Triple Therapy With Tegoprazan in H. Pylori Positive Patients

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ClinicalTrials.gov Identifier: NCT03498456

Recruitment Status : Completed

First Posted : April 13, 2018

Last Update Posted : May 8, 2020

Sponsor:

Information provided by (Responsible Party):

HK inno.N Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: Tegoprazan/Amoxicillin/Clarithromycin Drug: Lansoprazole/Amoxicillin/Clarithromycin	Phase 3

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	284 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	June 28, 2018
Actual Primary Completion Date :	December 31, 2019
Actual Study Completion Date :	December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Amoxicillin Amoxicillin sodium Clarithromycin Lansoprazole Dexlansoprazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tegoprazan/Amoxicillin/Clarithromycin Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg	Drug: 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. Other Name: Tegoprazan triple therapy (TAC)
Active Comparator: Lansoprazole/Amoxicillin/Clarithromycin Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg	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. Other Name: Lansoprazole triple therapy (LAC)

Outcome Measures

Primary Outcome Measures :

H. pylori eradication rate [ Time Frame: 6 weeks ]
Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498456

Locations

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of

Sponsors and Collaborators

HK inno.N Corporation

Investigators

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Principal Investigator:	Hwoon Yong Jung, Professor	Asan Medical Center

More Information

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Responsible Party:	HK inno.N Corporation
ClinicalTrials.gov Identifier:	NCT03498456
Other Study ID Numbers:	CJ_APA_307
First Posted:	April 13, 2018 Key Record Dates
Last Update Posted:	May 8, 2020
Last Verified:	May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Amoxicillin Clarithromycin Lansoprazole Dexlansoprazole Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors

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