Oxaceprol--a randomised, placebo-controlled clinical study in osteoarthritis with a non-conventional non-steroidal anti-inflammatory drug.

摘要

OBJECTIVE: To evaluate efficacy of therapy with oxaceprol in the treatment of symptomatic osteoarthritis of knee or hip. METHODS: A 3-week prospective, multicentric, randomised, double-blind, placebo-controlled study with 167 patients aged between 40 and 75 years with painful and radiologically confirmed knee or hip osteoarthritis. Patients were randomly assigned to receive oxaceprol 1200 mg/day or placebo for 3 weeks. At inclusion, osteoarthritis symptoms were minimum pain following exercise (standardised as pain after climbing 12-15 stairs) of 40 to 90 mm on a 100 mm pain scale and difficulties in climbing stairs. Efficacy criteria were changes in pain shown in a visual analogue scale (VAS), in the Lequesne index, and in assessments of joint limitation, joint complaint and therapeutic success. The primary end point was the pain following exercise. The confirmatory analysis was based on the Full Analysis data set using the t-test for independent samples. RESULTS: Baseline characteristics of both groups were comparable. In the primary endpoint a clinically relevant and statistically significant superiority of oxaceprol as compared to placebo could be demonstrated (mean improvement in pain following exercise was 16.6 mm in the oxaceprol and 4.5 mm in the placebo group, p = 0.002). The safety and tolerability was good, showing no statistically significant difference between oxaceprol and placebo. CONCLUSION: A statistically significant and clinically relevant efficacy of oxaceprol was shown. The good safety and tolerability of oxaceprol was confirmed.