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

HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor antagonist (H2RA), is being developed for the treatment of patients with signs and symptoms of osteoarthritis, rheumatoid arthritis, mild to moderate pain or dysmenorrhea who are at risk of developing ibuprofen-associated upper gastrointestinal ulcers.

Study with completed results acquired from Horizon in 2024.

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.