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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT00984815
• Study type: Interventional
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Completion date: July 2011