Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Condition: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Low Back Pain; Nociceptive Pain
Intervention: HZT-501
Intervention description: Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: NSAID; Chronic Pain; Osteoarthritis; Rheumatoid Arthritis

Summary:

      The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a
      fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients
      that require long-term NSAID treatment.
    

Eligibility criteria:

        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.