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

Inclusion Criteria:

• Patient is capable of understanding the purpose and risks of the study and is ableto 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 thecoming year for conditions including but not limited to: osteoarthritis, rheumatoidarthritis, chronic low back pain, chronic regional pain syndrome, chronic softtissue pain.

• Female patients of childbearing potential and male patients with partners ofchildbearing potential must agree to use medically acceptable methods ofcontraception throughout the entire study period.

• Patient is willing and able to comply with the prescribed treatment protocol andevaluations.

Exclusion Criteria:

• Patient has a history of or experienced any of the following:

• NSAID-associated and/or primary peptic ulcer disease-associated seriousgastrointestinal complications such as perforation of ulcers, gastric outletobstruction 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 timesthe upper limit of normal at Screening

• History of acute myocardial infarction, unstable cardiac arrhythmias, and/or strokewithin the 6 months prior to study entry

• Uncontrolled congestive heart failure

• Uncontrolled hypertension

• Patient currently is participating in an investigational drug study, or patientparticipated in an investigational drug study within the 30 days prior to studyentry.

• 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 theInvestigator, could interfere with the conduct of the study or could put the patientat unacceptable risk.