NCT00666575
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country2,105 target enrollmentDecember 2004
Overview
- Phase
- Phase 3
- Intervention
- Gabapentin
- Conditions
- Transient Insomnia
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 2105
- Locations
- 1
- Primary Endpoint
- Adverse Events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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
Investigators
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
Arms & Interventions
Gabapentin
Intervention: Gabapentin
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse Events
Time Frame: Day 45
Secondary Outcomes
- 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)
Study Sites (1)
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