Status:
COMPLETED
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease
Lead Sponsor:
HK inno.N Corporation
Conditions:
Erosive Reflux Disease
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
Brief 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 admini...
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)
Eligibility Criteria
Inclusion
- Erosive eshophagitis(LA calssfication Grades A to D) with in 30 days prior to Randomization
- Those who have experienced heartburn symptoms within 7 days prior to Visit 1(screening date)
Exclusion
- Unalbe to undergo upper GI endoscopy
- H. pylori positive
- Those who cannot write a clinical trial subject diary
- 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
Key Trial Info
Start Date :
February 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2022
Estimated Enrollment :
218 Patients enrolled
Trial Details
Trial ID
NCT05267743
Start Date
February 16 2021
End Date
May 25 2022
Last Update
July 29 2022
Active Locations (1)
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1
Wonkwang University Hospital
Iksan, Muwang-ro 895, South Korea, 54538