Phlogenzym® in the Treatment of Periarthritis Humeroscapularis Tendopathica (MU-695419)

Phlogenzym^® in the Treatment of Periarthritis Humeroscapularis Tendopathica

Efficacy and Tolerance
Study No.: MU-695419
Randomised double-blind study phase III with parallel groups vs. diclofenac according to the guidelines of good clinical practice (GCP)
Integrated biometric-medical final report according to ICH E3 guidelines

Primary Investigator: Prim. Univ.-Prof. Gert Klein, M.D.

Rehabilitation Center for Rheumatic Diseases and Diseases of the Cardiovascular Systém, Thorerstrasse 26, A-5760 Saalfelden, Austria

Evaluation by: MUCOS Pharma GmbH & Co, Clinical Research Dpt., Malvenweg 2, , D-82538 Geretsried
Report by: PharmaScript, Primelweg 2, D-82538 Geretsried

Summary

This double-blind clinical trial could demonstrate that the therapy of a periarthritis humeroscapularis tendopathica with the proteolytic enzyme preparation Phlogenzym is at least as successful as with the non-steroidal antiinflammatory drug diclofenac. An even moderate superiority of the enzymes was calculated by the Mann-Whitney statistics.

40 patients with periarthritis were taken into this trial and randomised into two groups. 20 patients received the enzymes (enzyme group) and 20 patients diclofenac (diclofenac group). The data of all patients was evaluable.

The principal investigator was Prof. Gert Klein, M.D., rehabilitation center of rheumatic diseases and diseases of the cardiovascular system, Ludwig Boltzmann-Institut, Thorerstrasse 26, A5760 Saalfelden, Austria.

As the study had to be performed in a "double-dummy" design, all patients received 2 tablets t.i.d. (i.e. 6 tablets per day) of "enzyme tablets" and 1 capsule b.i.d. (i.e. 2 capsules per day) of "antirheumatic agent". Thus, the patients took either 6 tablets of active Phlogenzym^® or 100 mg diclofenac for 3 weeks, depending on the group.

At baseline the patients were comparable with regard to age, sex, weight, height, and the symptoms (p > 0.05, Wilcoxon-Mann-Whitney-U-test).

As main endpoint for statistical evaluation the sumscore of the various kinds of pain and dysfunction was defined. As secondary criteria the various kinds of pain, the restricted movement, the amount of analgesic drugs taken and the global judgements by the physician and the patients were evaluated descriptively.

Both the main endpoint (sum score) and the secondary criteria showed statistical equivalence. The Mann-Whitney statistics for the main endpoint has even proven a "moderate" superiority of the enzymes: MW statistics = 0.6405, 90% Cl 0.4675 - 0.8136.

The various kinds of pain and the sum score showed also a better improvement in the patients of the enzyme group than of the diclofenac group.

The global judgement of the efficacy of the drug by the physician in the enzyme group was 1.4 ("very good" to "good") and by the patients 1.5 ("very good" to "good"). In the diclofenac group the physician judged the efficacy of the drug as 1.7 ("very good" to "good") and the patients as 1.9 ("good"). The differences between the groups were not significant (p > 0.05).

The tolerance of the drugs was judged by the physician in the enzyme group and in the placebo group as 1.2 ("very good") and by the patients as 1.3 ("very good" to "good"). There were no significant differences between the groups (p > 0.05).

Adverse events were documented in three patients in the enzyme group (nausea and vomiting, exanthema of the face, allergic exanthema of both upper arms) and in two patients in the diclofenac group (exanthema of the diclofenac group (exanthema of the face). They started on average after 2.7 days in the enzyme group and after 9.0 days in the diclofenac group. The duration was on average 4.3 days in the enzyme group and 4.0 days in the diclofenac group. They were judged as "mild" to "moderate". In the enzyme group two patients were without sequelae and one patient had moderate sequelae and was in need of ambulatory treatment and in the diclofenac group both patients remained without sequelae. In all cases the patient's outcome was without damage. The frequency of adverse events did not differ significantly (p = 1.000).