Clinical trial NCT00699608: An Evaluation of Potential Next-day Residual Effects of Eszopiclone in Healthy Volunteers.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Sleep Initiation and Maintenance Disorders
Keywords: Zopiclone
Hypnotic
Residual effects
Eszopiclone
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-18
Enrollment: 91
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)
timeFrame: 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)
Secondary outcomes:
measure: Mean Tracking Error (MTE) Assessed During the CTT
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: CTT Mean Reaction Time
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Critical Flicker Fusion Test-Ascending Threshold
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Critical Flicker Fusion Test -Descending Threshold
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Critical Flicker Fusion Test-Overall Threshold
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Total Number of Attempted Symbol Substitutions, as Assessed by the Digit Symbol Substitution Test
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Total Number of Correct Symbol Substitutions, as Assessed by the Digital Symbol Substitution Test
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: 1-Back Percentage of Correct Responses
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: 3-Back Percentage of Correct Responses
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: 1-Back Reaction Time
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: 3-Back Reaction Time
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Sedation Score, as Assessed by the Linear Analogue Rating Scales
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Mood Score, as Assessed by the Linear Analogue Rating Scales
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
measure: Coordination Score, as Assessed by the Linear Analogue Rating Scales
timeFrame: 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: