Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial
Efficacy and Safety of Tegoprazan-Based Dual, Triple, and Quadruple Therapies as First-Line Regimens for Helicobacter Pylori Eradication: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Helicobacter pylori (H. pylori) infection remains a significant global health burden, strongly associated with peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma. Current international and Chinese guidelines endorse multidrug regimens as first-line eradication therapy. The predominant approach, particularly in China, is bismuth-containing quadruple therapy (BQT). This regimen combines a proton pump inhibitor (PPI) or a bismuth agent with two antibiotics (selected from agents such as clarithromycin, amoxicillin, quinolones, furazolidone, nitroimidazoles, or tetracycline), typically administered for 7 to 14 days.
Despite its established position, BQT faces substantial challenges in real-world implementation. Polypharmacy, inherent in administering four distinct medications, creates a significant burden for patients, increasing the risk of dosing errors and non-adherence. Furthermore, the combination of multiple antimicrobials and bismuth frequently leads to substantial adverse events (e.g., gastrointestinal disturbances, taste alterations), which further compromise treatment adherence. Suboptimal adherence is a well-recognized factor contributing to treatment failure and the alarming rise in antimicrobial resistance (AMR).
In response to these challenges, simplified dual therapies have emerged as a promising alternative strategy. These regimens pair a potent acid suppressant - either a traditional PPI or the newer, more potent potassium-competitive acid blocker (P-CAB) class - with high-dose amoxicillin. Accumulating evidence suggests that such optimized dual therapies can achieve eradication rates comparable to BQT in treatment-naïve populations. Crucially, they demonstrate superior tolerability and significantly improved adherence profiles due to reduced pill burden and fewer side effects. This combination leverages the critical role of profound acid suppression in enhancing amoxicillin's efficacy against H. pylori while minimizing the use of additional antibiotics, thereby potentially mitigating AMR development.
However, a significant knowledge gap exists within this evolving paradigm. While amoxicillin-based dual therapy has been studied, the comparative efficacy of tetracycline-based dual therapy remains unexamined in rigorous controlled clinical trials. Tetracycline, a key component of some BQT regimens and salvage therapies, possesses distinct antimicrobial properties against H. pylori. Understanding its performance within a simplified dual therapy framework, particularly under potent acid suppression, is essential for expanding therapeutic options.
Building upon promising preliminary investigations demonstrating that optimized PPI-amoxicillin dual therapy consistently achieves >90% eradication rates in treatment-naïve patients, this research aims to further advance the field. We propose a prospective, randomized controlled trial to directly compare the effectiveness of two novel dual therapy regimens for first-line H. pylori eradication. Both regimens will utilize tegoprazan, a next-generation P-CAB known for its rapid, potent, and sustained acid-inhibitory effects. Tegoprazan will be co-administered with either high-dose amoxicillin or tetracycline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Fujian
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Xiamen, Fujian, China, 361015
- Zhongshan Hospital (Xiamen), Fudan University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 18 to 70 years;
- H. pylori infection diagnosed by ¹³C-urea breath test or rapid urease test during endoscopy;
- The patient infected with Helicobacter pylori has never undergone eradication therapy.
Exclusion Criteria:
- Patients with a definite history of allergy to the study drugs (tegoprazan, amoxicillin, tetracycline, or bismuth potassium citrate);
- Those who have used any proton pump inhibitors, potassium-competitive acid blockers, antibiotics, bismuth agents, or H₂ receptor antagonists within 4 weeks prior to enrollment;
- Those with concomitant severe cardiovascular, pulmonary, hepatic, renal, or other systemic diseases (e.g., New York Heart Association functional class III-IV, chronic kidney disease stage 3 or higher, Child-Pugh class B or higher cirrhosis);
- Those requiring long-term use of systemic corticosteroids, anticoagulants, or antiplatelet agents (excluding aspirin <100 mg daily);
- Pregnant or breastfeeding women;
- Those with a history of drug abuse or alcohol dependence within the past 1 year;
- Those with a current or prior history of malignancy at any site;
- Those with active gastrointestinal bleeding or unexplained iron deficiency anemia;
- Those with severe psychiatric disorders that may compromise compliance with the study;
- Those who have participated in other interventional clinical trials within 3 months prior to enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tegoprazan-Amoxicillin Dual Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 750 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.
|
50 mg twice daily (BID), d1-14.
