E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affected by Systemic Sclerosis with Raynaud’s Phenomenon |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042953 |
|
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 |
Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis |
|
E.2.2 | Secondary objectives of the trial |
- Evaluate pre- and post-therapy modifications through the evaluation of the FMD (flow-mediated dilation) of the brachial artery - Evaluate in vitro variations of the immunological status (regulatory lymphocytes, effector lymphocytes, pro- and anti-inflammatory cytokines) using immunochemical techniques and flux cytometry |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients suffering from Raynaud’s Phenomenon (mild to severe) and no counter indications for Cilostazol therapy - The study will be conducted on patients affected by Systemic Sclerosis followed in the ambulatory of Immunology of the Department of Internal Medicine - American College of Rheumatology criteria is applied for the diagnosis of Systemic Sclerosis, disease classification (Limited or Diffuse) is determined following LeRoy’s criteria. Disease activity will be evaluated by the EUSTAR Systemic Sclerosis Activity score |
|
E.4 | Principal exclusion criteria |
- Severe renal failure: ClCr < 25 ml/min. - Mild to severe hepatic failure. - Congestive heart failure. - Pregnancy and lactation. - Patients with hemorrhagic predisposition (e.g. peptic ulcer, hemorrhagic stroke in the last 3 months, surgical procedures in the last 6 months, diabetic proliferative retinopathy, arterial hypertension not controlled) - Patients assuming CYP3A4 or CYP2C19 inhibitors (e.g. cimetidine, diltiazem, eritromicin, ketoconazole, lansoprazole, omeprazole, HIV-1 protease inhibitors) - Patients with history of ventricular tachycardia, ventricular fibrillation, multifocal ventricular extrasistolia and long QT syndrome. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Evaluate the efficacy of Cilostazol in reducing the frequency and severity of Raynaud’s Phenomenon attacks in patients affected by Systemic Sclerosis |
|
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 | No |
E.6.4 | Safety | No |
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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |