- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00319215
Effects of Ramelteon on Driving Ability
A Study to Investigate the Residual Effects of Ramelteon (8 mg), Zopiclone (7.5 mg) and Placebo on Actual Driving, Memory, Psychomotor Performance and Mood
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Utrecht, Netherlands, 3584CA
- Utrecht Institute for Pharmaceutical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject is male or female, 21 - 55 years of age, inclusive
- The subject is capable of understanding and complying with the protocol requirements.
- The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
- The subject, if female, is non-pregnant and non-lactating.
- Possession of a valid driver's license for at least 3 years and a reported history of having driven at least 5000 km per year on average, for the last 3 years prior to entering into the trial.
- An SDLP level at the end of the driving test of the dress rehearsal that does not exceed 24 cm. This dress rehearsal is performed at Visit 1.
Exclusion Criteria:
- The subject has a known hypersensitivity to ramelteon, zopiclone or related compounds, including melatonin.
- The subject has participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to the first night of double-blind study medication, whichever is longer.
5.History or presence of any clinically significant gastrointestinal, cardiovascular, hepatic, renal, haematological, endocrine, respiratory, neurological or psychiatric disease 6.History of primary insomnia (DSM IV-TR criteria) within the past 6 months. 7.The subject has used any medication with psychotropic effects (e.g. antidepressants, anxiolytics, antihistamines) within 30 days of the initial visit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Standard Deviation of Lateral Position (SDLP); i.e. the weaving of the car.
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Standard Deviation of Speed (SDS)
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Secondary Outcome Measures
Outcome Measure |
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Mean Speed (MS)
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Mean Lateral Position (MLP)
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Word Learning test:Immediate recall, Delayed Recall, Recognition time & score
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Sternberg memory scanning test: reaction time and % errors
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Tracking task: RMS (tracking error)
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Divided attention test: RMS,reaction time and % errors
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DSST: number of copied symbols
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/316
- Studynumber:TAK-375/EC103
- EudraCT Number 2005-005553-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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