Osteoarthritis, Knee Clinical Trial
Official title:
Multi-center Double-blind Randomized Controlled Trial to Evaluate Effectiveness and Safety of Co-administered Traumeel® / Zeel® Intra-articular Injections vs Placebo in Patients With Moderate-to-Severe Pain With Osteoarthritis of the Knee
The aim of this study is to evaluate the effectiveness and safety of a combined Traumeel® / Zeel® injection against placebo (saline) in patients with moderate-to-severe pain associated with osteoarthritis of the knee.
The primary objective is to demonstrate the superiority of Traumeel® and Zeel®
co-administered intra-articular (IA) injections vs placebo IA injections on the change in
knee pain in patients with moderate to severe knee pain associated with osteoarthritis.
The secondary objectives are to evaluate reduction of pain and stiffness and change in
physical function.
Safety is evaluated by the incidence of treatment emergent adverse events during the
treatment period and follow up period for all randomized patients.
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