NCT00450216

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

A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 906 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine. The study is designed to determine whether the combination product reduces the rate of ulcer development in subjects who require long-term daily use of ibuprofen. Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion. Study with completed results acquired from Horizon in 2024.

Conditions

• Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2007-03-22
• Last updated: 2024-12-16
• Results posted: 2011-06-21