The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
..Date First Received: January 28, 2008
Last Updated: March 17, 2008
Verified by: Horizon Therapeutics, Inc., March 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2007
Overall Status: Active, not recruiting
Estimated Enrollment: 300
Brief Summary
Official Title: “Double-Blind Follow-On Safety Study of HZT-501 in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 or Horizon Protocol HZ-CA-303”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Detailed 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.
Outcome Measures for this Clinical Trial
Primary:
- The safety analysis will compare adverse event incidence rates between the treatment groups 28 weeks No
Criteria for Participation in this Clinical Trial
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.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Horizon Therapeutics, Inc.
PRA International
San Diego California 92122 United States
Additional Information
Information obtained from ClinicalTrials.gov on July 23, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00613106
Study ID Number: HZ-CA-304
ClinicalTrials.gov Identifier: NCT00613106
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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