E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with painful osteoarthritis in the knee |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female subjects with painful osteoarthritis of the knee |
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E.4 | Principal 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 · |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 16 |