NCT00699608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 12, 2010

Completed
Last Updated

June 5, 2012

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

June 17, 2008

Results QC Date

October 6, 2009

Last Update Submit

May 31, 2012

Conditions

Healthy SubjectsSleep Initiation and Maintenance Disorders

Keywords

ZopicloneHypnoticResidual effectsEszopiclone

Outcome Measures

Primary Outcomes (1)

  • Mean Tracking Error Assessed During the Continuous Tracking Test (CTT)

    Analysis was performed on the mean of the five assessments conducted 7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind) The CTT is a task (duration of 8 minutes) of psychomotor function that entails using a slider to keep a cursor in alignment with a moving target on a visual display unit screen. The movement of the target is the function of an irregular sine wave, and cursor accuracy is measured by the mean tracking error - the difference between the centers of target and cursor in pixels, sampled 5 times per second, over the test. Lower scores are indicative of more accurate tracking.

    7.5, 8, 8.5, 9, and 9.5 hours post-dose (double-blind)

Secondary Outcomes (14)

  • Mean Tracking Error (MTE) Assessed During the CTT

    7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)

  • CTT Mean Reaction Time

    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

    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

    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

    7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, and 11.5 hours post-dose (double-blind)

  • +9 more secondary outcomes

Study Arms (1)

Crossover

EXPERIMENTAL

All subjects received all three treatments in a randomised order

Drug: GSK1755165; placebo; zopiclone

Interventions

GSK1755165; placebo; zopicloneDRUG

Subjects receive either 3mg GSK1755165, matching placebo or 7.5mg zopiclone

Crossover

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female subjects providing written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Guildford, Surrey, GU2 7XP, United Kingdom

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

zopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

July 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 5, 2012

Results First Posted

May 12, 2010

Record last verified: 2011-03

Locations

GB(1)