Phlogenzym® in patients with lateral ankle joint distortions
Efficacy and the tolerance
Study Nr.: MU-91410
Randomised double blind clinical trial with two parallel groups against
Placebo
Integrierter biometrisch-medizinischer Abschlußbericht gemäß FDA- und
CPMP-Richtlinien
Primary Investigator: Dr. med. Marcel Baumüller
Münchner Straße 60, W-8060 Dachau, Germany
Evaluation by: MUCOS Pharma GmbH & Co, Abt. Klinische
Forschung, Kirchplatz 8, W-8192 Geretsried 1, Germany
Report by: PHARMASCRIPT, Kathi-Kobus-Steig 1, W-8190 Wolfratshausen,
Germany
Summary
The design of this study was a randomised double blind clinical trial with two parallel groups. The aim was to prove the antiinflammatory and antiedematous efficacy and the tolerance of PHLOGENZYMâ as compared with placebo in patients with lateral ankle joint distortions.
40 patients with traumatically induced swelling and pain of an ankle joint were taken into this study. The data of all patients were evaluable.
The study was carried out by Marcel Baumüller, M.D., Münchner Strasse 60, W-8060 Dachau, Germany.
The patients took daily 3 x 2 tablets. The duration of therapy was ten days. The drugs were randomised and blinded ("double dummy" method). Thus, 20 patients received the enzyme preparation and 20 placebo.
At baseline the patients were comparable with response to age, sex, height, weight, swelling, joint effusion, rest pain, pain on motion, extension, zero position, flexion and total flexibility of the joint.
The main endpoint for statistical evaluation was swelling at the 7th day of treatment. Secondary criteria were the variables flexibility, joint effusion and pain at the 7th day.
The swelling (as difference between the circumferences of injured and healthy joint) at the 7th day was statistically significant less = 6.4x10-7) in Ne PHLOGENZYM® group; all other symptoms - except joint effusion and rest pain - were statistically conspicously better in the enzyme treated group.
There was a clear difference after seven days of therapy for the enzyme treated group in the main and seconda- ry criteria. The swelling (difference injured to healthy leg) was reduced in the enzyme group by 66.7% and in the placebo group by 38.1 %. The flexibility improved until the 7th day by 62.0% (enzyme group) and by 37.3% (placebo group), respectively. Also the joint effusion was reduced by 78.6% (enzyme group) and 53.8 (placebo group). The rest pain improved by 86.7% (enzyme group) and 72.2% (placebo group) and the pain on motion by 62.1 % (enzyme group) and 39.3% (placebo group), respectively.
The efficacy of the drugs was judged by the physician after seven days' therapy as 1.5 ("very good" to "good") in the enzyme group and as 2.8 ("moderate") in the placebo group; by the patients as 1.4 ("very good" to "good") in the enzyme group and as 2.4 ("good" to "moderate") in the placebo group. The judgement differed between both groups statistically conspicously (physician: p = 1.1x10-4 , patients: p = 4.1x 10-4). The tolerance of the drugs was judged by the physician after seven days' therapy in both groups as "very good" (1.2 and 1.3) and by the patients as "very good" (1.2) in the enzyme group and as "very good" to "good" (1.4) in the placebo group.
There were no adverse events documented in any group.
Lék pro vnitřní užití. Čtěte pečlivě příbalovou
informaci.
Inzertní stránky společnosti MUCOS Pharma CZ, s.r.o. - tel: (+420)-267 750
003