Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2006-03-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Interventions
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Ramelteon 8 mg
Zopiclone 7.5 mg
Eligibility Criteria
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Inclusion Criteria
2. The subject is capable of understanding and complying with the protocol requirements.
3. The subject or the subject's legally acceptable representative signs a written, informed consent form prior to the initiation of any study procedures.
4. The subject, if female, is non-pregnant and non-lactating.
5. 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.
6. 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
2. 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.
21 Years
55 Years
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Utrecht Institute for Pharmaceutical Sciences
OTHER
Principal Investigators
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Joris Verster, PhD
Role: PRINCIPAL_INVESTIGATOR
Utrecht Institute for Pharmaceutical Sciences
Locations
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Utrecht Institute for Pharmaceutical Sciences
Utrecht, Utrecht, Netherlands
Countries
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References
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Mets MA, de Vries JM, de Senerpont Domis LM, Volkerts ER, Olivier B, Verster JC. Next-day effects of ramelteon (8 mg), zopiclone (7.5 mg), and placebo on highway driving performance, memory functioning, psychomotor performance, and mood in healthy adult subjects. Sleep. 2011 Oct 1;34(10):1327-34. doi: 10.5665/SLEEP.1272.
Other Identifiers
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Studynumber:TAK-375/EC103
Identifier Type: -
Identifier Source: secondary_id
EudraCT Number 2005-005553-22
Identifier Type: -
Identifier Source: secondary_id
05/316
Identifier Type: -
Identifier Source: org_study_id