Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment
1 other identifier
interventional
86
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2009
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 23, 2009
CompletedFirst Posted
Study publicly available on registry
September 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedResults Posted
Study results publicly available
July 25, 2013
CompletedDecember 18, 2024
November 1, 2024
1.8 years
September 23, 2009
March 18, 2013
November 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events
54 weeks
Secondary Outcomes (3)
Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Baseline and 54 Weeks
Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Baseline and 54 Weeks
Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
Baseline and 54 Weeks
Study Arms (1)
HZT-501
EXPERIMENTALOpen-label treatment with HZT-501
Interventions
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (4)
University of Illinois Medical Center, Department of Medicine
Chicago, Illinois, 60612-7323, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053, United States
Altoona Center for Clinical Research Altoona Arthritis
Duncansville, Pennsylvania, 16635, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Related Publications (1)
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.
PMID: 25495134DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amy Y. Grahn, MS
- Organization
- Horizon Pharma
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2009
First Posted
September 25, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 18, 2024
Results First Posted
July 25, 2013
Record last verified: 2024-11