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Completed

NCT Number: NCT05649540

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changshu No.1 People's Hospital, Changshu, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages between 18 and 70 years; Sexes eligible for study: both;
  • patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
  • 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;
  • voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion criteria

  • allergic reactions to the study drugs;
  • patients with peptic ulcer;
  • patients who underwent eradication therapy for Helicobacter pylori during the last six months;
  • 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;
  • patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
  • patients who have history of esophageal or gastric surgery;
  • pregnant or lactating women;
  • patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
  • Alcohol abusers
  • MALT lymphoma of stomach or malignant tumor

Treatment and study plan

Vonoprazan

Drug

Potassium-competitive acid blocker

Amoxicillin

Drug

Antibiotic for H. pylori eradication

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2022
Registry last updated
Nov 19, 2024

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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