Mesalazine Effects in Sporadic Colorectal Adenoma Patients

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Several studies indicate that mesalazine might have a preventive effect on recurrence of adenomas in patients with and without inflammatory bowel disease. As mesalazine has limited adverse effects, it is an attractive candidate for chemoprevention. In this study we aim to investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal adenomas.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• age: 50-75 years

• having undergone complete colonoscopy with polypectomy for removal of

• 2 or more colorectal adenomas, irrespective of size, and/or

• 1 colorectal adenoma:

• of at least 1 cm in diameter and/or

• located proximal to the splenic flexure and/or

• with high-grade dysplasia and/or villous histology

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

• diabetes mellitus (higher risk for developing renal disease)

• coagulation disorder or anticoagulant use, which cannot be temporarily discontinued (precludes biopsy taking)

• asthma

• prescription use of acetylsalicylic acid or calcium carbasalate (high- and low-dose) or other NSAIDs

• use of medicines which may interact with mesalazine: methotrexate, thiopurines, cyclosporine, coumarin anticoagulants and rifampicin