A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance
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
1 other identifier
interventional
773
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
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)
Subjective sleep latency
Hour +8
Secondary Outcomes (12)
Stanford Sleepiness Scale
Hour +13
Vital signs
Hour +8
Adverse events
Hour +13
Subjective number of awakenings
Hour +8
Subjective wake after sleep onset
Hour +8
- +7 more secondary outcomes
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
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 (10)
Pfizer Investigational Site
San Diego, California, 92108, United States
Pfizer Investigational Site
Ocala, Florida, 34471, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Metairie, Louisiana, 70001, United States
Pfizer Investigational Site
New York, New York, 10025, United States
Pfizer Investigational Site
Thornwood, New York, 10594, United States
Pfizer Investigational Site
Raleigh, North Carolina, 27612, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904, 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
January 1, 2005
Last Updated
February 2, 2021
Record last verified: 2008-04