Disturbed Sleep Model Study.
This study has been completed.
Information provided by (Responsible Party):
First received: February 23, 2007
Last updated: May 31, 2012
Last verified: February 2011
Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.
Sleep Initiation and Maintenance Disorders
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||A Double-blind, Double-dummy, Randomised, Placebo-controlled,Four-way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Total Sleep Time measured overnight across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
Secondary Outcome Measures:
- The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
|Study Start Date:||January 2007|
Contacts and Locations