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

PHASE3CompletedINTERVENTIONAL
Enrollment

906

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

August 31, 2008

Study Completion Date

October 31, 2008

Conditions
Ulcer
Interventions
DRUG

Ibuprofen/famotidine

HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks

DRUG

Ibuprofen

Ibuprofen 800mg administered orally 3 times daily for 24 weeks

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY