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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-05-25

Brief Summary

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This study is designed to evaluate the efficacy and safety of Tegoprazan 50mg, compared to Lansoprazole 30mg in patients with healed erosive reflux disease confirmed by endoscopy following oral administration once daily(QD) of 2 weeks or 4 weeks.

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Detailed Description

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This is a double blind, radomized, active-controlled, phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (Tegoprazan 50mg, Lansoprazole 30mg)

Conditions

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Erosive Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan 50mg QD

Tegoprazan 50mg tablet, once daily, oral administration

Group Type EXPERIMENTAL

Tegoprazan 50mg QD

Intervention Type DRUG

Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Lansoprazole 30mg QD

Lansoprazole 30mg capsule, once dauly, oral administration

Group Type ACTIVE_COMPARATOR

Lansoprazole 30mg QD

Intervention Type DRUG

Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Interventions

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Tegoprazan 50mg QD

Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Intervention Type DRUG

Lansoprazole 30mg QD

Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
2. Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)

Exclusion Criteria

1. Unalbe to undergo upper GI endoscopy
2. H. pylori positive
3. Those who cannot write a clinical trial subject diary
4. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3cm length(LSBE), eosinophilic oesophagitis, active digestive ulcer or gastric bleeding on an upper GI endoscopy

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No