An Evaluation of Potential Next-Day Residual Effects of Eszopiclone in Healthy Volunteers. - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00699608

Purpose

This study will explore potential next-day residual effects of a single evening dose of 3mg of the hypnotic, eszopiclone, 7.5mg of zopiclone, and placebo, in healthy adult subjects.

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK1755165; placebo; zopiclone	Phase III

Drug Information available for: Zopiclone Eszopiclone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
Official Title:	A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study to Evaluate Potential Next-Day Residual Effects of a Single Evening Dose of 3mg Eszopiclone and 7.5mg Zopiclone in Healthy Adult Subjects.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mean Tracking error assessed during Continuous Tracking Test (CTT) [ Time Frame: 7.5-10.5h post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Digit Symbol Substitution Test (DSST), N-Back tasks, Critical Flicker Fusion (CFF), Linear Analogue Rating Scales (LARS), adverse events, vital signs, clinical laboratory assessments, pregnancy tests & physical examination. [ Time Frame: 7.5-10.5h post-dose ] [ Designated as safety issue: No ]

Enrollment:	91
Study Start Date:	July 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Crossover: Experimental All subjects received all three treatments in a randomised order	Drug: GSK1755165; placebo; zopiclone Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

Eligibility

Ages Eligible for Study:	25 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

INCLUSION CRITERIA:

Healthy male and female subjects providing written informed consent.

EXCLUSION CRITERIA:

Significant medical disorders;
Sleeping difficulties; alcohol and/or substance abuse;
Recent use of psychotropic medications, or need to use them during study;
Very high BMI or very low BMI or bodyweight;
Known hypersensitivity to the study medications or their excipients;
Unwilling or unable to meet certain lifestyle or dietary restrictions during the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699608

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ESZ111503
Study First Received:	June 17, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00699608 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

Residual effects
Hypnotic
Eszopiclone
Zopiclone

Study placed in the following topic categories:

Zopiclone
Hypnotics and Sedatives
Central Nervous System Depressants
Healthy

Additional relevant MeSH terms:

Zopiclone
Therapeutic Uses
Physiological Effects of Drugs
Hypnotics and Sedatives

Central Nervous System Depressants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009