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

NCT00984815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2024-12-18

Study results available
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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.

Conditions

Interventions

DRUG

HZT-501

Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00984815 on ClinicalTrials.gov