41CLINICAL STUDIES RANDOMIZED CONTROLLED CLINICAL TRIALS

Traumeel® and Zeel® T, with statistical significance seen only in the PhGA at specific study visits (days 29, 71 and 85).

Treatment groups were similar with regard to AEs, particularly when considering that patients taking Traumeel® and Zeel® T completed the study more often than saline-treated patients.

The serious ADR rate was well below the targeted 1:30,000 patient-years rate as recommended by the 2011 Consensus Guideline of the Osteoarthritis Research Society International for OA treatments being investigated in randomized clinical trials (RCTs).67

Conclusion Traumeel® and Zeel® T co-administered intra-articular injections are significantly

superior to placebo in reducing knee pain in subjects with moderate-to-severe pain associated with knee osteoarthritis.

Traumeel® and Zeel® T treatment results in a clinically relevant reduction of pain for patients with osteoarthritis of the knee over a three-month period.

The pain reduction of Traumeel® and Zeel® T in the MOZArT study is comparable to other intra-articular injection therapies and higher than for oral therapies.

The co-administration of Traumeel® and Zeel® T is safe and very well tolerated.