Trials / Completed
CompletedNCT00666575
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,105 (estimated)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2004-12-01
- Completion
- 2005-05-01
- First posted
- 2008-04-25
- Last updated
- 2021-02-02
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00666575. Inclusion in this directory is not an endorsement.