A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance
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
1 other identifier
interventional
309
1 country
5
Brief Summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2004
Shorter than P25 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 25, 2008
CompletedFebruary 2, 2021
April 1, 2008
April 23, 2008
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Latency to persistent sleep as measured by polysomnography
Hour +8
Secondary Outcomes (22)
Subjective wake after sleep onset
Hour +8
Subjective total sleep time
Hour +8
Subjective assessment of sleep refreshment
Hour +8
Subjective assessment of sleep quality
Hour +8
Stanford Sleepiness Scale
Hour +13
- +17 more secondary outcomes
Study Arms (3)
Gabapentin 250 mg
EXPERIMENTALGabapentin 500 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged \>/= 18 years
- Females of child-bearing potential using medically-acceptable method of birth control \>/= 1 month prior to screening
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Pfizer Investigational Site
Glendale, California, 91206, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
New York, New York, 10025, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 25, 2008
Study Start
October 1, 2004
Study Completion
November 1, 2004
Last Updated
February 2, 2021
Record last verified: 2008-04