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Last Updated: December 12, 2019

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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.
NCT00011297 Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 2 1969-12-31 This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.
NCT00015106 Resperine, Gabapentin, or Lamotrigine for the Treatment of Cocaine Dependence: 2 - 7 Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-11-01 The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the treatment of cocaine dependence using reserpine, gabapentin, or lamotrigine vs. an unmatched placebo control.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gabapentin

Condition Name

Condition Name for Gabapentin
Intervention Trials
Pain 28
Pain, Postoperative 20
Postoperative Pain 18
Restless Legs Syndrome 17
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Condition MeSH

Condition MeSH for Gabapentin
Intervention Trials
Pain, Postoperative 58
Neuralgia 46
Restless Legs Syndrome 25
Syndrome 23
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Clinical Trial Locations for Gabapentin

Trials by Country

Trials by Country for Gabapentin
Location Trials
United States 624
Japan 43
Canada 34
Brazil 17
Germany 12
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Trials by US State

Trials by US State for Gabapentin
Location Trials
California 44
New York 36
Texas 30
Florida 29
North Carolina 26
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Clinical Trial Progress for Gabapentin

Clinical Trial Phase

Clinical Trial Phase for Gabapentin
Clinical Trial Phase Trials
Phase 4 110
Phase 3 77
Phase 2/Phase 3 19
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Clinical Trial Status

Clinical Trial Status for Gabapentin
Clinical Trial Phase Trials
Completed 188
Recruiting 77
Not yet recruiting 53
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Clinical Trial Sponsors for Gabapentin

Sponsor Name

Sponsor Name for Gabapentin
Sponsor Trials
Pfizer 35
XenoPort, Inc. 17
National Institute on Drug Abuse (NIDA) 12
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Sponsor Type

Sponsor Type for Gabapentin
Sponsor Trials
Other 346
Industry 111
NIH 51
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