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

NCT00666575 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2105

Last updated 2021-02-02

No results posted yet for this study

Summary

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

Conditions

  • Transient Insomnia

Interventions

DRUG

Gabapentin

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

DRUG

Placebo

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2005-05-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00666575 on ClinicalTrials.gov