Status:
UNKNOWN
Niclosamide for Familial Adenomatous Polyposis
Lead Sponsor:
Yonsei University
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief 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 de...
Detailed Description
This clinical trial is a double-blind randomized controlled trial to evaluate the effect of niclosamide on polyps of colorectum and duodenum in FAP patients. FAP patients, satisfied an enrollment crit...
Eligibility Criteria
Inclusion
- Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age.
- FAP patients who have colonic or duodenal polyp.
- FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.
Exclusion
- FAP patients who had a history of colectomy within the previous 12 months or need to undergo colectomy within 8 months after randomization.
- FAP patients with malignant disease, including colorectal cancer.
- FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three or more times a week within 6 months of randomization.
- Pregnant or breast-feeding patients. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test).
Key Trial Info
Start Date :
February 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04296851
Start Date
February 14 2020
End Date
February 1 2023
Last Update
March 5 2020
Active Locations (1)
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1
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea