drugset / Trial / NCT00650871

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

NCT00650871

Phase 2 Completed 48 enrolled GlaxoSmithKline
RandomizedCrossoverDiagnostic

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.

Timeline

Start
2004-07-30
Primary completion
2005-08-30
Completion
2005-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Casopitant Small molecule 30 mg
Subject Casopitant Small molecule 90 mg