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news.Newron Pharmaceuticals has reported the completion of enrollment in a Phase II, randomized, placebo-controlled, double-blind, parallel-group, multi-centre study with ralfinamide in post-surgical dental pain.
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The study was designed to determine the safety, tolerability and preliminary evidence of preventive analgesic efficacy of orally administered ralfinamide at a dose range of 320/480mg per day, compared to placebo, in patients with third molar, post-extraction, dental pain. The study was performed in 15 study centres in India and Romania.
In the trial 202 patients were screened and 187 randomized (1:1) to ralfinamide or placebo. Patients received five days of pre-treatment with ralfinamide at 320mg/day or placebo prior to the day of molar-extraction surgery. On the day of surgery, patients received a total daily dose of ralfinamide at 480mg or placebo. On the two days following surgery, patients received treatment at 320mg/day of ralfinamide or placebo.