Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
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ClinicalTrials.gov Identifier: NCT00280436 |
Recruitment Status
:
Completed
First Posted
: January 23, 2006
Last Update Posted
: April 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders Insomnia | Drug: GW679769 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of GW679769 on Polysomnographic Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Elderly and Non-elderly Subjects With Primary Insomnia |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |
- Comparison of GW679769 and placebo on the average time needed to fall asleep after bedtime dosing on two consecutive nights, as assessed by electroencephalography and other physiological changes during sleep. [ Time Frame: 48 Hours ]
- Comparison of GW679769 and placebo on sleep maintenance and duration after bedtime dosing on two consecutive nights, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination. [ Time Frame: 48 Hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00280436

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00280436 History of Changes |
Other Study ID Numbers: |
MAD105514 |
First Posted: | January 23, 2006 Key Record Dates |
Last Update Posted: | April 16, 2015 |
Last Verified: | April 2015 |
Keywords provided by GlaxoSmithKline:
Polysomnography Electroencephalography Primary Insomnia Cognition Sleep |
Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Casopitant Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Neurokinin-1 Receptor Antagonists Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |