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)
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.
2 other identifiers
interventional
32
0 countries
N/A
Brief Summary
This trial is to investigate the effect on next-day driving performance and psychomotor performance in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2007
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedOctober 14, 2015
October 1, 2015
11 months
November 25, 2008
October 12, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The Standard Deviation of Lateral Position
Day 8
Secondary Outcomes (1)
Psychomotor and cognitive performance tasks
Day 8
Study Arms (4)
Treatment 1
EXPERIMENTALTreatment 2
EXPERIMENTALTreatment 3
PLACEBO COMPARATORTreatment 4
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
October 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
October 14, 2015
Record last verified: 2015-10