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 (Industry)

Overall Status

Completed

CT.gov ID

NCT00261586

Collaborator

(none)

Enrollment

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesics	Drug: aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib	Phase 4

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 2xday,rofecoxib 25mg 1xday. On Day 9, 1 dose aspirin & 1 dose study drug before endoscopy.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

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

Actual Study Completion Date :

Mar 1, 2004

Outcome Measures

Primary Outcome Measures

Percent arachidonic acid-induced platelet aggregation; Lanza Mucosal Injury Score of the stomach []

Secondary Outcome Measures

Serum thromboxane B2; plasma PGE2; shear-induced platlet aggregation; cyclooxygenase activity in stomach mucosal biopsies as assessed by PGE2 content []

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

In general good health with normal hemostatic (blood coagulation) parameters
able to swallow study medication
non-smoker
negative for H. pylori infection
if female, must not be pregnant or breast feeding

Exclusion Criteria:

Have taken anti-inflammatory drugs within one week of study entry, any analgesic within 24 hours before baseline endoscopy, or systemic steroids within 6 weeks of study entry
unable to tolerate oral drugs or have had gastrointestinal disease or prior gastrointestinal surgery that could interfere with the study medication
unable to understand or follow instructions
have a medical condition or clinically significant abnormal laboratory results that may be relevant to participation in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Investigators

Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.