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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00354809
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Insomnia Drug: GW679769 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia
Study Start Date : May 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Primary Outcome Measures :
  1. Comparison of GW679769 and placebo when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. [ Time Frame: 9 Days ]

Secondary Outcome Measures :
  1. Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment. [ Time Frame: 9 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00354809

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United States, Arizona
GSK Investigational Site
Glendale, Arizona, United States, 85306
United States, California
GSK Investigational Site
Glendale, California, United States, 91204
United States, Florida
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
GSK Investigational Site
Miami, Florida, United States, 33137
United States, Georgia
GSK Investigational Site
Fayetteville, Georgia, United States, 30214
GSK Investigational Site
Hinesville, Georgia, United States, 31313
GSK Investigational Site
Suwanee, Georgia, United States, 30024
United States, Kentucky
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
United States, Louisiana
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
GSK Investigational Site
Newton, Massachusetts, United States, 02459
United States, North Carolina
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73103
GSK Investigational Site
Clamart, France, 92140
GSK Investigational Site
Paris Cedex 04, France, 75181
GSK Investigational Site
Rouffach, France, 68250
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Schwalmstadt, Hessen, Germany, 34613
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline Identifier: NCT00354809    
Other Study ID Numbers: MAD105516
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
Primary Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action