Efficacy and Safety Study of Intra-articular Multiple Doses of Icatibant in Patients With Painful Knee Osteoarthritis

What Was Tested

This registered phase 2 trial tested Icatibant.

The primary objective is to compare the overall treatment effect on pain relief between icatibant and placebo.

The registry classes the interventions as drug.

More on the Plan

This is a multinational, randomized, placebo-controlled study to be conducted in Europe and the US.

Study medication will be administered by intra-articular injection 3 times in weekly intervals, being followed by an observation period of further 11 weeks.

Who Took Part

The registry lists 590 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female subjects with painful osteoarthritis of the knee.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Icatibant and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Icatibant.

Those kept unaware of assignments: participant and investigator.

It started in 2006-02 with completion listed for 2007-07.

It ran at 5 sites in United States (1), Austria (1), Czechia (1), Germany (1) and Poland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pain during activity, at rest and at night will be measured daily via an electronic patient diary (EPD) using a 100-unit visual analog scale (VAS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Icatibant in 590 people.

With 590 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Icatibant compound page, all human trials.