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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00352144 |
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
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Drug: Eszopiclone
Eszopiclone 3 mg
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2: Placebo Comparator
Placebo tablet
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Drug: Placebo
Placebo tablet
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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.
Ages Eligible for Study: | 21 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Responsible Party: | Sepracor Inc. ( Eszopiclone Medical Director ) |
Study ID Numbers: | 190-050 |
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 |