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Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis

NCT02388737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2020-02-21

Study results available
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Summary

This is a comparative study of vonoprazan (TAK-438) (10 mg or 20 mg) in participants in whom endoscopic healing of erosive esophagitis has been confirmed with vonoprazan or adequate treatment with a proton pump inhibitor (PPI), to demonstrate the non-inferiority of vonoprazan to lansoprazole in their maintenance treatment (6 months or 24 weeks) as well as to determine the clinically recommended dose for vonoprazan for maintenance therapy in erosive esophagitis.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Vonoprazan

Vonoprazan tablets

DRUG

Lansoprazole

Lansoprazole capsules or tablets

DRUG

Vonoprazan Placebo

Vonoprazan placebo-matching tablets

DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science, MD · Takeda Development Center Asia, Pte Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-01
Primary Completion
2018-12-24
Completion
2018-12-31

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 NCT02388737 on ClinicalTrials.gov