CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 150 target
Drug / intervention
Mesalamine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Proven tumor-free carriers of germline pathologic mutation in MMR genes (MLH1, MSH2, MSH6)
  • ✓Age 30 years or older
  • ✓Female contraception: post-menopausal >1 year, or using highly efficient contraception (<1% failure rate), or agreeing to abstain from heterosexual activity
  • ✓Negative pregnancy test at screening and before randomization (females of childbearing potential)
Key exclusion· 17
  • ✕Colorectal endoscopically non-removable benign neoplasia
  • ✕Germline PMS2 mutation carriers
  • ✕History of stage 3 and 4 colorectal cancer
  • ✕Metastatic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04920149Phase 2RecruitingOn TrackUpdated 18mo ago
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Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Ann-Sofie Backman·interventional·Posted Jun 9, 2021·Updated Dec 17, 2024

In Brief

A Phase 2 clinical trial evaluating Mesalamine and Placebo for Lynch Syndrome and 2 related conditions. Currently recruiting, targeting 150 participants across 8 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLynch Syndrome, Colon Cancer, Colon Neoplasm
CountriesDenmark, Sweden
CollaboratorsThe Swedish Research Council, Karolinska Institutet

Timeline

Phase 2Recruiting
20212022202320242025202620272028202920302031203220332034203520362037203820392040204120422043204420452046
First PostedJun 9, 2021
Enrollment StartMar 21, 2022
Primary CompletionSep 30, 2032
Study CompletionSep 30, 2045
TodayJul 2, 2026
Enrollment to primary: 10.5 yearsPosted 5.1 years agoPrimary completion in 6.2 years

Interventions

Mesalaminedrug

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

Placebodrug

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