At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 86 enrolled
Drug / intervention
HZT-501drug
Likely dose
HZT-501 800mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-Steroidal Anti-Inflammatory Drug Treatment
In Brief
A Phase 3 clinical trial evaluating HZT-501 for Osteoarthritis and 4 related conditions. Completed, enrolled 86 participants across 4 sites.
Detailed Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Rheumatoid Arthritis, Chronic Low Back Pain, Chronic Regional Pain Syndrome, Chronic Soft Tissue Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionJul 2011
TodayJul 2026
First PostedSep 25, 2009
Enrollment StartSep 1, 2009
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.8 years ago
Interventions
HZT-501drug
Fixed-dose combination oral tablet 800mg Ibuprofen/26.6 mg Famotidine taken three times per day