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Sponsored by: |
Adolor Corporation |
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Information provided by: | Adolor Corporation |
ClinicalTrials.gov Identifier: | NCT00626275 |
The purpose of this study is to evaluate the effectiveness of ADL5859 in relieving pain associated with rheumatoid arthritis (RA) compared with placebo and naproxen (similar to Aleve®). A second objective is to see whether the effect of ADL5859 differs after a single dose compared with multiple doses. The study drug, ADL5859, has not been previously tested in patients with RA; it is anticipated to provide pain relief in RA because it demonstrated effectiveness in animal studies.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: ADL5859 Drug: naproxen Drug: Placebo Drug: Lactose monohydrate, NF |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2a Randomized, Placebo- and Active-Controlled, Single-Dose, 3-Period, Crossover Study Followed by a Randomized, Placebo-Controlled, 14-Day, Parallel-Group Study Evaluating the Analgesic Efficacy and Safety of ADL 5859 in Subjects With Rheumatoid Arthritis |
Estimated Enrollment: | 60 |
Study Start Date: | October 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental
ADL5859
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Drug: ADL5859
Four 50-mg ADL5859 opaque, Swedish Orange, capsules (No. 0) as single dose
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A2: Active Comparator
500 mg naproxen
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Drug: naproxen
Two 250-mg naproxen capsules [each placed in an opaque, Swedish Orange capsule (No. 0) with lactose monohydrate, NF]AND two matching placebo capsules containing lactose monohydrate, NF
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A3: Placebo Comparator
Lactose monohydrate, NF
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Drug: Placebo
Four opaque, Swedish Orange, capsules (no.0), each containing lactose monohydrate,NF
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B1: Experimental
ADL5859
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Drug: ADL5859
Two 50-mg ADL5859 opaque, Swedish Orange, capsules (no.0) twice daily for 14 days
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B2: Placebo Comparator
Lactose monohydrate, NF
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Drug: Lactose monohydrate, NF
Two Opaque, Swedish Orange, No.0 capsules containing lactose monohydrate, NF, twice daily
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
New England Research Associates | |
Trumbull, Connecticut, United States, 06611 | |
United States, Florida | |
Covance Clinical Research Unit Inc. | |
Daytona Beach, Florida, United States, 32117 | |
United States, Maryland | |
The Center for Rheumatology and Bone Research | |
Wheaton, Maryland, United States, 20901 | |
United States, Nebraska | |
Heartland Clinical Research, Inc. | |
Omaha, Nebraska, United States, 68134 | |
United States, Nevada | |
Advanced Biomedical Research of America | |
Las Vegas, Nevada, United States, 89123 | |
United States, New York | |
Winthrop University Hospital, Clinical Trials Center | |
Mineola, New York, United States, 11501 | |
United States, Ohio | |
University Hospitals Case Medical Center, Division of Rheumatology, Rheumatology Clinical Research Unit | |
Beachwood, Ohio, United States, 44122 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635-8406 |
Study Director: | Bruce Berger, MD | Adolor Corporation |
Responsible Party: | Adolor Corporation ( Bruce Berger, MD ) |
Study ID Numbers: | 33CL232 |
Study First Received: | February 22, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00626275 |
Health Authority: | United States: Food and Drug Administration |
Rheumatoid arthritis arthritis |
Naproxen Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |