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

HK inno.N

Status and phase: Completed; Phase 4

Conditions: Erosive Reflux Disease

Treatments: Drug: Tegoprazan 50mg QD; Drug: Lansoprazole 30mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT05267743

IN_APA_402

Details and patient eligibility

About

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.

Full 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)

Enrollment: 218 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

218 participants in 2 patient groups

Tegoprazan 50mg QD

Experimental group

Description:

Tegoprazan 50mg tablet, once daily, oral administration

Treatment:

Drug: Tegoprazan 50mg QD

Lansoprazole 30mg QD

Active Comparator group

Description:

Lansoprazole 30mg capsule, once dauly, oral administration

Treatment:

Drug: Lansoprazole 30mg QD