Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
CompletedPhase 3NCT00450658
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
- Conditions
- Peptic Ulcer
- Interventions
- Sponsor
- Amgen
- Start date
- 2007-03
- Primary completion
- 2008-09
- Sex
- All
- Age range
- from 40 Years to 80 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00450658