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| Sponsored by: |
Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00352144 |
Purpose
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Insomnia |
Drug: Eszopiclone Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study |
| Enrollment: | 830 |
| Study Start Date: | October 2003 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
eszopiclone 3 mg tablet
|
Drug: Eszopiclone
Eszopiclone 3 mg
|
|
2: Placebo Comparator
Placebo tablet
|
Drug: Placebo
Placebo tablet
|
This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo.
Eligibility| Ages Eligible for Study: | 21 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Show 58 Study Locations
More Information
| Responsible Party: | Sepracor Inc. ( Eszopiclone Medical Director ) |
| Study ID Numbers: | 190-050 |
| Study First Received: | July 12, 2006 |
| Last Updated: | October 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00352144 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Sleep Initiation and Maintenance Disorders Zopiclone Mental Disorders |
Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
|
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |