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

NCT00450216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 906

Last updated 2024-12-16

Study results available
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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.

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 & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-08-31
Completion
2008-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00450216 on ClinicalTrials.gov