20 Years
65 Years
Both
Familial Adenomatous Polyposis
Trial Information
Inclusion Criteria:
1. Patients with familial adenomatous polyposis(FAP) who are 20 to 65 years of age.
2. FAP patients who had not undergone colectomy or have retained rectum after colectomy
and ileorectal anastomosis. 3. FAP patients who have five or more polyps 2mm or more
in diameter in endoscopic examination.
Exclusion Criteria:
1. FAP patients who had a history of colectomy within the previous 12 months or need to
undergo colectomy within 8 months after randomization.
2. FAP patients with malignant disease, including colorectal cancer.
3. FAP patients who used NSAIDs (non-steroidal anti-inflammatory drugs) or aspirin three
or more times a week within 6 months of randomization. 4. FAP patients with diabetes
mellitus. 5. Pregnant or breast-feeding patients. 6. Patients with abnormal results
of serum laboratory tests (renal function and liver function test) and significant
infectious or respiratory diseases.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
the mean percentage change of the number and size of polyps in colon and/or duodenum.
Outcome Description:
At the base-line endoscopy, India-ink tattoo will be placed in the ascending colon, sigmoid colon/rectum, and duodenum. In case of patient with retained rectum after colectomy and ileorectal anastomosis, sigmoidoscopy will be peformed. 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.
Outcome Time Frame:
After six-month administration of metformin/placebo, colonoscopy/sigmoidoscopy and upper gastrointestinal endoscopy will be performed.
Safety Issue:
No
Authority:
Korea: Institutional Review Board
Study ID:
4-2012-0491
NCT ID:
NCT01725490
Start Date:
November 2012
Completion Date:
September 2015
Related Keywords:
- Familial Adenomatous Polyposis
- chemoprevention, metformin, familial adenomatous polyposis
- Adenomatous Polyposis Coli
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