Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Lead Sponsor:
HK inno.N Corporation
Conditions:
Erosive Reflux Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
Detailed Description
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
Eligibility Criteria
Inclusion
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease
Exclusion
- Unable to undergo upper GI endoscopy
- Symptoms of primary or secondary esophageal movement disorders
- Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04309916
Start Date
May 22 2020
End Date
November 30 2021
Last Update
February 25 2022
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea, 03722