gamma-aminobutyric acid has been researched along with Adverse Drug Event in 21 studies
gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.
gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients." | 9.16 | Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. ( Bhadra, P; Lankford, DA; Resnick, EM; Roth, T; Whalen, E, 2012) |
| "Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG." | 9.16 | Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. ( Bhadra, P; Lankford, DA; Resnick, EM; Roth, T; Whalen, E, 2012) |
| "This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN)." | 9.12 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| "Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events." | 6.78 | 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) |
| " The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%)." | 6.78 | 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) |
| "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." | 6.78 | 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) |
| "This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN)." | 6.72 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| "Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated." | 6.72 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| "To assess the effect of pregabalin on polysomnographic (PSG) measures of sleep and patient-rated sleep, tiredness, and pain in fibromyalgia patients." | 5.16 | Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. ( Bhadra, P; Lankford, DA; Resnick, EM; Roth, T; Whalen, E, 2012) |
| "Patients with fibromyalgia treated with pregabalin had statistically significant and meaningful improvements in sleep, as assessed by PSG." | 5.16 | Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study. ( Bhadra, P; Lankford, DA; Resnick, EM; Roth, T; Whalen, E, 2012) |
| "This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN)." | 5.12 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| " Overall, there was a low quality of evidence that gabapentin, pregabalin, amitriptyline, and venlafaxine were effective in reducing pain intensity in patients with cancer pain." | 4.95 | Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review. ( de Graeff, A; Dijkstra, D; Jongen, JL; Mostovaya, I; van den Beuken-van Everdingen, MH; Vissers, KC, 2017) |
| " Diazepam (Valium) could cause cleft palate by mimicking GABA." | 3.67 | Neuropharmacologic teratogenesis and neurotransmitter regulation of palate development. ( Zimmerman, EF, 1984) |
| "Treatment options for postherpetic neuralgia (PHN), a complication of herpes zoster, are commonly unsatisfactory and associated with adverse events." | 2.78 | 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) |
| " The most frequently reported adverse events were dizziness (G-GR, 11%; placebo, 2%) and somnolence (G-GR, 5%; placebo, 3%)." | 2.78 | 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) |
| "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." | 2.78 | 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) |
| "This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with postherpetic neuralgia (PHN)." | 2.72 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| "Pregabalin, dosed BID, reduced neuropathic pain associated with PHN and was well tolerated." | 2.72 | Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial. ( Feister, HA; Rigaudy, L; Stoker, M; van Seventer, R; Versavel, M; Young, JP, 2006) |
| "To update our guidelines for the treatment of pain in patients with cancer, we performed a systematic review on the use of adjuvant analgesics in pain in cancer." | 2.55 | Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review. ( de Graeff, A; Dijkstra, D; Jongen, JL; Mostovaya, I; van den Beuken-van Everdingen, MH; Vissers, KC, 2017) |
| "In patients with cancer, pain is one of the most feared and burdensome symptoms." | 2.55 | Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review. ( de Graeff, A; Dijkstra, D; Jongen, JL; Mostovaya, I; van den Beuken-van Everdingen, MH; Vissers, KC, 2017) |
| "The treatment of pain associated with cancer should be tailored to the patient's personal preferences." | 2.55 | Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review. ( de Graeff, A; Dijkstra, D; Jongen, JL; Mostovaya, I; van den Beuken-van Everdingen, MH; Vissers, KC, 2017) |
