A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia
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
377
1 country
4
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.
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 Mar 2006
Shorter than P25 for phase_3
4 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
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 6, 2008
CompletedFirst Posted
Study publicly available on registry
May 8, 2008
CompletedFebruary 2, 2021
April 1, 2011
May 6, 2008
February 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Wake after sleep onset as measured by polysomnography (PSG)
Hour +8
Secondary Outcomes (20)
PSG Latency to Persistent Sleep
Hour +8
PSG Wake Time During Sleep
Hour +8
PSG WASO
Hour +8
PSG Sleep Onset Latency
Hour +8
Vital signs
Hour +8
- +15 more secondary outcomes
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45227, United States
Related Publications (1)
Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.
PMID: 25317090DERIVED
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
May 6, 2008
First Posted
May 8, 2008
Study Start
March 1, 2006
Study Completion
August 1, 2006
Last Updated
February 2, 2021
Record last verified: 2011-04