![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
CombinatoRx |
---|---|
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 |
---|---|---|
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 and Optional One-Year Extension |
Estimated Enrollment: | 250 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
CRx-102 (Dose 1)
|
Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
|
2: Experimental
CRx-102 (Dose 2)
|
Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
|
3: Experimental
CRx-102 (Dose 3)
|
Drug: prednisolone + dipyridamole
CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)
|
4: Active Comparator
Prednisolone
|
Drug: Prednisolone
Prednisolone
|
5: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo
|
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: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00521989 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Osteoarthritis Knee CRx-102 prednisolone |
dipyridamole CombinatoRx WOMAC |
Anti-Inflammatory Agents Vasodilator Agents Methylprednisolone Osteoarthritis Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Osteoarthritis, Knee Musculoskeletal Diseases Arthritis |
Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Joint Diseases Methylprednisolone acetate Rheumatic Diseases Cardiovascular Agents Glucocorticoids Phosphodiesterase Inhibitors Prednisolone Platelet Aggregation Inhibitors Peripheral Nervous System Agents Dipyridamole |
Anti-Inflammatory Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Methylprednisolone Osteoarthritis Physiological Effects of Drugs Hematologic Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Neuroprotective Agents Hormones Osteoarthritis, Knee Musculoskeletal Diseases |
Arthritis Therapeutic Uses Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Joint Diseases Gastrointestinal Agents Methylprednisolone acetate Enzyme Inhibitors Rheumatic Diseases Cardiovascular Agents Protective Agents Glucocorticoids Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents |