The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial
Phase 2
- Conditions
- Patients with both colorectal ACF and resectable polyps
- Registration Number
- JPRN-UMIN000029926
- Lead Sponsor
- Yokohama City University
- Brief Summary
TRA decreased rectal ACF
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with lesion which preferred early resection. 2.History of use of LTRA within 2months before trial entry. 3.History of malignant disease within 5 yeears before trial entry. 4.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 5.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease 6.Pregnancy or possibility of pregnancy 7.Contraindication to Montelukast 8.Allergy to Montelukast 9.Regular use of NSAIDs, metformin, piogrlitazone 10.Patients judged as inappropriate candidates for the trial by the investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change rectal ACF in LTRA group and control group after 8weeks intervention
- Secondary Outcome Measures
Name Time Method The number of rectal ACF before and after intervention in both group Ki67 labeling index of colorectal adnoema/cancer and normal mucosa before and after intervention Safety