A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
1 other identifier
interventional
2,105
1 country
23
Brief Summary
The purpose of this study is to assess the safety of gabapentin, as compared to placebo, in a potential over-the-counter population with reports of occasional sleeplessness
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2004
Shorter than P25 for phase_3
23 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
December 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 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)
Adverse Events
Day 45
Secondary Outcomes (10)
Pulse and Blood Pressure
Day 45
Subjective proportion of nights having difficulty sleeping
Day 45
Subjective Sleep Latency
Day 45
Subjective Wake After Sleep Onset
Day 45
Subjective Number of Awakenings
Day 45
- +5 more secondary outcomes
Study Arms (2)
Gabapentin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects \>/= 12 years of age who reported occasional sleeplessness in month prior to screening
You may not qualify if:
- Females who were pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Phoenix, Arizona, 85018, United States
Pfizer Investigational Site
Beverly Hills, California, 90211, United States
Pfizer Investigational Site
San Francisco, California, 94102, United States
Pfizer Investigational Site
Clearwater, Florida, 33765, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
New Port Richey, Florida, 34652, United States
Pfizer Investigational Site
Pembroke Pines, Florida, 33024, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33409, United States
Pfizer Investigational Site
Atlanta, Georgia, 30328, United States
Pfizer Investigational Site
Boise, Idaho, 83704, United States
Pfizer Investigational Site
Boise, Idaho, 83712, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46250, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89104, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89128, United States
Pfizer Investigational Site
Santa Fe, New Mexico, 87505, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Fort Worth, Texas, 76135, United States
Pfizer Investigational Site
San Antonio, Texas, 78205, United States
Pfizer Investigational Site
San Antonio, Texas, 78229, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84102, United States
Pfizer Investigational Site
West Jordan, Utah, 84088, 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
December 1, 2004
Study Completion
May 1, 2005
Last Updated
February 2, 2021
Record last verified: 2008-04