Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:06 PM
Study NCT ID:
NCT00872534
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2009-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Sponsor:
PLx Pharma
Organization:
Study Overview
Official Title:
A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2015-08
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:
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: