Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers

Phase 3 Completed 627 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: 2008-09
Completion: 2008-10

Publications

Bello AE, Kent JD, Holt RJ. Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. Phys Sportsmed. 2015 Jul;43(3):193-9. doi: 10.1080/00913847.2015.1066229. Epub 2015 Jul 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Famotidine	Other / unclassified	26.6 mg	Oral
Comparator	Ibuprofen	Small molecule	800 mg	Oral

Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers

Summary

Timeline

Publications

Drugs

Indications