worst possible pain) (NCT01954927)
Timeframe: From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.

Interventionscore on a scale (Median)
Gabapentin1.0
Placebo0.5

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Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo

The equivalent dose of morphine in mg (NCT01954927)
Timeframe: The 3-hour pain assessment was the pain assessment closest in time to the 3-hour time and was typically within 30 minutes of target. The time period was extended for 12 patients that were sleeping.

Interventionmg/kg (Median)
Gabapentin0.12
Placebo0.13

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Morphine Equivalent Doses Administered From Presentation to the Point of Decision for Either Admission or Discharge to Home

To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC between presentation to the acute care setting and the point of decision for either admission or discharge to home, in the gabapentin and placebo groups. (NCT01954927)
Timeframe: From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.

Interventionmg/kg (Median)
Gabapentin0.13
Placebo0.13

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Hospital Admission

To compare the rate of admission related to pain management, in the gabapentin vs. placebo groups. (Outcome: binary response - admitted or discharged) (NCT01954927)
Timeframe: From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.

,
InterventionParticipants (Count of Participants)
NoYes
Gabapentin3210
Placebo3212

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Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug

Pain scales used are the numerical rating system, the Faces Pain Scale, and the Faces, Legs, Arms, Cry and Consolability (FLACC) pain scale (for patients 7 years or older, ages 4-6 years, or less than 4 years, respectively). For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and 3 hours post administration of study drug is 33% or greater, then this patient will be defined as having a successful intervention. The proportions of successful interventions in the gabapentin and placebo groups will be estimated and compared using Z-test. (NCT01954927)
Timeframe: Baseline and 3 hours (±30 minutes) post administration of study drug. The 3-hour pain assessment time-period was extended for subjects that were sleep until the first available measurement.

,
InterventionParticipants (Count of Participants)
NoYes
Gabapentin1327
Placebo1725

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Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home

For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and Point of decision for either hospital admission or discharge to home is 33% or greater, then this patient will be defined as having a successful intervention. (NCT01954927)
Timeframe: From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.

,
InterventionParticipants (Count of Participants)
NoYes
Gabapentin1030
Placebo1727

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Difference in Pain Control When Adding Gabapentin to a Multimodal Pain Management Protocol in Pediatric Post-operative Posterior Spinal Fusion Patients.

"Patients will rate their pain using the Visual Analog Pain Scale (VAS). The VAS is a 10 cm line with anchors of no pain and worst pain imaginable. Patients rate their pain by marking on the 10 cm line where they feel their pain is at the time. The mark is then measured according to where it is along the 10 cm line and reported (range is 0.0 at the no pain end on the left up to 10.0 at the worst pain imaginable on the right). Lower pain scores on the VAS scale are considered a better outcome. The numbers seen in the outcome measure data table below represent an average of the total postoperative VAS scores recorded for each patient from each arm for the duration of their hospital stay." (NCT01977937)
Timeframe: five days

Interventionpain score on a scale (Mean)
Gabapentin2.46
Simple Syrup3.46

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Opiate Usage in the Gabapentin Group Versus Control.

Total the amount of Hydromorphone and Oxycodone used in milligrams per kilogram in each patient post-operatively, convert this amount to morphine equivalents, and determine if there is a significant difference between the Gabapentin versus Placebo group. (NCT01977937)
Timeframe: Five Days

Interventionmorphine equivalents mg per kg (Mean)
Gabapentin3.58
Simple Syrup5.33

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Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Nighttime

Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionvasomotor symptoms (VMS) per night (Mean)
mean VMS per night at baselinemean VMS per night at study completion
Open-label Gabapentin3.51.1

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Quality of Life-Menopause Specific

"The Quality of life-Menopause specific is assessed by the Menopause Specific Quality of Life (MENQOL).~The MENQOL is self-administered and consists of a total of 29 items in a Likert-scale format. Each item assesses the impact of one of four domains of menopausal symptoms, as experienced over the last month: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29). Items pertaining to a specific symptom are rated as present or not present, and if present, how bothersome on a zero (not bothersome) to six (extremely bothersome) scale. Means are computed for each subscale by dividing the sum of the domain's items by the number of items within that domain. Non-endorsement of an item is scored a 1 and endorsement a 2, plus the number of the particular rating, so that the possible score on any item ranges from 1-8. Total score also ranges from 1-8." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionscores on a scale (Mean)
MENQOL scores at baselineMENQOL scores at study completion
Open-label Gabapentin3.21.9

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Quality of Life-Overall

Quality of life-Overall was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). The Q-LES-Q is a 16-item self-report questionnaire that assesses enjoyment of and satisfaction with life. The scoring of the Q-LES-Q-SF involves summing only the first 14 items to yield a raw total score. The last two items are not included in the total score but are standalone items. The raw total score ranges from 14 to 70 with higher scores indicating higher quality of life enjoyment and satisfaction. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionscores on a scale (Mean)
Q-LES-Q scores at baselineQ-LES-Q scores at study completion
Open-label Gabapentin60.361.7

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Severity of Insomnia

"Severity of insomnia was measured throughout the study using the Insomnia Severity Index (ISI) .The ISI is a 7-item scale that evaluates the severity of insomnia retrospectively over the past week. The scale is more specific to insomnia symptoms than the Pittsburgh scale (PSQI), which focuses more broadly on overall sleep quality.~The ISI score ranges from a minimum of 0 to 28. A score of 0-7=no clinically significant insomnia, 8-14=subthreshold insomnia, 5-21=clinical insomnia (moderate severity), 22-28=clinical insomnia (severe), with higher values indicating more severe insomnia." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionscores on a scale (Mean)
mean ISI score at baselinemean ISI score at study completion
Open-label Gabapentin15.66.0

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Sleep Quality and Disturbances Over Past Month

"Sleep quality and disturbances during the past month were assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI also incorporates daytime functioning into the total score.~In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality." (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionscores on a scale (Mean)
PSQI total score at baselinePSQI total score at study completion
Open-label Gabapentin9.64.9

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Vasomotor Symptoms (VMS) Frequency, Severity, and Bothersomeness During Daytime

Vasomotor symptoms (VMS) were tracked and quantified prospectively using a daily hot flash diary. The hot flash diary was adapted from a 7-day self-report tool for vasomotor symptoms originally developed by the North Central Cancer Treatment Group (NCCTG). The diary asks for the subject to log number of hot flashes during the day and night, severity of hot flashes during day and night, and how bothersome the hot flashes were during day and night. Vasomotor symptoms were also systematically assessed at baseline, week 4, and week 7 using the Hot Flash-Related Daily Interference Scale (HFRDIS), a 10-item self-report questionnaire to determine perceived hot flash interference with quality of life and daily activities. (NCT02040532)
Timeframe: Baseline, study completion at 7 weeks

Interventionvasomotor symptoms (VMS) per day (Mean)
mean VMS per day at baselinemean VMS per day at study completion
Open-label Gabapentin4.12.2

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Numeric Pain Rating System (NPRS)

Fibromyalgia pain experienced by study subjects will be captured using NPRS at baseline visit, at each follow visits that are scheduled to occur every 4 weeks over 12 weeks of treatment period, and at the end of treatment visit that will occur 3 weeks after treatment period (12 weeks treatment period + 3 weeks = 15 weeks). Any difference in NPRS scores between baseline and any subsequent visits will indicate the magnitude of pain relief as reflected in digital scale of 0-10 (0=no pain, 10=worst pain imaginable). (NCT02052414)
Timeframe: 15 weeks

Interventionunits on a scale (Mean)
NPRS Baseline (Visit 1)NPRS on Week 4 (Visit 2)NPRS on week 8 (Visit 3)NPRS on Week 12 (Visit 4)NPRS on week 15 (Visit 5)
Gralise (Gabapentin ER)7.294.723.953.836.94

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Patient Global Impression of Change (PGIC)

Patient Global impression of Change (PGIC) is an outcome commonly used measure of the efficacy of treatments. PGIC is a 7 point scale that requires the subjects to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT02052414)
Timeframe: 15 Weeks.

Interventionunits on a scale (Mean)
PGIC After 4 weeksPGIC After 8 weeksPGIC After 12 weeksPGIC After 15 weeks
Gralise (Gabapentin ER)4.965.405.374.44

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Self Reported Side Effects.

Side / adverse effects were assessed at each follow up visits and resulted are as follows. (NCT02052414)
Timeframe: 15 Weeks

Interventionparticipants (Number)
Extremity SwellingWeight GainDrowsyDizzyIrritabilityDry EyesPainMood ChangesDifficulty ConcentratingDry MouthSuspected Drug interactionAcute DeleriumAdhesionNone
Gralise (Gabapentin ER)228332122111112

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Fibromyalgia Impact Questionnaire (FIQ)

The Fibromyalgia Impact Questionnaire (FIQ) is an instrument designed to quantitate the overall impact of fibromyalgia over many dimensions (e.g. function, pain level, fatigue, sleep disturbance, psychological distress etc.). It is scored from 0 to 100 with the latter number being the worst case. The average score for patients seen in tertiary care settings is about 50. The FIQ is widely used to assess change in fibromyalgia status. (NCT02052414)
Timeframe: 15 weeks.

Interventionunits on a scale (Mean)
FIQ BaselineFIQ Week 4FIQ Week 8FIQ Week 12FIQ Week 15
Gralise (Gabapentin ER)71.0441.8240.7939.2761.86

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Medical Outcome Study (MOS) Sleep Questionnaires

"Medical Outcomes Study (MOS) sleep questionnaires to assess how Fibromyalgia impacts patients' sleep in various areas.~Specifically, Data reported below measured number of hours subjects spent per night sleeping. MOS sleep questionnaires were assessed at each follow up visits. (visits 1, 2, 3, 4, and 5)." (NCT02052414)
Timeframe: 15 weeks

InterventionHours (Mean)
Sleep Quantity BaselineSleep Quantity week 4Sleep quantity week 8Sleep quantity week 12Sleep quantity week 15
Gralise (Gabapentin ER)5.867.176.817.046.23

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Reduction in Tampon Test Pain

"Reduction in the pain, as measured on a 10 point Likert scale, associated with the insertion and removal of a tampon. This is a validated surrogate for pain associated with intercourse. Subjects were asked to insert and remove a tampon each week and report the degree of pain associated with this. A score of 0 was defined as no pain, and a score of 10 was defined as worst imaginable pain." (NCT02099006)
Timeframe: 13 weeks

,
Interventionunits on a scale (Mean)
loperamideketaminegabapentinketoprofenamitriptyline/baclofen
Medications4.715.925.1256.175.43
Placebo5.295.924.8756.05.36

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Reduction in Daily Genital Pain.

"Each subject was asked to keep a symptom diary recording her daily genital pain, measured on a 10 point Likert scale. A score of 0 was defined as no pain and a score of 10 was defined as worst imaginable pain. These daily values were collected and a mean pain score for the period of treatment was calculated." (NCT02099006)
Timeframe: 13 weeks

,
Interventionunits on a scale (Mean)
LoperamideKetamineGabapentinamtriptyline/baclofenketoprofen
Medications2.43.423.703.875.05
Placebo2.922.773.413.615.05

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Pain Intensity Rating

Pain is reported verbally after each stimulus by the subject on a scale of 0 (no pain) to 10 (worst imagineable pain). For each individual the value used is the average of all presentations of the 50 degree stimulus. (NCT02155257)
Timeframe: Reported 5 seconds after each stimulus

Interventionunits on a scale (Mean)
Modafinil3.2
Placebo2.8
Gabapentin2.8

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Resting Pupil Diameter

Resting pupil diameter will be measured using an infrared camera to obtain baseline measurements 2 hours after dosing subject pupil diameter measurements will be repeated (NCT02155257)
Timeframe: Baseline and 2 hours

,,
Interventionmm (Mean)
Baseline2 Hours
Gabapentin6966.1
Modafinil6466.9
Placebo7270.9

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Cognitive Style

Cognitive style determined for each individual by subtracting the score in the Pain Catastrophizing Scale (CATS) questionnaire (with a score range of 0-52 with higher score showing more catastrophizing) from the Life Orientation Test Revised (LOT-R) questionnaire (score range of 0-24, with a higher score denoting a better outcome). Thus, the total score could range from ranges from -52 to 24, with lower scores indicating worse cognitive style related to pain reporting and higher scores indicating better cognitive style related to pain reporting. There are no subscales here. (NCT02155257)
Timeframe: baseline

Interventionscore on a scale (Mean)
Modafinil18.2
Placebo15.5
Gabapentin14.8

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Baseline Adjusted Mean Daily Oral Nutrition Score for Days 5-7

Score range: 0-15 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Gabapentin7.86
Metoclopramide4.01

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Desire to Continue Therapy at Study Endpoint

Scores: 0=no, 1=yes. Thus, a higher score indicates a better outcome. (NCT02163434)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Gabapentin0.67
Metoclopramide0.14

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Global Satisfaction of Treatment at the Study Endpoint.

Score range: 0-4 with higher score indicating a better outcome. (NCT02163434)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Gabapentin2.22
Metoclopramide0.63

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Percent of Subjects Requiring Repeat iv Hydration or Hospital Admission for HG From the Outpatient Setting.

(NCT02163434)
Timeframe: 1 week

InterventionParticipants (Count of Participants)
Gabapentin5
Metoclopramide5

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Baseline Adjusted Mean Daily Motherisk-PUQE Total Scores (Pregnancy-unique Quantification of Emesis and Nausea Scale) for Days 5-7

Score range: 6-30 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Gabapentin6.35
Metoclopramide13.22

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Baseline Adjusted Mean Daily Nausea Scores From the Motherisk-PUQE for Days 5-7.

