Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia

Completed · Phase 2

Conditions studied: Sleep Initiation and Maintenance Disorders, Insomnia

In brief

This study is designed to determine whether morning doses of GW679769, taken daily for 1 to 9 days, will promote sleep during the following night without significant post-dose thinking impairment and drowsiness in subjects with primary insomnia.

Key facts

Study ID

NCT00354809

Run by

GlaxoSmithKline

People needed

68

Starts

2006-05-01

Expected to finish

2007-07-01

Last updated by the study team

2015-04-16

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 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.

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, nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
• Use to moderate use of nicotine, caffeine and alcoholic products.

Where it is running

• GSK Investigational Site — Glendale, Arizona, United States
• GSK Investigational Site — Glendale, California, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Fayetteville, Georgia, United States
• GSK Investigational Site — Hinesville, Georgia, United States
• GSK Investigational Site — Suwanee, Georgia, United States
• GSK Investigational Site — Crestview Hills, Kentucky, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — New Orleans, Louisiana, United States
• GSK Investigational Site — Newton, Massachusetts, United States
• GSK Investigational Site — Fayetteville, North Carolina, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Clamart, France
• GSK Investigational Site — Paris, France
• GSK Investigational Site — Rouffach, France
• GSK Investigational Site — Munich, Bavaria, Germany
• GSK Investigational Site — Schwalmstadt, Hesse, Germany
• GSK Investigational Site — Göttingen, Lower Saxony, Germany
• GSK Investigational Site — Schwerin, Mecklenburg-Vorpommern, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany

Full record on ClinicalTrials.gov

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