Ketoprofen controlled release (CR) in the treatment of osteoarthrosis; a double blind, randomized multicentre study of single morning versus evening dose. Norwegian Study Group of General Practitioners.
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| 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.
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| Authors | O Vinje, H E Fagertun, E Laerum, H Lund, S Larsen |
| Journal | Scandinavian journal of primary health care (Scand J Prim Health Care) Vol. 11 Issue 2 Pg. 91-7 (Jun 1993) ISSN: 0281-3432 [Print] United States |
| PMID | 8356371 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial) |
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