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

Phase 3

Completed

Conditions: Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Chronic Regional Pain Syndrome
Chronic Soft Tissue Pain

Interventions: Drug: HZT-501

Registration Number: NCT00984815

Lead Sponsor: Amgen

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HZT-501	HZT-501	Open-label treatment with HZT-501

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	54 weeks

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Pain Intensity Scale of the Severity of Dyspepsia Assessment (SODA) Questionnaire at 54 Weeks	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	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	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.

Trial Locations

Locations (4): Altoona Center for Clinical Research Altoona Arthritis
🇺🇸
Duncansville, Pennsylvania, United States
Illinois Bone & Joint Institute
🇺🇸
Morton Grove, Illinois, United States
Metroplex Clinical Research Center
🇺🇸
Dallas, Texas, United States
University of Illinois Medical Center, Department of Medicine
🇺🇸
Chicago, Illinois, United States