Rectal mesalazine for FAP and MAP

Phase 1

• Conditions: Familial adenomatous polyposis(FAP) and MUTYH-associated polyposis (MAP); MedDRA version: 20.1 Level: PT Classification code 10056981 Term: Adenomatous polyposis coli System Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1 Level: LLT Classification code 10059327 Term: Familial adenomatous polyposis System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003076-13-PT
• Lead Sponsor: Instituto Português de Oncologia de Lisboa Francisco Gentil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

FAP or MAP patients submitted to colectomy and with previous
adenomas of the rectal stumps or ileal pouches.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Salicylates allergy, renal or hepatic insufficiency.
E.5

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified