Wobe-Mugos® in the therapy of herpes zoster
Efficacy and Tolerance
Study Nr.: MU-89105
Randomised double-blind multisite clinical trial with two parallel groups
against Acyclovir
Integrierter biometrisch-medizinischer Abschlußbericht gemäß FDA- und
CPMP-Richtlinien
Primary investigator: Dr. med. Peter Billigmann
Mörikestraße 11, W-5444 Polch, Germany
Auswertung durch: MUCOS Pharma GmbH & Co, Abt. Klinische
Forschung, Kirchplatz 8, W-8192 Geretsried 1, Germany
Bericht erstellt durch: PHARMASCRIPT, Kathi-Kobus-Steig 1, W-8190 Wolfratshausen,
Germany
Summary
In a randomised double-blind multisite clinical trial with two parallel groups the efficacy and the tolerance of WOBE-MUGOS® in the therapy of herpes zoster were to be compared with the virostatic drug Aciclovir.
192 patients with herpes zoster, verified by clinical symptoms and signs and/or demonstration of germs, were taken into this multisite study. 96 patients received WOBE-MUGOS®, 96 patients Aciclovir. The study was carried out in 21 centres. The data of all patients were evaluable.
The principal investigator was Peter W. Billigmann, M. D., Moerikestrasse 11, W-5444 Polch, Germany.
The patients took 4 trial-capsules WOBE-MUGOS® (equivalent to 15 tablets WOBE-MUGOS®) or aciclovir (equivalent to 4,000 mgs.) t.i.d. The therapy should last until all symptoms have disappeared, at least for two weeks.
At baseline, the patients were comparable with response to sex, height, weight and symptoms (redness, clear vesicles, purulent vesicles, hemorrhagic vesicles, necrosis, aberrent vesicles, localisation of herpes zoster, temperature, lymphadenopathy, hyperesthesia and segmental pain).
As main endpoints for statistical evaluation the segmental pain and segmental redness on day 14 and day 7 were defined. The tests were computed for equivalence.
The other clinical symptoms were evaluated exploratively.
For the main endpoint "segmental pain" there were no statistical differences (p > 0.05) on day 14 and day 7 among the treatment groups. Evaluation of the "segmental redness" on day 14 showed a significant difference (p = 0.015) in favour of the Aciclovir therapy. 0n day 7 there was no difference among the groups (p > 0.05). For the secondary criteria there were no statistically significant differences (p > 0.05) among the groups.
25 patients of the enzyme group and 16 patients of the aciclovir group complained of a post-zosteric neuralgia (PZN). There were no significant differences among the groups with intensity of pain and frequency (number per month) of pain attacks (p > 0.05).
The efficacy of the drug was judged at end of therapy by the physician as well as by the patients as 1.6 ("very good" to "good") in either group.
The tolerance of the drugs was judged by the physician at end of therapy as 1.2 ("very good" ) in the enzyme group and as 1.4 ("very good" to "good") in the aciclovir group; the judgement by the patients was 1.3 ("very good" to "good") in the enzyme group and 1.4 ("very good" to "good") in the aciclovir group. The differences were statistically not significant (p > 0.05).
Adverse events were documented in five patients of the enzyme group and in 13 patients of the aciclovir group.
Most of the adverse events affected the gastrointestinal tract. They started on average in the enzyme group after 5.2 days and in the aciclovir group after 4.4 days. The mean duration was in the enzyme group 4.8 days and in the aciclovir group 8.6 days. In both groups they were "moderate" on average. In the aciclovir group the therapy was therefore stopped in two cases. In this group there was no patient with residual complaints; in the enzyme group there was one patient with a slight residual complaint, but not in need of treatment. The number of ad- verse events was statistically less in the enzyme group (p < 0.05).
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