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The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial

The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial - The efficacy of LTRA for human ACF

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029926
Enrollment
40
Registered
2017-11-13
Start date
2017-11-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with both colorectal ACF and resectable polyps

Interventions

receive Montelukast 10mg for 8 weeks no treatment observation

Sponsors

Yokohama City University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with resectable polyps. 2.Patients with more than 5 rectal ACF 3.Willingness to provide written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The amount of change rectal ACF in LTRA group and control group after 8weeks intervention

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakuma Higurashi

Yokohama City University Department of Gastroenterology and Hepatology

takuma_h@yokohama-cu.ac.jp045-787-2640

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026