Tegoprazan- Versus PPI-based H. Pylori Eradication

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

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.

Study Overview

• Status: Recruiting
• Conditions: H.Pylori Infection

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jun-Hyung Cho; Phone Number: 9581 +82-2-709-9202; Email: chojhmd@naver.com

Study Locations

• South Korea
  • Seoul, South Korea, 04401
    • Recruiting
    • Digestive Disease Center, Soonchunhyang University Hospital
    • Contact: Jun-Hyung Cho, M.D.; Phone Number: +82-2-709-9202; Email: chojhmd@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

H. pylori-infected patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
PPI-BID group; Standard dose of PPI bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days
Tegoprazan-BID group; Tegoprazan 50 mg bid, amoxicillin 1000 mg bid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days
PPI-QID group; Standard dose of PPI bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid, tripotassium dicitrate bismuthate (DENOL) 300 mg bid 14 days
Tegoprazan-QID group; Tegoprazan 50 mg bid, amoxicillin 500 mg qid, clarithromycin 500 mg bid,tripotassium dicitrate bismuthate (DENOL) 300 mg bid for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rates	Urea breath test after completing H. pylori eradication regimen	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment compliance	Assessment of patients' numbers completing H. pylori eradication regimen	6 weeks
Drug-related adverse event rate	Bitter tongue, nausea/vomiting, bloating, diarrhea, and abdominal pain during H. pylori treatment	6 weeks

Collaborators and Investigators

• Sponsor: Soonchunhyang University Hospital
• Investigators: Principal Investigator: Jun-Hyung Cho, M.D., Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 8, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SCH-HP-2024-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No