Clinical trial · Interventional
Mesalazine Effects in Sporadic Colorectal Adenoma Patients
Chemopreventive Effects of Mesalazine in Patients at High Risk of Recurrent (Nonfamilial) Colorectal Adenomas
NCT01894685CI-TRIAL-00020110completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sporadic Colorectal Adenoma | Adenoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesalazine | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mesalazine
- description
- Mesalazine, 3 grams once daily for six months
- interventionNames
- Drug: Mesalazine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo, 3 grams, once daily for six months
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Apoptotic index
- timeFrame
- 6 months
- description
- Change in apoptotic index after treatment with mesalazine as compared to placebo
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.