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Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug (NSAID) Treatment
This study is currently recruiting participants.
Verified by Horizon Therapeutics, Inc., September 2009
First Received: September 23, 2009   Last Updated: September 24, 2009   History of Changes
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: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:


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: March 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HZT-501: Experimental
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

Contacts
Contact: Amy Y Grahn, MS 224-406-2234 agrahn@horizontherapeutics.com
Contact: Jeffrey W Sherman, MD 224-383-3000 ext 103 jsherman@horizontherapeutics.com

Locations
United States, Illinois
Illinois Bone & Joint Institute Recruiting
Morton Grove, Illinois, United States, 60053
Contact: Susan Nelson, RN     847-779-6770     snelson@ibji.com    
Principal Investigator: Alfonso Bello, MD            
University of Illinois Medical Center, Department of Medicine Not yet recruiting
Chicago, Illinois, United States, 60612-7323
Contact: Karen Bednar, RN     312-996-1926     kbednar@uci.edu    
Principal Investigator: Jay Goldstein, MD            
United States, Pennsylvania
Altoona Center for Clinical Research Altoona Arthritis Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Ashli Weyandt     814-693-0300 ext 154     ashliweyandt1125@yahoo.com    
Contact: Renea Weyandt     814-693-0300     reneaweyandt1125@yahoo.com    
Principal Investigator: Alan Kivitz, MD            
United States, Texas
Metroplex Clinical Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Sara Hibbard     214-424-0400     SHibbard@arthdocs.com    
Contact: Pricilla Diaz     214-424-0400        
Principal Investigator: Sharad Lakhanpal, MD            
Sponsors and Collaborators
Horizon Therapeutics, Inc.
Investigators
Principal Investigator: Alfonso Bello, MD, FACP Illinois Bone & Joint Institute
  More Information

No publications provided

Responsible Party: Horizon Therapeutics ( Jeffrey W. Sherman, MD )
Study ID Numbers: HZ-CA-401
Study First Received: September 23, 2009
Last Updated: September 24, 2009
ClinicalTrials.gov Identifier: NCT00984815     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Horizon Therapeutics, Inc.:
NSAID
Chronic Pain
Osteoarthritis
Rheumatoid Arthritis

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Osteoarthritis
Physiological Effects of Drugs
Arthritis, Rheumatoid
Pain
Signs and Symptoms
Pathologic Processes
Musculoskeletal Diseases
Sensory System Agents
Syndrome
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Autoimmune Diseases
Disease
Immune System Diseases
Joint Diseases
Nervous System Diseases
Low Back Pain
Rheumatic Diseases
Back Pain
Pharmacologic Actions
Analgesics, Non-Narcotic
Neurologic Manifestations
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 08, 2010