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NCT00659100 Clinical Trial

A Trial to Assess Consumer Self-Selection and Use of Gabapentin for Occasional Sleeplessness in an Over-the-Counter Environment

Transient Insomnia Clinical Trial

Official title:
A 3-Month, Open-Label, Pharmacy-Based, Actual-Use Trial in a Simulated Over-The-Counter (OTC) Environment to Assess Self-Selection and Consumer Use Patterns of Gabapentin 250 mg for Occasional Sleeplessness

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00659100
Other study ID # A9451159
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 2006
Est. completion date January 2007

Study information
Verified date April 2011
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 consumers' behaviors related to gabapentin self- selection and use, relative to warnings and directions for use, as described in the proposed over-the-counter (OTC) product label.

Recruitment information / eligibility
Status Completed
Enrollment 1254
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age of 18 years or older with symptoms of sleeplessness - Provided informed consent Exclusion Criteria: - Contraindications to use of gabapentin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin
Gabapentin 50 mg oral capsule 30 minutes before bedtime

Locations
Country Name City State
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Belton Missouri
United States Pfizer Investigational Site Bonita California
United States Pfizer Investigational Site Bountiful Utah
United States Pfizer Investigational Site Cary North Carolina
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Elk River Minnesota
United States Pfizer Investigational Site Fallbrook California
United States Pfizer Investigational Site Falls Church Virginia
United States Pfizer Investigational Site Hacienda Heights California
United States Pfizer Investigational Site Holly Springs Mississippi
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Independence Missouri
United States Pfizer Investigational Site La Mesa California
United States Pfizer Investigational Site Northfield Minnesota
United States Pfizer Investigational Site Oceanside California
United States Pfizer Investigational Site Ogden Utah
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Pearland Texas
United States Pfizer Investigational Site Pembroke Pines Florida
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Raleigh North Carolina
United States Pfizer Investigational Site Red Wing Minnesota
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Saint Louis Park Minnesota
United States Pfizer Investigational Site Salt Lake City Utah
United States Pfizer Investigational Site San Dimas California
United States Pfizer Investigational Site Syracuse Utah
United States Pfizer Investigational Site Taos New Mexico
United States Pfizer Investigational Site West Valley City Utah
United States Pfizer Investigational Site Weston 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 Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications) Throughout Day 90
Primary Subject compliance with directions for use (number of capsules per dose and the number of doses per day) Throughout Day 90
Secondary Adverse events Duration of study
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 NCT00666575 - A Study of the Safety of Gabapentin in a Potential Over-the-Counter Population With Occasional Sleeplessness Phase 3
Completed NCT00671398 - Efficacy of Ramelteon on Transient Insomnia in Healthy Adults Phase 3

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