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Mesalamine for colorectal cancer prevention program in Lynch syndrome

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514765-19-01
Enrollment
150
Registered
2024-11-27
Start date
2021-08-12
Completion date
Unknown
Last updated
2025-03-25

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

Conditions

Lynch syndrome, which is increasing the risk of developing colorectal cancer

Brief summary

Occurrence of any colorectal neoplasia (both benign and malignant tumors)

Detailed description

The number of colorectal neoplasia (both benign and malignant tumors) per patient, The tumor progress in the 4 ordered stages, The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and ≥45 years), Safety data are described and compared between groups in an exploratory manner

Interventions

DRUGPentasa Sachet 2 g depotgranulat
DRUGPentasa PLACEBO Sachet 2g in the granule formulation specifically designed to resemble the active drug product

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of any colorectal neoplasia (both benign and malignant tumors)

Secondary

MeasureTime frame
The number of colorectal neoplasia (both benign and malignant tumors) per patient, The tumor progress in the 4 ordered stages, The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and ≥45 years), Safety data are described and compared between groups in an exploratory manner

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026