Triple Therapy With Tegoprazan in H. Pylori Positive Patients
A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients
1 other identifier
interventional
284
1 country
1
Brief Summary
The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.
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 2018
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
First Submitted
Initial submission to the registry
April 8, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
June 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMay 8, 2020
May 1, 2020
1.5 years
April 8, 2018
May 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
H. pylori eradication rate
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.
6 weeks
Study Arms (2)
Tegoprazan/Amoxicillin/Clarithromycin
EXPERIMENTALTegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Lansoprazole/Amoxicillin/Clarithromycin
ACTIVE COMPARATORLansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg
Interventions
Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
Eligibility Criteria
You may qualify if:
- H. pylori positive based on the screening test
- Peptic ulcer disease
You may not qualify if:
- Prior treatment for H. pylori eradication
- Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
- Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hwoon Yong Jung, Professor
Asan Medical Center
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
April 8, 2018
First Posted
April 13, 2018
Study Start
June 28, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
May 8, 2020
Record last verified: 2020-05