Efficacy and safety of intra-articular multiple doses of 500 µg 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003258-87-DE

Enrollment

550

Registered

2006-01-10

Start date

2006-03-09

Completion date

Unknown

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with painful osteoarthritis in the knee

Interventions

Product Name: Icatibant acetate Product Code: Icatibant acetate Pharmaceutical Form: Solution for injection INN or Proposed INN: Icatibant acetate CAS Number: 138614-30-9 Current Sponsor code: HOE140

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 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 ·

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare the overall treatment effect of pain relief in the affected knee joint between icatibant and placebo in terms of daily average of general knee pain Visual Analog Scale score.;Secondary Objective: To assess the efficacy of icatibant in terms of onset, extent and duration of pain relief relative to triamcinolone (used as calibrator) To evaluate the safety of icatibant versus placebo and triamcinolone To evaluate overall conditions of daily life (reflected by patient´s global assessment and the Western Ontario McMaster Universities osteoarthritis questionnaire) after treatment with icatibant versus placebo and trimacinolone To assess systemic exposure of icatibant following intra-art. injection ;Primary end point(s): The primary efficacy endpoint will be the baseline-corrected daily averaged VAS score for general knee pain which comprises pain during activity, pain at rest and pain at night in a ratio of 1 : 1 : 1.	—

Measure

Time frame

Main Objective: The primary objective of the study is to compare the overall treatment effect of pain relief in the affected knee joint between icatibant and placebo in terms of daily average of general knee pain Visual Analog Scale score.;Secondary Objective: To assess the efficacy of icatibant in terms of onset, extent and duration of pain relief relative to triamcinolone (used as calibrator) To evaluate the safety of icatibant versus placebo and triamcinolone To evaluate overall conditions of daily life (reflected by patient´s global assessment and the Western Ontario McMaster Universities osteoarthritis questionnaire) after treatment with icatibant versus placebo and trimacinolone To assess systemic exposure of icatibant following intra-art. injection ;Primary end point(s): The primary efficacy endpoint will be the baseline-corrected daily averaged VAS score for general knee pain which comprises pain during activity, pain at rest and pain at night in a ratio of 1 : 1 : 1.

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Countries

Austria, Czech Republic, Germany, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026