A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach

This study has been completed.

Sponsor:

Information provided by:

Johnson & Johnson Consumer and Personal Products Worldwide

ClinicalTrials.gov Identifier:

NCT00261586

First received: December 2, 2005

Last updated: June 28, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 2, 2005

Last Updated Date

June 28, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00261586 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach

Official Title ^ICMJE

Effect of Analgesics on the Irreversible Inactivation of Cyclooxygenase-1 Activity by Low Dose Aspirin and Endoscopic Evaluation of the Gastric Mucosal Effect

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Condition ^ICMJE

Analgesics

Intervention ^ICMJE

Drug: aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00261586

Other Study ID Numbers ^ICMJE

CR002500

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Johnson & Johnson Consumer and Personal Products Worldwide

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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.

Information Provided By

Johnson & Johnson Consumer and Personal Products Worldwide

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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