Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia

NCT ID: NCT00354809

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-07-31

Brief Summary

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This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose 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 during 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

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

Glendale, Arizona, United States

Site Status

GSK Investigational Site

Glendale, California, United States

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GSK Investigational Site

Hallandale, Florida, United States

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GSK Investigational Site

Miami, Florida, United States

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GSK Investigational Site

Fayetteville, Georgia, United States

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GSK Investigational Site

Hinesville, Georgia, United States

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GSK Investigational Site

Suwanee, Georgia, United States

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GSK Investigational Site

Crestview Hills, Kentucky, United States

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GSK Investigational Site

Baton Rouge, Louisiana, United States

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GSK Investigational Site

New Orleans, Louisiana, United States

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GSK Investigational Site

Newton, Massachusetts, United States

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GSK Investigational Site

Fayetteville, North Carolina, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, United States

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GSK Investigational Site

Clamart, , France

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GSK Investigational Site

Paris, , France

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GSK Investigational Site

Rouffach, , France

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Schwalmstadt, Hesse, Germany

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GSK Investigational Site

Göttingen, Lower Saxony, Germany

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GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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United States France Germany

Other Identifiers

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MAD105516

Identifier Type: -

Identifier Source: org_study_id

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