Clinical trial NCT00984815: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain
Keywords: NSAID
Chronic Pain
Osteoarthritis
Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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 with completed results acquired from Horizon in 2024.

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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: 54 weeks
Secondary outcomes:
measure: Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
timeFrame: Baseline and 54 Weeks
measure: Change From Baseline in the Non-pain Symptoms Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
timeFrame: Baseline and 54 Weeks
measure: Change From Baseline in the Satisfaction With Dyspepsia-Related Health Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks
timeFrame: Baseline and 54 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Medical Center, Department of Medicine
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research Altoona Arthritis
state: Pennsylvania
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.