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
- 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
- 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
- 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.