(278) Efficacy and tolerability of FLECTOR Patch (diclofenac epolamine topical patch) in the treatment of minor soft tissue injury pain

Carr, W. David; Beks, P.J.; Jones, Chris; Rovati, Stefano; Magelli, Merrell; Sun, Shaoqiong

doi:10.1016/j.jpain.2008.01.199

Cited by 5 publications

(2 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, other randomized, double-blind, placebo-controlled studies have shown the DETP to have superior efficacy and similar tolerability to placebo in reducing acute pain due to other soft tissue injury, including pain from ankle sprain and minor soft tissue injury. [17][18][19] In addition, the etiology of back pain in this study was limited to back strain. Given that the indication for DETP includes pain due to minor strains, these patients might have been more likely to respond, especially within the maximum 14-day time frame, than patients with back pain due to other causes.…”

Section: Discussionmentioning

confidence: 99%

“…16 The DETP has been found to be an effective treatment for acute pain conditions such as ankle sprains 17,18 and minor soft tissue injuries. 19 Topical diclofenac has not been studied specifically in the setting of back strain. The objective of this study was to assess the effectiveness and safety of the DETP in patients with acute pain from back strain.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Effectiveness and Safety of Diclofenac Epolamine Topical Patch 1.3% for the Treatment of Acute Pain Due to Back Strain: An Open-Label, Uncontrolled Study

Gimbel¹,

Jacobs²,

Pixton³

et al. 2011

Phy Sportsmed

View full text Add to dashboard Cite

Background: The diclofenac epolamine topical patch 1.3% (DETP) is indicated for topical treatment of acute pain due to minor strains, sprains, and contusions. This exploratory, multicenter, open-label study evaluated effectiveness and safety of DETP in patients with acute pain due to back strain. Methods: Patients aged $ 18 years with acute pain due to nonradicular back strain with an average pain intensity of $ 4 (0 = no pain, 10 = pain as bad as you can imagine) entered a 3-day observation/washout period and completed daily diary modified Brief Pain Inventory assessments. At baseline, patients with an average pain intensity of $ 4 started DETP treatment (q12h). Patients were treated for 7 or 14 days, depending on investigator and patient assessment of pain resolution. Primary endpoint was mean change from baseline to end of treatment in average pain intensity. Key secondary endpoints included changes from baseline in least, worst, and current pain scores and Beck Depression Inventory ® II scores. Patients and investigators assessed patch satisfaction and global pain relief. Results: In 123 enrolled patients, baseline mean ± standard deviation average pain score was 6.5 ± 1.3, which decreased to 2.5 ± 2.4 (P , 0.0001) at end of treatment. Similarly, least, worst, and current pain scores were also reduced (P , 0.0001). Sixty-three percent of patients achieved $ 50% pain reduction from baseline. At the end of treatment, most patients (88%) were satisfied or very satisfied with DETP. For 85% of patients, investigators also reported being satisfied or very satisfied with DETP. Most patients (87%) and investigators (88%, rating the patient's response) rated global pain relief as moderate to complete. Fifteen patients experienced a total of 19 adverse events (AEs), 17 of which were mild to moderate, and 2 of which were severe. Three AEs were treatment related (application site rash, nausea, and tachycardia); 1 patient had a serious AE (noncardiac chest pain) considered unrelated to DETP. Conclusion: In this exploratory study, patients experienced well-tolerated relief for acute pain due to back strain, with $ 85% of patients and their investigators expressing satisfaction with DETP treatment.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%