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| Sponsor: | Sepracor, Inc. |
|---|---|
| Information provided by: | Sepracor, Inc. |
| ClinicalTrials.gov Identifier: | NCT00367965 |
Purpose
To demonstrate subjective sleep efficacy of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis (RA).
| Condition | Intervention | Phase |
|---|---|---|
|
Insomnia Arthritis, Rheumatoid |
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: | The Effect of Eszopiclone 3 mg Compared to Placebo on Daytime Function in Subjects With Insomnia Related to Rheumatoid Arthritis |
| Enrollment: | 153 |
| Study Start Date: | February 2004 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (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
|
A multicenter, randomized, double-blind, placebo controlled, parallel group study of eszopiclone 3 mg in subjects with insomnia related to rheumatoid arthritis.
Eligibility| Ages Eligible for Study: | 25 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 | |
| United States, Arizona | |
| Tucson, Arizona, United States | |
| United States, California | |
| Whittier, California, United States | |
| Santa Maria, California, United States | |
| United States, Connecticut | |
| Hamden, Connecticut, United States | |
| Danbury, Connecticut, United States | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Ocala, Florida, United States | |
| Tampa, Florida, United States | |
| Aventura, Florida, United States | |
| Sarasota, Florida, United States | |
| Vero Beach, Florida, United States | |
| Clearwater, Florida, United States | |
| Ft. Lauderdale, Florida, United States | |
| United States, Illinois | |
| Springfield, Illinois, United States | |
| United States, Kansas | |
| Kansas City, Kansas, United States | |
| Overland Park, Kansas, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Massachusetts | |
| Fall River, Massachusetts, United States | |
| United States, Michigan | |
| Lansing, Michigan, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Medford, New Jersey, United States | |
| United States, New York | |
| Rochester, New York, United States | |
| United States, North Carolina | |
| Winston-Salem, North Carolina, United States | |
| United States, North Dakota | |
| Fargo, North Dakota, United States | |
| United States, Ohio | |
| Mayfield Village, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| West Reading, Pennsylvania, United States | |
| Bethlehem, Pennsylvania, United States | |
| Norristown, Pennsylvania, United States | |
| United States, South Carolina | |
| Columbia, South Carolina, United States | |
| Myrtle Beach, South Carolina, United States | |
| United States, Tennessee | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Dallas, Texas, United States | |
| Lubbock, Texas, United States | |
| Amarillo, Texas, United States | |
| United States, Washington | |
| Everett, Washington, United States | |
More Information
| Responsible Party: | Sepracor Inc. ( Eszopiclone Medical Director ) |
| Study ID Numbers: | 190-055 |
| Study First Received: | August 23, 2006 |
| Last Updated: | November 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00367965 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Insomnia related to rheumatoid arthritis (RA) |
|
Sleep Initiation and Maintenance Disorders Autoimmune Diseases Immune System Diseases Joint Diseases Nervous System Diseases Arthritis, Rheumatoid Dyssomnias |
Sleep Disorders Rheumatic Diseases Sleep Disorders, Intrinsic Musculoskeletal Diseases Mental Disorders Arthritis Connective Tissue Diseases |