Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment

Inclusion Criteria:

• Patient is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
• Patient is male or female, aged 40 to 80 years of age.
• Patient is expected to require daily administration of an NSAID for at least the coming year for conditions including but not limited to: osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, chronic soft tissue pain.
• Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the entire study period.
• Patient is willing and able to comply with the prescribed treatment protocol and evaluations.

Exclusion Criteria:

• Patient has a history of or experienced any of the following:
• NSAID-associated and/or primary peptic ulcer disease-associated serious gastrointestinal complications such as perforation of ulcers, gastric outlet obstruction due to ulcers, and/or acute gastrointestinal bleeding
• NSAID-induced asthma exacerbation, acute renal failure, interstitial nephritis, and/or hepatitis
• Malignant disease of the gastrointestinal tract
• Erosive esophagitis
• Coronary artery bypass graft (CABG) surgery within the 14 days prior to study Day 0
• Uncontrolled diabetes mellitus as evidenced by Hemoglobin A1c > 7%
• Known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C
• Patient has active cardiac, renal, and/or hepatic disease, as evidenced by:
• Creatinine clearance < 45 mL/min (based on the Cockroft-Gault formula) at Screening
• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal at Screening
• History of acute myocardial infarction, unstable cardiac arrhythmias, and/or stroke within the 6 months prior to study entry
• Uncontrolled congestive heart failure
• Uncontrolled hypertension
• Patient currently is participating in an investigational drug study, or patient participated in an investigational drug study within the 30 days prior to study entry.
• Female patient has a positive urine pregnancy test at Screening and/or Study Day 0.
• Patient has a concomitant disease or condition that, in the opinion of the Investigator, could interfere with the conduct of the study or could put the patient at unacceptable risk.