In the Tegoprazan-Amoxicillin Dual Therapy group, amoxicillin 750 mg four times daily (QID) on days 1-14; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy group and the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, amoxicillin 1000 mg twice daily.
|
|
Experimental: Tegoprazan-Tetracycline Dual Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Tetracycline 500 mg orally four times daily (QID) after meals; Both administered for 14 consecutive days.
|
50 mg twice daily (BID), d1-14.
In the Tegoprazan-Tetracycline Dual Therapy group, tetracycline tablets 500 mg (Hainan Pharmaceutical Factory Co., Ltd.
No. 1 Pharmaceutical Factory) were administered four times daily; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy and Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy groups, tetracycline tablets 500 mg were administered three times daily.
|
|
Experimental: Tegoprazan-Amoxicillin-Tetracycline Triple Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1000 mg orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; All administered for 14 consecutive days.
|
50 mg twice daily (BID), d1-14.
In the Tegoprazan-Amoxicillin Dual Therapy group, amoxicillin 750 mg four times daily (QID) on days 1-14; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy group and the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, amoxicillin 1000 mg twice daily.
In the Tegoprazan-Tetracycline Dual Therapy group, tetracycline tablets 500 mg (Hainan Pharmaceutical Factory Co., Ltd.
No. 1 Pharmaceutical Factory) were administered four times daily; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy and Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy groups, tetracycline tablets 500 mg were administered three times daily.
|
|
Active Comparator: Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy
Tegoprazan 50 mg orally twice daily (BID) before meals; Amoxicillin 1000 mg orally twice daily (BID) after meals; Tetracycline 500 mg orally three times daily (TID) after meals; Bismuth Potassium Citrate Capsules 240 mg orally twice daily (BID) after meals; All administered for 14 consecutive days.
|
50 mg twice daily (BID), d1-14.
In the Tegoprazan-Amoxicillin Dual Therapy group, amoxicillin 750 mg four times daily (QID) on days 1-14; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy group and the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, amoxicillin 1000 mg twice daily.
In the Tegoprazan-Tetracycline Dual Therapy group, tetracycline tablets 500 mg (Hainan Pharmaceutical Factory Co., Ltd.
No. 1 Pharmaceutical Factory) were administered four times daily; in the Tegoprazan-Amoxicillin-Tetracycline Triple Therapy and Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy groups, tetracycline tablets 500 mg were administered three times daily.
In the Tegoprazan-Amoxicillin-Tetracycline-Bismuth Quadruple Therapy group, bismuth potassium citrate capsules 240 mg (Hunan Warner Pharmaceutical Co., Ltd.) were administered twice daily.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
H. pylori eradication rate
Time Frame: 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‰).
|
44 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Compliance rate of the drugs
Time Frame: 44 days
|
Compliance is defined as good when they had taken more than 80% of the total medication.
|
44 days
|
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Frequency of the adverse events
Time Frame: 44 days
|
Incidence rate of the adverse events, including taste distortion, abdominal distension, nausea, vomiting, abdominal pain, diarrhea, dizziness, headache, skin rash, and fatigue, etc.
|
44 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yucheng Zhu, Ph.D., Zhongshan Hospital (Xiamen), Fudan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Hydrocarbons
- Hydrocarbons, Cyclic
- Polycyclic Aromatic Hydrocarbons
- Hydrocarbons, Aromatic
- Polycyclic Compounds
- Amides
- Inorganic Chemicals
- Elements
- Metals
- Metals, Heavy
- Naphthacenes
- Tetracyclines
- Penicillin G
- beta-Lactams
- Lactams
- Ampicillin
- Penicillins
- Elements, Radioactive
- Radioisotopes
- Isotopes
- Tetracycline
- Bismuth
- Amoxicillin
- tegoprazan
Other Study ID Numbers
- ZYC-Hp2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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