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

Amgen627 enrolled

Overview

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.

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 subjects who require long-term daily use of ibuprofen. Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a 24 week treatment period or until they develop either an endoscopically-diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical laboratory measurements made, at selected times during the study. Endoscopic exams will be performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks following study completion. Study with completed results acquired from Horizon in 2024

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

627

Conditions

Peptic Ulcer

Interventions

HZT-501DRUG

HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks

IbuprofenDRUG

Ibuprofen 800mg orally 3 times daily for 24 weeks

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Subjects Who Develop Endoscopically-diagnosed Upper Gastrointestinal Ulcers Confirmed by Endoscopy.

The primary efficacy endpoint was the number of subjects with upper gastrointestinal (i.e., gastric and/or duodenal) ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.

Time frame: 24 weeks

Secondary Outcomes

Number of Subjects Who Develop Endoscopically-diagnosed Gastric Ulcers During the 24-week Treatment Period.

The secondary efficacy endpoint was the number of subjects with gastric ulcer at any time throughout 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.

Time frame: 24 weeks

Number of Subjects Who Develop Endoscopically-diagnosed Duodenal Ulcers During the 24-week Treatment Period.

The secondary efficacy endpoint was the number of subjects with duodenal ulcer at any time throughout the 24 weeks of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter with unequivocal depth. A subject is considered to have completed the study if all scheduled assessments up through the Week 24 visit have been performed.

Time frame: 24 weeks

The Incidence Rate of NSAID-associated Serious Gastrointestinal Complications.

The secondary efficacy endpoint was the number of subjects developing a NSAID-associated serious GI complication at any time throughout 6 months of treatment. A NSAID-associated serious GI complication was defined as a perforation of ulcers, gastric outlet obstruction due to ulcers, and/or GI bleeding.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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