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

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

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1254

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
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • Bonita, California, United States, 91902
        • Pfizer Investigational Site
      • Fallbrook, California, United States, 92028
        • Pfizer Investigational Site
      • Hacienda Heights, California, United States, 91746
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92054
        • Pfizer Investigational Site
      • Orange, California, United States, 92866
        • Pfizer Investigational Site
      • San Dimas, California, United States, 91773
        • Pfizer Investigational Site
    • Florida
      • Pembroke Pines, Florida, United States, 33026
        • Pfizer Investigational Site
      • Weston, Florida, United States, 33326
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21228
        • Pfizer Investigational Site
    • Minnesota
      • Elk River, Minnesota, United States, 55330
        • Pfizer Investigational Site
      • Northfield, Minnesota, United States, 55057
        • Pfizer Investigational Site
      • Red Wing, Minnesota, United States, 55066
        • Pfizer Investigational Site
      • Saint Louis Park, Minnesota, United States, 55426
        • Pfizer Investigational Site
    • Mississippi
      • Holly Springs, Mississippi, United States, 38625
        • Pfizer Investigational Site
    • Missouri
      • Belton, Missouri, United States, 64012
        • Pfizer Investigational Site
      • Independence, Missouri, United States, 64054
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87104
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87110
        • Pfizer Investigational Site
      • Taos, New Mexico, United States, 87571
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • Pfizer Investigational Site
      • Chapel Hill, North Carolina, United States, 27514
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • Pfizer Investigational Site
      • Raleigh, North Carolina, United States, 27606
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77088
        • Pfizer Investigational Site
      • Pearland, Texas, United States, 77581
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Ogden, Utah, United States, 84401
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84121
        • Pfizer Investigational Site
      • Syracuse, Utah, United States, 84075
        • Pfizer Investigational Site
      • West Valley City, Utah, United States, 84120
        • Pfizer Investigational Site
    • Virginia
      • Falls Church, Virginia, United States, 22041
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23233
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of 18 years or older with symptoms of sleeplessness
  • Provided informed consent

Exclusion Criteria:

  • Contraindications to use of gabapentin

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Gabapentin
Gabapentin 50 mg oral capsule 30 minutes before bedtime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)
Time Frame: Throughout Day 90
Throughout Day 90
Subject compliance with directions for use (number of capsules per dose and the number of doses per day)
Time Frame: Throughout Day 90
Throughout Day 90

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Duration of study
Duration of study

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

August 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 10, 2008

First Posted (Estimate)

April 16, 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, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9451159

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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