E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with chronic venous insufficiency |
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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 | 10013283 |
E.1.2 | Term | Disorder vascular peripheral |
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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 this study is to compare the efficacy of the two investigational medicinal products (IMPs) in the relief of sum of score of subjective symptoms of chronic venous insufficiency (CVI). |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of the two IMPs in the changes from baseline of individual subjective symptoms and objective signs of chronic venous insufficiency; To compare the incidence of deep venous thrombosis (DVT) and necessity of surgical procedures in the two treatment groups; To compare the activity of the two IMPs in the changes from baseline of coagulation laboratory parameters; To assess the general and local safety of the two IMPs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be enrolled at Visit 1 if they meet all the following criteria: 1. Written informed consent obtained; 2. Outpatients of either sex, aged between 18 and 75 years; 3. Patients with ultrasonography-confirmed chronic venous insufficiency (CVI); 4. Diagnosed CEAP (clinical component) class 2-5 CVI; 5. Presence of at least two subjective symptoms and of at least two signs of CVI (of at least moderate degree, i.e. score ≥ 2); 6. Patients co-operative attitude and able to understand and adhere to study protocol procedures and timelines. |
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E.4 | Principal exclusion criteria |
Patients will not be enrolled at Visit 1 if they meet any of the following criteria: 1. Patients being treated with anticoagulant, fibrinolytic, antiplatelet, hemorheologic agents; 2. Patients being treated with concomitant drugs potentially acting on coagulation or platelet aggregation parameters; 3. History or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 4. History or current evidence of liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; 5. History or current evidence of DVT; 6. Evidence of venous, diabetic or ischemic leg ulcers; 7. Presence of peripheral artery obstructive disease; 8. Immunocompromised patients; 9. Malignant disease or any other disease with life expectancy less than 2 years; 10. History of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; 11. Patients on artificial enteral or parenteral feeding; 12. Allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; 13. Pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; 14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 15. Patients who received any investigational drug within the last 12 weeks; 16. Patients who have been previously enrolled in this study; 17. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
therapeutic success (resolution of signs and symptoms of chronic venous insufficiency (CVI). |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | 2 |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 3 |