Double-blind, multicenter evaluation of the efficacy and tolerability of diclofenac dispersible in the treatment of acute soft-tissue injuries

Abstract

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 dispersible 50 mg or placebo three times daily for 3 to 7 days, with paracetamol allowed as a rescue analgesic. Of a total of 253 recruited patients, 247 patients (122 in the diclofenac dispersible group and 125 in the placebo group) were eligible for tolerability assessment and 229 patients (115 diclofenac dispersible and 114 placebo) were eligible for efficacy analysis. In the general, median reductions in the intensities of pain at rest, on movement, and on local pressure (as measured on 100-mm analog chromatic continuous scales) were greater with diclofenac dispersible than with placebo after treatment (differences did not reach statistical significance). At the center that recruited the largest number of patients, the initial median levels of pain at rest and on movement were considerably lower than those at the other centers. On reanalysis of the pain data without this center, a significant difference favoring diclofenac dispersible over placebo was noted for pain on movement and on local pressure ( P ≤ 0.044). With respect to daily assessment of pain severity, more patients in the diclofenac dispersible group had none or mild pain while fewer had moderate or severe pain during the early posttreatment days; this treatment difference versus placebo reached statistical significance on days 3 and 4 ( P ≤ 0.045). Nine (7.4%) of 122 patients in the diclofenac dispersible group reported adverse events, compared with 11 (8.8%) of 125 patients in the placebo group. Gastrointestinal complaints predominated in both groups, but severe diarrhea (4 patients) was reported with diclofenac dispersible only. We concluded that drinkable diclofenac dispersible provides effective relief of moderate-to-severe pain in the early stages of acute soft-tissue injury. In addition, the drug is well tolerated when used short-term for treatment of such injuries.