Score range: 2-10 with higher score indicating a worse outcome. (NCT02163434)
Timeframe: 1 week

Interventionunits on a scale (Mean)
Gabapentin2.01
Metoclopramide3.69

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Percentage of Subjects Abstinent From Alcohol (Key Secondary Endpoint)

Timeline Follow-back drinking data is used to calculate the % of subjects that report not drinking alcohol during weeks 22-25 (NCT02252536)
Timeframe: Weeks 22-25

InterventionParticipants (Count of Participants)
Sugar Pill16
Gabapentin Enacarbil17

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Alcohol Craving Score [Alcohol Craving Scale - Short Form (ACQ-SR-R)]

"The ACQ-SR-R contains 12-items adapted from the 47-item ACQ-NOW developed by Singleton et al (1994) to assess craving for alcohol among alcohol users in the current context (right now). Each item has a 1 to 7 raw score (from strongly disagree to strongly agree). Items 3, 8, and 11 are reverse keyed. A general craving index is derived by summing all items and dividing by 12. Minimum score is 1 and maximum score is 7. Higher scores are indicative of higher craving.~Mixed effects models as stated in Section 9.4.3 of the SAP will be generated for the total score and for the 4 subscales. Covariates for these models will be identified" (NCT02252536)
Timeframe: Weeks 24 and 26

Interventionscores on a scale (Least Squares Mean)
Sugar Pill2.5
Gabapentin Enacarbil2.5

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Weekly Mean Number of Drinks Per Week

Timeline Follow Back data used to calculate the weekly mean number of drinks per week (NCT02252536)
Timeframe: Weeks 22-25

Interventiondrinks per week (Least Squares Mean)
Sugar Pill21.4
Gabapentin Enacarbil23.1

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Weekly Mean Drinks Per Drinking Day

Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day (NCT02252536)
Timeframe: Weeks 22-25

Interventiondrinks per drinking day (Least Squares Mean)
Sugar Pill3.9
Gabapentin Enacarbil4.1

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Pittsburgh Sleep Quality Index (PSQI) Score

"The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of poor sleep quality." (NCT02252536)
Timeframe: Week 26

Interventionscore (Least Squares Mean)
Sugar Pill4.4
Gabapentin Enacarbil4.9

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Percentage of Subjects With no Heavy Drinking Days (PSNHDD)

The primary objective of the study is to compare the efficacy of HORIZANT (gabapentin enacarbil) Extended-Release Tablets 600 mg twice daily (BID) with matched placebo on the primary alcohol consumption outcome endpoint, percentage of subjects with no heavy drinking days (PSNHDD) during the last 4 weeks of treatment, among patients with Alcohol Use Disorder (AUD). (NCT02252536)
Timeframe: Weeks 22-25

Interventionpercentage of subjects with NHDD (Number)
Sugar Pill17.3
Gabapentin Enacarbil24.1

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Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 2-levels

"Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows:~Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g" (NCT02252536)
Timeframe: Weeks 22-25

InterventionParticipants (Count of Participants)
Sugar Pill69
Gabapentin Enacarbil80

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Percentage of Subjects With a World Health Organization (WHO) Drinking Risk Category Decrease of at Least 1-level

"Timeline Follow Back data is used to calculate the % of participants that decrease at least 1-level WHO drinking risk category. The WHO has developed a drinking risk categorical scale that can be used in a responder analysis approach to assess clinically relevant decreases in alcohol consumption (Aubin et al-2015). The WHO 1- and 2-level decrease endpoints are the percentage of subjects experiencing at least 1- and 2-level decrease in WHO levels of alcohol consumption, respectively, from the level at baseline (the period including the 28 days before screening) to the level during the last 4 weeks of the maintenance phase (Study Weeks 22-25). The WHO levels are as follows:~Males Females Low Risk 1 to 40g 1 to 20g Medium Risk 41 to 60g 21 to 40g High Risk 61 to 100g 41 to 60g Very High Risk 101+g 61+g" (NCT02252536)
Timeframe: Weeks 22-25

InterventionParticipants (Count of Participants)
Sugar Pill107
Gabapentin Enacarbil115

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Percentage of Heavy Drinking Days Per Week

Timeline Follow Back data used to calculate the % of heavy drinking days per week. Heavy drinking is 4+ drinks per day for females and 5+ drinks per day for males (NCT02252536)
Timeframe: Weeks 22-25

Interventionpercentage of days (Least Squares Mean)
Sugar Pill46.5
Gabapentin Enacarbil43.1

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Percentage of Days Abstinent Per Week

Timeline Follow Back daily drinking data used to calculate the % of days abstinent per week. (NCT02252536)
Timeframe: Weeks 22-25

Interventionpercentage of days (Least Squares Mean)
Sugar Pill49
Gabapentin Enacarbil49.3

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Cigarettes Per Week Among Smokers

"A quantity frequency interview of three questions to assess cigarette smoking behavior and other tobacco/nicotine containing products use during the study: 1) Over the past week, on how many days did you smoke cigarettes?, 2) On the days you smoked during the past week, how many cigarettes did you smoke on average?, and 3) Have you used any other tobacco or nicotine containing products besides cigarettes in the past week (e.g., cigars, cigarellos, pipes, bidis, or smokeless tobacco such as pan, chewing tobacco, or snuff, or nicotine replacement therapies such as patch or gum)?." (NCT02252536)
Timeframe: Weeks 22-25

Interventioncigarettes per week (Least Squares Mean)
Sugar Pill61.4
Gabapentin Enacarbil71

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Beck Depression Inventory - II

"The BDI-II is a 21-item multiple choice questionnaire that is used for measuring the severity of depression (Beck et al-1966). Each item is scored on a scale value of 0 to 3. The standardized cutoffs for depression severity are:~0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression" (NCT02252536)
Timeframe: Week 26

Interventionscore (Least Squares Mean)
Sugar Pill5.2
Gabapentin Enacarbil6.5

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Beck Anxiety Inventory (BAI) Score

The BAI consists of 21 questions about how the subject has been feeling in the last week, expressed as common symptoms of anxiety (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). This inventory was designed to minimize the overlap with depression scales (Beck et al-1988).The BAI has a maximum score of 63. The standardized cutoffs for anxiety severity are: 0-7: minimal level of anxiety 8-15: mild anxiety 16-25: moderate anxiety 26-63: severe anxiety (NCT02252536)
Timeframe: Week 26

Interventionscore (Least Squares Mean)
Sugar Pill3.3
Gabapentin Enacarbil4.6

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Average Numeric Pain Score

Pain was measured on a Visual Analogue Scale (VAS) rated from 0-10, where 0 was no pain and 10 was the worst pain imaginable. The numeric pain score was measured every 4 hours and the total score over 24 hours was averaged as the daily numeric pain score. The daily scores were then averaged over a 7 day period for a single average pain score. (NCT02330094)
Timeframe: baseline through day 7

Interventionscore on a scale (Mean)
Gabapentin5.2
Control5.8

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Pain Control Satisfaction Questionnaire

The Brigham and Women's Hospital Management of Post-operative Pain Patients discharge questionnaire (BWQ) was used to measure pain control satisfaction. The questionnaire was modified and transformed into a uniform scale so all numbers were on the same direction. Subjects were asked to answer six questions on a score of 0-5, for a total possible range of 0-30. A lower score indicated a better outcome (less pain) and higher pain control satisfaction and a higher score indicated a worse outcome (more pain) and lower pain control satisfaction. (NCT02330094)
Timeframe: Day 8

Interventionscore on a scale (Mean)
Gabapentin14
Control12.6

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Average Narcotic Consumption

The amount of narcotics administered, averaged over a 7 day period, calculated in total morphine equivalents (ME). (NCT02330094)
Timeframe: baseline through day 7

Interventionmilligrams (Mean)
Gabapentin19.4
Control20.2

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Percent of Subjects With no Heavy Drinking Days (PSNHDD)

The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT. (NCT02349477)
Timeframe: 4 months

InterventionParticipants (Count of Participants)
Gabapentin12
Placebo4

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Number of Participants With No Drinking Days by AWS Score and Medication

This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome). (NCT02349477)
Timeframe: 4 months

InterventionParticipants (Count of Participants)
Low AWS/Gabapentin2
Low AWS/Placebo3
High AWS/Gabapentin10
High AWS/Placebo1

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Percent of Subjects With no Drinking Days (PSNDD)

The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT. (NCT02349477)
Timeframe: 4 months

InterventionParticipants (Count of Participants)
Gabapentin8
Placebo2

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Number of Participants Readmitted to Mayo Clinic Within 30-days

(NCT02351934)
Timeframe: Within 30 days of release from hospital

InterventionParticipants (Count of Participants)
Furosemide + Enhanced Recovery After Surgery (ERAS)13
Enhanced Recovery After Surgery (ERAS)10

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Time to Stool Output

(NCT02351934)
Timeframe: Up to 4 days

Interventionhours (Median)
Furosemide + Enhanced Recovery After Surgery (ERAS)48.8
Enhanced Recovery After Surgery (ERAS)45.4

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Number of Participants With Acute Kidney Injury

Acute kidney injury (AKI) refers to an abrupt decrease in kidney function, resulting in the retention of urea and other nitrogenous waste products and in the dysregulation of extracellular volume and electrolytes. The term AKI has largely replaced acute renal failure (ARF), reflecting the recognition that smaller decrements in kidney function that do not result in overt organ failure are of substantial clinical relevance and are associated with increased morbidity and mortality. The AKI experienced by these patients was not considered an adverse event. (NCT02351934)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Furosemide + Enhanced Recovery After Surgery (ERAS)2
Enhanced Recovery After Surgery (ERAS)2

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Number of Participants With Hypokalemia

Hypokalemia is generally defined as a serum potassium level of less than 3.5 mmol/L. (NCT02351934)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Furosemide + Enhanced Recovery After Surgery (ERAS)2
Enhanced Recovery After Surgery (ERAS)3

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Length of Hospital Stay

Participants will be followed for the duration of hospital stay, an expected average of 2-7 days. (NCT02351934)
Timeframe: Up to 7 days

Interventionhours (Median)
Furosemide + Enhanced Recovery After Surgery (ERAS)99.6
Enhanced Recovery After Surgery (ERAS)80.6

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Number of Participants Requiring Nasogastric Tube Placement

(NCT02351934)
Timeframe: Up to 7 days

InterventionParticipants (Count of Participants)
Furosemide + Enhanced Recovery After Surgery (ERAS)6
Enhanced Recovery After Surgery (ERAS)1

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Patient Total Equivalent Analgesic Requirement (Morphine Equivalents)

Geometric Mean and Standard Deviation of patient total equivalent analgesic (NCT02355886)
Timeframe: 48 hours post-radical cystectomy

InterventionTotal oral morphine equivalents in mg (Geometric Mean)
Arm I (Gabapentin)297.65
Arm II (Placebo)396.16

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Patient Self-assessed Pain on Numerical Pain Scale

The two study groups compared on Patient self-assessed pain on numerical pain likert scale. Numeric Pain Scale was utilized with values of 0-10 with increasing severity. (NCT02355886)
Timeframe: Up to 48 hours post-radical cystectomy

InterventionSore on a scale (Mean)
Arm I (Gabapentin)5.15
Arm II (Placebo)7.67

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Length of Stay Following Radical Cystectomy

The two study groups will be compared by Length of stay following radical cystectomy (NCT02355886)
Timeframe: duration of hospital stay. Days to weeks

Interventiondays (Mean)
Arm I (Gabapentin)6.58
Arm II (Placebo)6.73

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VAS (Visual Analog Scale)

"The VAS is scored using a horizontal line 100mm in length. The scale is anchored by no pain (score of 0) and worst pain (score of 100)." (NCT02359110)
Timeframe: 2 -6 hours

,
Interventionunits on a scale (Least Squares Mean)
Hour 2Hour 6
Gabapentin37.838.7
Placebo33.936.9

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NRS (Numerical Rating Scale)

The NRS is a numerical scale ranging from 0-10 implemented with adults. Having no pain is rated as a 0 and the worst pain the patient could tolerate is rated as a 10. (NCT02359110)
Timeframe: 2-8 hours

,
Interventionunits on a scale (Least Squares Mean)
Hour 2Hour 4Hour 6Hour 8
Gabapentin3.55.45.35.7
Placebo3.45.55.85.1

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Total Morphine Consumption

(NCT02359110)
Timeframe: 12 hours post-operatively

Interventionmg (Mean)
Gabapentin14.3
Placebo14.7

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Number of Participants With Grade 3 or 4 Adverse Events, (Graded Using Common Terminology Criteria for Adverse Events Criteria 4.0)

Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Frequency distributions will summarize the safety outcome. (NCT02480114)
Timeframe: Up to 3 months post-treatment

InterventionParticipants (Count of Participants)
Arm I Standard of Care0
Arm II Standard of Care Plus Gabapentin0

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Frequency and Severity of General Systemic Symptoms (Surveys Such as the Neurotoxicity Scale, Profile of Mood States, and Quality of Life Form)

Pain severity will be correlated with frequency and severity of general systemic symptoms. Graphical and descriptive statistical summaries will be generated. Mixed-level general linear modeling will be used. All tests of statistical significance will maintain maximum Type I error of 0.05 (p < 0.05). Baseline pain scores will be included as a covariate in the analyses of the outcome. The General Symptom Survey is a ten item patient reported outcome measure and outcomes were averaged as there is only one item per symptom category. 0 represented no presence of the symptom with a score of 10 representing the most severe symptom. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care1.91
Arm II Standard of Care Plus Gabapentin1.23

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Change in Pain Associated With Radiation-induced Mucositis, (Pain Subscale of the Vanderbilt Head and Neck Symptom Survey (VHNSS))

The pain subscale is composed of 4 items of the Vanderbilt Head and Neck Symptom Survey. The subscale score was calculated by taking the first non-negative principle component of the 4 items. The scale was scores range from 0 to 10 with 10 representing the worst pain. (NCT02480114)
Timeframe: Up to 3 months post-treatment

Interventionscore on a scale (Median)
Arm I Standard of Care4.26
Arm II Standard of Care Plus Gabapentin3.68

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Detox Phase Completers

% of enrolled participants who completed the Detox Phase (NCT02543944)
Timeframe: 3 weeks (week 1-3)

InterventionParticipants (Count of Participants)
Gabapentin41
Placebo34

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NTX Transition Initiation

% of Participants who completed the detox and started the NTX transition (NCT02543944)
Timeframe: 3 days (wk 4 day 1 - week 4 day 3)

InterventionParticipants (Count of Participants)
Gabapentin33
Placebo29

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Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time

Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant) (NCT02543944)
Timeframe: Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition)

Interventionpercentage of urine positive samples (Mean)
Gabapentin35.0
Placebo41.6

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Vivitrol Injection Receivers

% of participants starting the NTX transition who received Vivitrol injection (NCT02543944)
Timeframe: 5 days (week 4 day 1 to week 4 day 5)

InterventionParticipants (Count of Participants)
Gabapentin12
Placebo12

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Change in Positive, Negative, Disorganization, and General Symptoms Over Time as Measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS)/the Scale of Psychosis-Risk Symptoms (SOPS)

Exploratory analyses will be conducted examining the effects of gabapentin on changes in Positive symptoms (P scores), negative symptoms (N scores) and general symptoms (G scores) and disorganization symptoms (D scores) compared to placebo. There are 19 items on the SIPS. Each item is scored 0-6. There are 5 positive symptom items (range=0-30), 6 negative symptom items (range=0-36), 4 disorganization symptom items (range=0-24), and 4 general symptom items (range=0-24). The range of scores is 0-114. A lower score at baseline indicates less symptoms, and therefore a negative change over the 6 week period indicates an improvement, and a positive change indicates worsening of symptoms. (NCT02557945)
Timeframe: 6 weeks

,
Interventionscore on a scale (Mean)
P score changeN score changeG score changeD score change
Gabapentin-1.5-1-1.52
Placebo0.66-1.660.5-2.5

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Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)

Exploratory analyses will be conducted on changes between gabapentin and placebo groups on the California Verbal Learning Test-Second Edition (CLVT-II) measures. The unit measured was 'learning slope', where higher slope indicates better memory and a lower slope indicates poorer memory. (NCT02557945)
Timeframe: 6 weeks

InterventionChange in raw learning slope (Mean)
Gabapentin0.1
Placebo-0.3

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Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)

Change from 6 week follow up minus baseline of left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment. (NCT02557945)
Timeframe: 6 weeks

Interventionpercent change (Mean)
Gabapentin-0.005
Placebo0.38

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Patient Overall Satisfaction With Postoperative Analgesia

Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied. (NCT02605187)
Timeframe: 24 and 48 hours after delivery

,,,
Interventionunits on a scale (Mean)
24 hours after delivery48 hours after delivery
Choice: High Protocol93.389.3
Choice: Low Protocol90.392.6
Choice: Medium Protocol94.191.2
No Choice87.289.9

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Count of Participants Who Need Opioid Use

Count of participants who need opioid use through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1314
Choice: Low Protocol148
Choice: Medium Protocol5042
No Choice2723

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Count of Participants With Presence of Pruritus

Count of participants with pruritus through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol137
Choice: Low Protocol113
Choice: Medium Protocol6329
No Choice2712

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Pruritus Score at 24 and 48 After Delivery

Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching. (NCT02605187)
Timeframe: 24 and 48 hours following delivery

,,,
Interventionunits on a scale (Mean)
24 hours after delivery48 hours after delivery
Choice: High Protocol4.51.1
Choice: Low Protocol1.70.2
Choice: Medium Protocol3.71.0
No Choice4.20.8

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Pain Scores

Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain. (NCT02605187)
Timeframe: 3, 6, 12, 24, 36 and 48 hours after delivery

,,,
Interventionunits on a scale (Mean)
Pain at rest at 3 hoursPain at movement at 3 hoursPain at rest at 6 hoursPain at movement at 6 hoursPain at rest at 12 hoursPain at movement at 12 hoursPain at rest at 24 hoursPain at movement at 24 hoursPain at rest tat 36 hoursPain at movement at 36 hoursPain at rest at 48 hoursPain at movement at 48 hours
Choice: High Protocol2.24.11.53.81.73.22.33.63.14.83.34.8
Choice: Low Protocol1.83.42.74.42.14.71.94.11.74.02.03.9
Choice: Medium Protocol1.93.22.23.81.93.62.24.32.64.52.03.6
No Choice1.63.22.34.01.53.02.24.51.53.51.73.5

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Opioid Consumption in the 0-48 Hour Study Periods.

Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods. (NCT02605187)
Timeframe: 0-24 and 24-48 hour postoperative periods

,,,
Interventionmilligram morphine equivalents (MMEQ) (Median)
0-24 hours24-48 hours
Choice: High Protocol530
Choice: Low Protocol50
Choice: Medium Protocol105
No Choice1010

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Counts of Participants Who Need Medical Treatment for Nausea

Counts of participants who need medical treatment of nausea through 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol90
Choice: Low Protocol91
Choice: Medium Protocol200
No Choice80

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Counts of Participants With Presence of Nausea

Count of participants with nausea through 48 hours after delivery. (NCT02605187)
Timeframe: 0-48 hours after delivery

InterventionParticipants (Count of Participants)
No Choice11
Choice: Low Protocol7
Choice: Medium Protocol33
Choice: High Protocol10

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Time to Discharge

Minutes from delivery until discharge. (NCT02605187)
Timeframe: Delivery through discharge (average 4 days)

Interventionminutes (Mean)
No Choice4771.9
Choice: Low Protocol4652.1
Choice: Medium Protocol5278.9
Choice: High Protocol5722.3

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Average Number of Vomiting Episodes After Delivery

(NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
Interventionvomiting episodes (Mean)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1.30
Choice: Low Protocol0.30
Choice: Medium Protocol0.50
No Choice0.60

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Count of Participants Who Need Medical Treatment of Pruritus

Count of participants who need medical treatment of pruritus during first 48 hours after delivery. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
InterventionParticipants (Count of Participants)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol30
Choice: Low Protocol20
Choice: Medium Protocol122
No Choice72

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Nausea Score Score at 24 and 48 After Delivery

Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea. (NCT02605187)
Timeframe: 0-24 and 24-48 hours after delivery

,,,
Interventionunits on a scale (Mean)
0-24 hours after delivery24-48 hours after delivery
Choice: High Protocol1.80.2
Choice: Low Protocol1.10.2
Choice: Medium Protocol1.50.2
No Choice1.30.3

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Change in Augmentation Severity Rating Scale Form Day 0 to Day 360 (270 Days After Discontinuation pf Dopaminergic Medication)

"Numeric Scale to assess degree of augmentation; Range 0-24; 0 is better, 24 is worst.~We compared the Augmentation severity scale on day 0 to day 360 (which is 270 days after this decrease of dopaminergic medication)" (NCT02642315)
Timeframe: Day 0 to day 360 (270 days after discontinuing dopaminergic medication)

Interventionscore on a scale (Median)
Day 0 augmentation scale scoreDay 360 Augmentation scale score
Open-label6.50

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Change in Augmentation Severity From Day 0 to Day 90

Augmentation severity rating scale; 0-24, 0 is better, 24 is worst (NCT02642315)
Timeframe: From Day 0 (Baseline) to Day 90

Interventionscore on a scale (Median)
Baseline90 days
Open-label6.50

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Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo-- Slope

"Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for gabapentin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain.~Slope is defined as change in pain . Values represent the slope of modeled worst daily pain (0-10 scale as described above) divided by the natural log of time (days) across all participants, extracted from the mixed effect model. The slope is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model." (NCT02685735)
Timeframe: Postoperative Day 1 through Postoperative Day 60

Interventionscore on a scale/ln(day) (Mean)
Gabapentin-0.107
Placebo-0.113

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Comparison of Adjusted Trajectory Model for Pain Between Gabapentin and Placebo--Intercept

"Daily pain intensity report for each subject was fitted using growth curve model with parameters of intercept (modeled initial pain) and slope of change in natural log of time, adjusted for prognostic predictors for gabapentin and placebo group separately. The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain.~Values represent an intercept of modeled worst daily pain on the first day after hospital discharge across all participants, extracted from the mixed effect model. The intercept is a number representative of all participants in the Arm and is an estimate with confidence limits based on the model." (NCT02685735)
Timeframe: The first day after hospital discharge up to 5 days post surgery

Interventionscore on a scale (Mean)
Gabapentin7.47
Placebo7.40

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Effect Pupil Diameter, Catastrophizing-optimism Construct, and Gabapentin on Model Fit of the Trajectory of Change in Worst Daily Pain After Surgery

"Daily pain intensity report for each subject was fitted using growth curve model, adjusted for pre-specified prognostic predictors . The daily pain intensity was the WORST pain (not the average pain) in the past 24 hr on a scale where 0 is no pain and 10 is worst imaginable pain.~Deviance values were calculated from the model fit with just pre-specified prognostic predictors (Model 1) and the model fit with these predictors plus pupil diameter, catastrophizing-optimism construct, gabapentin treatment and their interaction. Deviance is a goodness-of-fit statistic for a statistical model; it is often used for statistical hypothesis testing. It is a generalization of the idea of using the sum of squares of residuals (SSR) in ordinary least squares to cases where model-fitting is achieved by maximum likelihood. Deviance ranges from 0 to infinity. The smaller the number the better the model fits the sample data.~Model fits were compared using Chi-squared test." (NCT02685735)
Timeframe: Postoperative Day 1 through Postoperative Day 60

Interventionunitless (Number)
Adjusted Daily Worst Pain Trajectory Model (Model 1)37466
Pain Trajectory Model Plus Pupil, Cognitive Style, and Study Drug Factors (Model 2)37358

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Tampa Scale of Kinesiophobia

This 17-question scale assesses the degree of fear of pain from joint movement and is commonly used in orthopedic injury or surgery studies. The scale ranges from 17 to 68 with 17 indicating no fear of movement and 68 indicating severe fear. (NCT02685735)
Timeframe: Preoperative, 2 months after surgery, 6 months after surgery

,
Interventionscore on a scale (Median)
Preoperative2 months after surgery6 months after surgery
Gabapentin363433
Placebo373533

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Wisconsin Card Sort Task

This is a physical card sorting game which measures attention to shifts in implicit rules as the game progresses. Perseverative errors are the number of sequential errors when rules of the game shift and reflect dysfunction of attention. This score ranges from 0 to 64 with larger numbers reflecting more dysfunction of attention. (NCT02685735)
Timeframe: Preoperative, 2 months after surgery, 6 months after surgery

,
Interventionscore on a scale (Median)
Preoperative2 months after surgery6 months after surgery
Gabapentin7.06.05.0
Placebo6.06.05.0

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Iowa Gambling Task

This is a computer based card game which assesses risk taking and impulsivity in which a score of -100 to 100 is calculated. Lower numbers indicate greater impulsiivity (NCT02685735)
Timeframe: Preoperative, 2 months after surgery, 6 months after surgery

,
Interventionscore on a scale (Median)
Preoperative2 months after surgery6 months after surgery
Gabapentin41013
Placebo21216

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Subjective Pain at 2 Weeks Postop

"Assessment of the subject pain score postoperatively at 2 weeks. will use a numeric analog scale from 0-10.~The pain scale ranging from 0-10 with 0 representing No Pain and 10 representing the Worst Pain Possible" (NCT02703259)
Timeframe: 2 weeks

Interventionscore on a scale (Mean)
Gabapentin1.3
Control1.4

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Subjective Pain at 24 Hours Postoperative

Pain score assesses patient subjective pain via patient reported numeric analogue scale, range 0-10 with 0 being no pain and 10 being severe pain. (NCT02703259)
Timeframe: 24 hours

Interventionscore on a scale (Mean)
Gabapentin3.4
Control3.4

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Number of Patient With Gabapentin Adverse Effects at 2 Weeks Postoperatively

Will assess for known symptoms of gabapentin postoperatively at 2 weeks. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction (NCT02703259)
Timeframe: 2 weeks

,
InterventionParticipants (Count of Participants)
DizzinessBlurred visionSomnolenceDifficulty walkingTremulousnessNauseaVomiting
Control83215271
Gabapentin1241854120

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Number of Patient With Gabapentin Adverse Effects at 24 Hours Postoperatively

Will assess for known symptoms of gabapentin postoperatively at 24 hours. We will survey subjects regarding their experience of the following symptoms: dizziness/drowsiness, fatigue, loss of balance, blurry vision, tremulousness, swelling, nausea, vomiting, diarrhea, and allergic reaction (NCT02703259)
Timeframe: 24 hours

,
InterventionParticipants (Count of Participants)
DizzinessBlurred VisionSomnolenceDifficulty walkingTremulousnessNauseaVomiting
Control84231162515
Gabapentin177201311249

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Narcotic Use at 24 Hours Postop

Assessment of the amount of narcotic use postoperatively at 24 hours. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents (NCT02703259)
Timeframe: 24 hours

Interventionmorphine milligram equivalents (Mean)
Gabapentin158.8
Control175.0

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Narcotic Use at 2 Weeks Postop

Assessment of the amount of narcotic use postoperatively at 2 weeks. will use opioid equivalence table to convert all narcotic use to oxycodone equivalents (NCT02703259)
Timeframe: 2 weeks

Interventionmorphine milligram equivalents (Mean)
Gabapentin167.2
Control187.3

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Perioperative Nausea as Measured by 100-mm VAS

Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life. (NCT02725710)
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

,
Interventionunits on a scale (Median)
Baseline10 minutes30 minutes
Group 1: Placebo3.02.52.3
Group 2: Gabapentin3.01.01.0

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Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure

Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. (NCT02725710)
Timeframe: 5 minutes

Interventionscore on a scale (Mean)
Group 1: Placebo35.7
Group 2: Gabapentin37.1

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Number of Subjects Using Pain Medications

Pain medications included ibuprofen and oxycodone. (NCT02725710)
Timeframe: 24 hours post-operatively

,
InterventionParticipants (Count of Participants)
No pain medicationIbuprofen onlyIbuprofen and oxycodoneOxycodone only
Group 1: Placebo102396
Group 2: Gabapentin172361

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Perioperative Anxiety as Measured by the 100-mm VAS

Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious. (NCT02725710)
Timeframe: 5 minutes, 10 minutes, 30 minutes, discharge

,
Interventionunits on a scale (Median)
5 minutes10 minutes30 minutesDischarge
Group 1: Placebo24.514.513.310.5
Group 2: Gabapentin23.511.07.08.0

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Pain Score on the 100-mm VAS

Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. (NCT02725710)
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute

,
Interventionunits on a scale (Median)
Baseline10 minutes30 minutes
Group 1: Placebo3.319.812.6
Group 2: Gabapentin3.020.09.5

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Number of Subjects Experiencing Perioperative Vomiting

(NCT02725710)
Timeframe: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

,
InterventionParticipants (Count of Participants)
Baseline10 minutes30 minutes
Group 1: Placebo111
Group 2: Gabapentin025

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Number of Subjects Experiencing Side Effects

Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. (NCT02725710)
Timeframe: 10 minutes post-procedure

,
InterventionParticipants (Count of Participants)
DizzinessAtaxiaSomnolenceAstheniaHeadacheAmblyopia
Group 1: Placebo148373153
Group 2: Gabapentin206412753

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Pain Laboratory Measures - Descending Noxious Inhibitory Control (DNIC) - Average, Baseline

DNIC will be measured as the percent change in PPTh during the cold pressor tasks relative to baseline. A percent increase represents normal functioning of pain inhibitory processes. (NCT02737826)
Timeframe: Baseline

Interventionpercentage of change (Mean)
Gabapentin + Buprenorphine Taper312.5
Placebo + Buprenorphine Taper326.4

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Mean Score of Subjective Opioid Withdrawal Scale (SOWS)

