Status:
COMPLETED
A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Analgesics
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
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 th...
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 cardi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00261586
End Date
March 1 2004
Last Update
June 29 2011
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