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OpenTrials
Completed

NCT Number: NCT00659100

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

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.

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Key information

Conditions

Transient Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Contraindications to use of gabapentin

Treatment and study plan

Gabapentin

Drug

Gabapentin 50 mg oral capsule 30 minutes before bedtime

Primary outcomes

  1. Proportion of subjects who selected or purchased gabapentin for use (patients had symptoms consistent with indication and no contraindications)

    Time frame: Throughout Day 90

  2. Subject compliance with directions for use (number of capsules per dose and the number of doses per day)

    Time frame: Throughout Day 90

Secondary outcomes

  1. Adverse events

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Apr 16, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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