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The analgesic efficacy of an arginine salt of ibuprofen was compared to one of the commercially available forms of conventional ibuprofen in a 500-patient clinical trial in postoperative dental pain. Patients were administered a single dose of ibuprofen arginate (200 mg or 400 mg), conventional ibuprofen (200 mg or 400 mg), orplacebo in this double-blind, randomized, parallel-group trial. Results demonstrated that ibuprofen arginate was a safe and effective analgesia that was superior to conventional ibuprofen in both the amount of pain relief achieved and the time to onset of pain relief. Onset of analgesia, assessed as the median amount of time to achieve meaningful pain relief, was reached after 32 and 31 minutes with ibuprofen arginate 200 and 400 mg, respectively, and 64 and 58 minutes with conventional ibuprofen 200 and 400 mg, respectively (p < 0.05). Patients treated with ibuprofen arginate rated its overall effectiveness higher than those patients treated with conventional ibuprofen. Adverse event profiles were similar across all treatment groups.

Background: Dysmenorrhea produces painful abdominal cramps that can disrupt the personal lives and productivity of women.Objective: The aim of this study was to compare the analgesic efficacy, including onset and duration of pain relief, peak effect, and total effect, and tolerability of ibuprofen arginate with those of conventional ibuprofen in patients with moderate to severe pain associated with primary dysmenorrhea.Methods: Patients were administered a single dose of ibuprofen arginate (200 or 400 mg), conventional ibuprofen (200 or 400 mg), or placebo during each of 5 menstrual cycles in a single-center, double-blind, randomized, doubledummy, 5-cycle, crossover study. Patients recorded their pain intensity and pain relief at regularly scheduled intervals (10,20, 30, 40, 50, 60, and 90 minutes and 2, 3, 4, 5, and 6 hours) after taking the study medication, and all study observations were recorded in a patient diary. Pain intensity was rated using the following 4-point categoric rating scale: 0 ϭ none, 1 ϭ mild, 2 ϭ moderate, and 3 ϭ severe. Pain relief was rated on a 5-point scale as 0 ϭ none, 1 ϭ a little, 2 ϭ some, 3 ϭ a lot, and 4 ϭ complete relief. Tolerability of ibuprofen arginate was based on a comparison of the incidence of spontaneously reported adverse events in each of the treatment groups.Results: One hundred four patients entered the study. Of these, 81.7% were white; the mean (SD) age was 27.5 (5.0) years. A total of 65.4% of patients reported moderate pain from dysmenorrhea, and the remaining 34.6% reported severe pain; 20.2% of patients did not complete the study. The median time to achieve meaningful pain relief was ϳ30 minutes faster with ibuprofen arginate 400 mg than with either dose of conventional ibuprofen. Tolerability was similar across all treatments.Conclusions: In this study population of patients experiencing acute pain as a result of primary dysmenorrhea, ibuprofen arginate was associated with 327CURRENT THERAPEUTIC RESEARCH effective, tolerable analgesia and a more rapid onset of action than conventional ibuprofen. The faster onset of analgesia may have a role in clinical practice in treating women with dysmenorrhea. A faster onset of action may be important to women whose personal relationships, productivity, or ability to sleep is being adversely affected by pain. (Curr Ther Res Clin Exp. 2003;64:327-337)

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