Reduction of tenderness and hematoma by Phlogenzym® in volunteers with an experimental hematoma (MU-91416)
Principal investigator: Michael-W. Kleine, M.D.
Reduction of tenderness and hematoma by Phlogenzym® in volunteers
with an experimental hematoma. Efficacy and tolerance. Study No:
MU-91416. Double-blind
randomized experimental clinical parallel group study versus
placebo. Integrated biometrical-medical final report according
to FDA and CPMP guidelines. Egenhofenstrasse 18, D-82152 Planegg,
Germany. Evaluation by: MUCOS Pharma GmbH & Co, Clinical Research
Dept., Kirchplatz 8, D-82538 Geretsried, Germany. Report by:
PharmaScript, Kathi-Kobus-Steig 1, D-82515 Wolfratshausen, Germany
Summary
In a randomised double-blind experimental clinical trial phase II
(acc. to German Drug Law) with two parallel groups, the efficacy and
the tolerance of Phlogenzym® in reducing tenderness under
pressure and hematoma was tested as compared with placebo in
subjects with an experimentally induced hematoma on the flexor side
of the forearm.
46 healthy volunteers of either sex were taken into this study. 23
subjects received the enzyme preparation Phlogenzym® and
23 placebo. The data of all subjects were evaIuable.
The study was conducted by Michael-W. Kleine, M.D., Egenhofenstrasse
18, D-82152 Planegg, Germany.
The subjects received 60 tablets Phlogenzym® or placebo
for eleven days.
At baseline, the subjects were comparable with regard to age, sex,
height, weight and difference of values of tenderness on pressure
between healthy arm and arm with hematoma (Wilcoxon-Mann-Whitney-
and Student-t-test: p > 0.05).
The main endpoint for statistical evaluation was the difference of
the sums of the measured values of tenderness on pressure between
healthy arm and arm with hematoma from day 0 to day 10. As secondary
criterion the other data for efficacy were evaluated.
The main criterion, "the difference of the sums of the measured
values of tenderness on pressure between healthy arm and arm with
hematoma from day 0 to day 10", was statistically significant lower
(p < 0.0001) in the enzyme group. For the secondary criterion
"reduction of hematoma" there were differences between the groups
from day 2 in favor of the enzyme group, but without significance.
The tolerance of the drugs was judged by the physician and the
volunteers at end of therapy as 1.0 ("very good") in the enzyme
group and as 1.1 ("very good") in the placebo group, on average.
No adverse events had to be documented in either group.