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Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00280436
First received: January 19, 2006
Last updated: April 14, 2015
Last verified: April 2015
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Purpose
This study is designed to find the optimal (best) doses of GW679769 that promote sleep onset and maintain sleep during two consecutive nights of dosing without significant next-day 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 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 |
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 122 |
| Study Start Date: | January 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00280436
Show 26 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280436
Show 26 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00280436 History of Changes |
| Other Study ID Numbers: |
MAD105514 |
| Study First Received: | January 19, 2006 |
| Last Updated: | April 14, 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 |
ClinicalTrials.gov processed this record on August 18, 2017