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| Sponsor: | Sunovion |
|---|---|
| Information provided by: | Sunovion |
| 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
eszopiclone 3 mg
|
Drug: Eszopiclone
eszopiclone 3 mg
Other Names:
|
|
Placebo Comparator: 2
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. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
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
Show 38 Study Locations
More Information
| Responsible Party: | Eszopiclone Medical Director, Sunovion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00367965 History of Changes |
| Other Study ID Numbers: | 190-055 |
| Study First Received: | August 23, 2006 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Insomnia related to rheumatoid arthritis (RA) |
|
Arthritis Arthritis, Rheumatoid Sleep Initiation and Maintenance Disorders Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Sleep Disorders, Intrinsic Dyssomnias |
Sleep Disorders Nervous System Diseases Mental Disorders Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |