To Evaluate The Effects Of SB-649868 (10, 30 Mg And 60 Mg) On Subjects With Primary Insomnia - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00426816

Purpose

This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia

Condition	Intervention	Phase
Insomnia	Drug: SB-649868	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Efficacy Study
Official Title:	A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Effects of SB-649868 (10, 30 mg and 60 mg) on Sleep Continuity, PSG Sleep Recordings, Subjective Sleep Assessment, and Daytime Cognitive Function in Subjects With Primary Insomnia

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording. [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Objective PSG measures of sleep continuity including: wake during sleep (WDS), wake after sleep (WAS), and number of awakenings during sleep. Objective PSG measures of sleep structure [ Time Frame: throughout the study ]

Enrollment:	48
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male
18-64 years of age (inclusive),
Diagnosis of primary insomnia who have had symptoms for at least three months.

Exclusion Criteria:

Any clinically significant unstable medical or surgical condition (treated or untreated).
Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426816

Locations

Germany
GSK Investigational Site
Mannheim, Germany, 68159
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 20249
Germany, Brandenburg
GSK Investigational Site
Cottbus, Brandenburg, Germany, 03050
Germany, Mecklenburg-Vorpommern
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Germany, Nordrhein-Westfalen
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44263
Germany, Sachsen
GSK Investigational Site
Dresden, Sachsen, Germany, 01307

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OXS107714
Study First Received:	January 23, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00426816
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

primary insomnia
SB-649868
daytime cognitive function
PSG sleep recordings

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009