NCT04128917

Brief Summary

This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

October 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 21, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

October 15, 2019

Last Update Submit

May 10, 2021

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate

    Assess H. pylori eradication rate by UBT

    Day 49

Study Arms (3)

Tegoprazan 50 mg

EXPERIMENTAL

Tegoprazan 50 mg Triple Therapy

Drug: Tegoprazan

Tegoprazan 100 mg

EXPERIMENTAL

Tegoprazan 100 mg Triple Therapy

Drug: Tegoprazan

RAPAE01

ACTIVE COMPARATOR

RAPAE01 Triple Therapy

Drug: RAPAE01

Interventions

TegoprazanDRUG

Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral

Tegoprazan 100 mgTegoprazan 50 mg
RAPAE01DRUG

RAPAE01/Clarithromycin/Amoxicillin BID peroral

RAPAE01

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (1)

  • Park JY, Choi IJ, Kim GH, Hong SJ, Shin SK, Jeon SW, Kim JG. Comparative Efficacy of Potassium-Competitive Acid Blocker-Based Triple Therapy with Tegoprazan versus Vonoprazan for Helicobacter pylori Eradication: A Randomized, Double-Blind, Active-Controlled Pilot Study. Gut Liver. 2025 Sep 15;19(5):696-705. doi: 10.5009/gnl250067. Epub 2025 Jun 4.

    PMID: 40462641DERIVED

MeSH Terms

Interventions

tegoprazan

Study Officials

  • JAEGYU KIM

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

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

October 15, 2019

First Posted

October 16, 2019

Study Start

January 21, 2020

Primary Completion

December 21, 2020

Study Completion

January 29, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)