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Vonoprazan Study in Patients With Erosive Esophagitis to Evaluate Long-term Safety

NCT02679508 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2023-12-13

Study results available
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Summary

The purpose of this study is exploratorily evaluate the effect on gastric mucosal tissue and the safety of long-term administration (260 weeks: 5 years) of vonoprazan 10 mg or 20 mg in patients receiving maintenance treatment after healed erosive esophagitis (EE), and the curative effect of vonoprazan 20 mg versus lansoprazole in patients with EE.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Vonoprazan

Vonoprazan fumarate 10 mg or 20 mg capsules

DRUG

Lansoprazole

Lansoprazole 15 mg or 30 mg capsules

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-20
Primary Completion
2022-03-05
Completion
2022-03-05

Countries

  • Japan

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 NCT02679508 on ClinicalTrials.gov