NCT00984815

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	HZT-501	Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-09-25
• Last updated: 2024-12-18
• Results posted: 2013-07-25

Locations

4 sites across 1 country: United States