NCT00674752
Completed
Phase 3
A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study Of Gabapentin 250 mg And 500 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 country377 target enrollmentStarted: March 2006Last updated:
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Enrollment
- 377
- Locations
- 1
- Primary Endpoint
- Wake after sleep onset as measured by polysomnography (PSG)
Overview
Brief Summary
The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in 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 who reported occasional sleeplessness in the month prior to screening
- •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)
- •Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine
Arms & Interventions
A
Experimental
Intervention: Gabapentin (Drug)
B
Experimental
Intervention: Gabapentin (Drug)
C
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Wake after sleep onset as measured by polysomnography (PSG)
Time Frame: Hour +8
Secondary Outcomes
- Adverse events(Hour +13)
- PSG Sleep Efficiency(Hour +8)
- PSG Wake Time During Sleep(Hour +8)
- PSG Sleep Onset Latency(Hour +8)
- PSG Latency to Persistent Sleep(Hour +8)
- PSG WASO(Hour +8)
- PSG Percent of Stages 1, 2, 3, 4 and REM sleep(Hour +8)
- subjective Wake After Sleep Onset (WASO)(Hour +8)
- subjective Assessment of Sleep Quality(Hour +8)
- Vital signs(Hour +8)
- PSG NA(Hour +8)
- subjective Assessment of Sleep Refreshment(Hour +8)
- Karolinska Sleep Diary-Sleep (KSD) Quality Index(Hour +8)
- PSG Total wake time plus Stage 1 sleep(Hour +8)
- subjective Sleep Latency(Hour +8)
- KSD individual scores(Hour +8)
- PSG TST(Hour +8)
- subjective Total Sleep Time (TST)(Hour +8)
- PSG Percent slow wave sleep (Stages 3&4 combined)(Hour +8)
- subjective Number of Awakenings (NA)(Hour +8)
Investigators
Study Sites (1)
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