Niclosamide for Familial Adenomatous Polyposis

March 3, 2020 updated by: Yonsei University

The Chemopreventive Effect of Niclosamide in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 criteria, will be randomly assigned in a 2:1 ratio to receive niclosamide (650 mg) or placebo tablets orally once a day for 6 months. The base-line and six-month endoscopic examination (colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy) will be recorded, and photographs will be taken at the tattoo-marked area. The number and size of polyps, and a qualitative assessment of the total extent of polyposis will be measured. If there is no significant improvement in any of the 12 initial cases (niclosamide 8: placebo 4), this trial will be discontinued.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Internal Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: niclosamide
650mg daily
Drug: Niclosamide
The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.
Placebo Comparator: placebo
identical- appearing placebo
Drug: placebo
The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean percentage change of the number and size of polyps in colon and/or duodenum.
Time Frame: After six-month administration of niclosamide/placebo
At the base-line endoscopy (colonoscopy and upper gastrointestinal endoscopy), india-ink tattoo will be placed in the ascending colon, sigmoid colon/rectum, and duodenum. In case of the subjects with retained rectum after colectomy and ileorectal anastomosis, sigmoidoscopy will be performed. The base-line and six-month endoscopic examination will be recorded, and photographs will be taken at the tattoo-marked area and used for measurements of the number and size of polyps. The diameter of a polyp will be measured with the aid of biopsy forceps included in the photographic field, and only distinct polyps at least 2 mm in diameter will be counted.
After six-month administration of niclosamide/placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A qualitative assessment of the total extent of colorectal polyposis
Time Frame: After six-month administration of niclosamide/placebo
A qualitative assessment of the total extent of colorectal polyposis will be conducted via video review(at base line and month 6) by two endoscopists experienced in the management of FAP, and scored as the same as, better than, or worse than base-line endoscopic findings, without the endoscopists' being aware of treatment group.
After six-month administration of niclosamide/placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0566

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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