| "Paclitaxel treatment resulted in thermal hyperalgesia and in increased GABA transporter-1 (GAT-1) mRNA expression, but not that of other GABA transporters or GABA(A) ergic enzymes in the ACC compared to vehicle treatment." | 1.42 | Comprehensive analysis of the GABAergic system gene expression profile in the anterior cingulate cortex of mice with Paclitaxel-induced neuropathic pain. ( Masocha, W, 2015) |
| " The objective of the present study was to evaluate the efficacy and safety of OROS® hydromorphone combined with pregabalin in patients with chronic non-cancer neuropathic pain." | 1.40 | Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain. ( Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014) |
| " Dosage and side effects were recorded at each visit." | 1.40 | Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain. ( Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014) |
| " Initial mean dosage was 6." | 1.40 | Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain. ( Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014) |
| "Treatment for chronic non-cancer neuropathic pain can be complicated by side effects and drug interactions." | 1.40 | Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain. ( Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014) |
| "Seventeen percent (n = 224) had purely neuropathic pain." | 1.40 | Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain. ( Casali, M; Dauri, M; Lazzari, M; Sabato, AF; Sabato, E; Tufaro, G, 2014) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (4.76) | 18.7374 |
| 1990's | 1 (4.76) | 18.2507 |
| 2000's | 7 (33.33) | 29.6817 |
| 2010's | 12 (57.14) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Liu, Z | 1 |
| Shi, Q | 1 |
| Ding, D | 1 |
| Kelly, R | 1 |
| Fang, H | 1 |
| Tong, W | 1 |
| Arini, A | 1 |
| Mittal, K | 1 |
| Dornbos, P | 1 |
| Head, J | 1 |
| Rutkiewicz, J | 1 |
| Basu, N | 1 |
| Peckham, AM | 1 |
| Fairman, KA | 1 |
| Sclar, DA | 1 |
| Dauri, M | 1 |
| Lazzari, M | 1 |
| Casali, M | 1 |
| Tufaro, G | 1 |
| Sabato, E | 1 |
| Sabato, AF | 1 |
| Fukasawa, H | 1 |
| Muratake, H | 1 |
| Nagae, M | 1 |
| Sugiyama, K | 1 |
| Shudo, K | 1 |
| Masocha, W | 1 |
| Kottschade, L | 1 |
| Novotny, P | 1 |
| Lyss, A | 1 |
| Mazurczak, M | 1 |
| Loprinzi, C | 1 |
| Barton, D | 1 |
| van den Beuken-van Everdingen, MH | 1 |
| de Graeff, A | 1 |
| Jongen, JL | 1 |
| Dijkstra, D | 1 |
| Mostovaya, I | 1 |
| Vissers, KC | 1 |
| Melvin, CL | 2 |
| Carey, TS | 1 |
| Goodman, F | 1 |
| Oldham, JM | 1 |
| Williams, JW | 1 |
| Ranney, LM | 2 |
| Kish-Doto, J | 1 |
| Evans, WD | 1 |
| Squire, C | 1 |
| Williams, P | 1 |
| Tsavaris, N | 1 |
| Kopterides, P | 1 |
| Kosmas, C | 1 |
| Efthymiou, A | 1 |
| Skopelitis, H | 1 |
| Dimitrakopoulos, A | 1 |
| Pagouni, E | 1 |
| Pikazis, D | 1 |
| Zis, PV | 1 |
| Koufos, C | 1 |
| Schwan, S | 1 |
| Sundström, A | 1 |
| Stjernberg, E | 1 |
| Hallberg, E | 1 |
| Hallberg, P | 1 |
| Roth, T | 1 |
| Lankford, DA | 1 |
| Bhadra, P | 1 |
| Whalen, E | 1 |
| Resnick, EM | 1 |
| Sandercock, D | 1 |
| Cramer, M | 1 |
| Biton, V | 1 |
| Cowles, VE | 1 |
| Rauck, RL | 1 |
| Irving, GA | 1 |
| Wallace, MS | 1 |
| Vanhove, GF | 1 |
| Sweeney, M | 1 |
| Laustsen, G | 1 |
| Gilbert, M | 1 |
| Wimett, L | 1 |
| van Seventer, R | 1 |
| Feister, HA | 1 |
| Young, JP | 1 |
| Stoker, M | 1 |
| Versavel, M | 1 |
| Rigaudy, L | 1 |
| Baghdoyan, HA | 1 |
| Hussar, DA | 1 |
| Zimmerman, EF | 1 |
| Elger, CE | 1 |
| Bauer, J | 1 |
| Scherrmann, J | 1 |
| Widman, G | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis[NCT03996863] | 0 participants (Actual) | Interventional | 2019-08-01 | Withdrawn (stopped due to Drexel Oncology was shut down a few days before first patient in.) | |||
| Hypogastric Plexus Block and Ganglion Impar Block for Cervical and Endometrial Cancer Pain Management: A Randomized Controlled Trial of Efficacy and Safety[NCT05427058] | 36 participants (Anticipated) | Interventional | 2022-08-01 | Not yet recruiting | |||
| Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy[NCT04920097] | 240 participants (Anticipated) | Interventional | 2021-07-08 | Recruiting | |||
