Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication

August 9, 2024 updated by: Han Ying, Xijing Hospital of Digestive Diseases

Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:

  • Main indicators: the eradication rate of Helicobacter pylori for eradication.
  • Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1404

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.

Exclusion Criteria:

  • Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Rabeprazloe+bismuth+amoxicillin+clarithromycin 14days
14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Drug: Rabeprazloe+bismuth+amoxicillin+clarithromycin
PBAC: 14D: PPI: Rabeprazole 10mg bid; B: bismuth potassium citrate240mg bid/ colloidal bismuth pectin 300mg bid/ colloidal bismuth tartrate 220mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Experimental: Vonoprazan+amoxicillin+clarithromycin 14 days
14D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Drug: Vonoprazan+amoxicillin+clarithromycin 14 days
VAC14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Experimental: Vonoprazan+amoxicillin+clarithromycin 7 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Drug: Vonoprazan+amoxicillin+clarithromycin 7 days
VAC7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg bid; C: clarithromycin 500mg bid.
Experimental: Vonoprazan+tetracycline+furazolidone 14 days
14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Drug: Vonoprazan+tetracycline+furazolidone 14 days
VTF14: 14D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Experimental: Vonoprazan+tetracycline+furazolidone 7 days
7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Drug: Vonoprazan+tetracycline+furazolidone 7 days
VTF7: 7D: V: vonoprazan 20mg bid; T: tetracycline 500mg tid; F: furazolidone 100mg bid.
Experimental: Vonoprazan+amoxicillin+furazolidone 7 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; F: furazolidone 100mg bid.
Drug: Vonoprazan+amoxicillin+furazolidone 7 days
hVAF: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; F: furazolidone 100mg bid.
Experimental: Vonoprazan+amoxicillin+tetracycline 14 days
7D: V: vonoprazan 20mg bid; A:amoxicillin1000mg tid; T: tetracycline 500mg tid.
Drug: Vonoprazan+amoxicillin+tetracycline 14 days
hVAT: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid; T: tetracycline 500mg tid.
Experimental: Vonoprazan+amoxicillin 7 days
7D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.
Drug: Vonoprazan+amoxicillin 7 days
hVA7: 7D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.
Experimental: Vonoprazan+amoxicillin 14 days
14D:V: vonoprazan 20mg bid; A:amoxicillin1000mg tid.
Drug: Vonoprazan+amoxicillin 14 days
hVA14: 14D: V: vonoprazan 20mg bid; A: amoxicillin1000mg tid.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eradication rate of Helicobacter pylori
Time Frame: Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment
Evaluated by 13C/14C-urea Breath test results and/or monoclonal faecal antigen test results were assessed as negative for successful eradication and positive for negative for successful eradication, positive for failed eradication 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication and positive for (assessed by 13C/14C-urea breath test results and/or monoclonal faecal antigen test results, negative for successful eradication, positive for failure).
Helicobacter pylori eradication rate assessed 4-8 weeks after completion of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse effects
Time Frame: 14 days of treatment, and 28 days after treatment
According to the requirements of the "Drug Clinical Trial Management Code", the observation is carried out, and the adverse reactions of the patients during the administration of the drug are recorded. The severity, or intensity, of an AE refers to the extent to which an AE affects the subject' s daily activities. The intensity of the AE will be rated as mild (discomfort without influencing daily activities), moderate (discomfort partially influencing daily activities), or severe (discomfort with severe interruption with daily activities).
14 days of treatment, and 28 days after treatment
Symptom relief rate
Time Frame: 14 days of treatment, and 28 days after treatment
Patients were classified as no change, remission, cure, or exacerbation based on changes in clinical symptoms.
14 days of treatment, and 28 days after treatment
Treatment compliance
Time Frame: 7 or 14 days of treatment
Adherence was analysed according to medication possession ratio (MPR), where taking less than 80% of study drug during any evaluation period or failure to review was considered poor adherence;
7 or 14 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJLL-KY-20230499

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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