Phlogenzym® in the Treatment of
Periarthritis Humeroscapularis Tendopathica. (MU-695419)
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).
[See Abstract on Published Study]
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