An Evaluation of Potential Next-Day Residual Effects of Eszopiclone in Healthy Volunteers.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: GSK1755165, placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
Primary outcome: Mean Tracking error assessed during Continuous Tracking Test (CTT)
Secondary outcome: 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.
Eligibility
Minimum age: 25 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Guildford, Surrey GU2 7XP, United Kingdom
Additional Information
Starting date: July 2008
Last updated: June 18, 2008
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