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Helicobacter Pylori InfectionPhase 4NCT05649540

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

A Phase 4 study testing Vonoprazan and Amoxicillin in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Vonoprazan and Amoxicillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
13 sitesChina
Study dates
20 Jan 2023to 5 Nov 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
Show all 10Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Changshu No.1 People's Hospital

    Changshu, Jiangsu

  • Changzhou Traditional Chinese Medicine Hospital

    Changzhou, Jiangsu

  • The first people's hospital of Lianyungang

    Lianyungang, Jiangsu

  • Jiangsu Province Hospital on Integration of Chinese and Western Medicine

    Nanjing, Jiangsu

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu

  • Nanjing Jiangbei Hospital

    Nanjing, Jiangsu

  • Sir Run Run Hospital, Nanjing Medical University

    Nanjing, Jiangsu

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Taixing People's Hospital

    Taishing, Jiangsu

  • The Fourth People's Hospital of Taizhou

    Taizhou, Jiangsu

  • The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University

    Xuzhou, Jiangsu

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu

  • The Affiliated Zhangjiagang Hospital of Soochow University

    Zhangjiagang, Jiangsu

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Vonoprazan, Amoxicillin
Keywords
Helicobacter pylori, dual therapy, eradication rate, safety, microbiota

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VonoprazanDrug

    Potassium-competitive acid blocker

  • AmoxicillinDrug

    Antibiotic for H. pylori eradication

Study groups in NCT05649540
Study groupRoleWhat they receive
high dose amoxicillin with vonoprazan groupActive comparatorvonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Receives: Drug: Vonoprazan; Drug: Amoxicillin
standard dose amoxicillin with vonoprazan groupExperimentalvonoprazan 20mg bid and amoxicillin 1000mg bid for 14 days
Receives: Drug: Vonoprazan; Drug: Amoxicillin
low dose amoxicillin with vonoprazan groupExperimentalvonoprazan 20mg bid and amoxicillin 500mg tid for 14 days
Receives: Drug: Vonoprazan; Drug: Amoxicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Helicobacter pylori eradication rate

    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.

    Measured: four to eight weeks after completion of the medication

Secondary outcomes (3)

  1. Adverse event

    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.

    Measured: Within 7 days after completion of therapy

  2. Compliance Rate

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

    Measured: Within 7 days after completion of therapy

  3. Microbiota influence

    Collect the tongue coating and feces of some patients for flora analysis

    Measured: baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start20 Jan 2023
  3. Primary completion6 Jul 2024
  4. Study completion5 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05649540
Sponsor's protocol ID
KY20221124-07
Status last verified
Nov 2024
First submitted
6 Dec 2022
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.

    PubMed 26187502

  • Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 11;71(9):1724-1762. doi: 10.1136/gutjnl-2022-327745.

    PubMed 35944925

  • Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.

    PubMed 19109870

  • Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20.

    PubMed 32314468

  • Furuta T, Shirai N, Kodaira M, Sugimoto M, Nogaki A, Kuriyama S, Iwaizumi M, Yamade M, Terakawa I, Ohashi K, Ishizaki T, Hishida A. Pharmacogenomics-based tailored versus standard therapeutic regimen for eradication of H. pylori. Clin Pharmacol Ther. 2007 Apr;81(4):521-8. doi: 10.1038/sj.clpt.6100043. Epub 2007 Jan 10.

    PubMed 17215846

  • Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy. 2022 Mar;42(3):224-232. doi: 10.1002/phar.2662. Epub 2022 Feb 5.

    PubMed 35075679

  • Peng R, Cai P, Zhang Z, Lv S, Chen G, Xu Y, He B, Sun M, Dai X, Yan K, Shen L, Wang J, Li W, Yin R, Ge J, Hu D, Hu K, Xu X, Li H, Pan C, Duan Z, Gao X, Zhang Z, Liu W. Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial. Helicobacter. 2025 May-Jun;30(3):e70050. doi: 10.1111/hel.70050.

    PubMed 40481714

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vonoprazan and Amoxicillin in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Helicobacter pylori eradication rate (time frame: four to eight weeks after completion of the medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05649540, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

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