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NCT Number: NCT06682533

Tegoprazan- Versus PPI-based H. Pylori Eradication

In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.

Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 04401, South Korea

Location status: Recruiting

Location contact

Jun-Hyung Cho, M.D.

CONTACT

[email protected]

+82-2-709-9202

About this study

The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gastroscopy can be performed
  • H. pylori test and pathological analysis can be performed

Exclusion criteria

  • Age < 20 or > 80 years
  • Anemia (serum hemoglobin level < 10 g/dL)
  • Severe systemic disease
  • Advanced chronic liver disease
  • Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
  • History of H. pylori eradication
  • Drug allergy to antibiotics
  • History of gastric surgery
  • Recent history of upper gastrointestinal bleeding

Treatment and study plan

Primary outcomes

  1. H. pylori eradication rates

    Time frame: 6 weeks

    Urea breath test after completing H. pylori eradication regimen

Secondary outcomes

  1. Treatment compliance

    Time frame: 6 weeks

    Assessment of patients' numbers completing H. pylori eradication regimen

  2. Drug-related adverse event rate

    Time frame: 6 weeks

    Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment

Study contacts

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

Jun-Hyung Cho

CONTACT

[email protected]

+82-2-709-9202 ext. 9581

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Efficacy and Tolerability of 14-Day Tegoprazan-based Triple Therapy for Eradication of Helicobacter Pylori Eradication: A Retrospective Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Apr 23, 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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