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)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Famotidine; Ibuprofen

Criteria

Inclusion Criteria:

• Expected to continue to require daily administration of an NSAID for at least the coming 6 months.

• Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

Exclusion Criteria:

• Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303

• Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303

• Malignant Disease of the gastrointestinal tract

• Erosive esophagitis

• Clinically significant cardiac, renal or hepatic disease

• Uncontrolled diabetes

• Positive pregnancy test on Study Day 0

• Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.