E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients suffering from symptomatic Chronic Venous Disease (CVD). |
Pacientes adultos con insuficiencia venosa crónica (IVC) sintomática. |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Venous Disease |
Insuficiencia Venosa Crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066682 |
E.1.2 | Term | Chronic venous insufficiency |
E.1.2 | System Organ Class | 100000004866 |
|
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 demonstrate the clinical non inferiority of efficacy between Daflon 1000 mg (1 sachet per day) and Daflon 500 mg (2 tablets per day), in improving lower limb discomfort assessed by a 10 cm visual analogue scale (VAS) after eight weeks of treatment in patients suffering from CVD |
Demostrar la no inferioridad clínica en cuanto a eficacia entre Daflon® 1000 mg (1 sobre al día) y Daflon® 500 mg (2 comprimidos diarios) para mejorar las molestias en las extremidades inferiores, evaluadas mediante una escala visual analógica (EVA) de 10 cm, tras ocho semanas de tratamiento en pacientes con síntomas de IVC. |
|
E.2.2 | Secondary objectives of the trial |
To determinate the evolution of efficacy during the study of each symptoms (leg pain, leg heaviness assessed by 10 cm Visual Analogue Scale), the quality of life evolution in both group (assessed by CIVIQ-20), and the safety profile and so, the acceptability of Daflon 1000 mg as compared to Daflon 500 mg. |
Determinar la evolución de la eficacia durante el estudio de cada síntoma (dolor de piernas, pesadez de piernas evaluada mediante una escala visual analógica de 10 cm), la evolución de la calidad de vida en ambos grupos (evaluada mediante la escala CIVIQ-20) y el perfil de seguridad, así como la aceptabilidad de Daflon® 1000 mg en comparación con Daflon® 500 mg. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient 20 to 75 years old (inclusive), Male or female, Outpatients, Patients suffering from primary chronic venous disease Clinical class C0s to C4s on the most affected leg, according to the CEAP classification, |
Paciente de entre 20 y 75 años de edad, ambos inclusive. Hombre o mujer. Paciente ambulatorio. Insuficiencia venosa crónica primaria Clase clínica entre C0s y C4s en la pierna más afectada, según la clasificación CEAP. |
|
E.4 | Principal exclusion criteria |
Pregnancy, breastfeeding or possibility of becoming pregnant during the study |
Embarazo, lactancia materna o posibilidad de quedarse embarazada durante el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of Daflon 1000 trough: Lower limb discomfort related to CVD and assessed by a 10 cm visual analog scale |
Evaluar la eficacia de Daflon 1000 mediante: Molestias en las extremidades inferiores relacionadas con la IVC y evaluadas mediante una escala visual analógica de 10 cm |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At selection (ASSE), W0, W2, W4 and W8. |
En las visitas de selección (SEL), S0, S2, S4 y S8 |
|
E.5.2 | Secondary end point(s) |
1/ To evaluate the efficacy of Daflon 1000 trough: Leg pain assessed by VAS Leg heaviness assessed by VAS , Quality of life assessed by CIVIQ-20.
2/ To evaluate the safety of Daflon 1000 trough: a/Adverse events, b/vital signs and c/overall acceptability. |
1/Evaluar la eficacia del Daflon 1000 mediante: Dolor de piernas evaluado mediante una EVA . Pesadez de piernas evaluada mediante una EVA . Calidad de vida evaluada mediante la escala CIVIQ-20
2/Evaluar la seguridad del Daflon 1000 mediante: a/Acontecimientos adversos, b/Constantes vitales c/Aceptabilidad global |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1/at selection (ASSE), W0, W2, W4 and W8, 2/ a/b/ at each visit c/ at W8 |
1/en las visitas de selección, S0, S2, S4 y S8, 2/ a/b/ en cada visita c/ en S8 |
|
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | No |
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 |
Argentina |
Brazil |
Colombia |
Czech Republic |
Italy |
Malaysia |
Mexico |
Portugal |
Romania |
Russian Federation |
Slovenia |
Spain |
Thailand |
Turkey |
Vietnam |
|
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 Last Participant |
Última Visita del Último Paciente |
|
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 | 14 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 21 |