| Effects Of Pregabalin On Sleep Maintenance In Subjects With Fibromyalgia Syndrome And Sleep Maintenance Disturbance: A Randomized Placebo-Controlled 2-Way Crossover Polysomnography Study[NCT00883740] | Phase 3 | 119 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| 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 2 | 147 participants (Actual) | Interventional | 2006-04-30 | Completed | ||
| Efficacy and Safety of Pregabalin Sustained Release Tablet for Postherpetic Neuralgia -A Multicenter,Randomized, Double-blind, Placebo-controlled Trial[NCT02868801] | Phase 3 | 280 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
LPS, as determined by PSG, was the total number of epochs recorded on 2 consecutive nights divided by 2 at the end of each intervention period, from the beginning of the recording to the start of the first 20 consecutive non-wake epochs. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 41.63 |
| Pregabalin | 34.45 |
NAASO 1, as determined by PSG, was the number of times there was a wake period of at least one epoch in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage rapid eye movement (REM) epoch. The sum of 2 consecutive nights of recording was divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Awakenings (Least Squares Mean) |
|---|---|
| Placebo | 26.92 |
| Pregabalin | 24.51 |
NAASO 2, as determined by PSG, was the number of times that there was a wake period of at least two epochs in duration. Each entry counted was separated by a Stage 2 epoch, Stage 3 and 4 epoch, or Stage REM epoch. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Awakenings (Least Squares Mean) |
|---|---|
| Placebo | 10.16 |
| Pregabalin | 8.63 |
SE, as determined by PSG, was the TST divided by the time in bed, multiplied by 100. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Percentage of time asleep (Least Squares Mean) |
|---|---|
| Placebo | 77.21 |
| Pregabalin | 82.64 |
SWS, as determined by PSG, Stage 3 plus 4 sleep divided by TST times 100 was the percentage of TST. The sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Percentage of total sleep time (Least Squares Mean) |
|---|---|
| Placebo | 15.04 |
| Pregabalin | 17.18 |
TST, as determined by PSG, was the number of non-wake epochs from the beginning of recording to the end of the recording. TST was the sum of 2 consecutive nights of recording divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 370.6 |
| Pregabalin | 396.2 |
WASO was the sum of wake time during sleep measured in epochs (30 seconds of polysomnography [PSG]) recording) after the onset of persistent sleep and prior to final awakening and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording [i.e. awake epoch immediately prior to the end of the recording]) on 2 consecutive nights divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or Early Termination (ET)
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 70.69 |
| Pregabalin | 51.54 |
WTAS, as determined by PSG, was the total amount of time awake after the final awakening until the end of the 8 hours. WTAS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 9.19 |
| Pregabalin | 7.38 |
WTDS, as determined by PSG, was the total amount of time awake the participant experienced after the onset of persistent sleep and prior to the final awakening, or at the end of 8 hours of recording. WTDS was the sum of 2 consecutive nights of recordings divided by 2 at the end of each intervention period. (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) |
|---|---|
| Placebo | 63.38 |
| Pregabalin | 45.83 |
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was comprised of 12 items yielding 7 subscale scores and 2 index composite index scores. Sleep Disturbance subscale score (4 items): individual scores were transformed (actual raw score minus lowest possible score divided by possible raw score range times 100) and ranged from 0 to 100; higher score indicated greater disturbance. Total score ranged=0 to 100; higher score indicates greater intensity of attribute. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Change Week 1 to Week 5 (n=59, 56) | Change Week 7 to Week 11 (n=50, 52) | |
| Placebo | -19.0 | -2.23 |
| Pregabalin | -27.1 | -21.0 |
MOS-SS, a participant rated instrument used to assess sleep quantity and quality over the previous week, was compromised of 12 items yielding 7 subscale scores and 2 index composite index scores. Composite index included Sleep Problems Index II (9 items), scores ranged from 0 to 100; higher scores indicated greater sleep problems. Change was score at week x minus score at baseline. (NCT00883740)
