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| Sponsor: | 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
Hide Study Locations| United States, Alabama | |
| Huntsville, Alabama, United States | |
| Birmingham, Alabama, United States | |
| United States, Arizona | |
| Phoenix, Arizona, United States | |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Redlands, California, United States | |
| Irvine, California, United States | |
| Anaheim, California, United States | |
| San Diego, California, United States | |
| Oakland, California, United States | |
| United States, Colorado | |
| Longmont, Colorado, United States | |
| Denver, Colorado, United States | |
| Pueblo, Colorado, United States | |
| Aurora, Colorado, United States | |
| United States, Florida | |
| Naples, Florida, United States | |
| St. Petersburg, Florida, United States | |
| Jacksonville, Florida, United States | |
| Tampa, Florida, United States | |
| Pinellas Park, Florida, United States | |
| Orlando, Florida, United States | |
| Jupiter, Florida, United States | |
| Clearwater, Florida, United States | |
| Pembroke Pines, Florida, United States | |
| United States, Georgia | |
| Atlanta, Georgia, United States | |
| Blairsville, Georgia, United States | |
| United States, Illinois | |
| Elk Grove Village, Illinois, United States | |
| Chicago, Illinois, United States | |
| Northbrook, Illinois, United States | |
| United States, Indiana | |
| Evansville, Indiana, United States | |
| United States, Kansas | |
| Olathe, Kansas, United States | |
| Prairie Village, Kansas, United States | |
| United States, Maryland | |
| Chevy Chase, Maryland, United States | |
| Frederick, Maryland, United States | |
| United States, Massachusetts | |
| Newton, Massachusetts, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| Kansas City, Missouri, United States | |
| United States, Nebraska | |
| Lincoln, Nebraska, United States | |
| United States, Nevada | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| Hamilton, New Jersey, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, North Carolina | |
| Cary, North Carolina, United States | |
| United States, Ohio | |
| Cleveland, Ohio, United States | |
| Columbus, Ohio, United States | |
| Mogadore, Ohio, United States | |
| Cincinatti, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| Bala Cynwyd, Pennsylvania, United States | |
| United States, South Carolina | |
| Columbia, South Carolina, United States | |
| Anderson, South Carolina, United States | |
| United States, Texas | |
| Houston, Texas, United States | |
| Lubbock, Texas, United States | |
| San Antonio, Texas, United States | |
| Austin, Texas, United States | |
| Jackson, Texas, United States | |
| Plano, Texas, United States | |
| Dallas, Texas, United States | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States | |
| Brown Deer, Wisconsin, United States | |
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 Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |