Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216) — HZ-CA-304  

Rheumatoid Arthritis Clinical Trial

Official title: Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.

Clinical Trial Description

Subject who have completed the 24-week Treatment Period of Horizon Protocol HZ-CA-301 or HZ-CA-303 without developing an upper gastrointestinal ulcer and who are expected to continue to require daily administration of an NSAID for the next 6 months will receive treatment with the same study medication received while participating in HZ-CA-301 or HZ-CA-303. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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: NCT00613106
• Study type: Interventional
• Source: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Status: Completed
• Phase: Phase 3
• Start date: September 2007
• Completion date: October 2008