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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
Horizon Pharma Ireland, Ltd., Dublin Ireland

Tracking Information
First Submitted Date  ICMJE September 23, 2009
First Posted Date  ICMJE September 25, 2009
Results First Submitted Date  ICMJE March 18, 2013
Results First Posted Date  ICMJE July 25, 2013
Last Update Posted Date July 25, 2013
Study Start Date  ICMJE September 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Number of Participants With Treatment Emergent Adverse Events [ Time Frame: 54 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2009)
Severity of Dyspepsia Assessment Questionnaire (SODA) will be completed by the patients to assess tolerability every six weeks. [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Official Title  ICMJE Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Chronic Low Back Pain
  • Chronic Regional Pain Syndrome
  • Chronic Soft Tissue Pain
Intervention  ICMJE Drug: HZT-501
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Study Arms  ICMJE Experimental: HZT-501
Open-label treatment with HZT-501
Intervention: Drug: HZT-501
Publications * Bello AE, Kent JD, Grahn AY, Ball J, Holt RJ. One-year open-label safety evaluation of the fixed combination of ibuprofen and famotidine with a prospective analysis of dyspepsia. Curr Med Res Opin. 2015 Mar;31(3):397-405. doi: 10.1185/03007995.2014.999152. Epub 2015 Jan 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2013)
86
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2009)
100
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00984815
Other Study ID Numbers  ICMJE HZ-CA-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Horizon Pharma Ireland, Ltd., Dublin Ireland
Study Sponsor  ICMJE Horizon Pharma Ireland, Ltd., Dublin Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alfonso Bello, MD, FACP Illinois Bone & Joint Institute
PRS Account Horizon Pharma Ireland, Ltd., Dublin Ireland
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP