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 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 < or = 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 < or = 0.045).(ABSTRACT TRUNCATED AT 250 WORDS)