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Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)

NCT ID: NCT00613106

Last Updated: 2024-12-17

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

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Detailed Description

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Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303.

Study with completed results acquired from Horizon in 2024.

Conditions

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Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue 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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HZT-501

HZT-501: ibuprofen 800mg/famotidine 26.6mg

Group Type EXPERIMENTAL

HZT-501

Intervention Type DRUG

Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks

Ibuprofen

Ibuprofen 800mg

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Interventions

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HZT-501

Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks

Intervention Type DRUG

Ibuprofen

Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
* Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

Exclusion Criteria

* Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
* Malignant Disease of the gastrointestinal tract
* Erosive esophagitis
* Clinically significant cardiac, renal or hepatic disease
* Uncontrolled diabetes
* Positive pregnancy test on Study Day 0
* Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.
Minimum Eligible Age

40 Years

Maximum Eligible Age

81 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

Locations

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PRA International

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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HZ-CA-304

Identifier Type: -

Identifier Source: org_study_id