DOUBLE-BLIND, MULTICENTER EVALUATION OF THE EFFICACY AND TOLERABILITYOF DICLOFENAC DISPERSIBLE IN THE TREATMENT OF ACUTE SOFT-TISSUE INJURIES

In a randomized, double-blind, parallel-group, multicenter study, the efficacy and tolerability of diclofenac dispersible were compared with placebo in the treatment of acute soft-tissue injuries. Patients seen within 48 hours of a soft-tissue injury received either diclofenac di spersible 50 mg or placebo three times daily for 3 to 7 days, with par acetamol allowed as a rescue analgesic. Of a total of 253 recruited pa tients, 247 patients (122 in the diclofenac dispersible group and 125 in the placebo group) were eligible for tolerability assessment and 22 9 patients (115 diclofenac dispersible and 114 placebo) were eligible for efficacy analysis. In general, median reductions in the intensitie s of pain at rest, on movement, and on local pressure (as measured on 100-mm analog chromatic continuous scales) were greater with diclofena c dispersible than with placebo after treatment (differences did not r each statistical significance). At the center that recruited the large st number of patients, the initial median levels of pain at rest and o n movement were considerably lower than those at the other centers. On reanalysis of the pain data without this center, a significant differ ence favoring diclofenac dispersible over placebo was noted for pain o n movement and on local pressure (P less than or equal to 0.044). With respect to daily assessment of pain severity, more patients in the di clofenac dispersible group had none or mild pain while fewer had moder ate or severe pain during the early posttreatment days; this treatment difference versus placebo reached statistical significance on days 3 and 4 (P less than or equal to 0.045). Nine (7.4%) of 122 patients in the diclofenac dispersible group reported adverse events, compared wit h 11 (8.8%) of 125 patients in the placebo group. Gastrointestinal com plaints predominated in both groups, but severe diarrhea (4 patients) was reported with diclofenac dispersible only. We concluded that drink able diclofenac dispersible provides effective relief of moderate-to-s evere pain in the early stages of acute soft-tissue injury. In additio n, the drug is well tolerated when used short-term for treatment of su ch injuries.