NCT05267743

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: HK inno.N Corporation · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Erosive Reflux Disease

Interventions

Type	Name	Description
DRUG	Tegoprazan 50mg QD	Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.
DRUG	Lansoprazole 30mg QD	Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2022-03-04
• Last updated: 2022-07-29

Locations

1 site across 1 country: South Korea