MedTrace Logo

Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection

NCT03050359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 533

Last updated 2020-06-12

Study results available
· View outcomes & findings →

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.

Conditions

  • Duodenal Ulcer

Interventions

DRUG

TAK-438

TAK-438 tablets

DRUG

Lansoprazole

Lansoprazole capsules

DRUG

TAK-438 Placebo

TAK-438 placebo-matching tablets.

DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

DRUG

Bismuth-Containing Quadruple Therapy

1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).

Sponsors & Collaborators

Principal Investigators

  • Medical 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
2017-04-05
Primary Completion
2019-03-19
Completion
2019-07-19

Countries

  • China
  • Philippines
  • South Korea
  • Taiwan

Study Locations

More Related Trials

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 NCT03050359 on ClinicalTrials.gov