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KMID : 0378019970400070043
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New Medical Journal
1997 Volume.40 No. 7 p.43 ~ p.48
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Clinical Trial of Controlled Release Ketoprofen in Patients with Osteoarthritis of Knee
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Abstract
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We conducted a clinical study to evaluate the efficacy and safety of newly developed Controlled Release Ketoprofen for the treatment of knee osteoarthritis. We measured clini-cal variables including pain and inflammation, and laboratory variables and events of adverse drug reactions before and after oral administration of Controlled Release Ketoprofen to 25 patients with osteoarthritis. Seven patients dropped out. Total period of administration was eight weeks. Following results were obtained.
1. After eight weeks of Controlled Release Ketoprofen, we observed statistically signifi-cant improvement in pain on motion, pain on induction, swelling and tenderness.
2. The improvement of activities of daily living, pain at rest, limitation of motion, visual analogue pain scale, and morning stiffness was not statistically significant.
3. There was no significant changes on laboratory findings after eight weeks of Controlled Release Ketoprofen.
4. Adverse drug reactions were observed in cases. Adverse reactions were mild and improved with discontinuation or reduction of dose. Epigastric pain was observed in 6 out of 20 (40%) . There was no case whose stool occult blood test converted positively.
5. Overall efficacy observed by patient and physician after treatment revealed marked improvement or improvement in 70%.
In conclusion, Controlled Release Ketoprofen are effective and safe in the management of osteoarthritis of knee.
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