Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

NCT ID: NCT00280436

Last Updated: 2015-04-16

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-03-31

Brief Summary

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This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing 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

CROSSOVER

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.
* Nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones.
* Use to moderate use of nicotine, caffeine and alcoholic products.
Minimum Eligible Age

18 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

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

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GSK Investigational Site

Anaheim, California, United States

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GSK Investigational Site

Glendale, California, United States

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Glendale, California, United States

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Redlands, 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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Brandon, Florida, United States

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Kissimmee, Florida, United States

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Naples, Florida, United States

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Spring Hill, Florida, United States

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Austell, Georgia, United States

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Chicago, Illinois, United States

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GSK Investigational Site

Northfield, Illinois, United States

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Overland Park, Kansas, United States

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Chevy Chase, Maryland, United States

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Frederick, Maryland, United States

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Lincoln, Nebraska, United States

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Raleigh, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Lafayette Hill, Pennsylvania, United States

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Warwick, Rhode Island, United States

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GSK Investigational Site

Anderson, South Carolina, United States

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GSK Investigational Site

Austin, Texas, United States

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GSK Investigational Site

Fairfax, Virginia, United States

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Countries

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United States

Other Identifiers

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MAD105514

Identifier Type: -

Identifier Source: org_study_id

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