Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

November 15, 2024 updated by: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Study Type

Interventional

Enrollment (Actual)

900

Phase

  • 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
    • Jiangsu
      • Changshu, Jiangsu, China
        • Changshu No.1 People's Hospital
      • Changzhou, Jiangsu, China
        • Changzhou Traditional Chinese Medicine Hospital
      • Lianyungang, Jiangsu, China
        • The First People's Hospital of Lianyungang
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital on Integration of Chinese and Western Medicine
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital, Nanjing Medical University
      • Nanjing, Jiangsu, China
        • Sir Run Run Hospital, Nanjing Medical University
      • Nanjing, Jiangsu, China
        • Nanjing Jiangbei Hospital
      • Suzhou, Jiangsu, China
        • Second Affiliated Hospital of Soochow University
      • Taixing, Jiangsu, China
        • Taixing People's Hospital
      • Taizhou, Jiangsu, China
        • The Fourth People's Hospital of Taizhou
      • Xuzhou, Jiangsu, China
        • The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
      • Yangzhou, Jiangsu, China
        • Affiliated Hospital of Yangzhou University
      • Zhangjiagang, Jiangsu, China
        • The Affiliated Zhangjiagang Hospital of Soochow University

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Ages between 18 and 70 years; Sexes eligible for study: both;
  2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
  3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
  4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

  1. allergic reactions to the study drugs;
  2. patients with peptic ulcer;
  3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
  4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
  5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
  6. patients who have history of esophageal or gastric surgery;
  7. pregnant or lactating women;
  8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
  9. Alcohol abusers
  10. MALT lymphoma of stomach or malignant tumor

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: high dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Vonoprazan
Potassium-competitive acid blocker
Experimental: standard dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Vonoprazan
Potassium-competitive acid blocker
Experimental: low dose amoxicillin with vonoprazan group
vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days
Drug: Amoxicillin
Antibiotic for H. pylori eradication
Drug: Vonoprazan
Potassium-competitive acid blocker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Helicobacter pylori eradication rate
Time Frame: four to eight weeks after completion of the medication
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.
four to eight weeks after completion of the medication

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance Rate
Time Frame: Within 7 days after completion of therapy
Compliance was defined as poor when they had taken less than 80% of the total medication
Within 7 days after completion of therapy
Adverse event
Time Frame: Within 7 days after completion of therapy
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
Within 7 days after completion of therapy
Microbiota influence
Time Frame: baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy
Collect the tongue coating and feces of some patients for flora analysis
baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Chair: Zhenyu Zhang, Nanjing First Hospital, Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 20, 2023

Primary Completion (Actual)

July 6, 2024

Study Completion (Actual)

November 5, 2024

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20221124-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Helicobacter Pylori Infection

Clinical Trials on Amoxicillin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe