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)

Phase 3

Completed

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

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Ibuprofen	Ibuprofen	Ibuprofen 800mg
HZT-501	HZT-501	HZT-501: ibuprofen 800mg/famotidine 26.6mg

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	28 weeks	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.

Secondary Outcome Measures