Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
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
1 other identifier
interventional
351
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 18, 2019
CompletedFirst Submitted
Initial submission to the registry
July 14, 2019
CompletedFirst Posted
Study publicly available on registry
July 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2021
CompletedJanuary 27, 2023
January 1, 2023
2 years
July 14, 2019
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
24-week
Secondary Outcomes (1)
Endoscopic remission rate of EE at 12-week
12-week
Study Arms (2)
Tegoprazan 25mg QD
EXPERIMENTALTegoprazan 25mg tablet, once daily, oral administration
Lansoprazole 15mg QD
ACTIVE COMPARATORLansoprazole 15mg capsule, once daily, oral administration
Interventions
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Seoul Hospital
Seoul, 133-792, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oh Young Lee, Ph.D
Hanyang University Seoul Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2019
First Posted
July 16, 2019
Study Start
June 18, 2019
Primary Completion
June 23, 2021
Study Completion
June 23, 2021
Last Updated
January 27, 2023
Record last verified: 2023-01