A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
- Registration Number
- NCT00666575
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2105
Inclusion Criteria
- Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening
Exclusion Criteria
- Females who were pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Gabapentin Gabapentin -
- Primary Outcome Measures
Name Time Method Adverse Events Day 45
- Secondary Outcome Measures
Name Time Method Subjective proportion of nights having difficulty sleeping Day 45 Subjective Total Sleep Time Day 45 Subjective Assessment of Ease of Awakening Day 45 Subject Global Evaluation Day 45 Subjective Number of Awakenings Day 45 Pittsburg Sleep Quality Index Day 45 Subjective Sleep Latency Day 45 Pulse and Blood Pressure Day 45 Subjective Wake After Sleep Onset Day 45 Subjective Assessment of Sleep Quality Day 45
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸West Jordan, Utah, United States