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A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection

NCT04198363 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2023-09-07

Study results available
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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.

Conditions

  • Helicobacter Pylori

Interventions

DRUG

Vonoprazan

Vonoprazan Tablets

DRUG

Amoxicillin

Amoxicillin Capsules

DRUG

Clarithromycin

Clarithromycin Tablets

DRUG

Bismuth Potassium citrate

Bismuth Potassium citrate

DRUG

Esomeprazole

Esomeprazole Tablets

Sponsors & Collaborators

Principal Investigators

  • Study Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2021-11-01
Completion
2021-11-25

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198363 on ClinicalTrials.gov