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

Phase 4

Completed

• Conditions: Erosive Reflux Disease
• Interventions: Drug: Tegoprazan 50mg QD; Drug: Lansoprazole 30mg QD

• Registration Number: NCT05267743
• Lead Sponsor: HK inno.N Corporation

Brief Summary

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.

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 Timeline

• Study Start: 2021-02-16
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Primary Completion: 2022-05-25
• Study Completion: 2022-05-25
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegoprazan 50mg QD	Tegoprazan 50mg QD	Tegoprazan 50mg tablet, once daily, oral administration
Lansoprazole 30mg QD	Lansoprazole 30mg QD	Lansoprazole 30mg capsule, once dauly, oral administration

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wonkwang University Hospital; 🇰🇷 Iksan, Muwang-ro 895, Korea, Republic of