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Clinical Trials/EUCTR2006-000763-29-LT
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

Sanofi-Aventis Deutschland GmbH0 sites12 target enrollmentApril 13, 2006

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.

Registry
who.int
Start Date
April 13, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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