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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00354809
First received: July 18, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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 Intervention Phase
Sleep Initiation and Maintenance Disorders
Insomnia
Drug: GW679769
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 58
Study Start Date: May 2006
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354809

Locations
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
France
GSK Investigational Site
Clamart, France, 92140
GSK Investigational Site
Paris Cedex 04, France, 75181
GSK Investigational Site
Rouffach, France, 68250
Germany
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, 14050
GSK Investigational Site
Berlin, Germany, 10559
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 10117
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00354809     History of Changes
Other Study ID Numbers: MAD105516
Study First Received: July 18, 2006
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
cognition
Primary Insomnia
sleep
polysomnography

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014