The Subjective Opiate Withdrawal Scale (SOWS) consist of 16 symptoms rated in intensity by patients on a 5-point scale of intensity as follows: 0=not at all, 1=a little, 2=moderately, 3=quite a bit, 4=extremely. The total score is a sum of item ratings, and ranges from 0 to 64. (NCT02737826)
Timeframe: baseline

Interventionunits on a scale (Mean)
Gabapentin + Buprenorphine Taper17.3
Placebo + Buprenorphine Taper11.9

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Mean Score Pittsburgh Sleep Quality Index

The PSQI is a 19 item self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components (time gone to bed, how long it takes to go to sleep, wake up time, hours slept, issues sleeping, total hours slept etc.) that produce one global score. Each item is weighted on a 0-3 interval scale. The global score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, A lower scale is indicative of better sleep quality and higher score represents poor sleep quality. (NCT02737826)
Timeframe: baseline

Interventionunits on a scale (Mean)
Gabapentin + Buprenorphine Taper12.5
Placebo + Buprenorphine Taper10.6

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Mean Score of Current Opioid Measure (COMM)

COMM is a 17 item questionnaire that is used to examine concurrent misuse. The score range is from 0-28. A lower score represents participant showing less aberrant behaviors associates with misuse of option medications, and a higher score represents more aberrant behaviors associated with opioid medical misuse. (NCT02737826)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Gabapentin + Buprenorphine Taper16
Placebo + Buprenorphine Taper15

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Pain Self-report: Pain Catastrophizing Scale - Baseline

The Self Reporting Pain Catastrophizing scale consists of 13 items scored from 0 to 4. The total possible score is 52. A higher score indicates more catastrophizing thoughts are present. A lower score indicates less catastrophizing thoughts. (NCT02737826)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Gabapentin + Buprenorphine Taper21.9
Placebo + Buprenorphine Taper21.2

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Number of Participants Who Achieve Opioid Cessation

For Phase II, the primary outcome measure will be number of participants opioid who achieve cessation 8 weeks after stabilization at Week 10, evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: 8 weeks after stabilization at Week 10

InterventionParticipants (Count of Participants)
Phase II - Gabapentin + Buprenorphine Taper1
Phase II - Placebo + Buprenorphine Taper0

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Percentage of Patients Who Tolerate Buprenorphine Initiation

"For Phase I, the primary outcome measure is the percentage of patients who tolerate buprenorphine initiation within an 8-hour initiation period, as evidenced by a total score of 3 points when summing the following measures (1) moderate-good level of pain control (same or improved rating on a 0-10 visual analogue scale for pain) = 1 point, (2) mild to no withdrawal symptoms (≤10 on the Subjective Opioid Withdrawal Scale) = 1 point, and (3) willingness to continue to the stabilization and tapering phase of the study; yes = 1 point." (NCT02737826)
Timeframe: 8 hours post dose

InterventionParticipants (Count of Participants)
Phase I - Buprenorphine Initiation27

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Pain Laboratory Testing: Mechanical - Baseline

Mechanical (Pressure) Pain Threshold Assessment (PPTh): A digital anesthesiometer (IITC Life Sciences ElectroVonFrey) will be used to assess mechanical pain perception. Pain threshold to static mechanical stimuli will be determined by applying the rigid monofilament to the dorsum of each subject's right hand with increasing pressure (10 grams per second) until the participant indicates verbally that the pain threshold has been reached. (NCT02737826)
Timeframe: Baseline

Interventiongrams per second (Mean)
Gabapentin + Buprenorphine Taper284.2
Placebo + Buprenorphine Taper289.1

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Number of Participants Who Achieve Opioid Cessation Post-taper: 1 Month

Opioid cessation post taper: 1 month with opioid cessation measured through self-report, prescription drug monitoring data, and confirmatory UDS for a full panel of opioids. (NCT02737826)
Timeframe: 1 month post-taper

InterventionParticipants (Count of Participants)
Gabapentin + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper0
Placebo + Buprenorphine Taper - Opioid Cessation 1 Month Post-taper0

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Number of Participants Who Achieved Opioid Cessation Post-taper - 3 Months

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 3 months

InterventionParticipants (Count of Participants)
Gabapentin + Buprenorphine Taper - Opioid Cessation 3 Months Post-taper1
Placebo + Buprenorphine Taper - Opioid Cessation 3 Months Post-taper0

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Number of Participants Who Achieved Opioid Cessation Post-taper - 12 Months

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 12 months

InterventionParticipants (Count of Participants)
Gabapentin + Buprenorphine Taper - Opioid Cessation 12 Months Post-taper1
Placebo + Buprenorphine Taper - Opioid Cessation 12 Months Post-taper0

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Number of Participants Who Achieved Opioid Cessation Post-taper - 6 Months

Opioid cessation is evidenced as a score of 3 points when summing the following measures: self-report of no opioid use = 1 point; prescription drug monitoring data showing no opioid prescriptions filled in past 30 days = 1 point; and confirmatory negative urine toxicology for a full panel of opioids = 1 point. (NCT02737826)
Timeframe: Post-taper - 6 months

InterventionParticipants (Count of Participants)
Gabapentin + Buprenorphine Taper - Opioid Cessation 6 Months Post-taper1
Placebo + Buprenorphine Taper - Opioid Cessation 6 Months Post-taper0

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Mean Score of PROMIS Physical Function Short Form (PROMIS SF 10) - RAW SCORE PH

"The Mean score of Physical Function on PROMIS short form. The global physical health score is a sum of responses to 4 questions. The range is from 4-20. A lower score represents lower physical function.~The following questions will be asked: In general, how would you rate your physical health? (range is 1-5; 1 represents poor rating in health, 5 represents excellent rating of physical health) To what extent are you able to carry out your everyday physical activities such as walking, climbing stairs, carrying groceries, or moving a chair? (range is 1-5; 1 represents score of not at all, 5 represents score of completely) How would you rate your fatigue on average? (range is 1-5; 1 represents very severe fatigue, and 5 represents no fatigue) How would you rate your pain on average (range is 0-10; 0 represents no pain, 10 represents worst pain imaginable). The pain score is then recoded: 0, no pain = 5; 1, 2, or 3 = 4; 4, 5, or 6 =3; 7, 8, 9 =2;10 =1" (NCT02737826)
Timeframe: baseline

Interventionunits on a scale (Mean)
Gabapentin + Buprenorphine Taper10.3
Placebo + Buprenorphine Taper11

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Mean Pain With Coughing Score as Measured by VAS

"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain" (NCT02926573)
Timeframe: Baseline through post operative day 3

,
Interventionmm (Mean)
Post-operative Day 1 7AMPost-operative Day 1 10AMPost-operative Day 1 7PMPost-operative Day 2 7AMPost-operative Day 2 10AMPost-operative Day 2 7PMPost-operative Day 3 7AM
Gabapentin36363434283027
Placebo46454139394539

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Change in Daily Narcotic Consumption

Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption. (NCT02926573)
Timeframe: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.

Interventionmg/hour (Median)
Gabapentin1.60
Placebo1.59

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Mean Pain With Swallowing Score as Measured by VAS

"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain" (NCT02926573)
Timeframe: Baseline through post operative day 3

,
Interventionmm (Mean)
Post-operative Day 1 7AMPost-operative Day 1 10AMPost-operative Day 1 7PMPost-operative Day 2 7AMPost-operative Day 2 10AMPost-operative Day 2 7PMPost-operative Day 3 7AM
Gabapentin49464141374035
Placebo48515248455652

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Mean Pain With Resting Score as Measured by VAS

"Subjective pain scores were captured using the Visual Analog Scale (VAS). Subjects were asked to Please rate your current pain level with no movement (rest), with a cough, and with a swallow. Subjects marked a point on a 100-mm line anchored no pain on the left end and worst possible pain on the right end.~Pain literature reports that scores in the 10-30mm range correlate clinically with mild pain, in the 30-60 or 70mm range with moderate pain, and in the >70 range with severe pain" (NCT02926573)
Timeframe: Baseline through post operative day 3

,
Interventionmm (Mean)
Post-operative Day 1 7AMPost-operative Day 1 10AMPost-operative Day 1 7PMPost-operative Day 2 7AMPost-operative Day 2 10AMPost-operative Day 2 7PMPost-operative Day 3 7AM
Gabapentin44292527232522
Placebo46373232303332

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Nausea or Vomiting at Postoperation Follow-up Assessment

During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome. (NCT02944656)
Timeframe: Postoperative Day 1

Interventionunits on a scale (Mean)
Gabapentin Group2.3
Placebo Group3.2

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Moderate Pain at Postoperation Follow-up Assessment

"During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Moderate pain was defined according to the perception of each participant." (NCT02944656)
Timeframe: Postoperative Day 1

Interventionunits on a scale (Mean)
Gabapentin Group5.2
Placebo Group5.2

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Number of Participants Using Pain Medication

The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication. (NCT02944656)
Timeframe: Postoperative Day 1

InterventionParticipants (Count of Participants)
Gabapentin Group24
Placebo Group27

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Severe Pain at Postoperation Follow-up Assessment

"During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Severe pain was defined according to the perception of each participant." (NCT02944656)
Timeframe: Postoperative Day 1

Interventionunits on a scale (Mean)
Gabapentin Group3.5
Placebo Group3.2

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Anxiety Levels

"Participants reported how much anxiety they were currently experiencing on a 100-point scale where No Anxiety is scored as 0 and Extremely Anxious is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure." (NCT02944656)
Timeframe: Pre-procedure through post-procedure on Study Day 1

,
Interventionscore on a scale (Median)
Prior to procedure10 minutes post-procedure30 minutes post-procedure
Gabapentin Group66144
Placebo Group72172

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Pain at Time of Uterine Evacuation

"The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. No pain is scored as 0 and worst pain imaginable is scored as 100." (NCT02944656)
Timeframe: During the procedure on Study Day 1

,
Interventionscore on a scale (Mean)
Paracervical blockDilationAspiration
Gabapentin Group63.7964.5867.77
Placebo Group62.2166.1271.06

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Perioperative Nausea

"Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while worst nausea I have ever felt is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure." (NCT02944656)
Timeframe: Pre-procedure through post-procedure on Study Day 1

,
Interventionscore on a scale (Median)
Prior to procedure10 minutes post-procedure30 minutes post-procedure
Gabapentin Group2610
Placebo Group26125

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Perioperative Pain Level

"Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. No pain is scored as 0 and worst pain imaginable is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge)." (NCT02944656)
Timeframe: Pre-procedure through post-procedure on Study Day 1

,
Interventionscore on a scale (Mean)
Prior to procedureSpeculum removal10 minutes post-procedure30 minutes post-procedure
Gabapentin Group20.7644.1030.6420.89
Placebo Group22.4847.6143.6831.65

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Perioperative Vomiting

Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. (NCT02944656)
Timeframe: Pre-procedure through post-procedure on Study Day 1

,
InterventionParticipants (Count of Participants)
Prior to procedure10 minutes post-procedure30 minutes post-procedure
Gabapentin Group455
Placebo Group725

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Side Effects

Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes. (NCT02944656)
Timeframe: 10 and 30 minutes post procedure on Study Day 1

,
InterventionParticipants (Count of Participants)
Dizziness 10 minutes post-procedureDizziness 30 minutes post-procedureLack of muscle control 10 minutes post-procedureLack of muscle control 30 minutes post-procedureSleepiness/drowsiness 10 minutes post-procedureSleepiness/drowsiness 30 minutes post-procedureWeakness 10 minutes post-procedureWeakness 30 minutes post-procedureHeadache 10 minutes post-procedureHeadache 30 minutes post-procedureVision changes 10 minutes post-procedureVision changes 30 minutes post-procedure
Gabapentin Group271995383033205493
Placebo Group23159103429342844115

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Number of Participants With Delirium Tremens (DT)

The number of participants experiencing delirium tremens during their hospitalization (between admission and discharge). (NCT03012815)
Timeframe: During hospitalization (up to 240 hours)

InterventionParticipants (Count of Participants)
Gabapentin0
Benzodiazepine0

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Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7) Scale

GAD-7 is GAD-7 is a 7-item self-administered scale of Generalized Anxiety Disorder symptoms (0 = not at all to 3 = nearly every day). Total scores range from 0 to 21. Total scores of 0-4 = minimal anxiety, Total scores of 5-9 = mild anxiety, total scores of 10-14 = moderate anxiety and total scores of 15-21 = severe anxiety. (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-0.07
Benzodiazepine-3.79

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Mean Total Benzodiazepine Use

The total amount of benzodiazepines administered. Measured by lorazepam equivalent, mg. (NCT03012815)
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

Interventionmilligrams (Mean)
Gabapentin5.2
Benzodiazepine10.8

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Change in Cravings as Assessed by the Penn Alcohol Craving (PACS) Scale

PACS is a 5 item self-rated scale of alcohol craving (0 = none to 6 = strong urge). Total scores range from 0 (little craving for alcohol) to 30 (irresistible urge to drink alcohol) (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-8.12
Benzodiazepine-8.45

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Change in Sleepiness as Assessed by the Epworth Sleepiness Scale

The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their daytime sleepiness. (NCT03012815)
Timeframe: Baseline and 2 days

Interventionscore on a scale (Mean)
Gabapentin-0.03
Benzodiazepine0.07

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Maximun Alcohol Withdrawal Severity Per CIWA-Ar Scale

CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity (NCT03012815)
Timeframe: 4 days

Interventionscore on a scale (Mean)
Gabapentin13.15
Benzodiazepine12.81

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Mean Length of Hospital Stay

The length of hospital stay for Alcohol withdrawal syndrome. The time interval between admission and either discharge or the time at which Clinical Institute Withdrawal Assessment - Alcohol revised (CIWA-Ar) scores are <10 for 36 hours (up to 240 hours). Measured in hours. CIWA-Ar measures severity of 10 observed or measured alcohol withdrawal signs or symptoms. Zero to 7 points are assigned to each item, except for the last item, which is assigned 0-4 points, with a total possible score of 67. Total score ranges from 0 (best possible outcome)-67 (worst possible outcome). Lower scores (0-8) represent fewer withdrawal symptoms and less severity, scores > 8 represent more withdrawal symptoms and greater severity (NCT03012815)
Timeframe: Time to discharge or time to CIWA-Ar score < 10 for 36 hours (whichever came first) up to 240 hrs.

Interventionhours (Mean)
Gabapentin44.91
Benzodiazepine50.50

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Number of Participants Experiencing Seizure

The number of subjects who developed seizure during their hospitalization. (NCT03012815)
Timeframe: During hospitalization (up to 240 hours).

