Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia
A 28 Day, Polysomnographic and Subjective Assessment of GW679769 for the Treatment of Primary Insomnia: A Randomized, Double-blind, Parallel-Group, Placebo-Controlled Trial.
1 other identifier
interventional
342
2 countries
71
Brief Summary
This study is designed to find the optimal (best) doses of GW679769 that could be given daily to promote sleep onset and maintain sleep during the night without significant next-day thinking impairment and drowsiness in subjects with primary insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2006
Shorter than P25 for phase_2
71 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedApril 15, 2015
April 1, 2015
1.1 years
January 19, 2006
April 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of GW679769 and placebo on the time needed to fall asleep at bedtime on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and other physiological changes during sleep.
28 Days
Secondary Outcomes (1)
Comparison of GW679769 and placebo effects on sleep maintenance and duration on Nights 1/2, 13/14 and 27/28 of treatment, as assessed by electroencephalography and subject diaries, and on next-day memory, alertness and physical coordination.
28 Days
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of other sleep disorders such as sleep apnea or restless leg syndrome.
- Regular sleep habits, including bedtime between 9 PM and midnight.
- No nightshift/rotating shift work, frequent napping or planned travel across \>2 time zones.
- Use of nicotine, caffeine and alcoholic products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (71)
GSK Investigational Site
Birmingham, Alabama, 35213, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Burbank, California, 91506, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Irvine, California, 92618, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
National City, California, 91950, United States
GSK Investigational Site
San Diego, California, 92121, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Diego, California, 92161, United States
GSK Investigational Site
San Francisco, California, 94105, United States
GSK Investigational Site
Santa Rosa, California, 95405, United States
GSK Investigational Site
Norwalk, Connecticut, 06850, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Delray Beach, Florida, 33484, United States
GSK Investigational Site
Hallandale, Florida, 33009, United States
GSK Investigational Site
Largo, Florida, 33773, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Miami, Florida, 33176, United States
GSK Investigational Site
Pembroke Pines, Florida, 33026, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Hinesville, Georgia, 31313, United States
GSK Investigational Site
Macon, Georgia, 31201, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60634, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Crestview Hills, Kentucky, 41017, United States
GSK Investigational Site
Rockville, Maryland, 20852, United States
GSK Investigational Site
Newton, Massachusetts, 02459, United States
GSK Investigational Site
Troy, Michigan, 48085, United States
GSK Investigational Site
Hattiesburg, Mississippi, 39404, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Clementon, New Jersey, 08021, United States
GSK Investigational Site
West Seneca, New York, 14224, United States
GSK Investigational Site
Durham, North Carolina, 27705, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27157, United States
GSK Investigational Site
Beachwood, Ohio, 44122, United States
GSK Investigational Site
Cincinnati, Ohio, 45227, United States
GSK Investigational Site
Cincinnati, Ohio, 45246, United States
GSK Investigational Site
Cleveland, Ohio, 44130, United States
GSK Investigational Site
Gallipolis, Ohio, 45631, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Gresham, Oregon, 97020, United States
GSK Investigational Site
Clarks Summit, Pennsylvania, 18411, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Columbia, South Carolina, 29201, United States
GSK Investigational Site
Austin, Texas, 78756, United States
GSK Investigational Site
Bellaire, Texas, 77401, United States
GSK Investigational Site
Dallas, Texas, 75251, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Calgary, Alberta, T2X 2A8, Canada
GSK Investigational Site
Mississauga, Ontario, L5B4M4, Canada
GSK Investigational Site
Niagara Falls, Ontario, L2G 1J4, Canada
GSK Investigational Site
Parrry Sound, Ontario, P2A 1T3, Canada
GSK Investigational Site
Toronto, Ontario, M4P 1P2, Canada
GSK Investigational Site
Toronto, Ontario, M5G 1E2, Canada
GSK Investigational Site
Toronto, Ontario, M5T3A9, Canada
GSK Investigational Site
Toronto, Ontario, M6J 3S3, Canada
GSK Investigational Site
Montreal, Quebec, H4J 1C5, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Start
January 1, 2006
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
April 15, 2015
Record last verified: 2015-04