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Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

NCT04920149 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-17

No results posted yet for this study

Summary

Multicenter, multinational, randomized, 2-arm, double-blind, phase II clinical study with 2000mg mesalamine, or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients during and following daily intake for 2 years.

Conditions

Interventions

DRUG

Mesalamine

The IMP will be supplied as sachets with slow-releasing granules.

DRUG

Placebo

The IMP will be supplied as sachets with slow-releasing granules.

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Karolinska Institutet

    collaborator OTHER

  • Ann-Sofie Backman

    lead OTHER

Principal Investigators

  • Ann-Sofie Backman, MD PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2032-09-30
Completion
2045-09-30

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04920149 on ClinicalTrials.gov