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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: January 19, 2006
Last updated: May 31, 2012
Last verified: March 2011

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.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Drug: GW679769
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: 48 Hours ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 48 Hours ]

Enrollment: 120
Study Start Date: January 2006
Intervention Details:
    Drug: GW679769
    Other Name: GW679769

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280436

  Show 26 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00280436     History of Changes
Other Study ID Numbers: MAD105514
Study First Received: January 19, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Primary Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014