Abstract | OBJECTIVE: METHODS: This was a multicentre, randomised, double-blind, controlled trial; 397 patients with knee osteoarthritis participated and 324 completed the trial. They were randomly assigned 110 mg epicutaneous ketoprofen in 4.8 g Transfersome plus oral placebo (n = 138), 100 mg oral celecoxib plus placebo gel (n = 132), or both placebo formulations (n = 127) twice daily for 6 weeks. Primary efficacy outcome measures were the changes from baseline to end of the study on the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain subscale, physical function subscale and patient global assessment ( PGA) of response. RESULTS: The mean WOMAC pain subscale scores in the intent to treat population were reduced by 18.2 (95% confidence interval -22.1 to -14.3), 20.3 (-24.3 to -16.2) and 9.9 (-13.9 to -5.8) in the IDEA-033, celecoxib and placebo groups, respectively, and the physical function subscale score by 14.6 (-18.1 to -11.0), 16.6 (-20.2 to -13.0) and 10.2 (-13.8 to -6.6), respectively. The mean PGA of response scores were 1.8 (1.6 to 2.1), 1.7 (1.5 to 1.9) and 1.3 (1.1 to 1.5), respectively. The differences in change between IDEA-033 and placebo were statistically significant for pain subscale (p<0.01) and PGA of response (p<0.01). Gastrointestinal adverse events for IDEA-033 were similar to placebo. CONCLUSION:
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Authors | Matthias Rother, Bernard J Lavins, Werner Kneer, Klaus Lehnhardt, Egbert J Seidel, Stefan Mazgareanu |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 66
Issue 9
Pg. 1178-83
(Sep 2007)
ISSN: 0003-4967 [Print] England |
PMID | 17363401
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Drug Carriers
- Pyrazoles
- Sulfonamides
- Ketoprofen
- Celecoxib
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Topics |
- Administration, Cutaneous
- Administration, Oral
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, therapeutic use)
- Celecoxib
- Disability Evaluation
- Double-Blind Method
- Drug Carriers
- Female
- Humans
- Ketoprofen
(administration & dosage, therapeutic use)
- Least-Squares Analysis
- Male
- Middle Aged
- Osteoarthritis, Knee
(drug therapy, physiopathology)
- Pain Measurement
- Pyrazoles
(administration & dosage, therapeutic use)
- Skin Absorption
- Sulfonamides
(administration & dosage, therapeutic use)
- Treatment Outcome
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