Ketoprofen controlled release (CR) in the treatment of osteoarthrosis; a double blind, randomized multicentre study of single morning versus evening dose

Abstract

Objective - To compare the morning and evening dose of 200 mg ketoprofen controlled release formulation with regard to both efficacy and GI tolerability.

Design - Double-blind, randomized multicentre prospective trial with cross-over design combined with a parallel design.

Participants - One hundred and eight female and 55 male patients with osteoarthrosis in hip(s) or knee(s) necessitating treatment with nonsteroidal antiinflammatory drugs. Main outcome measure - The degrees of pain and stiffness and joint movement ability in joints with osteoarthrosis.

Results - Both the morning and the evening dose demonstrated a significant effect (p < 0.01) on all efficacy variables. The reduction in degree of pain in the afternoon and in the evening was significantly higher (p < 0.01) for the morning dose. The total frequency and degree of gastrointestinal discomfort increased significantly (p < 0.01) during both treatment periods. The increases were mainly caused by increased gastric pain and constipation. No significant differences were found between the two regimes regarding tolerability.

Conclusion - Ketoprofen controlled release given once daily in the morning compared to the evening to patients with osteoarthrosis may increase the efficacy without reducing the tolerability of the drug.

Key Words:

• chronobiology
• cross-over design
• ketoprofen
• osteoarthrosis