At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 533 enrolled
Drug / intervention
TAK-438 +4 moredrug
Likely dose
Bismuth-Containing Quadruple Therapy 1 gfrom 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, Double-Dummy, Phase 3 Study to Evaluate the Efficacy and Safety of Oral TAK-438 20 mg Compared to Lansoprazole 30 mg Once- or Twice-Daily in the Treatment of Endoscopically Confirmed Duodenal Ulcer Subjects With or Without Helicobacter Pylori Infection
In Brief
A Phase 3 clinical trial evaluating TAK-438, Lansoprazole, and 3 other interventions for Duodenal Ulcer. Completed, enrolled 533 participants across 81 sites in 4 countries.
Detailed Summary
The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuodenal Ulcer
CountriesChina, Philippines, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartApr 2017
Primary CompletionMar 2019
Study CompletionJul 2019
TodayJul 2026
First PostedFeb 10, 2017
Enrollment StartApr 5, 2017
Primary CompletionMar 19, 2019
Study CompletionJul 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.4 years ago
Interventions
TAK-438drug
TAK-438 tablets
Lansoprazoledrug
Lansoprazole capsules
TAK-438 Placebodrug
TAK-438 placebo-matching tablets.
Lansoprazole Placebodrug
Lansoprazole placebo-matching capsules
Bismuth-Containing Quadruple Therapydrug
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).