Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Arthritis NSAIDs Topical NSAID Diclofenac PENNSAID
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

Brief summary:
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life.

OA can occur in any joint, but usually affects the hands, knees, hips or spine.

The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.

Detailed description:

Arms:
arm 1: Diclofenac sodium 2.0% w/w arm 2: The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium

Interventions: intervention 1: PENNSAID Gel intervention 2: Vehicle
Intervention descriptions: intervention 1: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks intervention 2: 2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

Protocol document: