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

A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease

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.

Study Overview

• Status: Completed
• Conditions: Erosive Reflux Disease
• Intervention / Treatment: Drug: Tegoprazan 50mg QD; Drug: Lansoprazole 30mg QD

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Muwang-ro 895
    • Iksan, Muwang-ro 895, Korea, Republic of, 54538
      • Wonkwang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tegoprazan 50mg QD; Tegoprazan 50mg tablet, once daily, oral administration	Drug: Tegoprazan 50mg QD; Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.
Active Comparator: Lansoprazole 30mg QD; Lansoprazole 30mg capsule, once dauly, oral administration	Drug: Lansoprazole 30mg QD; Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
4 weeks cumulative ERD healing rate(%)	Healing is defined as "not present" erosions or fissures according to the LA classification.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 weeks ERD healing rate(%)	Healing is defined as "not present" erosions or fissures according to the LA classification.	2 weeks
Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type	Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)	2 weeks or 4 weeks
Percentage of days without heartburn through the clinical trial subject dairy (%)	On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms.	2 weeks or 4 weeks
RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)	Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux)	2 weeks or 4 weeks
Incidence of Adverse Events [Safety]	Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test	2 weeks or 4 weeks

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: Suk Chae Choi, Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: IN_APA_402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No