CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 510 enrolled
Drug / intervention
Vonoprazan +4 moredrug
Likely dose
Not stated in 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.

Search/NCT04198363
NCT04198363Phase 3Completed
CompareCT.gov

A Randomized Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral TAK-438 20 mg Compared to Esomeprazole 20 mg Twice Daily in Subjects With Helicobacter Pylori Infection

Takeda·interventional·Posted Dec 13, 2019·Updated Sep 7, 2023

In Brief

A Phase 3 clinical trial evaluating Vonoprazan, Amoxicillin, and 3 other interventions for Helicobacter Pylori. Completed, enrolled 510 participants across 29 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 13, 2019
Enrollment StartApr 30, 2020
Primary CompletionNov 1, 2021
Study CompletionNov 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.6 years ago

Interventions

Vonoprazandrug

Vonoprazan Tablets

Amoxicillindrug

Amoxicillin Capsules

Clarithromycindrug

Clarithromycin Tablets

Bismuth Potassium citratedrug

Bismuth Potassium citrate

Esomeprazoledrug

Esomeprazole Tablets