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

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

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2021-06-23

Brief Summary

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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.

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Detailed Description

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This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Conditions

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Healed Erosive Esophagitis

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 25mg QD

Tegoprazan 25mg tablet, once daily, oral administration

Group Type EXPERIMENTAL

Tegoprazan 25mg QD

Intervention Type DRUG

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

Lansoprazole 15mg QD

Lansoprazole 15mg capsule, once daily, oral administration

Group Type ACTIVE_COMPARATOR

Lansoprazole 15mg QD

Intervention Type DRUG

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

Interventions

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Tegoprazan 25mg QD

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

Intervention Type DRUG

Lansoprazole 15mg QD

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
2. Healed erosive esophagitis within 7 days prior to Randomization
3. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion Criteria

1. Unable to undergo upper GI endoscopy
2. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
3. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
4. History of acid-suppressive, esophageal or gastric surgeries

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No