E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Venous Insufficiency (CVI) CEAP Class C3 and C4 |
|
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 | 10066682 |
|
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 |
To show the superiority of Doxium 500 versus placebo in the reduction of oedema of the lower limbs in patients suffering from CVI (CEAP Class C3 or C4) |
|
E.2.2 | Secondary objectives of the trial |
Efficacy variables: Circumferences of the calf and the ankle, Quality of Life (questionnaire CIVIQ), symptoms (pain, discomfort, heavy and tired legs, tingling, itching and cramps), efficacy evaluation by both the investigator and the patient. Safety aspects and tolerability of the trial medication |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patient. Age 18 to 70 years. Suffering from unilateral or bilateral CVI CEAP Class C3 or C4. Presence of pitting oedema and discomfort and/or pain in at least one leg. Chronic oedema at a stable stage. Written informed consent |
|
E.4 | Principal exclusion criteria |
Diseases/symptoms that imitate the symptomatology of CVI (i.e. cardiac, hepatic, renal, orthopaedic, or other causes of leg oedema). Asymptomatic and/or symptomatic peripheral occlusive arterial disease. Diabetes mellitus Type I or II. Hypertension requiring a change in antihypertensive treatment within 6 weeks before study start. Operations of the venous system, sclerotherapy during the last 6 months. Phlebitis or deep leg vein thrombosis in the 3 months preceding inclusion in the study. Important obesity (BMI > 40 kg/m2). Wearing compressive stockings during the last 6 weeks. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the relative volume change in the most pathological leg assessed by water displacement volumetry |
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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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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
|
Last visit of the last subject |
|
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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |