Randomized, controlled, multi-center trial to evaluate the efficacy, tolerability, and safety of an (S)-ibuprofen gel vs. placebo in the local symptomatic and short-term treatment of pain in acute contusions of the soft tissues following blunt trauma

acute contusions of soft tissues

The CfB/pain intensity difference (PID) of NRS scores for POM at 24 hours (V2)

Time to first perceptible pain relief, The CfB/PID of NRS scores for spontaneous pain-on-movement (sPOM) at 24 hours (patient diary), The CfB for PAR measured by NRS at V2, The CfB for POM measured at V3, V4, V5, and V6., The CfB for PAR measured by NRS at V3, V4, V5, and V6, When possible, the CfB for sPOM measured at 6 (±2) 8 (±2), 12 (±2), 16 (±2), 24 (±4), 36 (±4), 48 (±4), 60 (±4), 72 (±4), 84 (±4), 96 (±4), 120 (±4), 144 (±4), and 168 (±24) hours (diary), The POM at the injured site recorded on an NRS scale in the presence of the investigator for the timepoints at V2, V3, V4, V5, and V6, Sum of PIDs (SPIDs) for POM at V2, V3, V4, V5, and V6, Baseline-adjusted area under the curve (AUC) for POM at the injured site recorded on an NRS scale in the presence of the investigator for the timepoints at V2, V3, V4, V5, and V6, The PAR measured by NRS at baseline, V2, V3, V4, V5, and V6, Time-specific PID for spontaneous pain-onmovement (sPOM) at all time points to be recorded in diary, Time-specific PID for PAR at all time points to be recorded in diary, Time-specific pain intensity (PI) for sPOM at all time points to be recorded in diary, Time-specific PI for PAR at all time points to be recorded in diary, Time to onset of meaningful pain relief (from direct response about what is meaningful to the individual patient), Time to complete pain relief based on patient assessment in the diary, Time to complete resolution of POM (Score = 0 of pain), Time to complete resolution of PAR (Score = 0 of pain), Time to the first request of rescue medication within the first 24 hours (if applicable), Proportion of patients taking rescue medication per dosing interval and during the entire evaluation period (if applicable), Responder rate (defined as the number of patients achieving 50% reduction from baseline in the NRS score for POM at 24 hours), Global efficacy assessment by investigator (5-point scale) at V2, V3, V4, and V6, Global efficacy assessments by patient (5-point scale) at V2, V3, V4, and V6, Overall dose of rescue medication (rescue medication use will be assessed at every visit except V1), Local tolerability (according to a 4-point scale) at every visit except V1, Vital signs (including blood pressure and pulse rate) and physical examination results at V1 and V6, Adverse events (AEs) at every visit

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