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

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ClinicalTrials.gov Identifier: NCT00984815
Recruitment Status : Completed
First Posted : September 25, 2009
Results First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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-term NSAID treatment.

Condition or disease Intervention/treatment Phase
Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Chronic Regional Pain Syndrome Chronic Soft Tissue Pain Drug: HZT-501 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 54 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
    The pain intensity scale of the SODA questionnaire ranges from 2 - 47. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the pain intensity questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.

  2. Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
    The non-pain symptom scale of the SODA questionnaire ranges from 7 - 35. Change from baseline compares the score at Week 54 to the baseline score for each participant that completed the non-pain symptom questions of the SODA questionnaire at baseline and Week 54. Higher scores indicate greater symptom severity and therefore a negative mean change from baseline is indicative of an improvement in symptoms.

  3. Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks [ Time Frame: Baseline and 54 Weeks ]
    The satisfaction with dyspepsia-related health scale of the SODA questionnaire ranges from 2 - 23. Change from baseline compares the score at Week 54 to the baseline score for each participant who completed the Satisfaction questions of the SODA questionnaire at baseline and Week 54. A positive change from baseline in the SODA satisfaction scale represents a participant's overall improved satisfaction with their dyspepsia-related health.


Eligibility Criteria

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharma Ireland, Ltd., Dublin Ireland
Investigators
Principal Investigator: Alfonso Bello, MD, FACP Illinois Bone & Joint Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Horizon Pharma Ireland, Ltd., Dublin Ireland
ClinicalTrials.gov Identifier: NCT00984815     History of Changes
Other Study ID Numbers: HZ-CA-401
First Posted: September 25, 2009    Key Record Dates
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013
Last Verified: June 2013

Keywords provided by Horizon Pharma Ireland, Ltd., Dublin Ireland:
NSAID
Chronic Pain
Osteoarthritis
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Back Pain
Low Back Pain
Nociceptive Pain
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
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents