Double-Blind Follow-on Safety Study of HZT-501 in Subjects Who Have Completed Participation in HZ-CA-301 or HZ-CA-303
Information source: Horizon Therapeutics, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
Intervention: ibuprofen/famotidine (Drug); ibuprofen (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Horizon Therapeutics, Inc.
Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Clinical Details
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
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Primary outcome: The safety analysis will compare adverse event incidence rates between the treatment groups
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 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 81 Years.
Gender(s): Both.
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.
Locations and Contacts
PRA International, San Diego, California 92122, United States
Additional Information
Starting date: September 2007
Ending date: November 2008
Last updated: March 17, 2008
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