The efficacy of LTRA for human ACF

Phase 2

• Conditions: Patients with both colorectal ACF and resectable polyps

• Registration Number: JPRN-jRCTs031180094
• Lead Sponsor: Misawa Noboru

Brief Summary

During the study period, 30 patients in the LTRA group and 10 patients in the no-treatment follow-up group were enrolled. In the LTRA group, the number of ACF decreased significantly from 7.9 +/- 3.0 (pre-treatment) to 5.5 +/- 3.3 (post-treatment, after 8 weeks of LTRA treatment) (p<0.001). While the number of ACFs in the no-treatment follow-up group was 11.0 +/- 5.4 at the baseline to 11.4+/- 5.8 after 8 weeks, no significant change the number of ACFs was observed (p=0.578).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-25
• Study Completion: 2020-05-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified