Mesalazine Effects in Sporadic Colorectal Adenoma Patients
Chemopreventive Effects of Mesalazine in Patients at High Risk of Recurrent (Nonfamilial) Colorectal Adenomas
1 other identifier
interventional
74
1 country
1
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 is an attractive candidate for chemoprevention. In this study we aim to investigate the antineoplastic properties of mesalazine in patients with sporadic colorectal adenomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 3, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 8, 2015
December 1, 2015
2.9 years
July 3, 2013
December 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Apoptotic index
Change in apoptotic index after treatment with mesalazine as compared to placebo
6 months
Proliferation index
Change in proliferation index and distribution of proliferating cells in crypts after treatment with mesalazine as compared to placebo
6 months
Secondary Outcomes (1)
Expression of β-catenin signaling pathway
6 months
Study Arms (2)
Mesalazine
EXPERIMENTALMesalazine, 3 grams once daily for six months
Placebo
PLACEBO COMPARATORPlacebo, 3 grams, once daily for six months
Interventions
Eligibility Criteria
You may qualify if:
- age: 50-75 years
- having undergone complete colonoscopy with polypectomy for removal of
- or more colorectal adenomas, irrespective of size, and/or
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. dr. (MD, PhD) P.D. Siersema
Study Record Dates
First Submitted
July 3, 2013
First Posted
July 10, 2013
Study Start
July 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 8, 2015
Record last verified: 2015-12