ClinicalTrials.gg
Status unknownNCT05196945Updated Feb 17, 2022

Vonoprazan Fumarate in Combination With Amoxicillin for the First-line Eradication of Helicobacter Pylori -- a Multicenter, Randomized, Parallel Controlled Study

A Phase 4 interventional study of vonoprazan fumarate + amoxicillin and Esomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate in Helicobacter Pylori Eradication Rate, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-17.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
316
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Helicobacter pylori infection is closely related to gastritis, peptic ulcer, mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can significantly improve and reduce HP-related diseases. International and domestic guidelines recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving an eradication rate of more than 80%. However, some disadvantages of these quadruple regimens, such as severe adverse reactions, high medical costs and low compliance, prevent their application in clinical practice. Studies at home and abroad have shown that high-dose proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for HP eradication, with good efficacy and compliance and low rate of adverse reactions. And because it is a single antibiotic therapy, we do not expect this regimen to increase antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive potassium acid blocker, is not affected by gene polymorphism, and has the advantage of stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors. In most parts of China, HP is characterized by high infection rate and antibiotic resistance rate, requiring higher eradication rate and safety regimen. This study compared the efficacy and safety of vonoprazan fumarate combined with amoxicillin and bismuth-containing quadruple regimen in first-line HP eradication, in order to find a more suitable regimen for HP eradication.

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Conditions studied

  • Helicobacter Pylori Eradication Rate
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In context

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age 18-70, regardless of gender; HP positive in 13C/14C breath test or pathological test; HP eradication has never been performed in the past; Based on the consensus of helicobacter pylori in 2017, it conforms to the HP eradication guideline; The patient voluntarily signed the informed consent.

Exclusion criteria

Exclusion Criteria:

History of drug allergy in this study; Liver and kidney dysfunction; Cardiopulmonary insufficiency; History of malignant tumor; Taking clopidogrel, warfarin and other drugs simultaneously may affect CYP2C19 metabolism; Pregnant or lactating women; Patients with severe mental illness; Those planning pregnancy; Previous upper gastrointestinal surgery history; Participated in any other clinical investigator in the last 3 months.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
316 participants (estimated)

Study arms

  • Experimental
    VA-dual

    14 days(vonoprazan fumarate tablets 20 mg/time, 2 times/day, oral +Amoxicillin 750mg/ time, 4 times/day, oral)

    Drug: vonoprazan fumarate + amoxicillin

  • Active comparator
    EACP - quadruple

    14days(Esomeprazole 20mg/ time, 2 times/day, oral+Amoxicillin 1g/ time, 2 times/day, oral+Clarithromycin 0.5g/ time, 2 times/day, oral+Bismuth potassium citrate 220mg/ time, twice a day, orally)

    Drug: Esomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate

Interventions

  • Drugvonoprazan fumarate + amoxicillin

    Drug pages: Vonoprazan · Amoxicillin

    vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral

  • DrugEsomeprazole +Amoxicillin+Clarithromycin+Bismuth potassium citrate

    Drug pages: Esomeprazole · Amoxicillin · Clarithromycin · Bismuth

    Esomeprazole 20mg/ time, 2 times/day, oral Amoxicillin 1g/ time, 2 times/day, oral Clarithromycin 0.5g/ time, 2 times/day, oral Bismuth potassium citrate 220mg/ time, twice a day, orally

06

What researchers measure

Primary outcomes

  1. H. pylori eradication rate

    Rate of h. pylori successfully eradicated;13C-urea breath testthat will be used to assess this outcome measure

    Time frame: 6 week

Secondary outcomes

  1. Adverse Event

    Rate of adverse event, serious adverse event; Questionnaire that will be used to assess this outcome measure.

    Time frame: 6 week

  2. Medical financial burden

    Medical financial burden;Questionnaire that will be used to assess this outcome measure.

    Time frame: 6 week

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05196945
Collaborators
Zhejiang University, People's Hospital of Chongqing, Tianjin Medical University General Hospital, Shengjing Hospital, The Second Affiliated Hospital of Dalian Medical University, Southern Medical University, China, First People's Hospital of Foshan, Guangzhou Panyu Central Hospital, First Affiliated Hospital of Shantou University Medical College, The Seventh Affiliated Hospital, Southern Medical University
Responsible party
pengxiang (Attending physician, Sixth Affiliated Hospital, Sun Yat-sen University) — Principal investigator
First posted
Jan 19, 2022
Start date
Mar 31, 2022 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Feb 17, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Vonoprazan · Amoxicillin

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