Status:
COMPLETED
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
Lead Sponsor:
Amgen
Conditions:
Ulcer
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Expected to require daily administration of an NSAID for at least the coming six months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, and chronic soft tissue pain.
- Did not use a NSAID within the 30 days prior to study entry
Exclusion
- History of erosive esophagitis
- History of any of the following serious gastrointestinal complications:
- perforation of ulcers,
- gastric outlet obstruction due to ulcers, or
- gastrointestinal bleeding.
- Active cardiac, renal, and/or hepatic disease
- Current Helicobacter pylori (H. pylori) infection
- Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin within the 14 days prior to study entry.
- Uncontrolled diabetes
- Uncontrolled hypertension
- Positive pregnancy test at screening
- Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Currently participating, or participation within 30 days prior to study entry, in an investigational drug study
- Please note that there are other additional criteria. The study center will determine if patients meet all of the criteria.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
906 Patients enrolled
Trial Details
Trial ID
NCT00450216
Start Date
March 1 2007
End Date
October 1 2008
Last Update
December 16 2024
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