Efficacy and safety of 3 intra-articular injections of 500 µg icatibant in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis, continued by an observation of safety and tolerability over a further double-blind 13-week period - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005946-35-SK

Enrollment

450

Registered

2007-04-03

Start date

2007-05-17

Completion date

Unknown

Last updated

2017-03-13

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

Conditions

patients with painful OA in the knee

Interventions

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

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 [5] (see Appendix A) · Age < 18 years · Diagnosis of OA < 3 months (based on the 1986 American College of Rheumatology (ACR) diagnostic criteria [3], see Appendix A) · Subjects with a low chance to meet the general knee pain score eligibility criteria for randomization at baseline (= 35 = 85 units on a 100-unit VAS)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare the overall treatment effect on pain relief between icatibant and placebo over a period of 3 months after the start of treatment.;Secondary Objective: The secondary objectives of the study are: to evaluate the safety of icatibant versus placebo over the full 6-month study period to evaluate overall conditions of daily life after treatment with icatibant versus placebo.;Primary end point(s): The primary efficacy variable will be the 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 on pain relief between icatibant and placebo over a period of 3 months after the start of treatment.;Secondary Objective: The secondary objectives of the study are: to evaluate the safety of icatibant versus placebo over the full 6-month study period to evaluate overall conditions of daily life after treatment with icatibant versus placebo.;Primary end point(s): The primary efficacy variable will be the 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

Slovakia

Outcome results

None listed

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