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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Sleep Initiation and Maintenance Disorders; Mental Disorders

Treatments: Drug: Placebo; Drug: Org 50081; Drug: zopiclone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798395

21105

P05794

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 4 patient groups, including a placebo group

Treatment 1

Experimental group

Treatment:

Drug: Org 50081

Drug: Org 50081

Treatment 2

Experimental group

Treatment:

Drug: Org 50081

Drug: Org 50081

Treatment 3

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment 4

Active Comparator group

Treatment:

Drug: zopiclone