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Sponsored by: |
CombinatoRx |
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Information provided by: | CombinatoRx |
ClinicalTrials.gov Identifier: | NCT00521989 |
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects.
CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand OA and RA. This is the first study to explore the efficacy of CRx-102 in knee OA. It is considered a dose-finding study and will also compare the potential benefits of CRx-102 treatment to both prednisolone administered alone and to placebo in this indication.
Condition | Intervention | Phase |
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Knee Osteoarthritis |
Drug: prednisolone + dipyridamole Drug: Prednisolone Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy of CRx-102 in Subjects With Symptomatic Knee Osteoarthritis |
Estimated Enrollment: | 250 |
Study Start Date: | August 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CRx-102 (Dose 1)
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Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
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2: Experimental
CRx-102 (Dose 2)
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Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
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3: Experimental
CRx-102 (Dose 3)
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Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
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4: Active Comparator
Prednisolone
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Drug: Prednisolone
Prednisolone
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5: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | CombinatoRx ( Medical Monitor ) |
Study ID Numbers: | CRx-102-006 |
Study First Received: | August 27, 2007 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00521989 |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis Knee CRx-102 prednisolone |
dipyridamole CombinatoRx WOMAC |
Osteoarthritis, Knee Musculoskeletal Diseases Methylprednisolone Osteoarthritis Joint Diseases Arthritis |
Prednisolone Methylprednisolone acetate Prednisolone acetate Rheumatic Diseases Dipyridamole Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Vasodilator Agents Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hematologic Agents Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Enzyme Inhibitors Cardiovascular Agents |
Protective Agents Neuroprotective Agents Glucocorticoids Hormones Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Therapeutic Uses Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents |