Titre du document / Document title

Efficacy and safety of 5% ibuprofen cream treatment in knee osteoarthritis. Results of a randomized, double-blind, placebo-controlled study

Auteur(s) / Author(s)

TRNAVSKY Karel ⁽¹⁾ ; FISCHER Michael ⁽²⁾ ; VÖGTLE-JUNKERT Ute ⁽²⁾ ; SCHREYGER Frank ⁽³⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Postgraduate Medical School, Prague, TCHEQUE, REPUBLIQUE
⁽²⁾ ClinResearch GmbH, Cologne, ALLEMAGNE
⁽³⁾ Dolorgiet Pharmaceuticals, St. Augustin/Bonn, ALLEMAGNE

Résumé / Abstract

Objective. To investigate the efficacy and safety of a cream containing 5% ibuprofen (Dolgit® 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 ≥ 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 ≥ 18 mm or ≥ 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). The study was then terminated. All secondary endpoints such as pain at rest, overall pain, Lequesne index, and global assessment of efficacy also showed the superiority of ibuprofen. No adverse event was recorded. Conclusion. The efficacy and safety of ibuprofen cream in treatment of primary knee OA were statistically significant and clinically relevant compared to placebo.

Revue / Journal Title

Journal of rheumatology   ISSN 0315-162X   CODEN JRHUA9 

Source / Source

2004, vol. 31, n^o3, pp. 565-572 [8 page(s) (article)] (35 ref.)

Langue / Language

Anglais

Editeur / Publisher

Journal of Rheumatology Publishing, Toronto, ON, CANADA  (1974) (Revue)

Mots-clés anglais / English Keywords

Exploration ; Radiodiagnosis ; Diseases of the osteoarticular system ; Degenerative disease ; Arthropathy ; Motion ; Pain ; Evaluation scale ; Analog ; Human ; Method ; Design ; Sequential ; Primary ; Osteoarthritis ; Knee ; Treatment ; Cream ; Ibuprofen ; Toxicity ; Radiography ;

Mots-clés français / French Keywords

Exploration ; Radiodiagnostic ; Système ostéoarticulaire pathologie ; Maladie dégénérative ; Arthropathie ; Mouvement ; Douleur ; Echelle évaluation ; Analogue ; Homme ; Méthode ; Conception ; Séquentiel ; Primaire ; Arthrose ; Genou ; Traitement ; Crème ; Ibuprofène ; Toxicité ; Radiographie ;

Mots-clés espagnols / Spanish Keywords

Exploración ; Radiodiagnóstico ; Sistema osteoarticular patología ; Enfermedad degenerativa ; Artropatía ; Movimiento ; Dolor ; Escala evaluación ; Análogo ; Hombre ; Método ; Diseño ; Secuencial ; Primario ; Artrosis ; Rodilla ; Tratamiento ; Crema ; Ibuprofeno ; Toxicidad ; Radiografía ;

Localisation / Location

INIST-CNRS, Cote INIST : 16024, 35400011930204.0290