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

Rheumatoid Arthritis Clinical Trial

Official title:

Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984815
• Other study ID #: HZ-CA-401
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2009
• Last updated: June 19, 2013
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: June 2013
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Chronic Low Back Pain
• Chronic Regional Pain Syndrome
• Chronic Soft Tissue Pain
• Low Back Pain
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Drug:
• HZT-501
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Locations

Country	Name	City	State
United States	University of Illinois Medical Center, Department of Medicine	Chicago	Illinois
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research Altoona Arthritis	Duncansville	Pennsylvania
United States	Illinois Bone & Joint Institute	Morton Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma Ireland, Ltd., Dublin Ireland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events		54 weeks	Yes
Secondary	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.	Baseline and 54 Weeks	Yes
Secondary	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.	Baseline and 54 Weeks	Yes
Secondary	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.	Baseline and 54 Weeks	Yes