Back to resultsA Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Primary Purpose
Transient Insomnia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Transient Insomnia
Eligibility Criteria
Inclusion Criteria:
- Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening
Exclusion Criteria:
- Females who were pregnant or breastfeeding
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Secondary Outcome Measures
Pulse and Blood Pressure
Subjective proportion of nights having difficulty sleeping
Subjective Sleep Latency
Subjective Wake After Sleep Onset
Subjective Number of Awakenings
Subjective Total Sleep Time
Subjective Assessment of Sleep Quality
Subjective Assessment of Ease of Awakening
Subject Global Evaluation
Pittsburg Sleep Quality Index
Full Information
NCT ID
NCT00666575
First Posted
April 23, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00666575
Brief Title
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transient Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
Primary Outcome Measure Information:
Title
Adverse Events
Time Frame
Day 45
Secondary Outcome Measure Information:
Title
Pulse and Blood Pressure
Time Frame
Day 45
Title
Subjective proportion of nights having difficulty sleeping
Time Frame
Day 45
Title
Subjective Sleep Latency
Time Frame
Day 45
Title
Subjective Wake After Sleep Onset
Time Frame
Day 45
Title
Subjective Number of Awakenings
Time Frame
Day 45
Title
Subjective Total Sleep Time
Time Frame
Day 45
Title
Subjective Assessment of Sleep Quality
Time Frame
Day 45
Title
Subjective Assessment of Ease of Awakening
Time Frame
Day 45
Title
Subject Global Evaluation
Time Frame
Day 45
Title
Pittsburg Sleep Quality Index
Time Frame
Day 45
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening
Exclusion Criteria:
Females who were pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Pfizer Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Pfizer Investigational Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94102
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Pfizer Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Pfizer Investigational Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Pfizer Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Pfizer Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Pfizer Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451146&StudyName=A%20Study%20of%20the%20Safety%20of%20Gabapentin%20in%20a%20Potential%20Over-the-Counter%20Population%20with%20Occasional%20Sleeplessness
Description
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Learn more about this trial
A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness
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