Exploratory Study to Standard Triple Therapy With Tegoprazan(by Dose) in H. Pylori Positive Patients
A Randomized, Double-Blind, Active-controlled, Multi-center, Therapeutic Exploratory Study to Evaluate the Safety and Efficacy of a Standard Triple Therapy With Tegoprazan (by Dose) in H. Pylori Positive Patients
1 other identifier
interventional
381
1 country
1
Brief Summary
This exploratory study is designed to compare safety and efficacy between a Tegoprazan dose-specific standard triple therapy and Lansoprazole standard triple therapy in H. pylori positive patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
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
February 27, 2023
CompletedFirst Submitted
Initial submission to the registry
May 23, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 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
CompletedJuly 6, 2023
July 1, 2023
1.8 years
May 23, 2023
July 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
H. pylori eradication rate
Assess H. pylori eradication rate by UBT
42 days
Study Arms (3)
Tegoprazan 50 mg
EXPERIMENTALTegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Tegoprazan 100 mg
EXPERIMENTALTegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Lansoprazole
ACTIVE COMPARATORLansoprazolee/Clarithromycin/ Amoxicillin BID peroral, 14 days
Interventions
Tegoprazan 50 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Tegoprazan 100 mg/Clarithromycin/ Amoxicillin BID peroral, 14 days
Lansoprazole/Clarithromycin/ Amoxicillin BID peroral, 14 days
Eligibility Criteria
You may qualify if:
- H. pylori positive at screening
- Subjects who have upper gastrointestinal disease
You may not qualify if:
- Having received prior therapy for eradication of H. pylori
- Prior use of P-CAB, proton pump inhibitors (PPIs), H2 receptor blockers within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 28 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung-Ang University Hosptial
Seoul, South Korea
Related Publications (1)
Park JY, Hong SJ, Choi IJ, Baik GH, Kim SM, Park JJ, Jeon SW, Kim KO, Lee SK, Jung HY, Oh JH, Park CH, Kim SW, Shim KN, Jee SR, Moon HS, Moon JS, Choi CW, Lee WS, Kim JG. Tegoprazan-Based Triple Therapy for Helicobacter pylori Eradication: A Phase III Multicenter Randomized Clinical Trial. Helicobacter. 2026 Jan-Feb;31(1):e70106. doi: 10.1111/hel.70106.
PMID: 41531249DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Gyu Kim
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
May 23, 2023
First Posted
July 6, 2023
Study Start
February 27, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
July 6, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share