Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Polyp and Adenoma Detection During Colonoscopy
Both
Polyp and Adenoma Detection During Colonoscopy
Trial Information
Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy
Polyp detection rate in colonoscopy following oral administration of methylene blue MMX
modified release tablets in subjects undergoing colonoscopy as outpatients.
Inclusion Criteria:
- Patients scheduled for screening or surveillance colonoscopy. Written informed
consent.Practising reliable contraception or sterile.Ability to understand and comply
with the protocol.
Exclusion Criteria:
- Pregnancy or lactation known or suspected hypersensitivity GI obstruction or
perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin
time,elevated serum creatinine.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Polyp and adenoma detection rate
Outcome Time Frame:
1 day
Safety Issue:
No
Authority:
Italy: Aifa-Agenzia Italiana del Farmaco
Study ID:
CB-17-01/05
NCT ID:
NCT01520337
Start Date:
January 2012
Completion Date:
Related Keywords:
- Polyp and Adenoma Detection During Colonoscopy
- Adenoma
- Polyps
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