InterventionParticipants (Count of Participants)
Gabapentin0
Benzodiazepine0

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Number of Participants With Adverse Events

Treatment-emergent adverse events (TEAE) was defined as an adverse event (AE) with onset after the start of the run-in period. A drug-related TEAE was a TEAE with at least a possible relationship to the study drug as assessed by the investigator. Serious TEAE was an AE considered serious. (NCT03053427)
Timeframe: From first dose of study drug up to week 13

,
InterventionParticipants (Count of Participants)
Any TEAEsDrug-related TEAEsTEAEs leading to deathSerious TEAEsDrug-related serious TEAEsTEAEs leading to discontinuation of study drugDrug-related TEAEs leading to disc. of study drug
Gabapentin Enacarbil946003044
Placebo713600043

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Change From Baseline in IRLS Score at Each Time Point

ANCOVA model with the baseline value as a covariate was used. (NCT03053427)
Timeframe: Baseline and weeks 1, 2, 4, 6, 8, 10, 12 and EoT (week 12)

,
Interventionunits on a scale (Least Squares Mean)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12EoT
Gabapentin Enacarbil-4.2-5.8-7.5-8.8-9.8-11.2-11.9-11.1
Placebo-3.1-4.3-6.0-7.4-8.8-9.6-10.5-10.2

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Change From Baseline in Pittsburgh Sleep Quality Index Total Score (PSQI)

The self-rated items of the PSQI generate seven component scores (range of subscale scores, 0-3). The sum of these seven component scores yielded one global score of subjective sleep quality (range, 0-21). Higher scores represent poorer subjective sleep. ANCOVA model with the baseline value as a covariate was used. (NCT03053427)
Timeframe: Baseline and EoT (week 12)

Interventionunits on a scale (Least Squares Mean)
Placebo-1.7
Gabapentin Enacarbil-1.7

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Percentage of Participants With a Patient-rated Clinical Global Impression (PCGI) Response

"PCGI was assessed by 7-point ordinate scale. Participants who were Very much improved or Much improved were defined as responders." (NCT03053427)
Timeframe: EoT (week 12)

Interventionpercentage of participants (Number)
Placebo50.5
Gabapentin Enacarbil56.4

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Change From Baseline in Restless Legs Syndrome (RLS) Pain Score

The scale range of RLS pain score was 0-10. Higher scores represent greater RLS pain intensity. ANCOVA model with the baseline value as a covariate was used. (NCT03053427)
Timeframe: Baseline and EoT (week 12)

Interventionunits on a scale (Least Squares Mean)
Placebo-0.9
Gabapentin Enacarbil-1.0

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Change From Baseline in International Restless Legs Syndrome Rating Scale (IRLS) Score at Week 12

The IRLS consisted of 10-item scale for assessing severity of restless legs syndrome (RLS) with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 to 40. Higher IRLS score indicated greater disease activity. Mixed Model of Repeated Measurements (MMRM) model with compound symmetry as a covariance structure was used. The explanatory variables of the model included treatment group, IRLS score at baseline, age category, estimated creatinine clearance category, time point, and interaction of treatment group and time point. (NCT03053427)
Timeframe: Baseline and week 12

Interventionunits on a scale (Least Squares Mean)
Placebo-10.5
Gabapentin Enacarbil-11.7

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Change From Baseline in Health Status Score of EuroQol-5 Dimension-5 Level (EQ-5D-5L)

Health status was assessed by general visual analog scale (VAS). The VAS ranges from 0 (worst health status) and 100 (best health status). (NCT03053427)
Timeframe: Baseline and EoT (week 12)

Interventionunits on a scale (Mean)
Placebo2.7
Gabapentin Enacarbil4.2

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Change From Baseline in Athens Insomnia Scale

Athens Insomnia Scale consisted of 8-item scale (range of subscale scores, 0-3). The scale range of Athens Insomnia was 0-24. Higher scores represent poorer sleep quality. ANCOVA model with the baseline value as a covariate was used. (NCT03053427)
Timeframe: Baseline and EoT (week 12)

Interventionunits on a scale (Least Squares Mean)
Placebo-2.5
Gabapentin Enacarbil-2.5

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Percentage of Participants With an Investigator-rated Clinical Global Impression (ICGI) Response

"ICGI was assessed by 7-point ordinate scale. Participants who were Very much improved or Much improved were defined as responders." (NCT03053427)
Timeframe: EoT (week 12)

Interventionpercentage of participants (Number)
Placebo53.2
Gabapentin Enacarbil57.4

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Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 4 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Mean)
Gabapentin3
Placebo Oral Capsule3.5

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Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D&E procedure. (NCT03080493)
Timeframe: Time of presentation for D&E (day after dilator insertion)

InterventionNumeric rating scale pain score change (Median)
Gabapentin0.5
Placebo Oral Capsule1

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Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment. (NCT03080493)
Timeframe: 5 minutes after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin1
Placebo Oral Capsule2

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Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 8 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin2
Placebo Oral Capsule2.5

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Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion

Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message. (NCT03080493)
Timeframe: 2 hours after insertion of last osmotic dilator

InterventionNumeric rating scale pain score change (Median)
Gabapentin3.5
Placebo Oral Capsule4

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Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)

Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion) (NCT03080493)
Timeframe: Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)

InterventionParticipants (Count of Participants)
Gabapentin35
Placebo Oral Capsule40

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Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.~0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure

"The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).~The higher the score the better quality of life.~Scores are standardized to a mean of 50 with a range of -0.809-70.71." (NCT03084536)
Timeframe: At baseline and 1 year post-surgery

Interventionscore on a scale (Median)
Preoperative PECS Blocks-3.1
Placebo PECS Blocks-0.8

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Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.~0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.~The scores for each subsection will be averaged." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure

"The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).~The higher the score the better quality of life.~Scores are standardized to a mean of 50 with a range of -1.465-77.09." (NCT03084536)
Timeframe: At baseline and 1 year post-surgery

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks1.9

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Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year

"The participant is asked to rate their pain by circling the one number that best describes their pain on the average.~0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain." (NCT03084536)
Timeframe: At 1 year

Interventionscore on a scale (Median)
Preoperative PECS Blocks0
Placebo PECS Blocks0

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Daily Narcotic Use

Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery (NCT03123861)
Timeframe: First 14 days after surgery

Interventionmorphine milliequivalents per day (Median)
Gabapentin1.6
Placebo Oral Capsule1.6

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Gluteal Pain During Normal Activities

Gluteal post-op pain will be measured by an item similar to that used for the primary outcome which asks for the average amount of gluteal pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain. (NCT03123861)
Timeframe: 7 days after surgery

Interventionunits on a scale (Mean)
Gabapentin2.1
Placebo Oral Capsule3.4

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Pain During Normal Activities (Surgical Pain Scale Item 2)

Post-operative pain at week 1 will be measured by item 2 of the surgical pain scale (SPS). This item asks for the average amount of pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain. (NCT03123861)
Timeframe: 7 days after surgery

Interventionunits on a scale (Mean)
Gabapentin1.6
Placebo Oral Capsule3.2

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Worst Pain (Surgical Pain Scale Item 4)

Post-operative pain will be measured by item 4 of the surgical pain scale (SPS). This item asks for how unpleasant or disturbing the worst pain was in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain (NCT03123861)
Timeframe: 7 days after surgery

Interventionunits on a scale (Mean)
Gabapentin2.4
Placebo Oral Capsule4.0

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24 Hour Pain Burden

Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable (NCT03151746)
Timeframe: 24 hours after surgery

Interventionscore on a scale (Mean)
Placebo4.11
Gabapentin3.11

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48 Hours Morphine Equivalents Consumed.

Total morphine equivalents in milligrams consumed during the first 48 hours after surgery. (NCT03151746)
Timeframe: Up to 48 hours after surgery

Interventionmorphine milligrams (Mean)
Placebo51.87
Gabapentin15.71

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QOR 40 Questionnaire Scores

Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure. (NCT03151746)
Timeframe: 48 hours after surgical procedure

Interventionscore on a scale (Mean)
Placebo181.3
Gabapentin187.5

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Change From Baseline Between Gralise® and Neurontin® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).

Miles per Hour (mph) (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3

Interventionmph (Least Squares Mean)
Gralise® (Gabapentin)0.831
Neurontin® (Gabapentin)0.947
Placebo0.851

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Detection Task (DET)

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

Interventionmsec (Least Squares Mean)
Gralise® (Gabapentin)0.00
Neurontin® (Gabapentin)0.00
Lyrica® (Pregabalin)-0.01
Placebo (Sugar Pill)-0.00

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Groton Maze Learning Test (GMLT).

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

InterventionNumber of errors on test (Least Squares Mean)
Gralise® (Gabapentin)-0.40
Neurontin® (Gabapentin)-0.01
Lyrica® (Pregabalin)-0.64
Placebo (Sugar Pill)3.32

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - Identification Task (IDN).

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

InterventionScore on Scale (Least Squares Mean)
Gralise® (Gabapentin)-0.00
Neurontin® (Gabapentin)0.00
Lyrica® (Pregabalin)-0.00
Placebo (Sugar Pill)0.01

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - International Shopping List Test (ISL)

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

InterventionScore on Scale (Least Squares Mean)
Gralise® (Gabapentin)0.36
Neurontin® (Gabapentin)0.82
Lyrica® (Pregabalin)0.03
Placebo (Sugar Pill)-0.01

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Change From Baseline Between Gralise® and Lyrica® in the Driving Simulator - Standard Deviation of Vehicle Speed (SDVS).

Miles per Hour (mph) (NCT03179345)
Timeframe: Baseline and Hour 3 on Day 3

Interventionmph (Least Squares Mean)
Gralise® (Gabapentin)0.831
Lyrica® (Pregabalin)1.319
Placebo0.851

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Cognitive Evaluation of Cogstate - One Card Learning (OCLT).

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

InterventionScore on Scale (Least Squares Mean)
Gralise® (Gabapentin)0.02
Neurontin® (Gabapentin)0.06
Lyrica® (Pregabalin)0.00
Placebo (Sugar Pill)0.03

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"Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Neurontin®"

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

Interventionfeet (Least Squares Mean)
Gralise® (Gabapentin)0.255
Neurontin® (Gabapentin)0.395
Placebo0.135

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Karolinska Sleepiness Scale (KSS).

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

Interventionunits on a scale (Least Squares Mean)
Gralise® (Gabapentin).774
Neurontin® (Gabapentin).264
Lyrica® (Pregabalin).868
Placebo (Sugar Pill).264

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Change From Baseline Between, Gralise® and Neurontin®, Gralise® and Lyrica® for Sedation Evaluation - Portland Neurotoxicity Scale (PNS).

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

,,,
Interventionscores on a scale (Least Squares Mean)
Vision (blurring, double vision)Energy Level (get up and go)Memory (ability to remember people, places, or thiWalking (balance)Interest (in activities)CoordinationTremor (shakiness)Concentration (ability to concentrate on a task)Speech (slurring words)ForgetfulnessSleepiness (fatigue, sedation, tiredness)MoodinessAlertnessAttention SpanMotivation
Gralise® (Gabapentin)0.0360.0990.0770.2060.0460.180-0.1030.0800.0350.1180.6930.1810.2970.0200.185
Lyrica® (Pregabalin)0.2490.3150.1250.4050.0960.350-0.0310.1370.0650.1751.1760.0980.6070.1460.368
Neurontin® (Gabapentin)0.3220.2560.1230.3270.0300.3920.0370.1640.1330.2270.6350.1630.4510.1330.232
Placebo (Sugar Pill)0.1150.331-0.0410.1070.0700.2180.0680.1820.1030.0790.5410.1000.3530.0150.271

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"Change From Baseline in the Standard Deviation of the Lateral Position (SDLP) Measured on the Driving Simulator Between Gralise® and Lyrica®"

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

Interventionfeet (Least Squares Mean)
Gralise® (Gabapentin)0.255
Lyrica® (Pregabalin)0.356
Placebo0.135

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To Compare the Relative Safety and Tolerability of Gralise®, Neurontin®, and Lyrica®.

"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

,,,
Interventionparticipants (Number)
Subjects with TEAESubjects with SAESubjects Discontinued due to AE
Gralise® (Gabapentin)600
Lyrica® (Pregabalin)1601
Neurontin® (Gabapentin)1301
Placebo (Sugar Pill)500

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Peak Positive Subjective Responses to Placebo.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration,for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg3.3
Gabapentin 1800 mg2.3

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Peak Positive Subjective Responses to Low Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg4.1
Gabapentin 1800 mg11.4

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Peak Positive Subjective Responses to Oxycodone (15mg)

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg1.9
Gabapentin 1800 mg4.7

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Peak Positive Subjective Responses to Oxycodone (15mg) + High Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg6.3
Gabapentin 1800 mg9.7

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Peak Positive Subjective Responses to Oxycodone (15mg) + Low Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg3.7
Gabapentin 18008.0

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Peak Positive Subjective Responses to Oxycodone (30mg)

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg2.7
Gabapentin 1800 mg5.3

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Peak Positive Subjective Responses to Oxycodone (30mg) + High Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg6.7
Gabapentin 1800 mg10.9

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Peak Positive Subjective Responses to Oxycodone (30mg) + Low Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg3.0
Gabapentin 1800 mg9.1

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Peak Positive Subjective Responses to High Alcohol Dose.

"Self-reported High measured on a 0-100 self-report visual analog scale. 0= Not-At-All 100=Extremely" (NCT03205423)
Timeframe: "Assessed every 15 minutes following drug administration, for a total of 360 minutes. Peak drug effect is the highest rating throughout the entire testing session."

