Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545526
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Metformin an anti-diabetic drug has recently been suggested to have a suppressive effect on tumorigenesis via inhibition of mTOR pathway and have an inhibitory effect on polyp recurrence after removal of sporadic colorectal polyps In addition metformin has a number of potential mechnisms of carciovascular bebefit We devised 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
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 satisfied an enrollment criteria will be randomly assigned in a 11 ratio to receive celecoxib monotherapy or combination of celecoxib and metformin orally for 6 months The base-line and six-month endoscopic examination colonoscopysigmoidoscopy 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None