Status:
RECRUITING
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Lead Sponsor:
Yonsei University
Conditions:
Familial Adenomatous Polyposis
Eligibility:
All Genders
20-55 years
Phase:
PHASE3
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 randomized, open-label, comparative study to evaluate the effect of combination of celecoxib and metformin on polyps of colorectum and duodenum in FAP patients. FAP patients, ...
Eligibility Criteria
Inclusion
- \- 1. Patients with familial adenomatous polyposis(FAP) who are 20 to 55 years of age.
- 2\. FAP patients who have colonic or duodenal polyp. 3. FAP patients who have five or more polyps 2mm or more in diameter in endoscopic examination.
Exclusion
- 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 3 months of randomization.
- 4\. Pregnant or breast-feeding patients. 5. Patients with cardiovascular diseases, peptic ulcer diseases and diabetes. 6. Patients with abnormal results of serum laboratory tests (renal function and liver function test).
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06545526
Start Date
August 13 2024
End Date
June 30 2026
Last Update
August 9 2024
Active Locations (1)
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1
Department of Internal Medicine, Yonsei University College of Medicine
Seoul, South Korea, 120-752