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

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Acetaminophen; Analgesics; Aspirin; Celecoxib; Ibuprofen; Naproxen; Rofecoxib

Criteria

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