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| Sponsor: | Adolor Corporation |
|---|---|
| Information provided by: | Adolor Corporation |
| ClinicalTrials.gov Identifier: | NCT00626275 |
Purpose
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 |
|---|---|---|
|
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 |
|---|---|
|
A1: Experimental
ADL5859
|
Drug: ADL5859
Four 50-mg ADL5859 opaque, Swedish Orange, capsules (No. 0) as single dose
|
|
A2: Active Comparator
500 mg naproxen
|
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
|
|
A3: Placebo Comparator
Lactose monohydrate, NF
|
Drug: Placebo
Four opaque, Swedish Orange, capsules (no.0), each containing lactose monohydrate,NF
|
|
B1: Experimental
ADL5859
|
Drug: ADL5859
Two 50-mg ADL5859 opaque, Swedish Orange, capsules (no.0) twice daily for 14 days
|
|
B2: Placebo Comparator
Lactose monohydrate, NF
|
Drug: Lactose monohydrate, NF
Two Opaque, Swedish Orange, No.0 capsules containing lactose monohydrate, NF, twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Rheumatoid arthritis arthritis |
|
Anti-Inflammatory Agents Autoimmune Diseases Naproxen Molecular Mechanisms of Pharmacological Action Immune System Diseases Joint Diseases Cyclooxygenase Inhibitors Physiological Effects of Drugs Arthritis, Rheumatoid Enzyme Inhibitors Rheumatic Diseases Gout Suppressants |
Pharmacologic Actions Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |