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Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Participants With Erosive Esophagitis

NCT02388724 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2019-06-03

Study results available
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Summary

The purpose of the study is to demonstrate the efficacy of vonoprazan (TAK-438) versus lansoprazole in the treatment of erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Vonoprazan

Vonoprazan tablets

DRUG

Lansoprazole

Lansoprazole capsules

DRUG

Vonoprazan Placebo

Vonoprazan placebo-matching tablets

DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

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
2015-03-24
Primary Completion
2017-07-27
Completion
2017-07-27

Countries

  • China
  • Malaysia
  • 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 NCT02388724 on ClinicalTrials.gov