Last updated: 11/04/2018 06:38:22

An evaluation of potential next-day residual effects of eszopiclone in healthy volunteers.

GSK study ID
ESZ111503
See study documents
Clinicaltrials.gov ID
NCT00699608
See results summary
EudraCT ID
2008-000406-36
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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:

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Interventions:
  • Drug: GSK1755165; placebo; zopiclone
    • Enrollment:
    91
    Primary completion date:
    2008-30-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, Sleep Initiation and Maintenance Disorders
    Product
    eszopiclone
    Collaborators
    Not applicable
    Study date(s)
    July 2008 to October 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    25 - 40 years
    Accepts healthy volunteers
    Yes
    • INCLUSION CRITERIA:
    • Healthy male and female subjects providing written informed consent.
    Inclusion and exclusion criteria
    Inclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Guildford, Surrey, United Kingdom, GU2 7XP
    Status
    Recruitment Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-30-10
    Actual study completion date
    2008-30-10

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website