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Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

NCT03070574 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-04-18

No results posted yet for this study

Summary

Multicenter, multinational, randomized, 3-arm, double-blind, phase II clinical study with 2400mg mesalamine, 1200mg mesalamine or placebo for prevention of colorectal neoplasia in Lynch Syndrome patients for 2 years.

Conditions

Interventions

DRUG

mesalamine 2400 MG (5-ASA)

For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers, each 1200mg of IMP (= 2400 mg), every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.

DRUG

mesalamine 1200 MG

For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers of IMP (1200 mg/placebo) every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.

OTHER

Placebo

For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers of IMP (placebo/placebo) every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.

Sponsors & Collaborators

  • Prof. Dr. Gabriela Möslein, Germany

    collaborator UNKNOWN

  • Prof. Dr. Hans Vasen, The Netherlands

    collaborator UNKNOWN

  • Prof. Dr. med. Jan Lubinski, Poland

    collaborator UNKNOWN

  • Prof. Dr. med. Yaron Niv, Israel

    collaborator UNKNOWN

  • Univ. Prof. Dr. Judith Karner-Hanusch, Austria

    collaborator UNKNOWN

  • Ann-Sofie Backman, MD PhD, Sweden

    collaborator UNKNOWN

  • Christoph Gasche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2019-04-10
Completion
2019-04-10

Countries

  • Austria
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT03070574 on ClinicalTrials.gov