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NCT07068607RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
400 (estimated)
First submitted
7 Jul 2025
Start date
1 Apr 2025
Primary completion date
1 Oct 2025
Lead sponsor
Yongquan Shi
NCT number
NCT07068607

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 400
  • From 1 Apr 2025 to the primary completion date, 1 Oct 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
  • 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);
  • Patients who have undergone upper gastrointestinal surgery;

Other illness

  • 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 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 with mental disorders;

Lab values

  • Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);

Other

  • Pregnant and lactating women;
  • Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
  • Patients with symptoms of dysphagia;
  • Patients who have participated in other clinical trials within the past 3 months;
  • Patients who refuse to sign the informed consent form.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Xijing Hosipital of Digestive Disease
Coordinator of this site? Confirm its status
Xi'anChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.