The efficacy of LTRA for human ACF

JRCT ID: jRCTs031180094

Registered date:25/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients with both colorectal ACF and resectable polyps
• Date of first enrollment: 15/12/2017
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Taking tablets of leukotriene receptor antagonist

Outcome(s)

• Primary Outcome: The amount of change rectal ACF in LTRA group and control group after 8 weeks intervention

Secondary Outcome

- The number of rectal ACF before and after intervention in both group
- Ki67 labeling index of colorectal adenoma/cancer and normal mucosa before and after intervention
- Safety

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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

Exclude 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.Patients judged as inappropriate candidates for the trial by the investigators

Related Information

• Primary Sponsor: Misawa Noboru
• Secondary Sponsor: Higurashi Takuma
• Source(s) of Monetary Support: Kanagawa Institute of Industrial Science and Technology
• Secondary ID(s): UMIN000029926