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

HK inno.N Corporation218 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

218

Conditions

Erosive Reflux Disease

Interventions

Tegoprazan 50mg QDDRUG

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

Lansoprazole 30mg QDDRUG

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Wonkwang University Hospital

Iksan, Muwang-ro 895, South Korea

Outcomes

Primary Outcomes

4 weeks cumulative ERD healing rate(%)

Healing is defined as "not present" erosions or fissures according to the LA classification.

Time frame: 4 weeks

Secondary Outcomes

2 weeks ERD healing rate(%)

Healing is defined as "not present" erosions or fissures according to the LA classification.

Time frame: 2 weeks

Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type

Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)

Time frame: 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.

Time frame: 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)

Time frame: 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

Time frame: 2 weeks or 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.