|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Utrecht Institute for Pharmaceutical Sciences |
|---|---|
| Collaborator: |
Takeda Global Research & Development Centre (Europe) Ltd. |
| Information provided by: | Utrecht Institute for Pharmaceutical Sciences |
| ClinicalTrials.gov Identifier: | NCT00319215 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia |
Drug: Ramelteon 8 mg Drug: Zopiclone 7.5 mg |
Phase I |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2006 |
| Study Completion Date: | July 2006 |
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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.
Contacts and Locations| Netherlands | |
| Utrecht Institute for Pharmaceutical Sciences | |
| Utrecht, Netherlands, 3584CA | |
| Principal Investigator: | Joris Verster, PhD | Utrecht Institute for Pharmaceutical Sciences |
More Information
| Study ID Numbers: | 05/316, Studynumber:TAK-375/EC103, EudraCT Number 2005-005553-22 |
| Study First Received: | April 26, 2006 |
| Last Updated: | April 24, 2007 |
| ClinicalTrials.gov Identifier: | NCT00319215 History of Changes |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
|
ramelteon zopiclone driving |
memory balance psychomotor |
|
Zopiclone Therapeutic Uses Physiological Effects of Drugs Hypnotics and Sedatives |
Central Nervous System Depressants Central Nervous System Agents Pharmacologic Actions |