Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment - Full Text View

Sponsor:	Horizon Therapeutics, Inc.
Information provided by:	Horizon Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00984815

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain	Drug: HZT-501	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Horizon Therapeutics, Inc.:

Primary Outcome Measures:

The safety of HZT-501 will be measured by adverse events, physical examinations (including vital signs and weight), and clinical laboratory assessments. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severity of Dyspepsia Assessment Questionnaire (SODA) will be completed by the patients to assess tolerability every six weeks. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	September 2009
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HZT-501 Open-label treatment with HZT-501	Drug: HZT-501 Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

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

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984815

Locations

United States, Illinois
University of Illinois Medical Center, Department of Medicine
Chicago, Illinois, United States, 60612-7323
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States, 60053
United States, Pennsylvania
Altoona Center for Clinical Research Altoona Arthritis
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Horizon Therapeutics, Inc.

Investigators

Principal Investigator:

Alfonso Bello, MD, FACP

Illinois Bone & Joint Institute

More Information

No publications provided

Responsible Party:	Jeffrey W. Sherman, MD, Horizon THerapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00984815 History of Changes
Other Study ID Numbers:	HZ-CA-401
Study First Received:	September 23, 2009
Last Updated:	July 15, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Horizon Therapeutics, Inc.:

NSAID
Chronic Pain
Osteoarthritis
Rheumatoid Arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Back Pain
Low Back Pain
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations

Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012