NCT00666575CompletedPhase 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 enrollmentStarted: December 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 2,105
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: Gabapentin (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
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)
Investigators
Study Sites (1)
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