Back to resultsStudy to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease
Primary Purpose
Erosive Reflux Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan 50mg QD
Lansoprazole 30mg QD
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Wonkwang University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tegoprazan 50mg QD
Lansoprazole 30mg QD
Arm Description
Tegoprazan 50mg tablet, once daily, oral administration
Lansoprazole 30mg capsule, once dauly, oral administration
Outcomes
Primary Outcome Measures
4 weeks cumulative ERD healing rate(%)
Healing is defined as "not present" erosions or fissures according to the LA classification.
Secondary Outcome Measures
2 weeks ERD healing rate(%)
Healing is defined as "not present" erosions or fissures according to the LA classification.
Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type
Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)
Percentage of days without heartburn through the clinical trial subject dairy (%)
On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms.
RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)
Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux)
Incidence of Adverse Events [Safety]
Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05267743
Brief Title
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease
Official Title
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in Patients With Erosive Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (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 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 administration once daily(QD) of 2 weeks or 4 weeks.
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)
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
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 50mg QD
Arm Type
Experimental
Arm Description
Tegoprazan 50mg tablet, once daily, oral administration
Arm Title
Lansoprazole 30mg QD
Arm Type
Active Comparator
Arm Description
Lansoprazole 30mg capsule, once dauly, oral administration
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 50mg QD
Intervention Description
Tegoprazan 50mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 30mg QD
Intervention Description
Lansoprazole 30mg tablets will be orally administered, once daily, for up to 2 weeks or 4 weeks.
Primary Outcome Measure Information:
Title
4 weeks cumulative ERD healing rate(%)
Description
Healing is defined as "not present" erosions or fissures according to the LA classification.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
2 weeks ERD healing rate(%)
Description
Healing is defined as "not present" erosions or fissures according to the LA classification.
Time Frame
2 weeks
Title
Healing rate(%) at 2 weeks and 4 weeks according to CYP2C19 genotype type
Description
Extensive Metaboliser (EM), Intermediate Metaboliser (IM), Poor Metaboliser (PM)
Time Frame
2 weeks or 4 weeks
Title
Percentage of days without heartburn through the clinical trial subject dairy (%)
Description
On days with no symptoms of heartburn, '0. It is defined as a case assessed as having no symptoms.
Time Frame
2 weeks or 4 weeks
Title
RDQ (Reflux Disease Questionnaire) evaluation(mean change in severity)
Description
Average scale change in RDQ severity and frequency at 2 weeks and 4 weeks after administration compared to before administration of investigational drugs for each category (heartburn, indigestion, acid reflux)
Time Frame
2 weeks or 4 weeks
Title
Incidence of Adverse Events [Safety]
Description
Physical examination(weight-kg)(height-cm), vital signs(SBP, DBP, heart rate, body temperature), adverse reactions, blood chemistry test
Time Frame
2 weeks or 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk Chae Choi
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonkwang University Hospital
City
Iksan
State/Province
Muwang-ro 895
ZIP/Postal Code
54538
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Reflux Disease
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