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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization

2. Healed erosive esophagitis within 7 days prior to Randomization

3. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion Criteria:

1. Unable to undergo upper GI endoscopy

2. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy

3. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)

4. History of acid-suppressive, esophageal or gastric surgeries