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

Insomnia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Effects of Morning Administration of GW679769 (10mg and 30 mg) on Polysomnograph Sleep Recordings, Subjective Sleep Assessment, Daytime Cognition and Psychomotor Function in Subjects With Primary Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354809
• Other study ID #: MAD105516
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: April 14, 2015
• Start date: May 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion criteria:

• 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.

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• GW679769

Locations

Country	Name	City	State
France	GSK Investigational Site	Clamart
France	GSK Investigational Site	Paris Cedex 04
France	GSK Investigational Site	Rouffach
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Goettingen	Niedersachsen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Schwalmstadt	Hessen
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Crestview Hills	Kentucky
United States	GSK Investigational Site	Fayetteville	North Carolina
United States	GSK Investigational Site	Fayetteville	Georgia
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Glendale	California
United States	GSK Investigational Site	Hallandale Beach	Florida
United States	GSK Investigational Site	Hinesville	Georgia
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	New Orleans	Louisiana
United States	GSK Investigational Site	Newton	Massachusetts
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Suwanee	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of GW679769 and placebo when taken daily in the morning, on the time needed to fall asleep at bedtime on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic.		9 Days
Secondary	Comparison of GW679769 and placebo on total sleep time and time awake after initial sleep onset on Days 1/2 and 8/9 of treatment, as assessed at a sleep clinic. Daily sleep questionnaires and mental functioning tests on Days 1 and 9 of treatment.		9 Days