Efficacy and safety of intra-articular multiple doses of 500 mg icatibant including 40 mg triamcinolone as calibrator in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis*After the clinical start of the study, an extension of the follow-up period has been established by Amendment n° 2, extending the observation period by further 26 weeks; thus, the overall study duration will become totally 39 weeks. - TRICAP

Phase 1

• Conditions: Subjects with painful osteoarthritis in the knee

• Registration Number: EUCTR2005-003258-87-SK
• Lead Sponsor: Sanofi Aventis Deutschland GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 27 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

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 another pain problem at localizations other than the target knee joint (e.g., migraine, low back pain etc., but also bilateral symptomatic knee OA)
·Any intra-articular injections within the previous 6 months of hyaluronic acid (HA) or within 3 months of corticosteroids, respectively
·Surgery of the lower extremities within the last 6 months, or clinically relevant trauma with impact on study objectives within the last 2 months
·Cardiovascular diseases or any abnormal findings in the electrocardiogram (ECG) that may require acute treatment or could otherwise interfere with the conduct of the trial
·Childbearing potential without an accepted contraceptive regimen, i.e., a measure with a proven low failure rate
·Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
·Symptoms of a clinically relevant illness in the 3 months before the study with possible impact on the study objectives (e.g. episodes of headache or migraine, intermittent paresis, peripheral obstructive arterial disease etc.)
·Pregnancy or breast-feeding
·History of hypersensitivity to the study drug or to drugs with a similar chemical structure
·Hypersensitivity to paracetamol (acetaminophen)
·Hypersensitivity to corticosteroids
·Diabetes mellitus type 1 or 2 (due to known interactions of triamcinolone with anti-diabetics resulting in glucose dysbalances)
·Treatment with anti-coagulation therapy
·Treatment with any investigational product in the last 3 months before study entry

Exclusion criteria at baseline (Visit 2)
Subjects presenting at baseline additionally with any of the following will not be included in the study:
·General knee pain score < 40 units and > 80 units on a 100-unit VAS
·Compliance of < 75% of the EPD entries during the entire screening phase
·Intake of paracetamol or any other OA-directed medication during the screening phase
·

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified