Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment
Information source: Horizon Therapeutics, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
Intervention: HZT-501 (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Horizon Therapeutics, Inc. Official(s) and/or principal investigator(s):
Alfonso Bello, MD, FACP, Principal Investigator, Affiliation: Illinois Bone & Joint Institute
Overall contact:
Amy Y Grahn, MS, Phone: 224-406-2234, Email: agrahn@horizontherapeutics.com
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.
Clinical Details
Official title: Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: The safety of HZT-501 will be measured by adverse events, physical examinations (including vital signs and weight), and clinical laboratory assessments.
Secondary outcome: Severity of Dyspepsia Assessment Questionnaire (SODA) will be completed by the patients to assess tolerability every six weeks.
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 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Amy Y Grahn, MS, Phone: 224-406-2234, Email: agrahn@horizontherapeutics.com
Illinois Bone & Joint Institute, Morton Grove, Illinois 60053, United States; Recruiting
Susan Nelson, RN, Phone: 847-779-6770, Email: snelson@ibji.com
Alfonso Bello, MD, Principal Investigator
University of Illinois Medical Center, Department of Medicine, Chicago, Illinois 60612-7323, United States; Not yet recruiting
Karen Bednar, RN, Phone: 312-996-1926, Email: kbednar@uci.edu
Jay Goldstein, MD, Principal Investigator
Altoona Center for Clinical Research Altoona Arthritis, Duncansville, Pennsylvania 16635, United States; Recruiting
Ashli Weyandt, Phone: 814-693-0300, Ext: 154, Email: ashliweyandt1125@yahoo.com
Renea Weyandt, Phone: 814-693-0300, Email: reneaweyandt1125@yahoo.com
Alan Kivitz, MD, Principal Investigator
Metroplex Clinical Research Center, Dallas, Texas 75231, United States; Recruiting
Sara Hibbard, Phone: 214-424-0400, Email: SHibbard@arthdocs.com
Pricilla Diaz, Phone: 214-424-0400
Sharad Lakhanpal, MD, Principal Investigator
Additional Information
Starting date: September 2009
Ending date: March 2011
Last updated: September 24, 2009
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