Conditions: Osteoarthritis
Keywords: Knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1176
Healthy volunteers: no

Brief summary:
To establish the therapeutic equivalence and safety of a generic Diclofenac Sodium Topical Gel, 1% with Voltaren® Gel 1% in subjects with osteoarthritis of the knee.

Detailed description:

Arms:
arm 1: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks arm 2: Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks arm 3: Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks

Interventions: intervention 1: Diclofenac Sodium Topical Gel, 1% intervention 2: Voltaren Topical Gel, 1% intervention 3: Vehicle Diclofenac Sodium Topical Gel
Intervention descriptions: intervention 1: Opaque, white gel intervention 2: Opaque, white gel intervention 3: Opaque, white gel

Protocol document: