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

NCT ID: NCT00659100

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Transient Insomnia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Gabapentin

Intervention Type DRUG

Gabapentin 50 mg oral capsule 30 minutes before bedtime

Interventions

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Gabapentin

Gabapentin 50 mg oral capsule 30 minutes before bedtime

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindications to use of gabapentin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Anaheim, California, United States

Site Status

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Bonita, California, United States

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Fallbrook, California, United States

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Hacienda Heights, California, United States

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La Mesa, California, United States

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Oceanside, California, United States

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Orange, California, United States

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San Dimas, California, United States

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Pembroke Pines, Florida, United States

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Weston, Florida, United States

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Baltimore, Maryland, United States

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Elk River, Minnesota, United States

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Northfield, Minnesota, United States

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Red Wing, Minnesota, United States

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Saint Louis Park, Minnesota, United States

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Holly Springs, Mississippi, United States

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Belton, Missouri, United States

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Independence, Missouri, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Taos, New Mexico, United States

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Cary, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Houston, Texas, United States

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Pearland, Texas, United States

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Bountiful, Utah, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Syracuse, Utah, United States

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West Valley City, Utah, United States

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Falls Church, Virginia, United States

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Richmond, Virginia, United States

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Countries

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United States

Related Links

Other Identifiers

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A9451159

Identifier Type: -

Identifier Source: org_study_id

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