drugset / Trial / NCT00521989

CRx-102 Osteoarthritis Multicenter Evaluation Trial

NCT00521989

Phase 2 Terminated 279 enrolled Zalicus
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2007-08
Primary completion
2009-07
Completion
2009-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Dipyridamole Other / unclassified 90 mg
Subject Dipyridamole Other / unclassified 180 mg
Subject Dipyridamole Other / unclassified 360 mg
Comparator Prednisolone Other / unclassified 2.7 mg

Indications