At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 179 enrolled
Drug / intervention
HZT-501 +1 moredrug
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.
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)
In Brief
A Phase 3 clinical trial evaluating HZT-501 and Ibuprofen for Osteoarthritis and 4 related conditions. Completed, enrolled 179 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
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
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedFeb 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedFeb 12, 2008
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.4 years ago
Interventions
HZT-501drug
Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks
Ibuprofendrug
Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks