A Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of Tegoprazan in GERD Patients With Nighttime Heartburn
1 other identifier
interventional
338
1 country
1
Brief Summary
This study aims to compare the nighttime heartburn improvement effect of Tegoprazan 50mg and Esomeprazole 40mg(or 20mg) in patients with GERD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2023
CompletedFirst Posted
Study publicly available on registry
January 27, 2023
CompletedStudy Start
First participant enrolled
March 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedAugust 3, 2023
August 1, 2023
1.8 years
January 18, 2023
August 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
2 weeks
Secondary Outcomes (2)
Time to first nighttime hearturn-free interval(days)
2 weeks
Percentage of days without daytime heartburn during the 2-week dosing period
2 weeks
Study Arms (2)
Tegoprazan 50mg
EXPERIMENTALTegoprazan 50mg, once daily, oral administration for two weeks
Esomeprazole 40mg or 20mg
ACTIVE COMPARATOR1. In case of ERD patients: Esomeprazole 40mg, qd, oral administration for two weeks 2. In case of NERD patients: Esomeprazole 20mg, qd, oral administration for two weeks
Interventions
Esomeprazole 20mg tablet 1. For patients with ERD: two Esomeprazole 20mg tablets 2. For patients with NERD: one Esomeprazole 20mg tablet
Eligibility Criteria
You may qualify if:
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease or non-erosive reflux disease
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sang Kil Lee, Ph.D
Severance Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
January 18, 2023
First Posted
January 27, 2023
Study Start
March 24, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
August 3, 2023
Record last verified: 2023-08