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Completed

NCT Number: NCT03498456

Triple Therapy With Tegoprazan in H. Pylori Positive Patients

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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Key information

Conditions

Helicobacter Pylori Infection

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tegoprazan/Amoxicillin/Clarithromycin

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.

Other names: Tegoprazan triple therapy (TAC)

Lansoprazole/Amoxicillin/Clarithromycin

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.

Other names: Lansoprazole triple therapy (LAC)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 13, 2018
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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