Timeframe: Week 1 (Baseline Intervention Period 1), Week 5 (End of Intervention Period 1), Week 7 (Baseline Intervention Period 2) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Units on a scale (Least Squares Mean) | |
|---|---|---|
| Change Week 1 to Week 5 (n=59, 56) | Change Week 7 to Week 11 (50, 52) | |
| Placebo | -16.4 | -0.98 |
| Pregabalin | -21.9 | -14.4 |
Pain intensity as measured by NRS; a participant rated scale 0 to 10 (0 = no pain to 10 = worst pain possible). Weekly values were calculated as the average of the participants daily pain scores. (NCT00883740)
Timeframe: Daily up to Day 73 or ET
| Intervention | Units on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 6.12 | 5.81 | 5.73 | 5.44 |
| Pregabalin | 5.42 | 5.10 | 5.14 | 4.92 |
LSO as reported on daily Subjective Sleep Questionnaire (SSQ), a participant reported subjective estimate of the amount of time to fall asleep after lights out. Weekly values were calculated as the average minutes reported on the participant's daily SSQ. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 51.23 | 49.94 | 48.92 | 46.70 |
| Pregabalin | 43.56 | 42.27 | 43.24 | 40.51 |
Sleep Quality as meassured by numeric rating scale (NRS), a participant rated scale 0 to 10, (0 = very poor sleep, 10 = excellent sleep). Weekly values were calculated as the average of the participants daily diary scores. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Unit on a scale (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 4.79 | 4.95 | 5.09 | 5.17 |
| Pregabalin | 5.70 | 6.09 | 5.96 | 6.06 |
sTST as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was asleep after lights out until final awakening. Weekly values were calculated as the average of the participants daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 336.8 | 341.9 | 344.1 | 352.5 |
| Pregabalin | 361.7 | 371.3 | 370.9 | 377.9 |
sWASO as reported on daily SSQ, a participant reported subjective estimate of the total amount of time the participant was awake after initial sleep onset until final awakening. Weekly values were calculated as the average of the participant's daily SSQ values. (NCT00883740)
Timeframe: Weeks 1, 2, 3 and 4 of Each Intervention Period or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | |
| Placebo | 80.86 | 75.48 | 74.97 | 69.65 |
| Pregabalin | 62.59 | 59.43 | 61.73 | 59.40 |
WASO, as determined by PSG, was the sum of wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual quarter of the night (eight hours in 2 hour increments). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) | |||
|---|---|---|---|---|
| Quarter 1 | Quarter 2 | Quarter 3 | Quarter 4 | |
| Placebo | 7.23 | 16.04 | 21.73 | 28.04 |
| Pregabalin | 5.98 | 10.04 | 14.90 | 22.60 |
WASO, as determined by PSG, was the wake time during sleep (number of wake epochs after the onset of persistent sleep and prior to final awakening) and wake time after sleep (the number of epochs after the final awakening until the end of PSG recording) on 2 consecutive nights divided by 2 at the end of each intervention period by each individual hour (8 hours total). (NCT00883740)
Timeframe: Week 5 (End of Intervention Period 1) and Week 11 (End of Intervention Period 2) or ET
| Intervention | Minutes (Least Squares Mean) | |||||||
|---|---|---|---|---|---|---|---|---|
| Hour 1 | Hour 2 | Hour 3 | Hour 4 | Hour 5 | Hour 6 | Hour 7 | Hour 8 | |
| Placebo | 1.96 | 5.66 | 7.09 | 8.95 | 10.55 | 11.26 | 10.96 | 17.08 |
| Pregabalin | 1.62 | 4.56 | 4.65 | 5.43 | 7.54 | 7.38 | 8.38 | 14.23 |
3 reviews available for gamma-aminobutyric acid and Adverse Drug Event
| Article | Year |
|---|---|
Pharmacological Treatment of Pain in Cancer Patients: The Role of Adjuvant Analgesics, a Systematic Review.
Topics: Amines; Analgesics; Anticonvulsants; Antidepressive Agents; Chemotherapy, Adjuvant; Cyclohexanecarbo | 2017 |
Effectiveness of antiepileptic drugs for the treatment of bipolar disorder: findings from a systematic review.
Topics: Amines; Anticonvulsants; Bipolar Disorder; Cyclohexanecarboxylic Acids; Drug-Related Side Effects an | 2008 |
Aggravation of focal epileptic seizures by antiepileptic drugs.
