Disturbed Sleep Model Study. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00440323

Purpose

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.

Condition	Intervention	Phase
Insomnia	Drug: SB-649868 Drug: Zolpidem	Phase I

MedlinePlus related topics: Noise

Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride Zolpidem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
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.

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 ]

Enrollment:	52
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
Healthy as judged by responsible physician.
No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

A positive result for the pre-study urine drug/ alcohol breath screen.
Abuse of alcohol.
Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440323

Locations

United Kingdom, Surrey
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XP

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	OXS104094, CRC 242
Study First Received:	February 23, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00440323
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

SB-649868,
Zolpidem,
Noise induced Situational insomnia,
healthy volunteers

Study placed in the following topic categories:

Zolpidem
Naphazoline
Sleep Initiation and Maintenance Disorders
Oxymetazoline
Guaifenesin
Phenylephrine

Mental Disorders
Dyssomnias
Sleep Disorders
Phenylpropanolamine
Healthy
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
Physiological Effects of Drugs

Nervous System Diseases
Central Nervous System Depressants
GABA Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009