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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HK inno.N Corporation
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

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