Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01483144
Status:
COMPLETED
Last Update Posted:
2021-06-08
First Post:
2011-11-21
Brief Title:
Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis FAP
Sponsor:
Cancer Prevention Pharmaceuticals Inc
Organization:
Cancer Prevention Pharmaceuticals Inc
Study Overview
Official Title:
Phase III Trial of the Safety and Efficacy of Eflornithine Combined With Sulindac Compared to Eflornithine Sulindac as Single Agents in Patients With Familial Adenomatous Polyposis
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this randomized double-blind Phase III trial is to determine if the combination of eflornithine plus sulindac is superior to sulindac or eflornithine as single agents in delaying time to the first occurrence of any FAP-related event This includes 1 FAP related disease progression indicating the need for excisional intervention involving the colon rectum pouch duodenum andor 2 clinically important events which includes progression to more advanced duodenal polyposis cancer or death
Detailed Description:
None
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