Back to resultsA Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Primary Purpose
Gastroesophageal Reflux Disease
Status
Recruiting
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 Gastroesophageal Reflux Disease
Eligibility Criteria
Inclusion Criteria: Subjects aged between 19 and 75 years Subjects who have erosive reflux disease or non-erosive reflux disease Exclusion Criteria: Unable to undergo upper GI endoscopy Symptoms of primary or secondary esophageal movement disorders Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
Sites / Locations
- Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tegoprazan 50mg
Esomeprazole 40mg or 20mg
Arm Description
Tegoprazan 50mg, once daily, oral administration for two weeks
In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
Outcomes
Primary 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
Secondary Outcome Measures
Time to first nighttime hearturn-free interval(days)
Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Percentage of days without daytime heartburn during the 2-week dosing period
Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05701540
Brief Title
A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Official Title
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
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 improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
Detailed Description
This is a multi-center, double-blind, randomized, active-controlled phase 4 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg or 20mg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
338 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 50mg
Arm Type
Experimental
Arm Description
Tegoprazan 50mg, once daily, oral administration for two weeks
Arm Title
Esomeprazole 40mg or 20mg
Arm Type
Active Comparator
Arm Description
In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks
In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
Intervention Type
Drug
Intervention Name(s)
Tegoprazan
Intervention Description
Tegoprazan 50mg tablet
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 20mg tablet
For patients with ERD: two Esomeprazole 20mg tablets
For patients with NERD: one Esomeprazole 20mg tablet
Primary 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 weeks
Secondary Outcome Measure Information:
Title
Time to first nighttime hearturn-free interval(days)
Description
Number of days to reach the first day without symptoms of nighttime heartburn after the administration of investigational drug
Time Frame
2 weeks
Title
Percentage of days without daytime heartburn during the 2-week dosing period
Description
Percentage of days without daytime heartburn = Number of days without daytime heartburn symptoms during the dosing period / Number of days when daytime heartburn was assessed x 100
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects aged between 19 and 75 years
Subjects who have erosive reflux disease or non-erosive reflux disease
Exclusion Criteria:
Unable to undergo upper GI endoscopy
Symptoms of primary or secondary esophageal movement disorders
Subjects who have undergone or are scheduled to undergo surgery that can affect gastric acid secretion(e.g. upper gastrectomy, vagotomy, etc)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae Hoon Kim
Phone
82-2-6477-0244
Email
luke.kim@inno-n.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jong Min Lee
Phone
82-2-6477-0251
Email
jongmin.lee6@inno-n.com
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Kil Lee, Ph.D
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
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