Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

Phase 3 Completed 86 enrolled Amgen

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.

Timeline

Start: 2009-09
Primary completion: 2011-07
Completion: 2011-07

Publications

Bello AE, Kent JD, Grahn AY, Ball J, Holt RJ. One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia. Curr Med Res Opin. 2015 Mar;31(3):397-405. doi: 10.1185/03007995.2014.999152. Epub 2015 Jan 9.

Drugs

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

Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment

Summary

Timeline

Publications

Drugs

Indications