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Niclosamide for Familial Adenomatous Polyposis

Primary Purpose

Familial Adenomatous Polyposis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Niclosamide
placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Adenomatous Polyposis focused on measuring chemoprevention, niclosamide, familial adenomatous polyposis

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Internal Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

niclosamide

placebo

Arm Description

650mg daily

identical- appearing placebo

Outcomes

Primary Outcome Measures

Mean percentage change of the number and size of polyps in colon and/or duodenum.
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.

Secondary Outcome Measures

A qualitative assessment of the total extent of colorectal polyposis
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.

Full Information

First Posted
March 3, 2020
Last Updated
March 3, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04296851
Brief Title
Niclosamide for Familial Adenomatous Polyposis
Official Title
The Chemopreventive Effect of Niclosamide in Patients With Familial Adenomatous Polyposis: Double Blinded Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 14, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Adenomatous Polyposis
Keywords
chemoprevention, niclosamide, familial adenomatous polyposis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double blind randomized
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
niclosamide
Arm Type
Experimental
Arm Description
650mg daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
identical- appearing placebo
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean percentage change of the number and size of polyps in colon and/or duodenum.
Description
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.
Time Frame
After six-month administration of niclosamide/placebo
Secondary Outcome Measure Information:
Title
A qualitative assessment of the total extent of colorectal polyposis
Description
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.
Time Frame
After six-month administration of niclosamide/placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TAE IL KIM, Ph.D
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac
Facility Information:
Facility Name
Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAE IL KIM, Ph.D
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

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Niclosamide for Familial Adenomatous Polyposis

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