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)

Study Overview
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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.

Official Title
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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 Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)

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

Intervention / Treatment
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* Drug: HZT-501
* Drug: Ibuprofen


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HZT-501<br>HZT-501: ibuprofen 800mg/famotidine 26.6mg | Drug: HZT-501<br>* Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks<br>|
| Active Comparator: Ibuprofen<br>Ibuprofen 800mg | Drug: Ibuprofen<br>* Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28 weeks |