EUCTR2006-000763-29-LT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sanofi-Aventis Deutschland GmbH
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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