E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients affecetd by Long standing ulcerative colitis |
Pazienti affetti da Colite Ulcerativa di lunga durata |
|
E.1.1.1 | Medical condition in easily understood language |
Patients affecetd by Long standing ulcerative colitis |
Pazienti affetti da Colite Ulcerativa di lunga durata |
|
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 | SOC |
E.1.2 | Classification code | 10017947 |
E.1.2 | Term | Gastrointestinal disorders |
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 |
Detection rate evaluation of intraepithelial tumors |
Valutazione dell'incidenza delle neoplasie intraepiteliali |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
male and Female patients, aged more than 18 years, affected by Long standing ulcerative colitis for more than 8 years. informed consent signed. |
Pazienti di entrambi i sessi, di eta superiore a 18 anni, affetti da colite ulcerativa da più di 8 anni. con consenso informato firmato. |
|
E.4 | Principal exclusion criteria |
Pregnancy, allergies, diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulosis with diverticulitis, heart failure, serious cardiovascular disease, severe liver failure, end-stage renal insufficiency. Presence of intraepithelial tumors. coagulation alterations. |
Gravidanza, allergie,malattie: ostruzione o perforazione gastrointestinale, megacolon tossico, resezioni del colon, diverticolite, scompenso cardiaco, grave insufficienza epatica, insufficienza renale terminale. presenza di neoplasie intraepiteliali o di altri tumori. Alterazioni della coagulazione. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Intraepithelial neoplasia detection rate. |
Incidenza di tumori intraepiteliali |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the Colonoscopy |
Durante la Coloscopia |
|
E.5.2 | Secondary end point(s) |
Extent and severity of the inflamed mucosa.
Mucosal staining efficacy.
Bowel cleansing quality.
Collection data of safety. |
Estensione e Gravità dell'infiammazione.
validità della colorazione della mucosa.
Qualità della pulizia intestinale.
Raccolta dei dati di sicurezza |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During Colonoscopy |
Durante la coloscopia |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 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
|
|
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 |