At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 627 enrolled
Drug / intervention
HZT-501 +1 moredrug
Likely dose
HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeksAI-extracted
Key inclusion· 2
- ✓Expected to require daily NSAID administration for at least 6 months for chronic pain conditions (osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, chronic soft tissue pain)
- ✓No NSAID use in the 30 days prior to study entry
Key exclusion· 9
- ✕History of erosive esophagitis
- ✕History of serious GI complications: ulcer perforation, gastric outlet obstruction, or GI bleeding
- ✕Active cardiac, renal, and/or hepatic disease
- ✕Current Helicobacter pylori (H. pylori) infection
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 HZT-501 and Ibuprofen for Peptic Ulcer. Completed, enrolled 627 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--
ConditionsPeptic Ulcer
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2007
First PostedMar 2007
Primary CompletionSep 2008
Study CompletionOct 2008
TodayJul 2026
First PostedMar 22, 2007
Enrollment StartMar 1, 2007
Primary CompletionSep 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.3 years ago
Interventions
HZT-501drug
HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks
Ibuprofendrug
Ibuprofen 800mg orally 3 times daily for 24 weeks