gamma-aminobutyric acid and Esophageal Reflux 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.

Research Excerpts

Excerpt	Relevance	Reference
"Patients diagnosed with fibromyalgia according to the American College of Rheumatology criteria, randomized to placebo or 300, 450, or 600 mg/day pregabalin, and with ≥ 1 postbaseline pain score were included."	8.86	Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. ( Bhadra, P; Petersel, D, 2010)
"Comorbid conditions are common among patients with fibromyalgia and their presence is not associated with altered pregabalin efficacy."	8.86	Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. ( Bhadra, P; Petersel, D, 2010)
"Patients diagnosed with fibromyalgia according to the American College of Rheumatology criteria, randomized to placebo or 300, 450, or 600 mg/day pregabalin, and with ≥ 1 postbaseline pain score were included."	4.86	Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. ( Bhadra, P; Petersel, D, 2010)
"Comorbid conditions are common among patients with fibromyalgia and their presence is not associated with altered pregabalin efficacy."	4.86	Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. ( Bhadra, P; Petersel, D, 2010)

Research

Studies (4)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Scores at Week 14

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	1 (25.00)	18.2507
2000's	1 (25.00)	29.6817
2010's	2 (50.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Lokshina, I	1
Feinstein, I	1
Agin, C	1
Katz, R	1
Sheen, VL	1
Ohaegbulam, C	1
Rencus, T	1
Tandon, D	1
Bhadra, P	1
Petersel, D	1
Blackshaw, LA	1
Staunton, E	1
Lehmann, A	1
Dent, J	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A 14-Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia[NCT00230776]	Phase 3	740 participants	Interventional	2005-10-31	Completed
A 13-week, Randomized, Double-Blind, Placebo-Controlled, Monotherapy Trial of Pregabalin (BID) in Patients With Fibromyalgia[NCT00645398]	Phase 3	751 participants (Actual)	Interventional	2004-09-30	Completed
A 14 Week, Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin Twice Daily In Patients With Fibromyalgia.[NCT00333866]	Phase 3	747 participants (Actual)	Interventional	2006-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

FIQ: 20-item self-administered questionnaire designed to assess areas such as health status, progress, and outcomes in participants with fibromyalgia. 11 items related to physical functioning, other items assess pain, fatigue, stiffness, difficulty working, and symptoms of anxiousness and depression. FIQ contains 10 sub-scales scored from 0 to 10, with higher scores indicating more impairment in the subscale attribute. Total score range from 0 to 100 with higher scores indicating more impairment. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14)

Intervention	Units on a scale (Least Squares Mean)
Placebo	-6.94
Pregabalin 300 mg	-8.11
Pregabalin 450 mg	-12.79
Pregabalin 600 mg	-8.38

Daily pain diary consists of 11-point NRS ranging from 0(no pain) to 10(worst possible pain). Participants rated their pain during past 24 hours, self-assessment done daily at awakening. Baseline=Last 7 available pain scores before taking study medication up to and including Day 1. Final weekly (endpoint) mean pain score is defined as the mean pain score from the last 7 pain diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Mean Sleep Quality Score at Endpoint (Up to Week 14)

Intervention	Units on a scale (Least Squares Mean)
Placebo	-0.73
Pregabalin 300 mg	-1.06
Pregabalin 450 mg	-1.29
Pregabalin 600 mg	-0.96

Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The endpoint (up to week 14) mean quality of sleep score was based on Least Squares (LS) Means using ANCOVA, with treatment group and center in the model and the baseline mean sleep score used as the covariate. Final weekly (endpoint) mean sleep quality score is defined as the mean sleep quality score from the last 7 sleep diary entries in the study while the participant was on study medication. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Multidimensional Assessment of Fatigue (MAF) at Week 14

Intervention	Units on a scale (Least Squares Mean)
Placebo	-0.94
Pregabalin 300 mg	-1.42
Pregabalin 450 mg	-1.72
Pregabalin 600 mg	-1.95

MAF is a 16-item self-administered questionnaire that yields a Global Fatigue Index (GFI), measures 4 dimensions of fatigue: degree and severity, amount of distress it causes, its timing and degree to which fatigue interferes with activities of daily living. Only 15 items are used to calculate the GFI. GFI score range from 1 (no fatigue) to 50 (severe fatigue). (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Pain Visual Analogue Scale (VAS) Scores at Week 14

Intervention	Units on a scale (Least Squares Mean)
Placebo	-1.91
Pregabalin 300 mg	-2.78
Pregabalin 450 mg	-3.32
Pregabalin 600 mg	-2.19

Pain visual analog scale (VAS): Participants assessed the severity of their pain using a 100 mm visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (worst possible pain), measurement on a scale corresponds to the magnitude of their pain. (NCT00333866)
Timeframe: Baseline, Week 14

Percentage of Participants With Optimal Sleep Assessed Using MOS-SS

Intervention	mm (Least Squares Mean)
Placebo	-10.30
Pregabalin 300 mg	-12.86
Pregabalin 450 mg	-17.75
Pregabalin 600 mg	-11.74

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more disturbance. (NCT00333866)
Timeframe: Baseline, Week 14

Total Daily Acetaminophen Dose

Intervention	Percentage of participants (Number)
Placebo	30.8
Pregabalin 300 mg	33.5
Pregabalin 450 mg	44.0
Pregabalin 600 mg	32.4

Acetaminophen (up to 4 gram/day as needed for pain relief) was an allowable concomitant medication as a rescue therapy. The total daily acetaminophen dose taken during double-blind treatment was calculated for each participant as: (total acetaminophen dose during the study) divided by (total number of study days). (NCT00333866)
Timeframe: Week 14

Change From Baseline in Fibromyalgia Impact Questionnaire (FIQ) Subscale Scores at Week 14

Intervention	mg/day (Least Squares Mean)
Placebo	460.65
Pregabalin 300 mg	449.14
Pregabalin 450 mg	508.53
Pregabalin 600 mg	724.42

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Week 14

Intervention	Units on a scale (Least Squares Mean)
	FIQ Physical Impairment (n=183,184,179,186)	FIQ Feel Good (n=182,184,178,183)	FIQ Work Missed (n=182,181,178,184)	FIQ Do Work (n=182,183,179,185)	FIQ Pain (n=183,184,179,185)	FIQ Fatigue (n=183,184,179,184)	FIQ Rested (n=183,184,179,185)	FIQ Stiffness (n=183,184,179,185)	FIQ Anxiety (n=183,184,179,185)	FIQ Depression (n=181,184,179,184)
Placebo	-0.09	-1.15	-0.13	-0.90	-0.97	-0.81	-0.94	-1.06	-0.48	-0.22
Pregabalin 300 mg	-0.26	-1.11	-0.29	-1.04	-1.18	-0.86	-1.17	-1.02	-0.66	-0.56
Pregabalin 450 mg	-0.35	-1.77	-0.75	-1.60	-1.72	-1.36	-1.47	-1.28	-1.12	-1.19
Pregabalin 600 mg	-0.26	-1.26	-0.27	-0.98	-1.10	-1.05	-1.40	-0.94	-0.68	-0.43

HADS: participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Medical Outcomes Study (MOS): Sub-scales at Week 14

Intervention	Units on a scale (Least Squares Mean)
	HADS Anxiety (HADS-A) Total	HADS Depression (HADS-D) Total
Placebo	-0.31	-0.11
Pregabalin 300 mg	-0.42	-0.33
Pregabalin 450 mg	-0.81	-0.70
Pregabalin 600 mg	-0.90	0.04

Participant-rated 12 item questionnaire assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no), as well as a 9-item overall sleep problems index. Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment. Scores transformed(actual raw score minus lowest possible score divided by possible raw score range*100);total score range:0-100,higher score=more intensity of attribute. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Short Form-36 (SF-36) Health Survey at Week 14

Intervention	Units on a scale (Least Squares Mean)
	Sleep Disturbance (n=183,183,177,185)	Snoring (n=172,174,174,177)	Shortness of Breath, Headache (n=182,182,177,184)	Quantity of Sleep (n=182,182,175,182)	Sleep Adequacy (n=183,183,179,185)	Somnolence (n=182,182,177,184)	Overall Sleep Problem Index (n=181,181,174,184)
Placebo	-5.99	-0.03	-0.67	0.41	7.62	-0.10	-4.83
Pregabalin 300 mg	-13.18	1.17	-9.62	0.61	10.19	0.67	-9.19
Pregabalin 450 mg	-19.26	4.89	-12.59	0.91	16.76	0.61	-13.07
Pregabalin 600 mg	-18.70	5.87	-9.91	0.76	11.97	1.92	-11.72

SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; Physical Component Score and Mental Component Score. Total score range for the summary scores = 0- 100, where higher score represents higher level of functioning. (NCT00333866)
Timeframe: Baseline, Week 14

Change From Baseline in Weekly Mean Sleep Quality Score

Intervention	Units on a scale (Least Squares Mean)
	Physical Functioning (n=184,184,177,186)	Physical Role Limitations (n=183,183,177,185)	Emotional Role Limitations (n=183,183,177,185)	Social Functioning (n=183,184,178,186)	Mental Health (n=183,184,178,186)	Bodily Pain (n=183,184,178,186)	Vitality (n=183,184,178,186)	General Health Perception (n=183,184,177,186)	Mental Component Score (n=182,183,176,184)	Physical Component Score (n=182,183,176,184)
Placebo	4.64	4.01	-2.31	0.75	-1.67	4.95	4.15	0.94	-1.27	2.47
Pregabalin 300 mg	5.22	4.40	1.44	4.10	1.65	7.77	4.89	2.76	0.87	2.60
Pregabalin 450 mg	6.63	5.50	3.93	5.76	4.25	10.32	9.25	3.67	2.39	3.01
Pregabalin 600 mg	4.13	5.03	1.56	3.60	2.41	7.53	7.29	2.21	1.35	2.34

Daily quality of sleep diary consists of 11-point NRS ranging from 0(best possible sleep) to 10(worst possible sleep). Participants rated their quality of sleep during past 24 hours, self-assessment done daily upon awakening. Baseline=Last 7 available scores before taking study medication up to and including Day 1. The weekly mean quality of sleep score was based on LS Means using mixed model repeated measures ANCOVA, with treatment, center, week, and treatment-by-week interaction in the model and the baseline mean sleep score used as the covariate. Weekly mean sleep quality score is defined as the mean of the last 7 daily sleep diary entries. (NCT00333866)
Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

Patient Global Impression of Change (PGIC)

Intervention	Units on a scale (Least Squares Mean)
	Week 1 (n=183,179,174,178)	Week 2 (n=180,172,168,174)	Week 3 (n=174, 164, 159,163)	Week 4 (n=165,157,155,156)	Week 5 (n=163, 150, 152,148)	Week 6 (n=159,145,148,144)	Week 7 (n=155,140,144,133)	Week 8 (n=149,133,142,127)	Week 9 (n=146,128,141,126)	Week 10 (n=144,125,139,126)	Week 11 (n=143,123,137,121)	Week 12 (n=141,121,135,119)	Week 13 (n=140,120,133,118)	Week 14 (n=134,115,128,111)	Overall (n=183,179,174,178)
Placebo	-0.38	-0.62	-0.75	-0.73	-0.82	-0.84	-0.91	-0.99	-1.11	-1.14	-1.09	-1.22	-1.05	-1.08	-0.91
Pregabalin 300 mg	-1.20	-1.48	-1.42	-1.52	-1.67	-1.56	-1.50	-1.60	-1.64	-1.75	-1.65	-1.62	-1.66	-1.73	-1.57
Pregabalin 450 mg	-1.08	-1.43	-1.56	-1.67	-1.69	-1.76	-1.83	-1.95	-1.94	-2.03	-1.92	-1.95	-1.93	-1.95	-1.76
Pregabalin 600 mg	-1.23	-1.59	-1.90	-2.01	-1.99	-2.15	-2.20	-2.25	-2.24	-2.34	-2.24	-2.29	-2.26	-2.29	-2.07

Number of participants with categorical change in overall status. PGIC: a participant-rated instrument assessing change in participant's overall status from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00333866)
Timeframe: Week 14

Article	Year
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010
Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert opinion on pharmacotherapy, 2010, Volume: 11, Issue:17 Topics: Adult; Analgesics; Clinical Trials, Phase III as Topic; Comorbidity; Dose-Response Relationship, Dru	2010

Article	Year
Diagnosis and treatment of glossopharyngeal and vagal neuropathies in a patient with laryngopharyngeal reflux. Anesthesiology, 2008, Volume: 109, Issue:4 Topics: gamma-Aminobutyric Acid; Gastroesophageal Reflux; Glossopharyngeal Nerve; Humans; Hypopharynx; Male;	2008
Gabapentin-induced exacerbation of myasthenia gravis. Muscle & nerve, 2010, Volume: 42, Issue:1 Topics: Aged; Amines; Cholinesterase Inhibitors; Cyclohexanecarboxylic Acids; Excitatory Amino Acid Antagoni	2010
Inhibition of transient LES relaxations and reflux in ferrets by GABA receptor agonists. The American journal of physiology, 1999, Volume: 277, Issue:4 Topics: Animals; Baclofen; Behavior, Animal; Deglutition; Esophagogastric Junction; Female; Ferrets; GABA Ag	1999

gamma-aminobutyric acid and Esophageal Reflux