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)
CompletedPhase 3NCT00613106
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
Study details
- Official title
- Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)
- Conditions
- Osteoarthritis
- Rheumatoid Arthritis
- Chronic Low Back Pain
- Chronic Regional Pain Syndrome
- Chronic Soft Tissue Pain
- Interventions
- Sponsor
- Amgen
- Start date
- 2007-09
- Primary completion
- 2008-10
- Sex
- All
- Age range
- from 40 Years to 81 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00613106