E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Microscopic colitis |
Colitis microscópica |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic diarrhea |
Diarrea Crónica |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10056979 |
E.1.2 | Term | Colitis microscopic |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 | 10048928 |
E.1.2 | Term | Colitis collagenous |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 | 10025268 |
E.1.2 | Term | Lymphocytic colitis |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 assess the efficacy of beclometasone dipropionate on microscopic colitis during short term follow-up (4 weeks) |
Evaluar la eficiacia del dipronionato de beclometasona en colitis microscópica a corto plazo (4 semanas) |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of beclometasone dipropionate on microscopic colitis during mid term follow-up (up to one year) To assess the efficacy of beclometasone dipropionate on microscopic colitis recurrences To assess the safety of beclometasone dipropionate on microscopic colitis To assess the efficacy of beclometasone dipropionate on microscopic colitis histologic changes |
Evaluar la eficacia del dipropionato de beclometasona en colitis microscópica a medio plazo (hasta un año) Evaluar la eficacia del dipropionato de beclometasona sobre las recidivas de colitis microscópica Evaluar la seguridad del dipropionato de beclometasona en colitis microscópica Evaluar la eficacia del dipropionato de beclometasona en cuanto a cambios microscópicos en la colitis microscópica |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients diagnosed of microscopic colitis (either lymphocitic or collagenous) |
Pacientes diagnosticados de colitis microscópica (tanto linfocítica como colaginosa) |
|
E.4 | Principal exclusion criteria |
Age under 18 Pregnancy or lactancy Either allergy or intolerance to the substance Corticosteroids treatment contra-indications Other causes of diarrhea |
Menos de 18 años Embarazo o lactancia Alergia o intolerancia al medicamento Contraindicaciones de tratamiento con Coriticoesteroides Otras causas de diarrea |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Diarrhea (3 or more depositions per day) |
Diarrea (3 o más deposiciones diarias) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 weeks 1 year |
4 semanas 1 año |
|
E.5.2 | Secondary end point(s) |
Faecal incontinence (involuntary faecal depositions) Weight loss (at least 5% of previous weight) Histological healing (dissapearance of histological changes) Histological response (improvement of histological changes without total healing) |
Incontinencia fecal (deposiciones fecales involuntarias) Pérdida de peso (al menos un 5% del peso previo) Curación histológica (desaparición de cambios histológicos) Respuesta histológica (mejoría parcial de los cambios histológicos) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 weeks 1 year |
4 semanas 1 año |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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 | No |
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
|
The end of the trial would happen when sample size is reached (after one year of follow up) or after tw years (one year of recruitment if sample size is not reached, followed by one year of follow up after last inclusion) |
Se llegará al final del Ensayo cuando se alcance el tamaño muestral (después de 1 año de seguimiento) o después de dos años (un año de reclutamiento, si no se alcanza el tamaño muestral, seguido de un año de seguimiento después de la fecha de la última inclusión) |
|
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 |