search
Back to results

A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

Primary Purpose

Sleep Initiation and Maintenance Disorders, Mental Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Org 50081
Org 50081
Placebo
zopiclone
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject has at least 3 years of car driving experience
  • Subject signs the trial Informed Consent Form
  • Subject is in a healthy condition as judged by the investigator
  • Subject has a regular sleep pattern

Exclusion Criteria:

  • Subject has insomnia or any other sleep disorder
  • Medication or drug use of any kind prior to the study
  • Relevant history or presence of a significant medical illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Active Comparator

    Arm Label

    Treatment 1

    Treatment 2

    Treatment 3

    Treatment 4

    Arm Description

    Outcomes

    Primary Outcome Measures

    The Standard Deviation of Lateral Position

    Secondary Outcome Measures

    Psychomotor and cognitive performance tasks

    Full Information

    First Posted
    November 25, 2008
    Last Updated
    October 12, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00798395
    Brief Title
    A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)
    Official Title
    A Randomized Double-blind, Placebo-controlled, 4-period Cross-over Study to Assess the Effect of Single and Multiple Doses of 1.5 mg and 4.5 mg Org 50081 and a Single Dose of 7.5 mg Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Initiation and Maintenance Disorders, Mental Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment 1
    Arm Type
    Experimental
    Arm Title
    Treatment 2
    Arm Type
    Experimental
    Arm Title
    Treatment 3
    Arm Type
    Placebo Comparator
    Arm Title
    Treatment 4
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Org 50081
    Intervention Description
    1.5 mg on day 1-7
    Intervention Type
    Drug
    Intervention Name(s)
    Org 50081
    Intervention Description
    4.5 mg on Day 1-7
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Once daily on Day 1-7
    Intervention Type
    Drug
    Intervention Name(s)
    zopiclone
    Intervention Description
    Single dose of 7.5 mg
    Primary Outcome Measure Information:
    Title
    The Standard Deviation of Lateral Position
    Time Frame
    Day 8
    Secondary Outcome Measure Information:
    Title
    Psychomotor and cognitive performance tasks
    Time Frame
    Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject has at least 3 years of car driving experience Subject signs the trial Informed Consent Form Subject is in a healthy condition as judged by the investigator Subject has a regular sleep pattern Exclusion Criteria: Subject has insomnia or any other sleep disorder Medication or drug use of any kind prior to the study Relevant history or presence of a significant medical illness

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Assess the Effect of Single and Multiple Doses Org 50081 and a Single Dose of Zopiclone on Next-day Driving Ability and Psychomotor Performance in Healthy Volunteers. (P05794) (COMPLETED)

    We'll reach out to this number within 24 hrs