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)

Amgen179 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

179

Conditions

Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain

Interventions

HZT-501DRUG

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

IbuprofenDRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 81 Years

Medical Language ↔ Plain English

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 didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303 * 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.

Locations (1)

PRA International

San Diego, California, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment Emergent Adverse Events

The objective of this study was to evaluate the long term safety of HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg). No efficacy analyses were planned or performed. Adverse event information was elicited from each participant by indirect questioning using a non-leading question, such as "Has anything bothered you since your last visit or is anything bothering you now?" Adverse event data may also have been volunteered by the participant to the investigator or designee. Physicians assessed the seriousness, severity and causality of each adverse event.

Time frame: 28 weeks

Data from ClinicalTrials.gov

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