A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Overview[ - collapse ][ - ]
| Purpose | 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 |
|---|---|
| Condition | Transient Insomnia |
| Intervention | Drug: Gabapentin Drug: Placebo |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Responsible Party | Pfizer |
| ClinicalTrials.gov Identifier | NCT00666575 |
| First Received | April 23, 2008 |
| Last Updated | April 23, 2008 |
| Last verified | April 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | April 23, 2008 |
|---|---|
| Last Updated Date | April 23, 2008 |
| Start Date | December 2004 |
| Estimated Primary Completion Date | May 2005 |
| Current Primary Outcome Measures | Adverse Events [Time Frame: Day 45] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness |
|---|---|
| Official Title | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population |
| Brief Summary | 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 |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Transient Insomnia |
| Intervention | Drug: Gabapentin Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days Drug: Placebo Matched placebo oral capsule 30 minutes prior to bedtime for 28 days |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 2105 |
| Estimated Completion Date | May 2005 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening Exclusion Criteria: - Females who were pregnant or breastfeeding |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00666575 |
|---|---|
| Other Study ID Numbers | A9451146 |
| Has Data Monitoring Committee | No |
| Information Provided By | Pfizer |
| Study Sponsor | Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Pfizer CT.gov Call Center Pfizer |
| Verification Date | April 2008 |
Locations[ + expand ][ + ]
| Pfizer Investigational Site | Mobile, Alabama, United States, 36608 |
|---|---|
| Pfizer Investigational Site | Phoenix, Arizona, United States, 85018 |
| Pfizer Investigational Site | Beverly Hills, California, United States, 90211 |
| Pfizer Investigational Site | San Francisco, California, United States, 94102 |
| Pfizer Investigational Site | Clearwater, Florida, United States, 33765 |
| Pfizer Investigational Site | Deland, Florida, United States, 32720 |
| Pfizer Investigational Site | New Port Richey, Florida, United States, 34652 |
| Pfizer Investigational Site | Pembroke Pines, Florida, United States, 33024 |
| Pfizer Investigational Site | West Palm Beach, Florida, United States, 33409 |
| Pfizer Investigational Site | Atlanta, Georgia, United States, 30328 |
| Pfizer Investigational Site | Boise, Idaho, United States, 83704 |
| Pfizer Investigational Site | Boise, Idaho, United States, 83712 |
| Pfizer Investigational Site | Indianapolis, Indiana, United States, 46250 |
| Pfizer Investigational Site | Las Vegas, Nevada, United States, 89104 |
| Pfizer Investigational Site | Las Vegas, Nevada, United States, 89128 |
| Pfizer Investigational Site | Santa Fe, New Mexico, United States, 87505 |
| Pfizer Investigational Site | Nashville, Tennessee, United States, 37203 |
| Pfizer Investigational Site | Austin, Texas, United States, 78705 |
| Pfizer Investigational Site | Fort Worth, Texas, United States, 76135 |
| Pfizer Investigational Site | San Antonio, Texas, United States, 78205 |
| Pfizer Investigational Site | San Antonio, Texas, United States, 78229 |
| Pfizer Investigational Site | Salt Lake City, Utah, United States, 84102 |
| Pfizer Investigational Site | West Jordan, Utah, United States, 84088 |