Status:
COMPLETED
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Lead Sponsor:
Amgen
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief 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-...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00984815
Start Date
September 1 2009
End Date
July 1 2011
Last Update
December 18 2024
Active Locations (4)
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1
University of Illinois Medical Center, Department of Medicine
Chicago, Illinois, United States, 60612-7323
2
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
3
Altoona Center for Clinical Research Altoona Arthritis
Duncansville, Pennsylvania, United States, 16635
4
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231