Status:
COMPLETED
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)
Lead Sponsor:
Amgen
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
40-81 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00613106
Start Date
September 1 2007
End Date
October 1 2008
Last Update
December 17 2024
Active Locations (1)
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1
PRA International
San Diego, California, United States, 92122