Effects Of GW679769 On Sleep Onset And Maintenance And Next Day Functioning In Subjects With Primary Insomnia

Completed · Phase 2

Conditions studied: Sleep Initiation and Maintenance Disorders, Insomnia

In brief

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.

Key facts

Study ID

NCT00280423

Run by

GlaxoSmithKline

People needed

342

Starts

2006-01-01

Expected to finish

2007-02-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Burbank, California, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Irvine, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — National City, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — Santa Rosa, California, United States
• GSK Investigational Site — Norwalk, Connecticut, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Delray Beach, Florida, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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