NCT00666939CompletedPhase 3
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter Study Of Gabapentin 100 mg and 250 mg in Transient Insomnia Induced By A Sleep Phase Advance
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country773 target enrollmentStarted: October 2004Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 773
- Locations
- 1
- Primary Endpoint
- Subjective sleep latency
Study Overview
Brief Summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged >/= 18 years
- •Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening
Exclusion Criteria
- •Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition)
- •Recreational drug use within past 30 days
Arms & Interventions
A
Experimental
Intervention: Gabapentin (Drug)
B
Experimental
Intervention: Gabapentin (Drug)
C
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Subjective sleep latency
Time Frame: Hour +8
Secondary Outcomes
- Vital signs(Hour +8)
- Subjective number of awakenings(Hour +8)
- Subjective wake after sleep onset(Hour +8)
- Karolinska Sleep Diary-Sleep (KSD) Quality Index(Hour +8)
- Adverse events(Hour +13)
- Subjective assessment of sleep quality(Hour +8)
- Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score)(Hour +8)
- Stanford Sleepiness Scale(Hour +13)
- Subjective total sleep time(Hour +8)
- Subjective assessment of sleep refreshment(Hour +8)
- KSD individual scores(Hour +8)
- Digit Symbol Substitution Test(Hour +8)
Investigators
Study Sites (1)
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