Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)

NCT05647278 | Completed Phase 4

• 1 other identifier: 2022-184
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief Summary

Standard eradication therapies using proton pump inhibitors (PPIs) require double doses to achieve sufficient acid suppression, yet failure rates remain high due to antibiotic resistance. Tegoprazan, a P-CAB agent, inhibits gastric acid more effectively than PPIs. This study hypothesizes that Tegoprazan-based dual therapy can achieve superior or non-inferior eradication rates compared to standard quadruple therapy. The study evaluates the antibacterial effect of Tegoprazan combined with high-dose Amoxicillin in H. pylori-infected patients.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Eradication

Outcome Measures

Primary Outcomes (1)

• Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment

  HP infection status will be determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.

  Week 4-8 post-treatment

Study Arms (3)

Tegoprazan 50mg QD

EXPERIMENTAL

Tegoprazan 50 mg once daily plus Amoxicillin 1000mg TID for up to 2 weeks

Drug: Tegoprazan 50 mg, tablets, orally, qd; Drug: amoxicillin 1000mg tid

Esomeprazole 20 mg BID

ACTIVE COMPARATOR

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Drug: Esomeprazole 20mg BID; Drug: amoxicillin +clarithromycin+colloidal bismuth pectin BID

Tegoprazan 50 mg BID

EXPERIMENTAL

Tegoprazan 50 mg twice daily plus Amoxicillin plus Amoxicillin 1000mg TID for up to 2 weeks

Drug: Tegoprazan 50 mg, tablets, orally, bid; Drug: amoxicillin 1000mg tid

Interventions

Tegoprazan 50 mg, tablets, orally, qd DRUG

Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

Tegoprazan 50mg QD

Esomeprazole 20mg BID DRUG

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Esomeprazole 20 mg BID

Tegoprazan 50 mg, tablets, orally, bid DRUG

Tegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

Tegoprazan 50 mg BID

amoxicillin +clarithromycin+colloidal bismuth pectin BID DRUG

amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks

Esomeprazole 20 mg BID

amoxicillin 1000mg tid DRUG

amoxicillin 1000mg tid

Tegoprazan 50 mg BID; Tegoprazan 50mg QD

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years with Hp-positive first sterilization were included in this study.
• Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

You may not qualify if:

• acute upper gastrointestinal bleeding.
• active gastric or duodenal ulcer.
• acute gastric or duodenal mucosal lesions.
• previous eradication treatment of Helicobacter pylori.
• penicillin/furazolidone allergy.
• surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy).
• Zollinger-Ellison syndrome or other hypergastric acid secretion diseases.
• severe neurological, cardiovascular, pulmonary, liver,renal, metabolic,gastrointestinal, urological, etc.
• Any fertile woman must use proper contraception.

Sponsors & Collaborators

• Zhang Xiaofeng,MD: lead

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

tegoprazan; Tablets; Esomeprazole; BID protein, human; Amoxicillin

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 12, 2022
• Study Start: November 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)