Trials / Completed
CompletedNCT00659100
A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,254 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gabapentin | Gabapentin 50 mg oral capsule 30 minutes before bedtime |
Timeline
- Start date
- 2006-08-01
- Completion
- 2007-01-01
- First posted
- 2008-04-16
- Last updated
- 2021-02-02
Locations
35 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00659100. Inclusion in this directory is not an endorsement.