E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a phase III trial. The population will be ambulatory men and women with knee osteoarthritis between 51 and 80 years old, in general good health |
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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 study has three primary endpoints: 1. JSW in the medial tibio-femoral knee joint measured by X-ray 2. Pain to be assessed by the WOMAC pain subscale 3. Function to be assessed by the WOMAC function subscale.
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E.2.2 | Secondary objectives of the trial |
Secondary endpoints include total WOMAC (pain, function and stiffness), pain (VAS), physical activity (VAS), global assessment (VAS, subject and physician), parameters derived from Magnetic Resonance Imaging (MRI), and radiographic parameters of the hand and biochemical measures of cartilage and bone turnover Evaluation of patients with hand OA by hand X-ray, and for pain, functional disability and stiffness (AUSCAN). Safety endpoints include adverse events by system organ class and lowest level term, changes in safety laboratory analyses (serum chemistry, hematology), and number of subjects with antibodies (Yes/No). An external Data Safety Monitoring Board will monitor subject safety on defined time points throughout the trial.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ambulatory men and women with knee osteoarthritis, between 51 and 80 years old, in general good health. |
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E.4 | Principal exclusion criteria |
Any disease or medication affecting the bone or cartilage metabolism (osteoporosis is allowed). • Conditions causing secondary osteoarthritis of the study joint • Obese study subjects with unilateral aggressive progressing knee OA. • Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years. • Any clinical signs or laboratory evidence for severe renal/liver/pulmonary, neurologic, cardiovascular, metabolic, hematological or psychiatric condition, which in the Investigator’s opinion would preclude the participant from adhering to the Protocol or completing the trial. • Diagnostic arthroscopy with a surgical procedure within 6 moths prior to the screening or plan to have a surgery during the clinical trial. • History of drug abuse or active alcoholism. • Any investigational drug(s) within 30 days prior to screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of the trial is to study the effect of oral calcitonin compared to placebo with three primary endpoints: 1.JSW in the medial tibio-femoral knee joint in the signal knee measured by X-ray 2. Pain to be assesses by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain sub score in the signal knee 3. Functional disability to be assessed by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) function sub score in the signal knee |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 24 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 24 |