Rectal mesalazine for FAP and MAP

Effect of topical mesalazine on the formation of adenomas in rectal stumps or ileal pouches of familial adenomatous polyposis or MUTYH associated polyposis patients after colectomy - MAPAF trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003076-13-PT

Enrollment

Registered

2019-06-07

Start date

2019-10-14

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: PENTASA enema Pharmaceutical Form: Enema INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: millilitre(s)/gram Concentration type: equal Concentration number: 1000-

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Salicylates allergy, renal or hepatic insufficiency. E.5

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the effect of topical mesalazine over the number of adenomas of the rectal stump or ileal pouch of FAP or MAP patients.;Secondary Objective: To test the effect of topical mesalazine over the adenomas' size, morphology and grade of dysplasia and over the mucosa's cellular proliferation index and nuclear beta-catenin expression in the rectal stumps or ileal pouches of FAP or MAP patients.;Primary end point(s): Number of rectal stump or ileal pouch adenomas larger than 5mm.;Timepoint(s) of evaluation of this end point: 0, 6, 12 and 18 months.	—

Measure

Time frame

Main Objective: To test the effect of topical mesalazine over the number of adenomas of the rectal stump or ileal pouch of FAP or MAP patients.;Secondary Objective: To test the effect of topical mesalazine over the adenomas' size, morphology and grade of dysplasia and over the mucosa's cellular proliferation index and nuclear beta-catenin expression in the rectal stumps or ileal pouches of FAP or MAP patients.;Primary end point(s): Number of rectal stump or ileal pouch adenomas larger than 5mm.;Timepoint(s) of evaluation of this end point: 0, 6, 12 and 18 months.

—

Secondary

Measure	Time frame
Secondary end point(s): Mean, median and maximal size of adenomas Number of villous or tubulo-villous adenomas. Number of adenomas with high-grade dysplasia. Number of adenomas larger than 1cm.;Timepoint(s) of evaluation of this end point: 0, 6, 12 and 18 months.	—

Countries

Portugal

Contacts

Public ContactIsadora Rosa

Instituto Português de Oncologia de Lisboa

isarosa@ipolisboa.min-saude.pt00351217229892

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026