• Phys Sportsmed · Nov 2017

    Randomized Controlled Trial

    Efficacy and safety assessment of acute sports-related traumatic soft tissue injuries using a new ibuprofen medicated plaster: results from a randomized controlled clinical trial.

    • Hans-Georg Predel, Mark P Connolly, Aomesh Bhatt, and Bruno Giannetti.
    • a Department of Preventive and Rehabilitative Sports and Performance Medicine , Deutsche Sporthochschule Köln , Köln , Germany.
    • Phys Sportsmed. 2017 Nov 1; 45 (4): 418-425.

    ObjectiveTo investigate the efficacy and safety of a recently developed ibuprofen medicated plaster in the treatment of acute sports impact injuries/contusions.MethodsIn this double-blind, multi-center, placebo-controlled, parallel group, phase 3 study (EudraCT Number: 2012-003257-2) patients (n = 132; ages 18 to 60 years) diagnosed with acute sports-related traumatic blunt soft tissue injury/contusion to the upper or lower limbs were randomized to receive either ibuprofen 200 mg plaster (n = 64) or placebo plaster (n = 68). Plasters were administered once daily for five consecutive days. The primary assessment was the area under the curve (AUC) of the visual analogue scale (VAS) of pain on movement (POM) over 0 to 72 h (VAS0-72).ResultsThe ibuprofen medicated plaster was associated with a reduction in pain on movement (POM) based on lower VAS AUC0-72h (2399.4 mm*h) compared with placebo (4078.9 mm*h) (least squares mean difference: - 1679.5 mm*h; P < 0.0001). The reduction in AUC of POM was also significantly greater for the ibuprofen medicated plaster compared with placebo at 12, 48, 24, and 120 h (P < 0.0001). Algometry/tenderness measurements found that the ibuprofen medicated plaster was associated with greater reduction in tenderness/pain than placebo at each timepoint (P values <0.0001). Seven patients experienced drug-related adverse events (n = 1 [1.6%] for the ibuprofen plaster, and n = 6 [8.8%] for placebo). All drug-related AEs were administration site reactions and were mild in intensity.ConclusionsThe results of this study indicate that ibuprofen medicated plaster results in rapid and clinically relevant reduction of pain in patients suffering from blunt musculoskeletal injuries or recurrent pain. The ibuprofen medicated plaster was well tolerated.

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