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NCT00666575 Clinical Trial

A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness

Transient Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00666575
Other study ID # A9451146
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2004
Est. completion date May 2005

Study information
Verified date April 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 2105
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening Exclusion Criteria: - Females who were pregnant or breastfeeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days
• Placebo
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days

Locations
Country Name City State
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Beverly Hills California
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Boise Idaho
United States Pfizer Investigational Site Clearwater Florida
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Port Richey Florida
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Santa Fe New Mexico
United States Pfizer Investigational Site West Jordan Utah
United States Pfizer Investigational Site West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Day 45
Secondary Pulse and Blood Pressure Day 45
Secondary Subjective proportion of nights having difficulty sleeping Day 45
Secondary Subjective Sleep Latency Day 45
Secondary Subjective Wake After Sleep Onset Day 45
Secondary Subjective Number of Awakenings Day 45
Secondary Subjective Total Sleep Time Day 45
Secondary Subjective Assessment of Sleep Quality Day 45
Secondary Subjective Assessment of Ease of Awakening Day 45
Secondary Subject Global Evaluation Day 45
Secondary Pittsburg Sleep Quality Index Day 45
See also
  Status Clinical Trial Phase
Completed NCT03331042 - SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. Phase 3
Completed NCT00594022 - Evaluation of Vestibular Stimulation to Help Occasional Sleeplessness N/A
Completed NCT00163046 - A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance Phase 3
Completed NCT00666939 - A Study of Single-Dose Gabapentin in Subjects With Transient Insomnia Induced by a Sleep Phase Advance Phase 3
Completed NCT00666770 - A Polysomnographic Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance Phase 3
Completed NCT00667108 - A Study of Single-Dose Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance Phase 3
Recruiting NCT05457790 - Feasibility and Preliminary Efficacy of Acceptance and Commitment Therapy (ACT) for Sleep Disturbances in Adults With Sickle Cell Disease (SCD) N/A
Not yet recruiting NCT04396327 - SM-1 vs. an Active Comparator in A Model of Transient Insomnia Phase 2
Withdrawn NCT03338764 - An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia Phase 3
Completed NCT01779830 - A Study of LY2624803 in Participants With Transient Insomnia Phase 1
Completed NCT00674752 - A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia Phase 3
Completed NCT00671398 - Efficacy of Ramelteon on Transient Insomnia in Healthy Adults Phase 3
Completed NCT00659100 - A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment Phase 3

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