Background NSAIDs are the first choice for management of acute musculoskeletal pain. Acute musculoskeletal pain is often associated with trauma, surgery, musculoskeletal injuries like strains, sprains and over-use injuries
Objectives The primary study endpoint was the estimate of the non-inferiority of the Test drug (Ketoprofen) vs. the Reference drug (Diclofenac). This was performed by assessment of the proportion of responders (response: 50% or more reduction of baseline VAS % (95%CI) at the end of treatment) in the two treatment groups.
Methods This phase III, randomised, blinded, active-control and non-inferiority study involved 697 adults with acute muskuloskeletal pain. Participants were randomised in a double blind manner to receive with a 1:1 ratio one patch of SKP-021 containing 30 mg of ketoprofen or one patch of Voltadolâ containing 140 mg of diclofenac sodium twice a day for 7 days. The efficacy measures were the percentage change from baseline to day 7 for the participant's assessment of pain as measured by a 100mm VAS, other clinical symptoms: [pain at resting, pain on exercise, local hot feeling, tenderness, swelling, mobility limitation, difficulties in daily activities, evaluated by four step rating (0=none, 1=mild, 2=moderate, 3=severe)]; Physician and Patient Overall Rating on patient's overall status change since the start of the study.
Results The study sample included 697 subjects, 426 F (61.1%) and 271 M (38.9%) ranging in age from 18 to 82 years (mean 51.6 median 53). No between groups differences were detected in baseline characteristics. Among the musculoskeletal diagnoses, there was a prevalence of muscular injury (77.8%), joint injury (19.1%) and tendon pain (3.2%), with no significant difference between the two groups.
Day 7 percentage of responders was 51.9 (46.6 to 57.1 CI) and 50.6 (45.3 to 55.8 CI) for the ketoprofen and diclofenac groups, respectively (p=0.734). The improvement of clinical symptoms was statistically significant in both groups (p<0.001 for all symptoms). The analysis carried out by the Cochran-Mantel-Haenszel test did not show any statistically significant differences between groups in the changes from baseline. The mean time to response was 4.94 days for Diclofenac and 4.87 days for Ketoprofen. The Log-Rank test (p=0.228) did not show any statistically significant difference on the survival curves of the two groups.One hundred and twenty four subjects reported one or more AEs for a total of 183 events: 65 subjects from the Diclofenac (18.7%), 99 events; 59 subjects from the Ketoprofen (16.9%), 84 events. The frequencies of subjects experiencing at least one AE are similar between treatment groups (P=0.541). No serious or severe AEs were reported. No photosensitivity reactions were reported. Skin reactions were statistically lower in the ketoprofen arm.
Conclusions The analysis of the data of this trial showed that the two formulations were equally effective and well tolerated in the treatment of acute musculoskeletal injuries.
Disclosure of Interest : P. Sarzi-Puttini Grant/research support: restricted grant from multinational company, F. Atzeni Grant/research support: restricted grant from multinationalcompany, C. Damiani Grant/research support: restricted grant from multinationalcompany, R. Casale Grant/research support: restricted grant from multinational company, M. Barbagallo Grant/research support: restricted grant from multinational company, M. Cazzola Grant/research support: restricted grant from multinational company