drugset / Trial / NCT00450216

Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment

NCT00450216

Phase 3 Completed 906 enrolled Amgen
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.

Timeline

Start
2007-03
Primary completion
2008-08
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Famotidine Other / unclassified 26.6 mg Oral
Subject Ibuprofen Small molecule 800 mg Oral

Indications