Subjects with symptomatic knee osteoarthritis
Conditions
Interventions
Product Name: Icatibant acetate
Product Code: HOE140
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Icatibant
CAS Number: 138614-30-9
Current Sponsor code: HOE140
Concentration unit:
Sponsors
Sanofi-Aventis Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the systemic exposure of icatibant after intra-articular injection;Secondary Objective: To evaluate the pharmacodynamic effect of icatibant via the Western Ontario McMaster Universities osteoarthritis pain questionnaire (WOMAC pain sub-score) and patient’s global assessment (PGA) To evaluate the safety of icatibant after intra-articular injection of a dose of 3 x 500 mcg;Primary end point(s): The primary endpoint will be the exposure of icatibant in the peripheral circulation; duration of observation will be 48 hours following each intra-articular injection. | — |
Countries
Lithuania
Outcome results
None listed