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NCT Number: NCT06382493

Tegoprazan-containing Sequential for H. Pylori

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location status: Recruiting

Location contact

Nayoung Kim, M.D.,Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)

Exclusion criteria

  • congestive heart failure, NYHA III or IV
  • end-stage renal disease
  • alcoholics
  • drug abusers
  • pregnant or nursing women

Treatment and study plan

Tegoprazan-containing sequential H. pylori eradication therapy

Drug

tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy

Esomeprazole-containing sequential H. pylori eradication therapy

Drug

Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)

Primary outcomes

  1. Eradication rate

    Time frame: 2 or 3 month

    Efficacy of H. pylori eradication therapy. confirmed by negative UBT test

Secondary outcomes

  1. Adverse events

    Time frame: up to 6 month

    any adverse events occured during or after intervention (eradication therapy)

Study contacts

Contact information is provided by the study sponsor or research team.

Jungwon Lee, Dr.

CONTACT

[email protected]

821093567758

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2024
Registry last updated
Apr 28, 2026

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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