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

NCT ID: NCT00984815

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-07-31

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.

Conditions

Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain

Keywords

NSAID; Chronic Pain; Osteoarthritis; Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HZT-501

Open-label treatment with HZT-501

Group Type: EXPERIMENTAL

HZT-501

Intervention Type: DRUG

Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Interventions

HZT-501

Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

University of Illinois Medical Center, Department of Medicine

Chicago, Illinois, United States

Illinois Bone & Joint Institute

Morton Grove, Illinois, United States

Altoona Center for Clinical Research Altoona Arthritis

Duncansville, Pennsylvania, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25495134 (View on PubMed)

Other Identifiers

HZ-CA-401

Identifier Type: -

Identifier Source: org_study_id