Topics: Acetates; Acute Disease; Adult; Amines; Anticonvulsants; Clinical Trials as Topic; Cyclohexanecarbox | 1998 |
5 trials available for gamma-aminobutyric acid and Adverse Drug Event
| Article | Year |
|---|---|
Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).
Topics: Adult; Aged; Amines; Antiemetics; Antineoplastic Agents; Cisplatin; Cyclohexanecarboxylic Acids; Dru | 2016 |
Effect of pregabalin on sleep in patients with fibromyalgia and sleep maintenance disturbance: a randomized, placebo-controlled, 2-way crossover polysomnography study.
Topics: Adult; Aged; Analgesics; Comorbidity; Cross-Over Studies; Dose-Response Relationship, Drug; Double-B | 2012 |
A gastroretentive gabapentin formulation for the treatment of painful diabetic peripheral neuropathy: efficacy and tolerability in a double-blind, randomized, controlled clinical trial.
Topics: Aged; Algorithms; Amines; Analgesics; Chemistry, Pharmaceutical; Cyclohexanecarboxylic Acids; Diabet | 2012 |
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.
Topics: Amines; Analgesics; Causality; Comorbidity; Cyclohexanecarboxylic Acids; Disorders of Excessive Somn | 2013 |
Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13-week, randomized trial.
Topics: Adult; Aged; Aged, 80 and over; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions | 2006 |
13 other studies available for gamma-aminobutyric acid and Adverse Drug Event
| Article | Year |
|---|---|
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da | 2011 |
A cell-free testing platform to screen chemicals of potential neurotoxic concern across twenty vertebrate species.
Topics: Acetylcholine; Animals; Biological Assay; Birds; Cell-Free System; Dopamine; Drug-Related Side Effec | 2017 |
Call for increased pharmacovigilance of gabapentin.
Topics: Adverse Drug Reaction Reporting Systems; Amines; Cyclohexanecarboxylic Acids; Drug-Related Side Effe | 2017 |
Long-term efficacy of OROS® hydromorphone combined with pregabalin for chronic non-cancer neuropathic pain.
Topics: Adult; Aged; Aged, 80 and over; Chronic Pain; Drug Tolerance; Drug-Related Side Effects and Adverse | 2014 |
Transdermal administration of aqueous pregabalin solution as a potential treatment option for patients with neuropathic pain to avoid central nervous system-mediated side effects.
Topics: Administration, Cutaneous; Analgesics; Animals; Central Nervous System; Dizziness; Drug-Related Side | 2014 |
Comprehensive analysis of the GABAergic system gene expression profile in the anterior cingulate cortex of mice with Paclitaxel-induced neuropathic pain.
Topics: Animals; Disease Models, Animal; Drug-Related Side Effects and Adverse Reactions; GABA Plasma Membra | 2015 |
Patterns of prescribing antiepileptic drugs for bipolar disorder.
Topics: Adult; Amines; Anticonvulsants; Bipolar Disorder; Cyclohexanecarboxylic Acids; Drug-Related Side Eff | 2008 |
Gabapentin monotherapy for the treatment of chemotherapy-induced neuropathic pain: a pilot study.
Topics: Adult; Aged; Amines; Analgesics; Cyclohexanecarboxylic Acids; Drug-Related Side Effects and Adverse | 2008 |
A signal for an abuse liability for pregabalin--results from the Swedish spontaneous adverse drug reaction reporting system.
Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Algorithms; Analgesics; Anticonvulsants; | 2010 |
A look back at the most influential drug approvals of 2005.
Topics: Amyloid; Analgesics; Anticonvulsants; Antiparkinson Agents; Diabetes Mellitus, Type 2; Diphtheria-Te | 2006 |
Hyperalgesia induced by REM sleep loss: a phenomenon in search of a mechanism.
Topics: Acetylcholine; Adenosine; Anxiety; Chronic Disease; Depression; Drug Therapy; Drug-Related Side Effe | 2006 |
New drugs 06, part II.
Topics: Analgesics; Benzeneacetamides; Benzoates; Bone Density Conservation Agents; Deferasirox; Diphosphona | 2006 |
Neuropharmacologic teratogenesis and neurotransmitter regulation of palate development.
Topics: Abnormalities, Drug-Induced; Acetylcholine; Animals; Cell Movement; Cleft Palate; Diazepam; Dopamine | 1984 |