Overview

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.