Clinical Evaluation of Niflumic Acid Gel in the Treatment of Uncomplicated Ankle Sprains

Abstract

A double-blind, placebo-controlled, multi-centre study was carried out to assess the efficacy and tolerability of percutaneous niflumic acid gel in the treatment of uncomplicated ankle sprains. Sixty patients were enrolled in three centres and were randomly allocated to receive treatment with 2.5% percutaneous niflumic acid gel or placebo gel applied 3-times daily for 7 days. Clinical evaluations were made on entry to the study, after 3 days and at the end of treatment. The major efficacy criteria were the pain felt by the patient and the investigators' and patients' global evaluation of effectiveness of the treatment. Adverse events that occurred were also noted. The results showed that topically applied 2.5% niflumic acid gel was superior to placebo in the treatment of ankle sprains in respect of all major parameters studied. Niflumic acid gel and the placebo were shown to be equally well tolerated. The study findings indicate that treatment with topical niflumic acid gel is effective in treating uncomplicated ankle sprains and results in improved clinical signs on Day 4 and after 7 days.