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)

Mental Disorders Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798395
• Other study ID #: P05794
• Secondary ID: 21105
• Status: Completed
• Phase: Phase 1
• First received: November 25, 2008
• Last updated: October 12, 2015
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Psychotic Disorders
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Org 50081
1.5 mg on day 1-7
• Org 50081
4.5 mg on Day 1-7
• Placebo
Once daily on Day 1-7
• zopiclone
Single dose of 7.5 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Standard Deviation of Lateral Position		Day 8	No
Secondary	Psychomotor and cognitive performance tasks		Day 8	No