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Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Sponsor
Nanjing First Hospital, Nanjing Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649540
Collaborator
(none)
900
Enrollment
13
Locations
3
Arms
11.5
Anticipated Duration (Months)
69.2
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: high dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Drug: Vonoprazan
Potassium-competitive acid blocker

Drug: Amoxicillin
Antibiotic for H. pylori eradication
Experimental: standard dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days

Drug: Vonoprazan
Potassium-competitive acid blocker

Drug: Amoxicillin
Antibiotic for H. pylori eradication
Experimental: low dose amoxicillin with vonoprazan group

vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days

Drug: Vonoprazan
Potassium-competitive acid blocker

Drug: Amoxicillin
Antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

  1. Helicobacter pylori eradication rate [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.

Secondary Outcome Measures

  1. Adverse event [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.

  2. Compliance Rate [Within 7 days after completion of therapy]

    Compliance was defined as poor when they had taken less than 80% of the total medication

  3. Microbiota influence [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changshu No.1 People's Hospital Changshu Jiangsu China
2 Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine Changzhou Jiangsu China
3 The first people's hospital of Lianyungang Lianyungang Jiangsu China
4 Jiangsu Province Hospital on Integration of Chinese and Western Medicine Nanjing Jiangsu China
5 Nanjing First Hospital, Nanjing Medical University Nanjing Jiangsu China
6 Sir Run Run Hospital, Nanjing Medical University Nanjing Jiangsu China
7 The Second Affiliated Hospital of Soochow Suzhou Jiangsu China
8 Taixing People's Hospital Taixing Jiangsu China
9 The Fourth People's Hospital of Taizhou Taizhou Jiangsu China
10 Department of Gastroenterology Wuxi People's Hospital Affiliated to Nanjing Medical University Wuxi Jiangsu China
11 The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University Xuzhou Jiangsu China
12 Affiliated Hospital of Yangzhou University Yangzhou Jiangsu China
13 Zhangjiagang First people's Hospital Zhangjiagang Jiangsu China

Sponsors and Collaborators

  • Nanjing First Hospital, Nanjing Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Zhenyu Zhang, Director of Gastroenterology, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT05649540
Other Study ID Numbers:
  • KY20221124-07
First Posted:
Dec 14, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhenyu Zhang, Director of Gastroenterology, Nanjing First Hospital, Nanjing Medical University
Helicobacter pylori
dual therapy
eradication rate
safety
microbiota
Additional relevant MeSH terms:
Amoxicillin

Study Results

No Results Posted as of Dec 14, 2022