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

NCT ID: NCT00450658

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

627 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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

Conditions

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Peptic Ulcer

Keywords

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ibuprofen famotidine ulcers NSAIDS pain arthritis chronic regional pain syndrome chronic soft tissue pain osteoarthritis rheumatoid arthritis chronic low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

HZT-501: Ibuprofen 800mg/Famotidine 26.6mg

Group Type EXPERIMENTAL

HZT-501

Intervention Type DRUG

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

2

Ibuprofen 800mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen 800mg orally 3 times daily for 24 weeks

Interventions

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HZT-501

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

Intervention Type DRUG

Ibuprofen

Ibuprofen 800mg orally 3 times daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Countries

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United States

References

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Bello AE, Kent JD, Holt RJ. Gastroprotective efficacy and safety of single-tablet ibuprofen/famotidine vs ibuprofen in older persons. Phys Sportsmed. 2015 Jul;43(3):193-9. doi: 10.1080/00913847.2015.1066229. Epub 2015 Jul 13.

Reference Type DERIVED
PMID: 26165391 (View on PubMed)

Other Identifiers

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HZ-CA-301

Identifier Type: -

Identifier Source: org_study_id