Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441519
Status:
COMPLETED
Last Update Posted:
2009-01-12
First Post:
2007-02-27
Brief Title:
A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
Sponsor:
POZEN
Organization:
POZEN
Study Overview
Official Title:
An Open-Label Investigator-Blinded Stratified Randomized Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin
Status:
COMPLETED
Status Verified Date:
2009-01
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 compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
Detailed Description:
Primary To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 81 mg enteric coated EC aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers
Secondary To evaluate the safety and gastrointestinal tolerability including ulcerogenic potential and the effect on gastric pH of PA 325
Secondary To evaluate the safety and gastrointestinal tolerability including ulcerogenic potential and the effect on gastric pH of PA 325
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