Viewing Study NCT00442052



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Last Modification Date: 2024-10-26 @ 9:31 AM
Study NCT ID: NCT00442052
Status: COMPLETED
Last Update Posted: 2007-03-01
First Post: 2007-02-27

Brief Title: To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin
Sponsor: POZEN
Organization: POZEN

Study Overview

Official Title: An Open-Label Investigator-Blinded Randomized Parellel Group Study to Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA 325 Versus Enteric-Coated Aspirin
Status: COMPLETED
Status Verified Date: 2007-02
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: 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 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers
Detailed Description: PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal GI adverse events in patients requiring daily aspirin This study is designed as a Proof of Concept study to evaluate the gastroprotective effects pharmacokinetic profile and safety of PA 325 in healthy volunteers

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 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers

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