Pharmacokinetics, pharmacodynamics and safety of intra-articular multiple doses of 500 mcg icatibant in an uncontrolled 13-week multi-center study in patients with symptomatic knee osteoarthritis - TRICAPEKA
- Conditions
- Subjects with symptomatic knee osteoarthritis
- Registration Number
- EUCTR2006-000763-29-LT
- Lead Sponsor
- Sanofi-Aventis Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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
- Subjects with knee OA of Kellgren & Lawrence grade < II
- Age < 18 years
- Diagnosis of OA < 3 months (based on the 1986 American College of Rheumatology (ACR) diagnostic criteria
- History of inflammatory or infectious joint disease of an origin other than OA
- Acute major trauma
- Existence of a relevant pain problem at localizations other than the target knee joint (e.g., migraine, low back pain etc., but also bilateral symptomatic knee OA)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method