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

February 1, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Actual Use Study of the Safety and Tolerability of Gabapentin 500 mg in a Potential OTC Population

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2105

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Pfizer Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94102
        • Pfizer Investigational Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Pfizer Investigational Site
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83704
        • Pfizer Investigational Site
      • Boise, Idaho, United States, 83712
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89104
        • Pfizer Investigational Site
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76135
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78205
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Pfizer Investigational Site
      • West Jordan, Utah, United States, 84088
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Matched placebo oral capsule 30 minutes prior to bedtime for 28 days
Experimental: Gabapentin
Drug: Gabapentin
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: Day 45
Day 45

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulse and Blood Pressure
Time Frame: Day 45
Day 45
Subjective proportion of nights having difficulty sleeping
Time Frame: Day 45
Day 45
Subjective Sleep Latency
Time Frame: Day 45
Day 45
Subjective Wake After Sleep Onset
Time Frame: Day 45
Day 45
Subjective Number of Awakenings
Time Frame: Day 45
Day 45
Subjective Total Sleep Time
Time Frame: Day 45
Day 45
Subjective Assessment of Sleep Quality
Time Frame: Day 45
Day 45
Subjective Assessment of Ease of Awakening
Time Frame: Day 45
Day 45
Subject Global Evaluation
Time Frame: Day 45
Day 45
Pittsburg Sleep Quality Index
Time Frame: Day 45
Day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9451146

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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