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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00368056 |
To assess next day driving ability and psychomotor/memory function following a single night time dose of eszopiclone in insomnia patients.
Condition | Intervention | Phase |
---|---|---|
Primary Insomnia |
Drug: Eszopiclone Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study |
Official Title: | Effects of a Single Evening Dose of 3 mg Eszopiclone on Next Day Driving Ability and Psychomotor/Memory Function in Patients With Primary Insomnia Compared to Placebo |
Enrollment: | 32 |
Study Start Date: | April 2005 |
Study Completion Date: | June 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
eszopiclone 3 mg
|
Drug: Eszopiclone
eszopiclone 3 mg
|
2: Placebo Comparator
Placebo tablet
|
Drug: Placebo
Placebo tablet
|
The study is a single centre, randomised, double blind, placebo controlled 2-way crossover design in a group of 32 male and female primary insomnia patients. The medications under investigation are eszopiclone and placebo. Patients will receive the study medications and placebo on the evening of Day 2 of each treatment period. Performance will be assessed on Day 3 of each treatment period. Each treatment period will be separated by at least a 7-day washout period.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Responsible Party: | Sepracor Inc. ( Eszopiclone Medical Director ) |
Study ID Numbers: | 190-060 |
Study First Received: | August 23, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00368056 |
Health Authority: | United States: Food and Drug Administration |
Sleep Initiation and Maintenance Disorders Zopiclone Mental Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Nervous System Diseases |