Clinical trials: Gabapentin
Hot Flashes
Breeze3:Study of Gabapentin Extended Release in the Treatment of Vasomotor Symptoms(Hot Flashes)in Postmenopausal Women
Depomed's Gabapentin Extended Release is an investigational, extended release formulation of Gabapentin that is being studied for the treatment of Hot Flashes/Hot Flushes in postmenopausal women
- Trial name
- Breeze3 (NCT01080300)
- Testing
- Gabapentin Extended Release
- Where
- 66 sites in United States
- Volunteers
- 600 people
- Sponsor
- Depomed
Transient Insomnia
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
The purpose of this study is to assess consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.
- Trial name
- NCT00659100
- Testing
- Gabapentin
- Where
- 35 sites in United States
- Volunteers
- 1,254 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Diabetic Neuropathy
A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy
The purpose of this study is to evaluate the effectiveness and safety of tramadol hydrochloride (HCl) 37.5 miligram (mg)/acetaminophen 325 mg compared to gabapentin in participants with diabetic neuropathic (nerve disorder caused…
- Trial name
- NCT00634543
- Testing
- Tramadol hydrochloride/ Acetaminophen, Gabapentin
- Volunteers
- 162 people
- Sponsor
- Janssen Korea, Ltd., Korea
Painful Diabetic Neuropathy
Trazodone/Gabapentin Fixed Dose Combination Products in Painful Diabetic Neuropathy
The primary objective of the study is to collect preliminary information on the effect of three doses of trazodone/gabapentin FDC products on pain intensity in patients with painful diabetic neuropathy after 8-week treatment…
- Trial name
- NCT03749642
- Testing
- trazodone/gabapentin 2.5/25 mg, trazodone/gabapentin 5/50 mg, trazodone/gabapentin 10/100
- Where
- 30 sites in Czechia, France and 2 more
- Volunteers
- 240 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Healthy
Bioequivalence Study of Gabapentin 400 mg Capsules Under Fed Conditions
To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a 1000 mg dose in healthy, adult, male and female…
- Trial name
- NCT00778765
- Testing
- 400 mg Gabapentin Capsules
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Transient Insomnia
A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
- Trial name
- NCT00163046
- Testing
- Gabapentin
- Where
- 3 sites in United States
- Volunteers
- 256 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
RLS
An Efficacy and Safety Evaluation of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
The primary objective of the trial is to evaluate the efficacy of HORIZANT 300 mg and 600 mg, compared to placebo, at 12 weeks of treatment, for the treatment of Restless Legs Syndrome (RLS) in adolescents (13 to 17 years of age)…
- Trial name
- RLS (NCT02560766)
- Testing
- HORIZANT 300 mg, HORIZANT 600 mg
- Where
- 12 sites in United States
- Volunteers
- 132 people
- Sponsor
- XenoPort, Inc.
Epilepsy, Partial Seizure Disorder
Comparative Study Of Pregabalin And Gabapentin As Adjunctive Therapy In Subjects With Partial Seizures
To compare the efficacy of pregabalin and gabapentin, as adjunctive therapy in subjects with partial seizures.
- Conditions
- Epilepsy, Partial Seizure Disorder, Epilepsies, Partial, Complex Partial Seizure Disorder
- Trial name
- NCT00537940
- Testing
- Pregabalin, Gabapentin
- Where
- 8 sites in Costa Rica, El Salvador and 2 more
- Volunteers
- 482 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome (RLS)
Study to Assess the Effect of Gabapentin Enacarbil on Simulated Driving in Healthy Subjects
This is a double-blind, placebo-and active-controlled 3-period crossover study designed to assess the effect of GEn 600 mg on simulated driving performance in healthy volunteers.
- Trial name
- NCT01411124
- Testing
- gabapentin enacarbil, diphenhydramine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- XenoPort, Inc.
Epilepsy
Bioequivalence Study of 300 mg Gabapentin
The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent. Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer).
- Trial name
- NCT01738893
- Testing
- Gabapentin 300 mg
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Renal Pelvis Cancer, Restless Legs Syndrome
Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in the Adverse Events…
- Conditions
- Renal Pelvis Cancer, Restless Legs Syndrome, Epilepsy, Neuropathic Pain
- Trial name
- NCT01138124
- Testing
- Gabapentin prescriptions
- Volunteers
- 54,202 people
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
XP13512 (Gabapentin Enacarbil) Extension Study in Patients With Restless Legs Syndrome.
The primary objective of this trial is to assess the long-term safety and efficacy of XP13512 (Gabapentin Enacarbil) taken once daily for the treatment of patients suffering from Restless Legs Syndrome (RLS).
- Trial name
- NCT00333359
- Testing
- XP13512 (GEn)
- Volunteers
- 581 people
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome (RLS)
Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment
To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.
- Trial name
- NCT01981941
- Testing
- Gabapentin enacarbil
- Where
- 5 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Inc
Restless Legs Syndrome
Dose-Response and Pharmacokinetics of Gabapentin Enacarbil (GEn [XP13512 / GSK1838262]) in Restless Legs Syndrome
The objective of the study was to generate the data necessary to determine the gabapentin exposure produced by 4 dose levels of GEn (600 mg, 1200 mg, 1800 mg, and 2400 mg) or placebo, and the corresponding relief of symptoms in…
- Trial name
- XP081 (NCT01332305)
- Testing
- GEn (XP13512/GSK1838262)
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- XenoPort, Inc.
Epilepsies, Partial
Drug Use Investigation Of Gabapentin
The objective of the this surveillance is to collect information about 1)adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3)…
- Trial name
- NCT00567268
- Testing
- Gabapentin
- Volunteers
- 1,273 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Restless Legs Syndrome
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin enacarbil) for long-term treatment of restless legs syndrome patients.
- Trial name
- NCT02658188
- Testing
- ASP8825
- Where
- 10 sites in Japan
- Volunteers
- 182 people
- Sponsor
- Astellas Pharma Inc
Pain
Placebo Controlled Dose-Response Study Of PD-217,014 In The Treatment Of Postherpetic Neuralgia
The purpose of this study is to determine the effectiveness of PD-217,014 in the treatment of chronic pain following a shingles infection.
- Trial name
- NCT00159640
- Testing
- PD-217,014
- Where
- 32 sites in Australia, Canada and 4 more
- Volunteers
- 315 people
- Sponsor
- Pfizer
Restless Legs Syndrome (RLS)
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
The objective of this study was to assess the efficacy of once-daily oral administration of gabapentin enacarbil versus placebo, based on the change in International Restless Legs Syndrome Rating Scale (IRLS) score in…
- Trial name
- NCT03053427
- Testing
- Gabapentin enacarbil
- Where
- 46 sites in Japan
- Volunteers
- 375 people
- Sponsor
- Astellas Pharma Inc
Healthy
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
This study will examine the next-day residual effects of a nighttime dose of gabapentin 250 mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on simulated driving performance in normal…
- Trial name
- NCT01888497
- Testing
- Gabapentin, Diphenhydramine citrate, Triazolam
- Where
- 4 sites in United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Chronic Pain
Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain
The objective of the study is to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age assessed…
- Trial name
- GABA-2 (NCT03275012)
- Testing
- Gabapentin + Morphine
- Sponsor
- Pharmaceutical Research Management srl