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

Erosive Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267743
• Other study ID #: IN_APA_402
• Status: Completed
• Phase: Phase 4
• Start date: February 16, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: July 2022
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Erosive Reflux Disease
• Gastroesophageal Reflux

Intervention

Drug:
• Tegoprazan 50mg QD
Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.
• Lansoprazole 30mg QD
Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Wonkwang University Hospital	Iksan	Muwang-ro 895

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 weeks cumulative ERD healing rate(%)	Healing is defined as "not present" erosions or fissures according to the LA classification.	4 weeks
Secondary	2 weeks ERD healing rate(%)	Healing is defined as "not present" erosions or fissures according to the LA classification.	2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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