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NCT00280436 Clinical Trial

Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00280436
Other study ID # MAD105514
Secondary ID
Status Completed
Phase Phase 2
First received January 19, 2006
Last updated April 14, 2015
Start date January 2006
Est. completion date March 2007

Study information
Verified date April 2015
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 122
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• GW679769

Locations
Country Name City State
United States GSK Investigational Site Anaheim California
United States GSK Investigational Site Anderson South Carolina
United States GSK Investigational Site Austell Georgia
United States GSK Investigational Site Austin Texas
United States GSK Investigational Site Brandon Florida
United States GSK Investigational Site Chevy Chase Maryland
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Fairfax Virginia
United States GSK Investigational Site Frederick Maryland
United States GSK Investigational Site Glendale California
United States GSK Investigational Site Glendale California
United States GSK Investigational Site Kissimmee Florida
United States GSK Investigational Site Lafayette Hill Pennsylvania
United States GSK Investigational Site Lincoln Nebraska
United States GSK Investigational Site Naples Florida
United States GSK Investigational Site Northfield Illinois
United States GSK Investigational Site Oklahoma City Oklahoma
United States GSK Investigational Site Overland Park Kansas
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site Redlands California
United States GSK Investigational Site San Diego California
United States GSK Investigational Site San Diego California
United States GSK Investigational Site Spring Hill Florida
United States GSK Investigational Site Tucson Arizona
United States GSK Investigational Site Warwick Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 48 Hours
Secondary 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. 48 Hours
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