Combining Celecoxib and Metformin to Prevent Polyps in Familial Adenomatous Polyposis
The Chemopreventive Effect of Celecoxib Monotherapy Versus Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis: a Pilot Randomized, Open-label, Comparative Study
This study is testing if taking celecoxib with metformin can help prevent the growth of polyps in people with familial adenomatous polyposis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 20 Years to 55 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06545526 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining celecoxib, a non-steroidal anti-inflammatory drug, with metformin, an anti-diabetic medication, in preventing the growth of polyps in patients with familial adenomatous polyposis (FAP). Participants aged 20 to 55 with five or more polyps will be randomly assigned to receive either celecoxib alone or the combination treatment for six months. The study will involve endoscopic examinations to assess the number and size of polyps before and after treatment. This approach aims to find a safer and more effective chemopreventive strategy for FAP patients.
Who should consider this trial
Good fit: Ideal candidates are FAP patients aged 20 to 55 with five or more polyps measuring 2mm or more.
Not a fit: Patients who have undergone recent colectomy, have malignant disease, or have certain cardiovascular or gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of polyp development and subsequent colorectal cancer in FAP patients.
How similar studies have performed: While the combination of celecoxib and metformin is a novel approach, previous studies have shown promise in using individual agents for polyp prevention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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 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 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).
Where this trial is running
Seoul
- Department of Internal Medicine, Yonsei University College of Medicine — Seoul, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.