drugset / Trial / NCT04296851

Niclosamide for Familial Adenomatous Polyposis

NCT04296851

Phase 2 Unknown 72 enrolled Yonsei University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Familial adenomatous polyposis (FAP) leads to adenomas and eventual adenocarcinomas in colon and less frequently, duodenum. Chemopreventive strategies have been studied in FAP patients to delay the development of adenomas and cancers. The non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclooxygenase-2 inhibitor have shown the regression of colorectal and duodenal adenomas in FAP patients. However, these drugs showed gastrointestinal damage and cardiovascular risks, and new preventive strategies are needed. Niclosamide, an anti-helminthic drug, has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of Wnt pathway, and have no significant safety issues. The investigators devised a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in FAP patients.

Timeline

Start
2020-02-14
Primary completion
2022-12
Completion
2023-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Niclosamide Unknown 650 mg Oral