An assessment of the efficacy and safety of diclofenac potassium liquid-filled capsules in patients with various levels of baseline pain intensity

AbstractContext:Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC; Zipsor) is a novel formulation of diclofenac potassium used to treat mild to moderate acute pain.Objective:To investigate whether DPSGC 25 mg provided significant reduction in pain intensity compared with placebo, regardless of baseline pain intensity, a post hoc analysis was performed of pooled data from two replicate randomized controlled trials (NCT00366444 and NCT00375934) that evaluated the safety and efficacy of DPSGC in postbunionectomy treatment.Methods:Patients from the two randomized trials were assigned to one of two subgroups: patients with baseline numerical pain rating scale (NPRS) scores of 4 or greater to less than 7 and those with baseline NPRS scores of 7 or greater. Within each subgroup, efficacy and safety of DPSGC was compared with placebo.Results:Across the two studies, 73 DPSGC- and 59 placebo-treated patients had baseline pain intensity scores ranging from 4 or greater to less than 7, while 128 DPSGC- a...