Analgesic efficacy and safety of the diclofenac epolamine topical patch 13% (DETP) in minor soft tissue injury

Kerry Kuehl, W. Carr, J. Yanchick, M. Magelli, S. Rovati

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

The diclofenac epolamine topical patch 1.3% was designed to deliver analgesic concentrations of diclofenac to an underlying soft tissue injury site, while limiting systemic exposure to diclofenac. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the diclofenac epolamine topical patch for the treatment of acute pain due to minor soft tissue injury. Patients (1865 years, inclusive) with clinically significant minor soft tissue injuries (mild or moderate sprain, strain, or contusion) incurred within 7 days of study entry and having pain scores 5 on a Visual Analog Scale of 010 were enrolled. Patients were randomized to receive the diclofenac epolamine topical patch (n=207) or placebo patch (n=211) application twice daily for 14 days or until pain resolution. Patients recorded pain scores every 12h at the time of patch removal using the Visual Analog Scale. Investigator-assessed global response to therapy was also evaluated. Safety data were collected throughout the study. Twice-daily treatment with diclofenac epolamine topical patch produced a statistically significant reduction in mean pain score relative to baseline by an additional 18.2% in the diclofenac epolamine topical patch group (0.435±0.268) compared with the placebo group (0.532±0.293) (p=0.002; overall) beginning after application of the second patch. Consistent with this treatment effect, median time to pain resolution was shortened by 2 days in the diclofenac epolamine topical patch group relative to the placebo group (p=0.007). These results were reinforced independently by investigators who reported treatment as good or excellent for 58% of diclofenac epolamine topical patch-treated patients compared with 49% in the placebo patch group (p=0.008). The most common adverse events were treatment site related (n=16, 7.9% diclofenac epolamine topical patch; n=12, 5.8% placebo patch). Most (80%) patients reported tolerability as excellent or good. In conclusion, the diclofenac epolamine topical patch provides effective, rapid pain relief for the treatment of acute pain from minor soft tissue injury and appears generally safe and well tolerated.

Original languageEnglish (US)
Pages (from-to)635-643
Number of pages9
JournalInternational Journal of Sports Medicine
Volume32
Issue number8
DOIs
StatePublished - 2011

Fingerprint

Soft Tissue Injuries
Analgesics
Safety
Placebos
Pain
Diclofenac
Acute Pain
Visual Analog Scale
Therapeutics
Research Personnel
Sprains and Strains
diclofenac hydroxyethylpyrrolidine
Contusions

Keywords

  • acute pain treatment
  • clinical trial
  • diclofenac topical patch
  • musculoskeletal injury
  • NSAID

ASJC Scopus subject areas

  • Orthopedics and Sports Medicine

Cite this

Analgesic efficacy and safety of the diclofenac epolamine topical patch 13% (DETP) in minor soft tissue injury. / Kuehl, Kerry; Carr, W.; Yanchick, J.; Magelli, M.; Rovati, S.

In: International Journal of Sports Medicine, Vol. 32, No. 8, 2011, p. 635-643.

Research output: Contribution to journalArticle

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abstract = "The diclofenac epolamine topical patch 1.3{\%} was designed to deliver analgesic concentrations of diclofenac to an underlying soft tissue injury site, while limiting systemic exposure to diclofenac. This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of the diclofenac epolamine topical patch for the treatment of acute pain due to minor soft tissue injury. Patients (1865 years, inclusive) with clinically significant minor soft tissue injuries (mild or moderate sprain, strain, or contusion) incurred within 7 days of study entry and having pain scores 5 on a Visual Analog Scale of 010 were enrolled. Patients were randomized to receive the diclofenac epolamine topical patch (n=207) or placebo patch (n=211) application twice daily for 14 days or until pain resolution. Patients recorded pain scores every 12h at the time of patch removal using the Visual Analog Scale. Investigator-assessed global response to therapy was also evaluated. Safety data were collected throughout the study. Twice-daily treatment with diclofenac epolamine topical patch produced a statistically significant reduction in mean pain score relative to baseline by an additional 18.2{\%} in the diclofenac epolamine topical patch group (0.435±0.268) compared with the placebo group (0.532±0.293) (p=0.002; overall) beginning after application of the second patch. Consistent with this treatment effect, median time to pain resolution was shortened by 2 days in the diclofenac epolamine topical patch group relative to the placebo group (p=0.007). These results were reinforced independently by investigators who reported treatment as good or excellent for 58{\%} of diclofenac epolamine topical patch-treated patients compared with 49{\%} in the placebo patch group (p=0.008). The most common adverse events were treatment site related (n=16, 7.9{\%} diclofenac epolamine topical patch; n=12, 5.8{\%} placebo patch). Most (80{\%}) patients reported tolerability as excellent or good. In conclusion, the diclofenac epolamine topical patch provides effective, rapid pain relief for the treatment of acute pain from minor soft tissue injury and appears generally safe and well tolerated.",
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