At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 906 enrolled
Drug / intervention
Ibuprofen/famotidine +1 moredrug
Likely dose
Ibuprofen/famotidine 26.6mgfrom 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.
A Randomized, Double-Blind, Phase 3 Study of the Efficacy and Safety of HZT-501 in Subjects Requiring NSAID Treatment
In Brief
A Phase 3 clinical trial evaluating Ibuprofen/famotidine and Ibuprofen for Ulcer. Completed, enrolled 906 participants.
Detailed Summary
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcer
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionAug 2008
Study CompletionOct 2008
TodayJul 2026
First PostedMar 22, 2007
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.3 years ago
Interventions
Ibuprofen/famotidinedrug
HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks
Ibuprofendrug
Ibuprofen 800mg administered orally 3 times daily for 24 weeks