Interventionunits on a scale (Mean)
Gabapentin 0 mg4.8
Gabapentin 1800 mg8.6

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Prefrontal Glx Concentrations

Concentrations of Glx (i.e., glutamate + glutamine), referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy. (NCT03220776)
Timeframe: Day 5 of each experimental condition

Interventionmmol/kg (Mean)
N-Acetylcysteine21.59
Gabapentin21.69
Placebo Oral Tablet22.25

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Prefrontal GABA+ Concentrations

Concentrations of GABA+, referenced to unsuppressed water and corrected for within-voxel CSF proportion, in dorsal anterior cingulate cortex measured via Proton Magnetic Resonance Spectroscopy (i.e., MEGA-PRESS). (NCT03220776)
Timeframe: Day 5 of each experimental condition

Interventionmmol/kg (Mean)
N-Acetylcysteine3.90
Gabapentin3.93
Placebo Oral Tablet3.73

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Change in Total FACT-HN Scores From Baseline to Follow-up

Scale: Functional Assessment of Cancer Therapy-Trial Outcome (FACT-HN), range 0-148, higher scores indicate better outcomes (NCT03269344)
Timeframe: Administered at baseline and at 6-week follow-up endpoint, approximately 13 weeks

Interventionunits on a scale (Median)
Control Arm-15.0
Experimental Arm-20.0

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Feeding Tube Placement

Measure of number of patients who required feeding tube placement at any time during the study period (NCT03269344)
Timeframe: Evaluated placement of feeding tube from baseline (start of radiation) to 6 weeks post-treatment, approximately 13 weeks

InterventionParticipants (Count of Participants)
Control Arm6
Experimental Arm18

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Percent Weight Lost

Percent weight lost from baseline to week 7 of treatment (end of treatment) (NCT03269344)
Timeframe: Percent change from baseline to week 7 of treatment

InterventionPercent change (Median)
Control Arm-10.7
Experimental Arm-11.4

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Average Opioid Use, Measured in Morphine Equivalents Per Day.

(NCT03269344)
Timeframe: Over the entire study period from baseline to follow-up, approximately 13 weeks

InterventionDaily morphine equivalents (Median)
Control Arm15.6
Experimental Arm22.2

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Change in PRO-CTCAE Scores From Baseline to Follow-up

Scale: Patient-reported outcomes of Common Terminology Criteria for Adverse Events (PRO-CTCAE), 5-point Likert scale, higher scores indicate worse outcomes. Range of scores 0-40 (min-max). (NCT03269344)
Timeframe: Evaluated change in scores from baseline to 6 weeks post-treatment, approximately 13 weeks

Interventionunits on a scale (Median)
Control Arm1.0
Experimental Arm6.5

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Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy

Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy. (NCT03334721)
Timeframe: Day 5 of each experimental condition

,
InterventionInstitutional Units (Mean)
GABA (randomization order 1, gabapentin 1st)GABA (randomization order 2, placebo 1st)
Gabapentin2.6252.609
Placebo Oral Capsule2.6962.720

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"VAS Score 2: How Much Pain do You Feel in Your Operative Site When Moving?"

Surgical site pain. Scale 0-10, with 0 best and 10 worst. (NCT03334903)
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).

Interventionscore on a 10-point scale (Mean)
Standard of Care3.84
Postoperative Gabapentin Regimen3.54

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Opioid Consumption

Mean opioid consumption, measured in mg of morphine equivalents. (NCT03334903)
Timeframe: 2-3 months following surgery (total amount measured at second postoperative appointment; means assessed afterwards).

Interventionmorphine equivalents (Mean)
Standard of Care287.0
Postoperative Gabapentin Regimen281.1

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"VAS Score 4: How Bad is Your Nausea?"

Nausea. Scale 0-10, with 0 best and 10 worst. (NCT03334903)
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).

Interventionscore on a 10-point scale (Mean)
Standard of Care0.36
Postoperative Gabapentin Regimen0.17

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"VAS Score 1: How Much Pain do You Feel in Your Operative Site When Resting?"

Surgical site pain. Scale 0-10, with 0 best and 10 worst (NCT03334903)
Timeframe: 2-3 months after surgery (at 2nd postoperative appointment)

Interventionscore on 10-point scale (Mean)
Standard of Care2.26
Postoperative Gabapentin Regimen2.46

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"VAS Score 3: How Well Are You Sleeping?"

Sleep quality. Scale 0-10 with 0 worst and 10 best. (NCT03334903)
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).

Interventionscore on a 10-point scale (Mean)
Standard of Care5.73
Postoperative Gabapentin Regimen6.38

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Days Taking Opioids

Number of days until patients are finished consuming opioid medications after discharge. (NCT03334903)
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).

Interventiondays (Mean)
Standard of Care14.8
Postoperative Gabapentin Regimen18.7

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"VAS Score 5: How Satisfied Are You With Your Pain Management?"

Satisfaction. Scale 0-10 with 0 worst and 10 best. (NCT03334903)
Timeframe: 2-3 months following surgery (measured at second postoperative appointment).

Interventionscore on a 10-point scale (Mean)
Standard of Care7.83
Postoperative Gabapentin Regimen8.48

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Number of Intensive Care Unti (ICU) Days

"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

InterventionICU days (Mean)
Original MMPR - Descending Dose Arm0.21
MAST MMPR - Escalating Dose Arm0.21

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Number of Participants Discharged From the Hospital With an Opioid Prescription

(NCT03472469)
Timeframe: Up to 30 days

InterventionParticipants (Count of Participants)
Original MMPR - Descending Dose Arm527
MAST MMPR - Escalating Dose Arm476

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Pain as Assessed by Score on the Numeric Rating Scale (NRS)

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)

Interventionunits on a scale (Median)
Original MMPR - Descending Dose Arm3.3
MAST MMPR - Escalating Dose Arm3.3

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Pain as Assessed by Score on the Behavioral Pain Scale (BPS)

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)

Interventionscore on a scale (Median)
Original MMPR - Descending Dose Arm2.5
MAST MMPR - Escalating Dose Arm2.3

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Number of Ventilator Days

"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

Interventionventilator days (Mean)
Original MMPR - Descending Dose Arm0.08
MAST MMPR - Escalating Dose Arm0.06

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Overall Costs

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)

Interventiondollars (Median)
Original MMPR - Descending Dose Arm20093
MAST MMPR - Escalating Dose Arm19561

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Opioid Use Per Day

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)

InterventionMME per day (Median)
Original MMPR - Descending Dose Arm48
MAST MMPR - Escalating Dose Arm34

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Pharmacy Costs

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)

Interventiondollars (Median)
Original MMPR - Descending Dose Arm507
MAST MMPR - Escalating Dose Arm397

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Number of Hospital Days

"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

Interventionhospital days (Mean)
Original MMPR - Descending Dose Arm4.97
MAST MMPR - Escalating Dose Arm5.12

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Time to Opioid Cessation as a Measure of Opioid Utilization

(NCT03472521)
Timeframe: Up to 12 weeks

Interventionweeks (Median)
Gabapentin2
Control2

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Pain Report

Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain). (NCT03472521)
Timeframe: 12 weeks

Interventionweeks (Median)
Gabapentin7
Control12

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Functional Recovery

Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function. (NCT03472521)
Timeframe: 12 weeks

Interventionweeks (Median)
Gabapentin8
Control11

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Falls

rate of falls (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention5300
Observational1272

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Nausea

rate of nausea (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention1340
Observational5232

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Falls

rate of falls (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention4274
Observational4242

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Constipation

rate of constipation (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention13220
Observational1992

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Constipation

rate of constipation (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention4274
Observational7212

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Additional Post Op Pain

post-operative pain: measured on a 0 (no pain) -10 (worst) numeric rating scale (NRS) at 6hrs, 12hrs, 2 weeks, and 2 months. A score of 0(no pain) is preferable to 10(worst possible pain) (NCT03540030)
Timeframe: 6hrs, 12hrs, 2weeks, 2 months

,
Interventionscore on a scale (Median)
6 Hrs12 hrs2 weeks2 months
Non-Opioid Intervention0.000.820
Observational241.30.7

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Simple Shoulder Test

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. (NCT03540030)
Timeframe: 2 Weeks

Interventionscore on a scale (Median)
Observational2.0
Non-Opioid Intervention2.0

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Simple Shoulder Test

Simple Shoulder Test (SST) activity score. Range 0-12. 0 = worse activity score. (NCT03540030)
Timeframe: 2 Months

Interventionscore on a scale (Median)
Observational6
Non-Opioid Intervention6

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Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. (NCT03540030)
Timeframe: 2 Weeks

,
Interventionscore on a scale (Median)
PCSMCS
Non-Opioid Intervention35.059.1
Observational36.756.3

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Veterans RAND 12 Item Health Survey (VR-12©) Physical Health Subscore, and Mental Health Subscore

quality of life using VR-12 subscores. Physical Health (PCS) subscore and Mental Health (MCS) subscore, not summed. Range reported in weighted units. Physical Health subscore: 1 point increase in PCS is associated with 6% lower total health care expenditures, 5% lower pharmacy expenditures, 9% lower rate of hospital inpatient visits, 4% lower rate of medical provider visits, 5% lower rate of hospital outpatient visits. Mental Health sub score a 1 point increase in MCS is associated with 7% lower total health care expenditures, 4% lower pharmacy expenditures, 15% lower rate of hospital inpatient visits, and 4% lower rate of medical provider visits. Both PCS/MCS are score 0-100 with 100 indicating the highest level of health. (NCT03540030)
Timeframe: 2 Months

,
Interventionscore on a scale (Median)
PCSMCS
Non-Opioid Intervention40.360.8
Observational38.458.7

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Pain Satisfaction

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. (NCT03540030)
Timeframe: 2 Weeks

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention3410
Observational2712

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Pain Satisfaction

Satisfaction with overall pain using Numeric Pain Rating (NRS) scale. yes, no. No being better than yes. (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention2924
Observational2352

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Post Op Pain

Pain at patient discharge or 24-hours, whichever comes first - measured on a 0 (no pain) -10 (worst possible pain) numeric rating scale (NRS). A score of 0(no pain) is preferable to 10(worst possible pain) (NCT03540030)
Timeframe: 24 hours

Interventionscore on a scale (Median)
Observational3.0
Non-Opioid Intervention2.0

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Nausea

rate of nausea (NCT03540030)
Timeframe: 2 Months

,
InterventionParticipants (Count of Participants)
YesNoUnknown
Non-Opioid Intervention1300
Observational0282

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Morphine Use

Morphine milli-equivalents In-hospital post-operative. Continuous scale of MME, no defined better/worse. Measured as number and dose of medications taken. For example, if the patient received an opioid, the drug and dose was recorded and converted to MME. A time frame of when to assess opioid use in-hospital post-operative was not used but was a continuous monitor for rescue opioid from in-hospital post-operative through discharge. (NCT03540030)
Timeframe: In-hospital Stay

InterventionMorphine milli-equivalents (Median)
Observational45.0
Non-Opioid Intervention19.0

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ASES

American Shoulder and Elbow Surgeons (ASES) Shoulder Score for pain and function. Range 0-100. Low score = worse shoulder condition. Function, disability, and pain subscores (all ranges 0-50), and are summed for total ASES score. (NCT03540030)
Timeframe: 2 Weeks

Interventionunits on a scale (Median)
Observational54.3
Non-Opioid Intervention54.2

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Average Pain Score at 24, 48 and 72 Hours Post-operatively

"Participants were assessed by rating their pain according to the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= no pain, 10=worst pain imaginable)~The minimum and maximum pain scores per participant were aggregated at timepoints of 24 hours, 48 hours, and 72 hours after the start of post-operative treatment" (NCT03679013)
Timeframe: at 24, 48, and 72 hours after the start of post-operative treatment

,
Interventionscore on a scale (Mean)
Minimum Pain Score at 24 hoursMaximum Pain Score at 24 hoursMinimum Pain Score at 48 hoursMaximum Pain Score at 48 hoursMinimum Pain Score at 72 hoursMaximum Pain Score at 72 hours
Opioid Based Standard of Care Regimen.1716.7502.5
Opioid Sparing Pain Regimen.0.093.180.183.6402.36

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Number of Participants With Ileus During Hospitalization

The number of participants with occurrences of ileus during hospitalization. (NCT03679013)
Timeframe: Surgery completion through study completion up to one week.

InterventionParticipants (Count of Participants)
Opioid Based Standard of Care Regimen.0
Opioid Sparing Pain Regimen.0

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The Number of Patients With Requests for Breakthrough Opioid Pain Medication in Opioid Standard of Care Regimen Compared to Non-opioid Multimodal Pain Relief Regimen (Experimental Group).

"Number of patients with requests for breakthrough pain medication. Requests for breakthrough pain medication is defined as having pain scores >4 using the Numeric Rating Scale: a dimensional measurement of pain intensity; 0-10 scale for scoring pain (0= no pain, 10worst pain imaginable)" (NCT03679013)
Timeframe: 24 hours, 48 hours, 72 hours after post-surgical treatment

,
InterventionParticipants (Count of Participants)
24 hours48 hours72 hours
Opioid Based Standard of Care Regimen.771
Opioid Sparing Pain Regimen.211

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Changes in Surgical Field Visibility

"according to change in Fromm and Boezaart surgical field category scale ranging from 0 (no bleeding) to 5 (severe bleeding) where: 0 No Bleeding.~Slight bleeding- no blood suctioning required.~Slight bleeding- occasional blood suctioning required.~Slight bleeding- frequent blood suctioning required, operative field is visible for some seconds after evacuation.~Moderate bleeding- frequent blood suctioning required, operative field is only visible immediately after evacuation.~Severe bleeding- constant blood suctioning required, bleeding appears faster than can be removed by suction .Surgery is hardly possible, and sometimes impossible." (NCT03850093)
Timeframe: scale was assessed by the surgeon every 15 minutes from the start of surgical procedure till the end

,,
Interventionscore on a scale (Median)
15 minutes30 minutes45 minutes60 minutes75 minutes90 minutes105 minutes
Bisoprolol2111100
Control4333232
Gabapentin2111111

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Mean Arterial Blood Pressure Change

effect of intervention on the change of mean arterial blood pressure allover study period (NCT03850093)
Timeframe: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery

,,
Interventionmm Hg (Mean)
preinductionafter induction1 minute after intubation5 minutes after intubation10 minutes after intubation15 minutes after intubation30 minutes after intubation45 minutes after intubation60 minutes after intubation75 minutes after intubation90 minutes after intubation105 minutes after intubation
Bisoprolol86.472.376.267.267.770.266.264.766.769.466.167.2
Control92.478.292.278.676.57466.664.669.967.762.770
Gabapentin85.674.480.670.766.465.464.463.361.962.56363.1

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Surgeon Satisfaction (Categorical)

surgeon satisfaction score where given 5 for very satisfied, 4 for satisfied, 3 for neutral, 2 for dissatisfied and 1 for very dissatisfied then number of satisfied (satisfaction score = 5) and disatisfied (satisfaction score less than 5) surgeons was compared between groups (NCT03850093)
Timeframe: at the end of surgery

,,
InterventionParticipants (Count of Participants)
surgeon satisfaction achieved (score≥ 4)surgeon satisfaction not achieved(score< 4)
Bisoprolol220
Control107
Gabapentin210

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Visual Analogue Scale (VAS) for Postoperative Pain

postoperative visual analogue score (VAS) for pain where 0 is no pain and 10 severe intolerable pain (NCT03850093)
Timeframe: 0n full recovery, 3 and 6 hrs. after recovery

,,
Interventionscore on a scale (Median)
on full recovery3hrs. after recovery6hrs after recovery
Bisoprolol433
Control543
Gabapentin211

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Number of Patients Who Recieve Both IV Nitroglycerin and Propranolol During Operative Procedure

need for both IV nitroglycerine and propranolol intraoperatively (NCT03850093)
Timeframe: at the end of surgery

InterventionParticipants (Count of Participants)
Gabapentin0
Bisoprolol0
Control6

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Blood Loss

total intraoperative blood loss (mL) (NCT03850093)
Timeframe: at the end of surgery

InterventionmL (Median)
Gabapentin20
Bisoprolol20
Control80

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Number of Patients Who Recieved Intraoperative IV Nitroglycerin During Operative Procedure

need for additional intraoperative IV vasodilators (nitroglycerine (NCT03850093)
Timeframe: at the end of surgery

InterventionParticipants (Count of Participants)
Gabapentin0
Bisoprolol0
Control5

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Number of Patients Who Recieved Intraoperative IV Propranolol During Operative Procedure

the need for additional beta blockers (propranolol) (NCT03850093)
Timeframe: at the end of surgery

InterventionParticipants (Count of Participants)
Gabapentin0
Bisoprolol0
Control1

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Heart Rate Change

effect of intervention on the change of heart rate allover study period (NCT03850093)
Timeframe: were recorded before oral premedication (baseline), pre-induction, after induction of anesthesia, 1, 5, 10, 15 minutes after intubation and then every 15 minutes until the end of surgery

,,
Interventionbeats/ minute (Mean)
preinductionafter induction1 minute after intubation5 minutes after intubation10 minutes after intubation15 minutes after intubation30 minutes after intubation45 minutes after intubation60 minutes after intubation75 minutes after intubation90 minutes after intubation105 minutes after intubation
Bisoprolol73.167.873.370.666.366.667.767.166.36666.567.4
Control85.885.996.289.387.890.285.880.187.384.588.197
Gabapentin82.674.983.377.175.474.773.47575.375.772.775.7

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Time to 1st Postoperative Rescue Analgesia

time to 1st postoperative rescue analgesia (starting from administration of the studied drug) (NCT03850093)
Timeframe: on administration of 1st postoperative rescue analgesia

Interventionminutes (Median)
Gabapentin60
Bisoprolol30
Control20

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Change in TNF-alpha

Mean change in TNF-alpha values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionpg/ml (Mean)
Low-dose Naltrexone0.27
Gabapentin0.47
Placebo0.21

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Number of Participants With a Change in HIV Viral Load Suppression Status

Defined as number of participants who change from suppressed to unsuppressed or unsuppressed to suppressed from lab tests (NCT04052139)
Timeframe: Baseline, 8-weeks

InterventionParticipants (Count of Participants)
Low-dose Naltrexone1
Gabapentin0
Placebo0

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Change in Past Week Pain Severity

Change in past week pain severity (score 0 [no pain] -10 [high pain]) from baseline to week 8. Pain severity will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionunits on a scale (Mean)
Low-dose Naltrexone-0.97
Gabapentin-2.12
Placebo-1.85

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Change in IL-1beta

Mean change in IL-1beta values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionpg/ml (Mean)
Low-dose Naltrexone0.30
Gabapentin0.95
Placebo0.41

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Change in Percentage of Past Month Heavy Drinking Days

Mean percentage of change in self-reported heavy drinking in the past 30 days of alcohol consumption obtained via the Timeline Followback (TLFB) method. The NIAAA definition of heavy drinking is used (> 4 drinks in a day for men; > 3 drinks in a day for women). Participants were asked about their alcohol consumption on each day in the previous 30 days. (NCT04052139)
Timeframe: Baseline, 8-weeks

Intervention% of change in heavy drinking days (Mean)
Low-dose Naltrexone3.07
Gabapentin-4.22
Placebo-4.63

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Change in Biomarker IL-10

Mean change in IL-10 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). (NCT04052139)
Timeframe: Baseline, 8 weeks

Interventionpg/ml (Mean)
Low-dose Naltrexone-0.13
Gabapentin0.07
Placebo-0.26

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Change in Biomarker IL-6

Mean change in IL-6 values measured on blood samples collected using commercially available enzyme-linked immunosorbent assay kits (R&D Systems). (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionpg/ml (Mean)
Low-dose Naltrexone-0.12
Gabapentin0.04
Placebo0.29

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Change in CD4 Count

Defined as mean change in CD4 values from lab assay (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventioncell/mm^3 (Mean)
Low-dose Naltrexone15.85
Gabapentin-106.47
Placebo-52.13

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Change in Cold Pain Tolerance

Mean change in the number of seconds a participant can keep their hand submerged in a container of iced water. Participants were instructed to keep their hand in as long as they could, up to 3 minutes. (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionseconds (Mean)
Low-dose Naltrexone-14.78
Gabapentin-3.33
Placebo-3.15

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Change in Past Week Pain Interference

Change in past week pain interference (score 0 [no pain]-10 [high pain]) from baseline to week 8. Pain interference will be measured using the Brief Pain Inventory, which allows patients to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function (NCT04052139)
Timeframe: Baseline, 8-weeks

Interventionunits on a scale (Mean)
Low-dose Naltrexone-1.73
Gabapentin-1.97
Placebo-2.14

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Pain Score as Measured by the NRS-11 Scale

The Numerical pain Rating Scale (NRS-11) is an 11-point numerical pain rating scale used to measure levels of pain. The lowest possible score is 0 with 0 meaning no pain, and the highest possible score is 10 with 10 meaning severe pain. (NCT04230980)
Timeframe: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7

,
Interventionscores on a scale (Mean)
Post-Operative Day 0Post-Operative Day 1, midnightPost-Operative Day 1, before noonPost-Operative Day 1, after noonPost-Operative Day 2, midnightPost-Operative Day 2, before noonPost-Operative Day 2, after noonPost-Operative Day 3, before noonPost-Operative Day 3, after noonPost-Operative Day 4, before noonPost-Operative Day 4, after noonPost-Operative Day 5, before noonPost-Operative Day 5, after noonPost-Operative Day 6, before noonPost-Operative Day 6, after noonPost-Operative Day 7, before noonPost-Operative Day 7, after noon
Gabapentin1.912.272.022.522.191.941.811.571.561.141.291.641.481.561.411.36.99
Placebo3.053.243.333.653.833.773.53.162.982.442.932.542.792.262.502.252.12

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Opioid Consumption, as Measured by Number of Tablets Taken.

Participants were requested to self-report the number of opioid tablets (oxycodone, 5mg) that they had taken since the last survey. (NCT04230980)
Timeframe: Post-operative day 0 (the day of surgery, after surgery was completed) through post-operative day 7

,
InterventionNumber of oxycodone 5mg tablets consumed (Mean)
Post-Operative Day 0Post-Operative Day 1, midnightPost-Operative Day 1, before noonPost-Operative Day 1, after noonPost-Operative Day 2, midnightPost-Operative Day 2, before noonPost-Operative Day 2, after noonPost-Operative Day 3, before noonPost-Operative Day 3, after noonPost-Operative Day 4, before noonPost-Operative Day 4, after noonPost-Operative Day 5, before noonPost-Operative Day 5, after noonPost-Operative Day 6, before noonPost-Operative Day 6, after noonPost-Operative Day 7, before noonPost-Operative Day 7, after noon
Gabapentin1.111.141.21.141.181.181.121.091.091.061.031.001.071.001.0011
Placebo1.541.241.381.271.231.481.521.21.111.101.001.001.081.121.041.051.05

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Neuropathic Pain

To determine if the time from injury influences the prevalence of neuropathic pain in acute SCI. Average of the pain during the previous 7 days on self-identified nerve or neuropathic pain levels (0-10) on 5 different measurements at the time of discharge on the Neuropathic Pain Scale. 0 being best (no pain)- 10 being worst pain. Total score range from 0 to 50. (NCT04256603)
Timeframe: Through completion of the study, up to 4 weeks after injury.

Interventionunits on a scale (Mean)
Gabapentin Group13.3
No Gabapentin Group15.6

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Pain Score

100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain (NCT04292171)
Timeframe: 5 minutes postoperative

Interventionscore on a scale (Median)
Gabapentin Arm17
Placebo Arm17

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Pain Score 24

Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain (NCT04292171)
Timeframe: 24 hours postop

Interventionscore on a scale (Median)
Gabapentin Arm0
Placebo Arm1

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Pain Score at 30 Minutes Postoperative

100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain (NCT04292171)
Timeframe: 30 minutes postoperative

Interventionscore on a scale (Median)
Gabapentin Arm20
Placebo Arm23

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Vomiting

Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme (NCT04292171)
Timeframe: 24 hours postoperative

InterventionVAS 100mm (Mean)
Gabapentin Arm0.85
Placebo Arm0.74

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Nausea

Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme (NCT04292171)
Timeframe: 24 hours postoperative

InterventionVAS 100mm (Mean)
Gabapentin Arm1.74
Placebo Arm1.74

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Operative Time

minutes (NCT04429022)
Timeframe: 0-300 minutes

Interventionminutes (Mean)
Prospective Cohort128.80
Historical Control139.69

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Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period

Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period (NCT04429022)
Timeframe: 0-14 days

InterventionParticipants (Count of Participants)
Prospective Cohort1
Historical Control3

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Estimated Blood Loss

milliliters (mL) (NCT04429022)
Timeframe: 0-300 minutes

Interventionmilliliters (Mean)
Prospective Cohort63.50
Historical Control58.46

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort1.75
Historical Control5.43

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Length of Stay in Hours

Length of stay in hours (NCT04429022)
Timeframe: 0- 240 hours

Interventionhours (Mean)
Prospective Cohort12.05
Historical Control35.82

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Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)

Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort2.00
Historical Control5.32

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Total Opioid Pain Medications Required Through 3-24h Post op in MME

Total opioid pain medications required through 3-24h post op in MME (NCT04429022)
Timeframe: 3-24 hours after surgery

Interventionmorphine milligram equivalents (MME) (Mean)
Prospective Cohort.20
Historical Control12.27

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Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain (NCT04429022)
Timeframe: 0-3 hours after surgery

Interventionscore on a scale (Mean)
Prospective Cohort3.82
Historical Control5.13

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AUClast of Gabapentin

Area under the effect time profile from time 0 to the time of the last quantifiable concentration (AUClast) of gabapentin (NCT04570436)
Timeframe: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

Interventionnanograms*hour/milliliter (Mean)
Gabapentin 600 mg41848.88
Gabapentin 1200 mg66972.60
Gabapentin 1800 mg80483.05

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Cmax of Gabapentin

Maximum plasma concentration (Cmax) of gabapentin (NCT04570436)
Timeframe: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Interventionnanograms/milliliter (Mean)
Gabapentin 600 mg4223.47
Gabapentin 1200 mg6106.90
Gabapentin 1800 mg7373.15

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Terminal Half-life of Gabapentin

Terminal half-life (t½) of gabapentin (NCT04570436)
Timeframe: up to 72 hours after treatment (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

InterventionHours (Mean)
Gabapentin 600 mg7.69
Gabapentin 1200 mg13.83
Gabapentin 1800 mg14.43

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Tmax of Gabapentin

Time when the maximum concentration of gabapentin is reached (NCT04570436)
Timeframe: Up to 72 hours after treatments (concentrations were measured at the following timepoints after each treatment for thisoutcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 and 72 hours)

InterventionHours (Median)
Gabapentin 600 mg2.78
Gabapentin 1200 mg2.55
Gabapentin 1800 mg2.55

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"Bipolar VAS for Overall Drug Liking at 72 Hour Post Dose"

"100 mm visual analog scale for the question Overall, my liking for this drug is where0 = definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 72 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.56
Diazepam 20 mg61.46
Gabapentin 600 mg55.68
Gabapentin 1200 mg55.10
Gabapentin 1800 mg53.46

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"Bipolar VAS for Take Drug Again at 36 Hour Post Dose"

"100 mm visual analog scale for the question I would take this drug again where 0 =definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 36 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.27
Diazepam 20 mg64.95
Gabapentin 600 mg55.33
Gabapentin 1200 mg55.73
Gabapentin 1800 mg54.93

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"Bipolar VAS for Drug Liking (Time for Maximum Effect, Emax [TEmax])"

Time after dosing when the maximum effect for Drug Liking VAS is reached (NCT04570436)
Timeframe: up to 72 hours after treatments

InterventionHours (Median)
Placebo0.2
Diazepam 20 mg1.51
Gabapentin 600 mg2.0
Gabapentin 1200 mg2.0
Gabapentin 1800 mg2.5

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"Bipolar VAS for Drug Liking (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])"

"Area under the effect-time profile from time 0 to the time of the last available data for the Drug liking visual analog scale which 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. The minimum and maximum possible scores are approximately 0 and 7200 if a subject scores 0 mm (strong disliking) and 100 mm (strong liking) respectively at every timepoint up to 72 hours." (NCT04570436)
Timeframe: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Interventionunits on a scale * hour (Mean)
Placebo3441.77
Diazepam 20 mg3778.02
Gabapentin 600 mg3588.67
Gabapentin 1200 mg3601.72
Gabapentin 1800 mg3652.27

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"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."

"Drug liking assesses how much a participant likes or dislikes a drug effect at the time the question 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" (NCT04570436)
Timeframe: up to 72 hours after treatments

InterventionScore on a scale (Mean)
Placebo51.98
Diazepam 20 mg79.37
Gabapentin 600 mg61.95
Gabapentin 1200 mg61.39
Gabapentin 1800 mg60.95

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"Unipolar VAS for High (Area Under the Effect-time Profile From Time 0 to the Time of the Last Quantifiable Concentration [AUEClast])"

"Area under the effect-time profile from time 0 to the time of the last available data for the High visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question I am feeling high where 0 =not at all and 100 =extremely. The minimum and maximum possible scores are 0 and approximately 7200 if a subject scores 0 mm (not at all) and 100 mm (extremely) respectively at every timepoint up to 72 hours." (NCT04570436)
Timeframe: Up to 72 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5,1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, 48, and 72 hours)

Interventionunits on a scale * hour (Mean)
Placebo15.06
Diazepam 20 mg250.38
Gabapentin 600 mg83.08
Gabapentin 1200 mg112.74
Gabapentin 1800 mg109.07

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"Bipolar VAS for Take Drug Again at 24 Hour Post Dose"

"100 mm visual analog scale for the question I would take this drug again where 0 =definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 24 hours after treatment

InterventionScore on a scale (Mean)
Placebo48.66
Diazepam 20 mg63.10
Gabapentin 600 mg58.28
Gabapentin 1200 mg55.63
Gabapentin 1800 mg54.90

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"Bipolar VAS for Overall Drug Liking at 36 Hour Post Dose"

"100 mm visual analog scale for the question Overall, my liking for this drug is where0 = definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 36 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.59
Diazepam 20 mg61.83
Gabapentin 600 mg54.75
Gabapentin 1200 mg55.63
Gabapentin 1800 mg53.49

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"Bipolar VAS for Take Drug Again at 72 Hour Post Dose"

"100 mm visual analog scale for the question I would take this drug again where 0 =definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 72 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.17
Diazepam 20 mg63.88
Gabapentin 600 mg55.90
Gabapentin 1200 mg53.76
Gabapentin 1800 mg54.46

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"Bipolar VAS for Overall Drug Liking at 48 Hour Post Dose"

"100 mm visual analog scale for the question Overall, my liking for this drug is where0 = definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 48 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.68
Diazepam 20 mg61.07
Gabapentin 600 mg54.83
Gabapentin 1200 mg54.66
Gabapentin 1800 mg53.37

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"Bipolar VAS for Take Drug Again at 48 Hour Post Dose"

"100 mm visual analog scale for the question I would take this drug again where 0 =definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 48 hours after treatment

InterventionScore on a scale (Mean)
Placebo49.24
Diazepam 20 mg62.24
Gabapentin 600 mg55.90
Gabapentin 1200 mg52.80
Gabapentin 1800 mg53.59

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"Bipolar VAS for Overall Drug Liking at 24 Hour Post Dose"

"100 mm visual analog scale for the question Overall, my liking for this drug is where0 = definitely not, 50 = neutral, and 100 = definitely so." (NCT04570436)
Timeframe: At 24 hours after treatment

InterventionScore on a scale (Mean)
Placebo48.20
Diazepam 20 mg63.66
Gabapentin 600 mg57.10
Gabapentin 1200 mg54.15
Gabapentin 1800 mg53.90

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"Unipolar VAS for High (Maximum Effect, Emax)"

"Maximum effect on the 100 mm visual analog scale for the question I am feeling high where 0 = not at all and 100 =extremely" (NCT04570436)
Timeframe: up to 72 hours after treatments

InterventionScore on a scale (Mean)
Placebo5.80
Diazepam 20 mg61.56
Gabapentin 600 mg23.02
Gabapentin 1200 mg26.93
Gabapentin 1800 mg27.66

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"Unipolar VAS for High (Time for Maximum Effect, Emax [TEmax])"

"Time after dosing when the maximum effect for High VAS is reached" (NCT04570436)
Timeframe: up to 72 hours after treatments

InterventionHours (Median)
Placebo0.20
Diazepam 20 mg1.96
Gabapentin 600 mg1.50
Gabapentin 1200 mg2.00
Gabapentin 1800 mg2.50

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AUClast of Oxycodone

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms*hour/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose229.31
Gabapentin 600 mg and Oxycodone HCl 20 mg224.79
Gabapentin 1200 mg and Oxycodone HCl 20 mg234.65

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AUClast of Gabapentin

Area under the plasma concentration/time profile from time 0 to the time of the last quantifiable concentration of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatment (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms*hour/milliliter (Mean)
Gabapentin 600 mg Single Dose39.76
Gabapentin 1200 mg Single Dose61.42
Gabapentin 600 mg and Oxycodone HCl 20 mg47.31
Gabapentin 1200 mg and Oxycodone HCl 20 mg72.73

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AUCinf of Oxycodone

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms*hour/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose233.29
Gabapentin 600 mg and Oxycodone HCl 20 mg228.40
Gabapentin 1200 mg and Oxycodone HCl 20 mg234.94

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AUCinf of Gabapentin

Area under the plasma concentration/time curve from time 0 extrapolated to infinity time of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms*hour/milliliter (Mean)
Gabapentin 600 mg Single Dose41.42
Gabapentin 1200 mg Single Dose65.38
Gabapentin 600 mg and Oxycodone HCl 20 mg48.58
Gabapentin 1200 mg and Oxycodone HCl 20 mg75.18

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"Unipolar VAS for High: Time to Maximum Effect (TEmax)"

"Time after dosing when the maximum effect for High VAS is reached" (NCT05319756)
Timeframe: up to 48 hours after treatments

Interventionhours (Median)
Placebo Single Dose0.25
Oxycodone HCl 20 mg Single Dose1.00
Gabapentin 600 mg Single Dose0.26
Gabapentin 1200 mg Single Dose0.27
Gabapentin 600 mg and Oxycodone HCl 20 mg1.00
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.50

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"Unipolar VAS for High - Maximum Effect (Emax)"

"Maximum effect on the 100 mm visual analog scale for the question I am feeling high where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Mean)
Placebo Single Dose13.45
Oxycodone HCl 20 mg Single Dose77.36
Gabapentin 600 mg Single Dose28.61
Gabapentin 1200 mg Single Dose25.21
Gabapentin 600 mg and Oxycodone HCl 20 mg81.86
Gabapentin 1200 mg and Oxycodone HCl 20 mg88.74

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"Unipolar VAS for Good Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel good drug effects where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo2.54
Oxycodone HCl 20 mg Single Dose27.91
Gabapentin 600 mg Single Dose6.13
Gabapentin 1200 mg Single Dose8.73
Gabapentin 600 mg and Oxycodone HCl 20 mg34.72
Gabapentin 1200 mg and Oxycodone HCl 20 mg32.71

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"Unipolar VAS for Bad Drug Effect"

"100 mm visual analog scale for the question At this moment, I can feel bad drug effects where 0 = not at all and 100 = extremely" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo0.19
Oxycodone HCl 20 mg Single Dose4.41
Gabapentin 600 mg Single Dose0.82
Gabapentin 1200 mg Single Dose0.97
Gabapentin 600 mg and Oxycodone HCl 20 mg4.10
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.41

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"Unipolar VAS for Any Drug Effect"

"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" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo3.77
Oxycodone HCl 20 mg Single Dose28.46
Gabapentin 600 mg Single Dose6.63
Gabapentin 1200 mg Single Dose7.88
Gabapentin 600 mg and Oxycodone HCl 20 mg34.34
Gabapentin 1200 mg and Oxycodone HCl 20 mg33.76

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Half-life (t½) of Oxycodone

Half-life (t½) of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionhours (Median)
Oxycodone HCl 20 mg Single Dose4.12
Gabapentin 600 mg and Oxycodone HCl 20 mg3.84
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.90

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"Bipolar VAS for Take Drug Again"

"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" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo Single Dose53.43
Oxycodone HCl 20 mg Single Dose72.16
Gabapentin 600 mg Single Dose55.19
Gabapentin 1200 mg Single Dose58.05
Gabapentin 600 mg and Oxycodone HCl 20 mg79.16
Gabapentin 1200 mg and Oxycodone HCl 20 mg77.85

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"Bipolar VAS for Overall Drug Liking"

"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" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 24, 36, and 48 hours)

InterventionScore on a 100 mm scale (Least Squares Mean)
Placebo Single Dose51.75
Oxycodone HCl 20 mg Single Dose72.06
Gabapentin 600 mg Single Dose54.40
Gabapentin 1200 mg Single Dose58.25
Gabapentin 600 mg and Oxycodone HCl 20 mg75.90
Gabapentin 1200 mg and Oxycodone HCl 20 mg79.94

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 8 Hours (AUEC8)"

"Area under the effect-time profile from time 0 to 8 hours post-dose for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: Up to 8 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours)

Interventionunits on a scale * hour (Mean)
Placebo411.58
Oxycodone HCl 20 mg Single Dose551.53
Gabapentin 600 mg Single Dose421.12
Gabapentin 1200 mg Single Dose438.30
Gabapentin 600 mg and Oxycodone HCl 20 mg599.96
Gabapentin 1200 mg and Oxycodone HCl 20 mg574.98

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 4 Hours (AUEC4)"

"Area under the effect-time profile from time 0 to 4 hours post-dose for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: Up to 4 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, and 4 hours)

Interventionunits on a scale * hour (Mean)
Placebo208.32
Oxycodone HCl 20 mg Single Dose294.28
Gabapentin 600 mg Single Dose214.53
Gabapentin 1200 mg Single Dose220.08
Gabapentin 600 mg and Oxycodone HCl 20 mg305.08
Gabapentin 1200 mg and Oxycodone HCl 20 mg293.99

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 3 Hours (AUEC3)"

"Area under the effect-time profile from time 0 to 3 hours post-dose for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: up to 3 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, and 3 hours)

Interventionunits on a scale * hour (Mean)
Placebo155.48
Oxycodone HCl 20 mg Single Dose219.31
Gabapentin 600 mg Single Dose161.07
Gabapentin 1200 mg Single Dose164.03
Gabapentin 600 mg and Oxycodone HCl 20 mg223.22
Gabapentin 1200 mg and Oxycodone HCl 20 mg214.99

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"Bipolar VAS for Drug Liking - Time to Maximum Effect (TEmax)"

Time after dosing when the maximum effect for Drug Liking VAS is reached (NCT05319756)
Timeframe: up to 48 hours after treatments

Interventionhours (Median)
Placebo Single Dose0.25
Oxycodone HCl 20 mg Single Dose1.00
Gabapentin 600 mg Single Dose0.25
Gabapentin 1200 mg Single Dose0.28
Gabapentin 600 mg and Oxycodone HCl 20 mg1.00
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.50

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 1 Hour (AUEC1)"

"Area under the effect-time profile from time 0 to 1 hour post-dose for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: Up to 1 hour post-dose (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, and 1 hour)

Interventionunits on a scale * hour (Mean)
Placebo50.17
Oxycodone HCl 20 mg Single Dose58.86
Gabapentin 600 mg Single Dose51.28
Gabapentin 1200 mg Single Dose50.61
Gabapentin 600 mg and Oxycodone HCl 20 mg57.02
Gabapentin 1200 mg and Oxycodone HCl 20 mg55.76

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve From Time 0 to the Last Available Data (AUEClast)"

"Area under the effect-time profile from time 0 to the time of the last available data for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionunits on a scale * hour (Mean)
Placebo Single Dose2394.21
Oxycodone HCl 20 mg Single Dose2661.43
Gabapentin 600 mg Single Dose2422.37
Gabapentin 1200 mg Single Dose2444.4
Gabapentin 600 mg and Oxycodone HCl 20 mg2744.86
Gabapentin 1200 mg and Oxycodone HCl 20 mg2759.57

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"Area Under the Effect Curve for High VAS (AUEClast)"

"Area under the effect-time profile from time 0 to the time of the last available data for the High visual analog scale which measures on a 100 mm visual analog scale the subject's response to the question I am feeling high where 0 = not at all and 100 =extremely" (NCT05319756)
Timeframe: Up to 48 hours after treatments (Assessments were made at the following timepoints after each treatment: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionunits on a scale * hour (Mean)
Placebo Single Dose33.45
Oxycodone HCl 20 mg Single Dose321.75
Gabapentin 600 mg Single Dose86.41
Gabapentin 1200 mg Single Dose123.74
Gabapentin 600 mg and Oxycodone HCl 20 mg512.08
Gabapentin 1200 mg and Oxycodone HCl 20 mg425.01

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Tmax of Oxycodone

Time when the maximum concentration of Oxycodone is reached (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionhours (Median)
Oxycodone HCl 20 mg Single Dose1.15
Gabapentin 600 mg and Oxycodone HCl 20 mg1.15
Gabapentin 1200 mg and Oxycodone HCl 20 mg1.63

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"Bipolar VAS for Drug Liking: Area Under the Effect Curve to 2 Hours (AUEC2)"

"Area under the effect-time profile from time 0 to 2 hours post-dose for the Drug liking visual analog scale which 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" (NCT05319756)
Timeframe: Up to 2 hours after treatments (Assessments were made at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, and 2 hours)

Interventionunits on a scale * hour (Mean)
Placebo102.62
Oxycodone HCl 20 mg Single Dose140.44
Gabapentin 600 mg Single Dose105.20
Gabapentin 1200 mg Single Dose107.19
Gabapentin 600 mg and Oxycodone HCl 20 mg138.72
Gabapentin 1200 mg and Oxycodone HCl 20 mg133.84

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Tmax of Gabapentin

Time when the maximum concentration of gabapentin is reached (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

InterventionHours (Median)
Gabapentin 600 mg Single Dose3.13
Gabapentin 1200 mg Single Dose3.13
Gabapentin 600 mg and Oxycodone HCl 20 mg3.13
Gabapentin 1200 mg and Oxycodone HCl 20 mg3.13

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Half-life (t½) of Gabapentin

Half-life (t½) of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

InterventionHours (Mean)
Gabapentin 600 mg Single Dose9.14
Gabapentin 1200 mg Single Dose10.62
Gabapentin 600 mg and Oxycodone HCl 20 mg8.20
Gabapentin 1200 mg and Oxycodone HCl 20 mg9.19

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Cmax of Oxycodone

Maximum plasma concentration of Oxycodone (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionnanograms/milliliter (Mean)
Oxycodone HCl 20 mg Single Dose44.92
Gabapentin 600 mg and Oxycodone HCl 20 mg43.82
Gabapentin 1200 mg and Oxycodone HCl 20 mg40.79

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Cmax of Gabapentin

Maximum plasma concentration of gabapentin (NCT05319756)
Timeframe: Up to 48 hours after treatments (concentrations were measured at the following timepoints after each treatment for this outcome measure: 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 36, and 48 hours)

Interventionmicrograms/milliliter (Mean)
Gabapentin 600 mg Single Dose4.16
Gabapentin 1200 mg Single Dose6.07
Gabapentin 600 mg and Oxycodone HCl 20 mg4.17
Gabapentin 1200 mg and Oxycodone HCl 20 mg6.18

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"Bipolar Visual Analog Scale (VAS) for Drug Liking Maximum Effect (Emax)."

"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" (NCT05319756)
Timeframe: up to 48 hours after treatments

InterventionScore on a 100 mm scale (Mean)
Placebo54.89
Oxycodone HCl 20 mg Single Dose87.40
Gabapentin 600 mg Single Dose57.89
Gabapentin 1200 mg Single Dose63.62
Gabapentin 600 mg and Oxycodone HCl 20 mg88.43
Gabapentin 1200 mg and Oxycodone HCl 20 mg92.17

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