Tegoprazan-Based Dual Therapy With Amoxicillin vs Tetracycline for H. Pylori Eradication

Not Applicable

Not yet recruiting

• Conditions: Helicobacter Pylori Eradication; High-dose Dual Therapy
• Interventions: Drug: Tegoprazan; Drug: Amoxicillin 250Mg Cap; Drug: Tetracycline 500 Mg; Drug: Bismuth

• Registration Number: NCT06977841
• Lead Sponsor: Zhongshan Hospital (Xiamen), Fudan University

Brief Summary

Current first-line Helicobacter pylori eradication protocols involve multidrug regimens comprising a proton pump inhibitor (PPI) or bismuth agent combined with dual antibiotics (e.g., clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline) administered for 7-14 days. In China, the bismuth-containing quadruple therapy (BQT) remains the standard first-line treatment for H. pylori infection. However, BQT implementation is challenged by polypharmacy burdens, substantial adverse events, and suboptimal treatment adherence. Emerging evidence suggests that simplified dual therapies pairing acid suppressants (PPIs or potassium-competitive acid blockers \[P-CABs\]) with high-dose amoxicillin achieve comparable eradication rates to BQT while demonstrating superior tolerability and adherence profiles. Notably, the comparative efficacy of tetracycline-based versus amoxicillin-based dual regimens remains unexamined in controlled clinical trials. Our preliminary investigations established that optimized PPI-amoxicillin dual therapy achieves \>90% eradication rates in treatment-naïve populations. Building on these findings, this prospective randomized controlled trial will comparatively assess the effectiveness of tegoprazan-a novel P-CAB exhibiting potent acid inhibition-when co-administered with either amoxicillin or tetracycline in H. pylori-positive adults. The investigation aims to establish an evidence framework for streamlining eradication protocols through pharmacodynamic optimization while mitigating antimicrobial resistance development.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-10
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-10
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1. Age from 18 to 65 years;
2. H.pylori infection diagnosed by 13C-urea breath test;
3. The patient infected with Helicobacter pylori has never undergone eradication therapy.

Exclusion Criteria

1. Allergy to any of the medications;
2. Zollinger-Ellison syndrome, GC, Upper gastrointestinal bleeding, or Active peptic ulcer;
3. Coexistence of significant concomitant illnesses, including heart disease, renal failure, hepatic disease, previous abdominal surgery, lactation, or pregnancy;
4. Patients who had used PPI/P-CAB drugs, and antibiotics in the past 12 weeks;
5. Unwillingness to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tegoprazan-Amoxicillin Dual Therapy	Tegoprazan	-
Tegoprazan-Amoxicillin Dual Therapy	Amoxicillin 250Mg Cap	-
Tegoprazan-Tetracycline Dual Therapy	Tegoprazan	-
Tegoprazan-Tetracycline Dual Therapy	Tetracycline 500 Mg	-
Tegoprazan-Amoxicillin-Tetracycline Triple Therapy	Tegoprazan	-
Tegoprazan-Amoxicillin-Tetracycline Triple Therapy	Amoxicillin 250Mg Cap	-
Tegoprazan-Amoxicillin-Tetracycline Triple Therapy	Tetracycline 500 Mg	-
Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy	Tegoprazan	-
Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy	Amoxicillin 250Mg Cap	-
Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy	Tetracycline 500 Mg	-
Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy	Bismuth	-

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	44 days	Assessed by 13C-urea breath test (13C-UBT) at 30 days post-treatment. Eradication success was defined as a negative result (delta over baseline value \<4‰).

Secondary Outcome Measures

Name	Time	Method
Frequency of the adverse events	44 days	Incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
Compliance rate of the drugs	44 days	Compliance is defined as good when they had taken more than 80% of the total medication.

Trial Locations

Locations (1)

Zhongshan Hospital (Xiamen), Fudan University; 🇨🇳 Xiamen, Fujian, China