Status:
COMPLETED
Mesalazine Effects in Sporadic Colorectal Adenoma Patients
Lead Sponsor:
UMC Utrecht
Conditions:
Sporadic Colorectal Adenoma
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief 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...
Detailed Description
Rationale: Patients with sporadic colorectal adenomatous polyps removed by polypectomy have a high rate of polyp recurrence and carry an increased risk for the development of colorectal carcinoma (CRC...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01894685
Start Date
July 1 2012
End Date
June 1 2015
Last Update
December 8 2015
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX