Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Long Standing Ulcerative Colitis
Both
Long Standing Ulcerative Colitis
Trial Information
Intraepithelial Neoplasia Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Patients With Long Standing Ulcerative Colitis Undergoing Colonoscopy.
Inclusion Criteria:
- endoscopically verified UC signed written informed consent
Exclusion Criteria:
- Known or suspected GI obstruction or perforation Liver or renal impairment,
malignancy, pregnancy or lactation, suppressed PT.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Intraepithelial neoplasia detection rate
Outcome Time Frame:
1 year
Safety Issue:
No
Authority:
Italy: AIFA Agenzia Italiana del Farmaco
Study ID:
CB-17-01/04
NCT ID:
NCT01520324
Start Date:
January 2012
Completion Date:
Related Keywords:
- Long Standing Ulcerative Colitis
- Neoplasms
- Colitis
- Colitis, Ulcerative
- Ulcer
- Carcinoma in Situ
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