Phase 3
N=906
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00450216 ↗Enrolled (actual)
906
Serious AEs
3.9%
Results posted
Jun 2011
Primary outcome: Primary: Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers — 55; 52 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ibuprofen/famotidine (Drug); Ibuprofen (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Develop Endoscopically-diagnosed Gastric Ulcers |
55; 52 | <0.0001 sig |
| SECONDARY Number of Participants Who Develop Endoscopically-diagnosed Upper Gastrointestinal (UGI) Ulcers During the 24-week Treatment Period. |
63; 61 | <0.0001 sig |
| SECONDARY Number of Participants Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period. |
8; 14 | 0.0006 sig |
| SECONDARY The Number of Participants Developing Non-steroidal Anti-inflammatory (NSAID)Associated Serious Gastrointestinal Complications (Perforation of Ulcers, Gastric Outlet Obstruction Due to Ulcers, Gastrointestinal Bleeding) |
3; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00450216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.