Chemopreventive effects of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas

Phase 2

Completed

• Conditions: sporadic colorectal adenoma; sporadic colorectal adenomatous polyps; 10017934; 10017987

• Registration Number: NL-OMON38274
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

- Within 6 months before study entry having undergone complete colonoscopy with polypectomy for removal of sporadic adenomatous polyps. This should be 2 or more adenomas, irrespective of size, and/or one adenoma with a diameter of at least 1 cm and/or with proximal localization and/or with villous aspects or high-grade dysplasia.
- age 50-75 years

Exclusion Criteria

- inflammatory bowel disease
- familial colorectal cancer syndrome
- history of colorectal carcinoma
- history of surgery to the large bowel (except appendectomy)
- chronic renal insufficiency
- chronic hepatic insufficiency
- allergy to salicylates
- asthma
- diabetes mellitus
- coagulation disorder or anticoagulant use, which cannot be temporarily discontinued
- regular intake of thiopurines, methotrexate or cyclosporin
- prescription use of aspirin (high- and low-dose) or other NSAIDs

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effect of treatment with mesalazine on apoptotic and proliferation indices<br /><br>and distribution of proliferating cells relative to the placebo group. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The effect of treatment with mesalazine on the mRNA and protein expression of &beta;-<br /><br>catenin signalling pathway components relative to the placebo group.</p><br>