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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal

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.