Patients affecetd by Long standing ulcerative colitis MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Methylene blue 25mg tablets
Product Code: NA
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: METHYLENE BLUE
Current Sponsor code: NA
Other descriptive name: NA
Concentr
Sponsors
COSMO TECHNOLOGIES LTD
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: none;Primary end point(s): Intraepithelial neoplasia detection rate.;Timepoint(s) of evaluation of this end point: During the Colonoscopy;Main Objective: Detection rate evaluation of intraepithelial tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Extent and severity of the inflamed mucosa. Mucosal staining efficacy. Bowel cleansing quality. Collection data of safety.;Timepoint(s) of evaluation of this end point: During Colonoscopy | — |
Countries
Italy
Contacts
Public ContactDipartimento di Gastroenterologia
IRCCS HUMANITAS
Outcome results
None listed