Phase 3 N=627 Randomized Quadruple-blind Prevention

Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers

Peptic Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT00450658 ↗

Enrolled (actual)

627

Serious AEs

2.4%

Results posted

Jun 2011

Primary outcome: Primary: Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy. — 40; 38 participants — p=0.0018

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: HZT-501 (Drug); Ibuprofen (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Amgen
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.	40; 38	0.0018 sig
SECONDARY Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.	37; 34	0.0051 sig
SECONDARY Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.	3; 9	0.0017 sig
SECONDARY The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.	0; 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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00450658). 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.