Efficacy and tolerability of DHEP-heparin plaster in reducing pain in mild-to-moderate muscle contusions: a double-blind, randomized trial

  • Hoffmann P
  • Kopačka P
  • Gugliotta B
 et al. 
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Abstract

Objectives:
To investigate if the 180-mg diclofenac epolamine and heparin sodium
5600 IU medicated plaster (DHEP-heparin) is more effective for pain
reduction in mild-to-moderate contusions than the reference diclofenac
epolamine 180 mg plaster (DHEP).
Research design and methods:
This multicenter, multinational, prospective, double-blind versus
reference comparator and versus placebo, controlled trial had balanced
random assignment in three parallel treatment groups. The DHEP-heparin
medicated plaster was compared to the DHEP medicated plaster and a
placebo medicated plaster. A total of 331 outpatients, aged >= 18 and 65 years, with unilateral mild-to-moderate muscle contusion, pain on
standardized movement of >= 50 mm, and superficial hematoma of 14 cm(2) completed the study. Plasters were applied each morning, for >=
20 hours daily for 14 consecutive days. Outcomes were assessed in three
visits, over 14 days, plus patients' daily self-assessment.
Clinical trial registration:
05DCz/FHp11 - Eudra CT n: 2005-003829-31
Main outcome measures:
Primary efficacy endpoint was mean change from baseline in pain on
movement after 3 days of treatment, compared between groups. Secondary
efficacy endpoints included mean daily change from baseline in pain on
movement during treatment, pain level as assessed at control visits
after 7 and 14 days, time (days) to hematoma disappearance based on
patients' daily evaluations, rescue medication use, and overall
treatment efficacy as judged by both patients and investigators.
Results:
Pain progressively declined in all groups, more rapidly in DHEP-heparin
recipients, compared to DHEP, and in both active treatment groups
compared to placebo. Adverse events were recorded in 24 of the 355
(6.7%) exposed patients, and generally resolved without need to
interrupt treatment.
Conclusion:
The DHEP-heparin plaster is superior to the reference DHEP plaster in
reducing pain associated with mild-to-moderate muscle contusion. Both
active treatments were significantly more effective than placebo, and
each showed a comparably favorable, placebo-like safety profile.

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Authors

  • Peter Hoffmann

  • Pavel Kopačka

  • Barbara Gugliotta

  • Stefano Rovati

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