Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

NCT ID: NCT00280423

Last Updated: 2015-04-15

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

PHASE2

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-02-28

Brief Summary

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This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.

Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Difficulty going to sleep and/or staying asleep for at least the past 3 months.
* Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
* Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.

Exclusion Criteria

* History of other sleep disorders such as sleep apnea or restless leg syndrome.
* Regular sleep habits, including bedtime between 9 PM and midnight.
* No nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones.
* Use of nicotine, caffeine and alcoholic products.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Burbank, California, United States

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Huntington Beach, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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National City, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Norwalk, Connecticut, United States

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DeLand, Florida, United States

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Delray Beach, Florida, United States

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Hallandale, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Hinesville, Georgia, United States

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Macon, Georgia, United States

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Stockbridge, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Overland Park, Kansas, United States

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Crestview Hills, Kentucky, United States

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Rockville, Maryland, United States

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Newton, Massachusetts, United States

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Troy, Michigan, United States

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Hattiesburg, Mississippi, United States

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Las Vegas, Nevada, United States

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Clementon, New Jersey, United States

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West Seneca, New York, United States

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Durham, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Gallipolis, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Gresham, Oregon, United States

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Clarks Summit, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Columbia, South Carolina, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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Salt Lake City, Utah, United States

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Calgary, Alberta, Canada

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Mississauga, Ontario, Canada

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Niagara Falls, Ontario, Canada

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Parrry Sound, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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MAD103894

Identifier Type: -

Identifier Source: org_study_id

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