NCT00650871

A Study to Evaluate the Effects of GW679769 on Sleep and Cognitive Function in Subjects With Primary Insomnia

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of GW679769 (30mg and 90mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

A study to investigate the effects of GW679769 on sleep and cognition. Potential subjects participate in a clinical screening visit and a two-night PSG recording session in the sleep laboratory. Eligible subjects then participate in three separate two-night PSG sessions in which they are randomized to receive placebo or one of two doses of GW679769 60 minutes prior to bedtime, one treatment for each session in a balanced order. Each treatment session is separated by a two-week drug-free period and occur on the same day of the week. A safety follow-up visit occurs 2 weeks after the last treatment session.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
DRUG	GW679769
DRUG	Placebo

Timeline

• Start date: 2004-07-30
• Primary completion: 2005-08-30
• Completion: 2005-08-30
• First posted: 2008-04-02
• Last updated: 2017-08-08

Locations

7 sites across 1 country: United States