Triple Therapy With Tegoprazan in H. Pylori Positive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tegoprazan/Amoxicillin/Clarithromycin

Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg

Group Type EXPERIMENTAL

Tegoprazan/Amoxicillin/Clarithromycin

Intervention Type DRUG

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/Amoxicillin/Clarithromycin

Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg

Group Type ACTIVE_COMPARATOR

Lansoprazole/Amoxicillin/Clarithromycin

Intervention Type DRUG

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.

Interventions

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Tegoprazan/Amoxicillin/Clarithromycin

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.

Intervention Type DRUG

Lansoprazole/Amoxicillin/Clarithromycin

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.

Intervention Type DRUG

Other Intervention Names

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Tegoprazan triple therapy (TAC) Lansoprazole triple therapy (LAC)

Eligibility Criteria

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Inclusion Criteria

* H. pylori positive based on the screening test
* Peptic ulcer disease

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No