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Completed

NCT Number: NCT06412588

Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NanJing Frist Hospital

Nanjing, Jiangsu, 210006, China

About this study

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years old;
  • Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
  • Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
  • Voluntarily join this trial and sign the informed consent form.

Exclusion criteria

  • Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
  • Patients with confirmed active peptic ulcer;
  • Patients who have received Helicobacter pylori eradication therapy within half a year;
  • Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
  • Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
  • History of esophageal or gastric surgery;
  • Pregnant or lactating women;
  • Alcoholism
  • Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
  • Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
  • Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.

Treatment and study plan

Vonoprazan+amoxicillin+doxycycline+bismuth for 14 days

Drug

Group A:The patient was treated with oral Vonoprazan 20 mg, bid + amoxicillin 1.0 g, bid + doxycycline 0.1 g, bid + bismuth for 14 days.

Other names: Doxycycline-based Bismuth Quadruple Therapy

Vonoprazan+Amoxicillin

Drug

Group B: Patients were treated with oral Vonoprazan 20mg, bid + amoxicillin 1.0g, bid for 14 days.

Other names: Vonoprazan+Amoxicillin Dual therapy

Vonoprazan+doxycycline

Drug

Group C: Patients were treated with oral Vonoprazan 20 mg, bid + doxycycline 0.1 g, bid for 14 days.

Other names: Vonoprazan+doxycycline Dual therapy

Primary outcomes

  1. HP eradication rate

    Time frame: 4-6 weeks after the end of the last dose

    The eradication effect of Helicobacter pylori was tested by 13C-UBT or 14C-UBT

Secondary outcomes

  1. Patient compliance

    Time frame: Within 3 days after the end of treatment

    Rate of drug consumption during the treatment period of the subjects

Other outcomes

  1. Security observations

    Time frame: Within 3 days after the end of treatment

    Adverse drug reactions

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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