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

January 25, 2023 updated by: HK inno.N Corporation

A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tegoprazan 25mg QD
Tegoprazan 25mg tablet, once daily, oral administration
Drug: Tegoprazan 25mg QD
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
Active Comparator: Lansoprazole 15mg QD
Lansoprazole 15mg capsule, once daily, oral administration
Drug: Lansoprazole 15mg QD
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HK inno.N Corporation

Investigators

  • Principal Investigator: Oh Young Lee, Ph.D, Hanyang University Seoul Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2019

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

July 14, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJ_APA_305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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