Clinical trials: Gabapentin
- Drug or intervention Gabapentin
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
RLS
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS
The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633683)
- Testing
- HORIZANT 600 mg
- Where
- 11 sites in United States
- Volunteers
- 144 people
- Sponsor
- XenoPort, Inc.
Chronic Pain
Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain
This study evaluates the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population.
- Trial name
- GABA-1 (NCT02722603)
- Testing
- gabapentin, tramadol
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 2 people
- Sponsor
- Pharmaceutical Research Management srl
Epilepsies, Partial
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00603473
- Testing
- gabapentin
- Where
- 26 sites in Japan
- Volunteers
- 92 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.
RLS
A PK and Safety Evaluation of HORIZANT (Gabapentin Enacarbil) in Adolescents With Moderate-to-Severe Primary RLS
The primary objective is to assess the pharmacokinetics (PK) of gabapentin following the single-dose administration of HORIZANT (Gabapentin Enacarbil) in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe…
- Trial name
- RLS (NCT02633657)
- Testing
- HORIZANT 300 mg
- Where
- 4 sites in United States
- Sponsor
- XenoPort, Inc.
Restless Legs Syndrome
Specified Drug Use-Results Survey of Regnite
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
- Trial name
- NCT01887613
- Testing
- Regnite
- Where
- 7 sites in Japan
- Volunteers
- 1,597 people
- Sponsor
- Astellas Pharma Inc
Epilepsies, Partial
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00620555
- Testing
- gabapentin
- Where
- 22 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pain, Neuropathic, Epilepsy
Cancer in Patients With Gabapentin (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 AERS or in the…
- Conditions
- Pain, Neuropathic, Epilepsy, Renal Pelvis Cancer, Pancreatic Cancer
- Trial name
- NCT01236053
- Testing
- Gabapentin prescriptions
- Volunteers
- 2,323,608 people
- Sponsor
- GlaxoSmithKline
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.
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
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
Transient Insomnia
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
- Trial name
- NCT00666575
- Testing
- Gabapentin
- Where
- 23 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.