A Study to Assess the Effect of Single and Multiple Doses... | NCT00798395

Studies
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)

NCT00798395

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Oct 14, 2015Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Sleep Initiation and Maintenance Disorders
Mental Disorders

Interventions

Org 50081
Org 50081
Placebo
zopiclone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
21105

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.

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Nov 25, 2008

First Submission Date that Met QC Criteria

Nov 25, 2008

First Posted Date

Nov 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2015

Last Update Posted Date

Oct 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment 1	Experimental	Drug: Org 50081
Treatment 2	Experimental	Drug: Org 50081
Treatment 3	Placebo Comparator	Drug: Placebo
Treatment 4	Active Comparator	Drug: zopiclone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Org 50081	Drug	1.5 mg on day 1-7	Treatment 1
Org 50081

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Standard Deviation of Lateral Position		Day 8

Secondary Outcomes

Measure	Description	Time Frame
Psychomotor and cognitive performance tasks		Day 8

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D001523	Mental Disorders

ID	Term
D000078785	Mirtazapine
C515050	zopiclone