Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

NCT07068607 | Recruiting Phase 4

• 1 other identifier: KY20252096-F-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.

Conditions

Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

  The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication

  28 days after treatment

Secondary Outcomes (1)

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (4)

Vonoprazan - amoxicillin dual therapy

EXPERIMENTAL

Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days

Drug: Vonoprazan; Drug: Amoxicillin

Vonoprazan-tetracycline dual therapy

EXPERIMENTAL

Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days

Drug: Vonoprazan; Drug: Tetracycline 500mg tid

Vonoprazan-minocycline dual therapy

EXPERIMENTAL

Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days

Drug: Vonoprazan; Drug: Minocycline

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Drug: Vonoprazan; Drug: Bismuth; Drug: Clarithromycin 500 mg; Drug: Amoxicillin

Interventions

Vonoprazan DRUG

Vonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Also known as: Vonoprazan - amoxicillin dual therapy

Bismuth-containing quadruple therapy; Vonoprazan - amoxicillin dual therapy; Vonoprazan-minocycline dual therapy; Vonoprazan-tetracycline dual therapy

Tetracycline 500mg tid DRUG

Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days

Vonoprazan-tetracycline dual therapy

Minocycline DRUG

Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days

Vonoprazan-minocycline dual therapy

Bismuth DRUG

Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Bismuth-containing quadruple therapy

Clarithromycin 500 mg DRUG

Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Bismuth-containing quadruple therapy

Amoxicillin DRUG

Vonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days

Bismuth-containing quadruple therapy; Vonoprazan - amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 70 years, regardless of gender;
• Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
• For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.

You may not qualify if:

• Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
• Patients with contraindications to the study drug or who are allergic to the study drug;
• Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
• Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);
• Pregnant and lactating women;
• Patients who have undergone upper gastrointestinal surgery;
• Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
• Patients with symptoms of dysphagia;
• Patients with evidence of bleeding or iron - deficiency anemia;
• Patients with a history of malignant tumors;
• Patients with a history of drug or alcohol abuse within the past 1 year;
• Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
• Patients with mental disorders;
• Patients who have participated in other clinical trials within the past 3 months;
• Patients who refuse to sign the informed consent form.

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Gastritis; Dyspepsia; Stomach Neoplasms; Peptic Ulcer

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Tetracycline; Minocycline; Bismuth; Clarithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Erythromycin; Macrolides; Polyketides; Lactones; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Yongquan Shi, Ph. D

CONTACT

86-29-84771515; shiyquan@fmmu.edu.cn

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: Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)