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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05267743

Enrollment

218

Registered

2022-03-04

Start date

2021-02-16

Completion date

2022-05-25

Last updated

2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Reflux Disease

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)

Interventions

DRUGTegoprazan 50mg QD

Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

DRUGLansoprazole 30mg QD

Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026