Status:
COMPLETED
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Lead Sponsor:
HK inno.N Corporation
Conditions:
Healed Erosive Esophagitis
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief 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 follow...
Detailed Description
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
Eligibility Criteria
Inclusion
- Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- Healed erosive esophagitis within 7 days prior to Randomization
- No heartburn and regurgitation within 7 days prior to Randomization
Exclusion
- Unable to undergo upper GI endoscopy
- 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
- Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- History of acid-suppressive, esophageal or gastric surgeries
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2021
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT04022096
Start Date
June 18 2019
End Date
June 23 2021
Last Update
January 27 2023
Active Locations (1)
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1
Hanyang University Seoul Hospital
Seoul, South Korea, 133-792