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

Phase 3

Completed

• Conditions: Healed Erosive Esophagitis
• Interventions: Drug: Lansoprazole 15mg QD; Drug: Tegoprazan 25mg QD

• Registration Number: NCT04022096
• Lead Sponsor: HK inno.N Corporation

Brief 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.

Detailed Description

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 Timeline

• Study Start: 2019-06-18
• Study First Submitted: 2019-07-14
• Study First Submitted QC: 2019-07-14
• Study First Posted: 2019-07-16
• Primary Completion: 2021-06-23
• Study Completion: 2021-06-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lansoprazole 15mg QD	Lansoprazole 15mg QD	Lansoprazole 15mg capsule, once daily, oral administration
Tegoprazan 25mg QD	Tegoprazan 25mg QD	Tegoprazan 25mg tablet, once daily, oral administration

Primary Outcome Measures

Name	Time	Method
Endoscopic remission rate of EE at 24-week	24-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)

Secondary Outcome Measures

Name	Time	Method
Endoscopic remission rate of EE at 12-week	12-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)

Trial Locations

Locations (1)

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of