Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261586
Status:
COMPLETED
Last Update Posted:
2011-06-29
First Post:
2005-12-02
Brief Title:
A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach
Sponsor:
Johnson Johnson Consumer and Personal Products Worldwide
Organization:
Johnson Johnson Consumer and Personal Products Worldwide
Study Overview
Official Title:
Effect of Analgesics on the Irreversible Inactivation of Cyclooxygenase-1 Activity by Low Dose Aspirin and Endoscopic Evaluation of the Gastric Mucosal Effect
Status:
COMPLETED
Status Verified Date:
2011-06
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 study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin 81 mg to study their bleeding properties and their effects on the stomach in healthy volunteers
Detailed Description:
The purpose of this randomized multiple-dose single-blind parallel-group study is to examine in healthy volunteers the effects of analgesics given in approved daily doses in addition to daily cardio-protective doses of aspirin 81 mg on the stomach All subjects are examined endoscopically before receiving study medication and at the end of treatment on Day 9 Each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken daily on Days 1 through 8 four doses of acetaminophen 1000 mg three doses of ibuprofen 400 mg two doses of naproxen sodium 440 mg in the morning and 220 mg in the evening four doses of aspirin 650 mg two doses of celecoxib 200 mg one dose of rofecoxib 25 mg or no additional study medication On Day 9 one dose of aspirin 81 mg and only one dose of the assigned treatment drug are taken prior to having an endoscopy The primary endpoints of the study are the effects of the analgesics on the inhibition of COX-1 activity by aspirin and any injury to the stomach mucosa as determined by direct endoscopic observation Safety assessments consist of routine monitoring for adverse events as well as endoscopic examination of gastric mucosa for erosions and ulcerations occurring during the treatment phase The study hypothesis is that the effects of acetaminophen on the stomach do not differ from the effects of ibuprofen naproxen aspirin celecoxib or rofecoxib 81 mg aspirin and 1of 7 treatments for 8 days acetaminophen 1000mg 4xday ibuprofen 400mg 3xday naproxen 440mg morning and 220mg evening no additional study medication aspirin 650mg 4xday celecoxib 200mg 2xdayrofecoxib 25mg 1xday On Day 9 1 dose aspirin 1 dose study drug before endoscopy
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