An open label, multi-centric trial to assess the safety and efficacy of an Esflurbiprofen Topical System (EFTS) in the local symptomatic and short-term treatment of pain in contusions.

acute contusion of the upper or lower limbs

Adverse events (AEs)

VAS score on POM at before bed time on Day 1, 24, 48, 72, 96, 120, 168 h and related PIDs and SPIDs, VAS score on PAR at before bed time on Day 1, 24, 48, 72, 96, 120, 168 h and related PIDs and SPIDs, Time to meaningful/optimal reduction of pain defined as 30 % (meaningful) and 50 % (optimal) reduction of VAS on POM, Time to complete resolution of pain-on-movement defined as POM VAS value of 0 mm, Time to complete resolution of pain-at-rest defined as PAR VAS value of 0 mm, Responder rate 1 (defined as the number of patients achieving at least 50 % reduction from baseline in the VAS score for POM at 48 h), Responder rate 2 (defined as the number of patients able to resume training/normal physical activity by 168 h), Resolution of contusions (defined as the percentage of patients who showed POM=PAR=0 at 168 h), Global efficacy assessments by physician (GEA, 5-point scale: 0=no response; 1=poor response; 2=fair response; 3=good response; 4=excellent response) at 48, 72, and 168 h, Global efficacy assessments by patient (GEA, 5-point scale: 0=no response; 1=poor response; 2=fair response; 3=good response; 4=excellent response) at 48, 72, and 168 h, Use of rescue medication at every visit except Visit 1, Local tolerability (skin damage/reaction according to an 8-point scale) at Visit 6, Adhesive power of the EFTS will be visually assessed and classified by the site staff in a 5-point-score (0=≥ 90 % adhered / 1= ≥75 % to <90 % adhered / 2=≥50 % to <75 % adhered / 3=>0 % to <50 % adhered / 4=completely detached) at Visits 2-5 (24 h after EFTS application), Adhesive power of the EFTS will be visually assessed and classified by the subject in a 5-point-score (0=≥ 90 % adhered / 1= ≥75 % to <90 % adhered / 2=≥50 % to <75 % adhered / 3=>0 % to <50 % adhered / 4=completely detached) at before/after bed time and 24 h after each EFTS application

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