Efficacy and tolerability of a new ibuprofen 200mg plaster in patients with acute sports-related traumatic blunt soft tissue injury/contusion

ABSTRACT

Background: Ibuprofen is used for the treatment of non-serious pain. This study assessed the efficacy and safety of a new ibuprofen plaster for the treatment of pain associated with acute sports impact injuries/contusions.

Methods: In this randomised, double-blind, multi-centre, placebo controlled, parallel group study, adults (n = 130; 18–58 years of age) diagnosed with acute sports-related blunt soft tissue injury/contusion were randomized to receive either ibuprofen 200 mg plaster or placebo plaster. Plasters were administered once daily for five consecutive days. The primary assessment was area under the visual analogue scale (VAS) of pain on movement (POM) over 0 to three days (VAS AUC_0-3d). Other endpoints included algometry AUC from 0 to three days (AUC_0-3d) and 0 to five days (AUC_0-5d), to evaluate improvement of sensitivity at the injured site, and patient and investigator global assessment of efficacy. Safety was monitored throughout the study.

Results: The ibuprofen plaster resulted in superior reduction in AUC_0-3d compared with placebo; the Least Squares (LS) mean difference was 662.82 mm*h in favour of the ibuprofen 200mg plaster (P = 0.0011). The greater improvement in VAS AUC of POM was also observed after 12 h, 24 h, and five days of therapy. Tenderness also significantly improved with the ibuprofen plaster compared with placebo; LS mean difference in algometry/tenderness AUC_0-3d was 1.87 N/cm²*d and AUC_0-5d was 1.87 N/cm²*d (P values ≤0.0004). At all study timepoints, a greater percentage of patients and investigators rated the effectiveness of the ibuprofen 200 mg plaster as good/excellent than the placebo plaster. Treatment-emergent adverse events for the ibuprofen plaster were few (≤1.5%) and were mild in severity.

Conclusions: The results of this study indicate 200 mg plaster is effective and safe for the treatment of pain due to acute sports-related traumatic blunt soft tissue injury/contusion in adults.

KEYWORDS:

• Ibuprofen
• pain
• efficacy
• safety
• convenience
• plaster
• tenderness

Acknowledgements

We wish to acknowledge the contributions of the following individuals: Emma Field, Reckitt Benckiser Clinical; Bernard Ng, Reckitt Benckiser Medical Approver.

Declaration of interests

HG Predel was a paid investigator for conducting this study. MP Connolly was paid by the sponsoring organisation for his contributions to the project. MP Connolly holds no financial interest in the sponsoring organisation. F Lewis is an employee of Reckitt Benckiser. A Bhatt is an employee of Reckitt Benckiser, and holds shares in the sponsoring organization. B Giannetti was member of the CRO that managed the study paid by Reckitt Benckiser. B Giannetti declares no financial holdings in Reckitt Benckiser. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This study was funded by Reckitt Benckiser.