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) (HZ-CA-304)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
179 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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