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

Phase 3CompletedNCT04022096

HK inno.N Corporation351 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

351

Conditions

Healed Erosive Esophagitis

Interventions

Tegoprazan 25mg QDDRUG

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

Lansoprazole 15mg QDDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hanyang University Seoul Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Endoscopic remission rate of EE at 24-week

Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)

Time frame: 24-week

Secondary Outcomes

Endoscopic remission rate of EE at 12-week

Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)

Time frame: 12-week

Data from ClinicalTrials.gov

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