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)

October 12, 2015 updated by: Merck Sharp & Dohme LLC

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Drug: Org 50081
1.5 mg on day 1-7
Drug: Org 50081
4.5 mg on Day 1-7
Experimental: Treatment 2
Drug: Org 50081
1.5 mg on day 1-7
Drug: Org 50081
4.5 mg on Day 1-7
Placebo Comparator: Treatment 3
Drug: Placebo
Once daily on Day 1-7
Active Comparator: Treatment 4
Drug: zopiclone
Single dose of 7.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Standard Deviation of Lateral Position
Time Frame: Day 8
Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychomotor and cognitive performance tasks
Time Frame: Day 8
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2015

Last Update Submitted That Met QC Criteria

October 12, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05794
  • 21105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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