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Efficacy and safety of intra-articular multiple doses of 500 mg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-ce...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-003258-87

Efficacy and safety of intra-articular multiple doses of 500 mg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis *After the clinical start of the study, an extension of the follow-up period has been established by Amendment n° 2, extending the observation period by further 26 weeks; thus, the overall study duration will become totally 39 weeks

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Extrait

The primary objective of the study is to compare the overall treatment effect of pain relief in the affected knee joint between icatibant and placebo in terms of daily average of general knee pain Visual Analog Scale score.

Critère d'inclusion

  • Subjects with painful osteoarthritis in the knee

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