Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis Knee CRx-102 prednisolone dipyridamole CombinatoRx WOMAC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 279
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 2.7 mg prednisolone plus 90 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 2: 2.7 mg prednisolone plus 180 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 3: 2.7 mg prednisolone plus 360 mg dipyridamole

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. The dipyridamole dose was divided equally between the two time points, 8AM and 1PM arm 4: 2.7 mg prednisolone

Subjects were dose twice daily through day 98. Prednisolone at 2.7 mg/d was administered as 1.8 mg at 8AM and 0.9 mg at 1PM. arm 5: Placebo

Subjects were dose twice daily through day 98.

Interventions: intervention 1: CRx-102 (2.7/90) intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 (2.7/180) intervention 5: CRx-102 (2.7/360)
Intervention descriptions: intervention 1: CRx-102 dose 1 intervention 2: Prednisolone intervention 3: Placebo intervention 4: CRx-102 dose 2 intervention 5: CRx-102 dose 3

Protocol document: