Abstract | OBJECTIVES: 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 ≤10 × 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 |
Journal | Current medical research and opinion
(Curr Med Res Opin)
Vol. 28
Issue 8
Pg. 1313-21
(Aug 2012)
ISSN: 1473-4877 [Electronic] England |
PMID | 22762346
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Antifibrinolytic Agents
- Placebos
- diclofenac hydroxyethylpyrrolidine
- Diclofenac
- Heparin
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Topics |
- Administration, Topical
- Adolescent
- Adult
- Aged
- Algorithms
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Antifibrinolytic Agents
(administration & dosage, adverse effects)
- Casts, Surgical
- Contusions
(complications, drug therapy)
- Diclofenac
(administration & dosage, adverse effects, analogs & derivatives)
- Double-Blind Method
- Female
- Heparin
(administration & dosage, adverse effects)
- Humans
- Male
- Middle Aged
- Muscular Diseases
(complications, drug therapy)
- Pain
(drug therapy, etiology)
- Placebos
- Severity of Illness Index
- Treatment Outcome
- Young Adult
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