Efficacy and safety of 3 intra-articular injections of 500 µg icatibant in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis, continued by an observation of safety and tolerability over a further double-blind 13-week period - NA
Phase 1
- Conditions
- patients with painful OA in the knee
- Registration Number
- EUCTR2006-005946-35-SK
- Lead Sponsor
- sanofi-aventis recherche & développement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Male and female subjects with painful osteoarthritis of the knee
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
. Subjects with knee OA of Kellgren & Lawrence grade < II [5] (see Appendix A)
· Age < 18 years
· Diagnosis of OA < 3 months (based on the 1986 American College of Rheumatology (ACR) diagnostic criteria [3], see Appendix A)
· Subjects with a low chance to meet the general knee pain score eligibility criteria for randomization at baseline (= 35 = 85 units on a 100-unit VAS)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to compare the overall treatment effect on pain relief between icatibant and placebo over a period of 3 months after the start of treatment.;Secondary Objective: The secondary objectives of the study are:<br>to evaluate the safety of icatibant versus placebo over the full 6-month study period<br>to evaluate overall conditions of daily life after treatment with icatibant versus placebo.;Primary end point(s): The primary efficacy variable will be the averaged VAS score for general knee pain which comprises pain during activity, pain at rest and pain at night in a ratio of 1 : 1 : 1.
- Secondary Outcome Measures
Name Time Method