Treatment of knee osteoarthritis with a topical non-steroidal antiinflammatory drug. Results of a randomized, double-blind, placebo-controlled study on the efficacy and safety of a 5% ibuprofen cream.

The efficacy and safety of a 5% ibuprofen cream (Dolgit cream) in primary knee osteoarthritis was assessed in this double-blind, randomized, placebo-controlled, parallel-group study with an adaptive sequential design. The background of the study was the need to confirm the efficacy of ibuprofen cream. Patients aged 40-75 years, with a visual analog scale (VAS) score of pain on motion of 40 mm, a Lequesne index score of 5-13 points, and a Kellgren and Lawrence radiographic score of grade II-III were enrolled between September 1999 and November 2000. The study medication was applied in a 10-cm strip t.i.d. for 7 days on the more painful knee. In the active group, each strip contained approximately 200 mg ibuprofen. The main outcome measure was the response rate to the treatment compared between both groups. Response was defined as a reduction of pain on motion, self-assessed on a VAS, of > or = 20 mm compared with baseline. The planned interim analysis after inclusion of 2 x 50 patients showed a response rate of 32 (64.0%) in the ibuprofen group and 15 (30.0%) in the placebo group (p = 0.000615). The study could then be terminated. All secondary endpoints, pain at rest, pain on pressure, Lequesne index and overall assessment, also confirmed the statistically significant differences between the groups. No drug-related adverse events were recorded. The study confirmed the efficacy of ibuprofen cream by demonstrating its statistically significant and clinically relevant superiority over the placebo cream in the treatment of primary knee osteoarthritis.

RCT Entities:   Population Interventions Outcomes