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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 April 2015 |
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Main ID: |
NCT00354809 |
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Date of registration:
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18/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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68 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00354809 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Germany
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United States
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Insomnia
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Sleep Initiation and Maintenance Disorders
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Intervention(s)
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Drug: GW679769
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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MAD105516
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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