Tegoprazan- Versus PPI-based H. Pylori Eradication

Last updated: April 27, 2025
Sponsor: Soonchunhyang University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06682533
SCH-HP-2024-11
  • Ages 20-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gastroscopy can be performed

  • H. pylori test and pathological analysis can be performed

Exclusion

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- receptorantagonists, or antibiotics

  • History of H. pylori eradication

  • Drug allergy to antibiotics

  • History of gastric surgery

  • Recent history of upper gastrointestinal bleeding

Study Design

Total Participants: 200
Study Start date:
December 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Digestive Disease Center, Soonchunhyang University Hospital

    Seoul, 04401
    Korea, Republic of

    Active - Recruiting

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