Back to resultsStudy to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Primary Purpose
Healed Erosive Esophagitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan 25mg QD
Lansoprazole 15mg QD
Sponsored by
About this trial
This is an interventional treatment trial for Healed Erosive Esophagitis
Eligibility Criteria
Inclusion Criteria:
- Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- Healed erosive esophagitis within 7 days prior to Randomization
- No heartburn and regurgitation within 7 days prior to Randomization
Exclusion Criteria:
- Unable to undergo upper GI endoscopy
- Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
- Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- History of acid-suppressive, esophageal or gastric surgeries
Sites / Locations
- Hanyang University Seoul Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tegoprazan 25mg QD
Lansoprazole 15mg QD
Arm Description
Tegoprazan 25mg tablet, once daily, oral administration
Lansoprazole 15mg capsule, once daily, oral administration
Outcomes
Primary Outcome Measures
Endoscopic remission rate of EE at 24-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
Secondary Outcome Measures
Endoscopic remission rate of EE at 12-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04022096
Brief Title
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
Official Title
A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
June 23, 2021 (Actual)
Study Completion Date
June 23, 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 is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
Detailed Description
This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healed Erosive Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tegoprazan 25mg QD
Arm Type
Experimental
Arm Description
Tegoprazan 25mg tablet, once daily, oral administration
Arm Title
Lansoprazole 15mg QD
Arm Type
Active Comparator
Arm Description
Lansoprazole 15mg capsule, once daily, oral administration
Intervention Type
Drug
Intervention Name(s)
Tegoprazan 25mg QD
Intervention Description
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Lansoprazole 15mg QD
Intervention Description
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
Primary Outcome Measure Information:
Title
Endoscopic remission rate of EE at 24-week
Description
Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
Time Frame
24-week
Secondary Outcome Measure Information:
Title
Endoscopic remission rate of EE at 12-week
Description
Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)
Time Frame
12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
Healed erosive esophagitis within 7 days prior to Randomization
No heartburn and regurgitation within 7 days prior to Randomization
Exclusion Criteria:
Unable to undergo upper GI endoscopy
Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
History of acid-suppressive, esophageal or gastric surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Young Lee, Ph.D
Organizational Affiliation
Hanyang University Seoul Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
133-792
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 Esophagitis
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