Status:
COMPLETED
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
Lead Sponsor:
Amgen
Conditions:
Peptic 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 a nonsteroidal anti-inflammatory drug (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,
- 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 :
627 Patients enrolled
Trial Details
Trial ID
NCT00450658
Start Date
March 1 2007
End Date
October 1 2008
Last Update
December 16 2024
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