Status:
COMPLETED
Effects of Ramelteon on Driving Ability
Lead Sponsor:
Utrecht Institute for Pharmaceutical Sciences
Collaborating Sponsors:
Takeda
Conditions:
Insomnia
Eligibility:
All Genders
21-55 years
Phase:
PHASE1
Brief 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 performa...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00319215
Start Date
March 1 2006
End Date
July 1 2006
Last Update
April 25 2007
Active Locations (1)
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1
Utrecht Institute for Pharmaceutical Sciences
Utrecht, Utrecht, Netherlands, 3584CA