Clinical Evidence (Mozart Study)
A safe and effective treatment for pain in moderate to severe knee osteoarthritis
- The achieved pain relief was clinically relevant (minimal clinically important improvement of -32.6 mm)
- Even after 99 days the percentage of subjects achieving decrease in WOMAC pain subscale score of at least -32.6 mm compared to baseline was significantly higher than in the placebo group
- In this double-blind, randomized, controlled trial, a mineral/biological multi-extract combination was shown to be a safe and effective treatment for pain in moderate to severe knee OA
Mozart Study Design
In this multi-center, double-blind, randomized, controlled trial, 232 patients with moderate-to-severe chronic knee OA were randomized to 3 weekly IA injections of either combined
Zeel Injection Solutions or saline by clinical investigators experienced with use of the IA injection route. The primary efficacy variable was change in knee pain from Baseline to End-of-Study (Week 17) as measured by the WOMAC OA Pain Subscale (Section A, 1–5) 100 mm VAS. Secondary measures included Total WOMAC and sub-scores for stiffness (B), and physical function (C), change in pain following a 50 ft. walk (100 mm VAS), patient and physician global assessments.
Clinical relevance was assessed by comparing proportions of patients with reductions from baseline in WOMAC A scores greater than a validated benchmark Minimal Clinically Important Difference (MCID). This was chosen as =32.6 mm (the most conservative value) based on a study of outpatients with knee or hip OA where WOMAC VAS MCIDs ranged from=7.9mm to=32.6mm [see Tauback et al., Ann Rheum Dis. 2005; 64(1):29–33 in the description of the WOMAC index published by ACR]. Safety was assessed by monitoring of vital signs, physical examinations of the target knee, adverse events and concomitant medications.
|Number of Participants||119||113||232|
|Age Mean ± Standard Deviation||60.7 ± 9.11||59.7 ± 8.68||60.2 ± 8.90|
|Region of Enrollment|
WOMAC Pain Score
Figure: Mean WOMAC A (Pain) Changes from baseline. Solutions did not discriminate for WOMAC A Pain as expected after only 1 of 3 injections on Day 8 (p=0.3715), but subsequently was significantly different (p=0.05) on Days 15, 43, 57, 71, 85 and 99 (primary endpoint day), and approached significance on Day 29 (p=0.0686).
Clinical Relevant Pain Relief
Figure: Percentage of subjects achieving decrease in WOMAC pain subscale score of ≥ 32.6 mm from baseline. ). Logistic regressions showed the proportion of MCID responders was not significant on Day 8. As this was an expected finding, it served as a no-effect internal-model-validation. Traumeel & Zeel Injection Solutions was significantly different (p=0.05) on all subsequent days except Day 29 (approached significance, p=0.0599).
50’ Walk Test
Figure: Mean changes from baseline in 50’ walk pain.
Reference:Lozada C et al. A Multi-Center Double-Blind, Randomized, Controlled Trial (db-RCT) to Evaluate the Effectiveness and Safety of Co-Administered Traumeel® (Tr14) and Zeel® (Ze14) Intra articular (IA) Injections Versus IA Placebo in Patients with Moderate-to-Severe Pain Associated with OA of the Knee ACR Annual Meeting, Abstract Number: 2896. 2014.
PDF for download of ACR and EULAR abstract View