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

Primary Purpose

Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HZT-501
Sponsored by
Horizon Pharma Ireland, Ltd., Dublin Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring NSAID, Chronic Pain, Osteoarthritis, Rheumatoid Arthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Illinois Medical Center, Department of Medicine
  • Illinois Bone & Joint Institute
  • Altoona Center for Clinical Research Altoona Arthritis
  • Metroplex Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HZT-501

Arm Description

Open-label treatment with HZT-501

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events

Secondary Outcome Measures

Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 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
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
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.

Full Information

First Posted
September 23, 2009
Last Updated
June 19, 2013
Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT00984815
Brief Title
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Official Title
Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Pharma Ireland, Ltd., Dublin Ireland

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
Keywords
NSAID, Chronic Pain, Osteoarthritis, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HZT-501
Arm Type
Experimental
Arm Description
Open-label treatment with HZT-501
Intervention Type
Drug
Intervention Name(s)
HZT-501
Intervention Description
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Description
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.
Time Frame
Baseline and 54 Weeks
Title
Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Description
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.
Time Frame
Baseline and 54 Weeks
Title
Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Description
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.
Time Frame
Baseline and 54 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Bello, MD, FACP
Organizational Affiliation
Illinois Bone & Joint Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center, Department of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
Country
United States
Facility Name
Illinois Bone & Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Altoona Center for Clinical Research Altoona Arthritis
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25495134
Citation
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.
Results Reference
derived

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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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