NCT00521989

CRx-102 Osteoarthritis Multicenter Evaluation Trial

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Zalicus · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	CRx-102 (2.7/90)	CRx-102 dose 1
DRUG	Prednisolone	Prednisolone
DRUG	Placebo	Placebo
DRUG	CRx-102 (2.7/180)	CRx-102 dose 2
DRUG	CRx-102 (2.7/360)	CRx-102 dose 3

Timeline

• Start date: 2007-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-08-29
• Last updated: 2014-04-29
• Results posted: 2014-04-29

Locations

58 sites across 2 countries: United States, Canada