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Last Updated: February 25, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR GABAPENTIN

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505(b)(2) Clinical Trials for Gabapentin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00236223 The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery Terminated Glostrup University Hospital, Copenhagen Phase 4 2005-10-01 Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
OTC NCT00659100 A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment Completed Pfizer Phase 3 2006-08-01 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.
OTC NCT00666575 A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness Completed Pfizer Phase 3 2004-12-01 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 Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Gabapentin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001482 New Drugs in the Treatment of Mood Disorders Completed National Institute of Mental Health (NIMH) Phase 2 1995-05-01 This clinical study compares the effectiveness of two anticonvulsants Lamotrigine (Lamictal) Monotherapy and Gabapentin (Neurontin) in patients with treatment resistant affective disorders. We initially have found that the response rate to lamotrigine (51%) exceeded that of gabapentin (28%) or placebo (21%). In this study the placebo phase has been dropped so that we examine possible clinical and biological factors predictors of response. The drugs will be given in a randomized order for six weeks each and you will not know when you are on a given one. There will be a 2-4 week "washout" period between treatments. If you respond well to one of these treatments, a longer open continuation period will be offered at the end of this study. This would involve one or both drugs in combination. A variety of rating scales and brain imaging procedures will also be offered before and during each drug evaluation. Both lamotrigine and gabapentin are generally well tolerated. A serious potentially life threatening rash occurs in about 1/500 patients treated with lamotrigine, however. Common side effects are rash, dizziness, unsteadiness, double vision, blurred vision, nausea, vomiting, insomnia, sedation, and headache. These side effects are usually mild, and resolve with continued time on the drug or a decrease in dosage.
NCT00006773 Bortezomib in Treating Patients With Recurrent Glioma Terminated National Cancer Institute (NCI) Phase 1 2001-05-01 Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed Glaxo Wellcome Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed Parke-Davis Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
NCT00007670 Does Gabapentin and Lamotriginel Have Significantly Fewer Side-Effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly. Completed VA Office of Research and Development Phase 3 1998-01-01 New onset epilepsy in the elderly occurs in 45,000-50,000 elderly patients each year. These patients are especially vulnerable to side effects from medications because of changes caused by the aging process and the fact that these patients often have many common diseases for which they are already receiving medications for so that the likelihood of drug interactions is increased. Two new drugs, gabapentin and lamotrigine, have recently been approved by the FDA as antiepileptic drugs. These drugs have demonstrated efficacy in the treatment of partial onset seizures, the most common seizures in the elderly. These new compounds also have favorable side effect profiles and infrequent drug-drug interactions and, therefore, would be expected to be well-tolerated in the elderly.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gabapentin

Condition Name

Condition Name for Gabapentin
Intervention Trials
Pain 31
Pain, Postoperative 27
Postoperative Pain 19
Restless Legs Syndrome 17
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Condition MeSH

Condition MeSH for Gabapentin
Intervention Trials
Pain, Postoperative 69
Neuralgia 50
Syndrome 25
Restless Legs Syndrome 25
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Clinical Trial Locations for Gabapentin

Trials by Country

Trials by Country for Gabapentin
Location Trials
United States 640
Japan 43
Canada 35
Brazil 17
Egypt 14
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Trials by US State

Trials by US State for Gabapentin
Location Trials
California 48
New York 39
Texas 30
Pennsylvania 29
Florida 29
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Clinical Trial Progress for Gabapentin

Clinical Trial Phase

Clinical Trial Phase for Gabapentin
Clinical Trial Phase Trials
Phase 4 124
Phase 3 83
Phase 2/Phase 3 23
[disabled in preview] 77
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Clinical Trial Status

Clinical Trial Status for Gabapentin
Clinical Trial Phase Trials
Completed 193
Recruiting 91
Not yet recruiting 76
[disabled in preview] 45
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Clinical Trial Sponsors for Gabapentin

Sponsor Name

Sponsor Name for Gabapentin
Sponsor Trials
Pfizer 35
XenoPort, Inc. 17
National Cancer Institute (NCI) 12
[disabled in preview] 21
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Sponsor Type

Sponsor Type for Gabapentin
Sponsor Trials
Other 409
Industry 111
NIH 52
[disabled in preview] 15
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