Back to resultsStudy to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Primary Purpose
Erosive Reflux Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease
Exclusion Criteria:
- 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.)
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tegoprazan 50mg
Esomeprazole 40mg
Arm Description
Tegoprazan 50mg tablet, once daily, oral administration
Esomeprazole 40mg tablet, once daily, oral administration
Outcomes
Primary Outcome Measures
Time to first nighttime heartburn-free interval (days))
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
Secondary Outcome Measures
Percentage of days without nighttime heartburn during the 2-week dosing period
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04309916
Brief Title
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Official Title
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 50mg
Arm Type
Experimental
Arm Description
Tegoprazan 50mg tablet, once daily, oral administration
Arm Title
Esomeprazole 40mg
Arm Type
Active Comparator
Arm Description
Esomeprazole 40mg tablet, once daily, oral administration
Intervention Type
Drug
Intervention Name(s)
Tegoprazan
Intervention Description
Tegoprazan 50mg tablet
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 40mg tablet
Primary Outcome Measure Information:
Title
Time to first nighttime heartburn-free interval (days))
Description
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Percentage of days without nighttime heartburn during the 2-week dosing period
Description
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Time Frame
2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects aged between 19 and 75 years
Subjects who have erosive reflux disease
Exclusion Criteria:
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Kil Lee, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
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