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Effects of Ramelteon on Driving Ability

NCT00319215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2007-04-25

No results posted yet for this study

Summary

The primary purpose of this study is to investigate the effects of bedtime administration of a single dose of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on next-morning on-road driving performance. In addition, the drugs' effects on balance are evaluated during the night, and the next morning residual effects on memory and psychomotor performance.

Conditions

Interventions

DRUG

Ramelteon 8 mg

DRUG

Zopiclone 7.5 mg

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Utrecht Institute for Pharmaceutical Sciences

    lead OTHER

Principal Investigators

  • Joris Verster, PhD · Utrecht Institute for Pharmaceutical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Completion
2006-07-31

Countries

  • Netherlands

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319215 on ClinicalTrials.gov