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.
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
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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