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Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis

NCT04022096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2023-01-27

No results posted yet for this study

Summary

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

Conditions

  • Healed Erosive Esophagitis

Interventions

DRUG

Tegoprazan 25mg QD

Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.

DRUG

Lansoprazole 15mg QD

Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Oh Young Lee, Ph.D · Hanyang University Seoul Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-18
Primary Completion
2021-06-23
Completion
2021-06-23

Countries

  • South Korea

Study Locations

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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 NCT04022096 on ClinicalTrials.gov