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Completed

NCT Number: NCT00666575

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

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

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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

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects >/= 12 years of age who reported occasional sleeplessness in month prior to screening

Exclusion criteria

  • Females who were pregnant or breastfeeding

Treatment and study plan

Gabapentin

Drug

Gabapentin 500 mg oral capsule 30 minutes prior to bedtime for 28 days

Placebo

Drug

Matched placebo oral capsule 30 minutes prior to bedtime for 28 days

Primary outcomes

  1. Adverse Events

    Time frame: Day 45

Secondary outcomes

  1. Pulse and Blood Pressure

    Time frame: Day 45

  2. Subjective proportion of nights having difficulty sleeping

    Time frame: Day 45

  3. Subjective Sleep Latency

    Time frame: Day 45

  4. Subjective Wake After Sleep Onset

    Time frame: Day 45

  5. Subjective Number of Awakenings

    Time frame: Day 45

  6. Subjective Total Sleep Time

    Time frame: Day 45

  7. Subjective Assessment of Sleep Quality

    Time frame: Day 45

  8. Subjective Assessment of Ease of Awakening

    Time frame: Day 45

  9. Subject Global Evaluation

    Time frame: Day 45

  10. Pittsburg Sleep Quality Index

    Time frame: Day 45

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Apr 25, 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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