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Efficacy and safety of 5% ibuprofen cream treatment in knee osteoarthritis
TRNAVSKY K; FISCHER M; VOGTLEJUNKERT U
J RHEUMATOL , 2004, vol. 31, n° 3, p. 565-572 Doc n°: 112716 Localisation : Bibliothèque Universitaire de Médecine de Nancy Descripteurs : DE56 - TRAITEMENTS - GENOU Objective. To investigate the efficacy and safety of a cream containing 5% ibuprofen (Dolgit(R) cream) in primary knee osteoarthritis (OA) in a double-blind, randomized, placebo-controlled, parallel-group study using an adaptive sequential design. Methods. Patients of both sexes aged 40-75 years, with a visual analog scale (VAS) score for pain on motion of greater than or equal to 40 mm, a Lequesne index score of 5-13, and a Kellgren-Lawrence radiographic score grade II-III were enrolled between January 2001 and July 2001. Study medication was applied in a 10-cm strip tid for 7 days on the more painful knee. Each strip of the active treatment contained approximately 200 mg ibuprofen. The primary efficacy variable was the treatment response rate compared between the 2 groups. Response was defined as a reduction of pain on motion, self-assessed on VAS, of greater than or equal to 18 mm or greater than or equal to 23% compared to baseline. Results. The second interim analysis scheduled post-inclusion of 2 x 25 patients revealed a response rate of 21 patients (84.0%) in the ibuprofen group and of 10 patients (40.0%) in the placebo group (p = 0.0015). Langue : ANGLAIS |
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