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Helicobacter Pylori InfectionPhase 4NCT05469685

Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

A Phase 4 study testing Vonoprazan and Amoxicillin in people with Helicobacter Pylori Infection, run by Nanjing First Hospital, Nanjing Medical University at 10 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- amoxicillin dual therapy for Helicobacter Pylori eradication Read more about this study

Who is it for?
Ages 18 to 65 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
914 participants
Where
10 sitesChina
Study dates
1 Aug 2022to 30 Sep 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages between 18 and 65 years; Sexes eligible for study: both;
  • patients who are diagnosed with Helicobacter pylori;
  • 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 9Show fewer
  • pregnant or lactating women;
  • patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
  • Alcohol abusers

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine

    Nanjing, Jiangsu

  • Nanjing First Hospital, Nanjing Medical University

    Nanjing, Jiangsu

  • Changshu No.1 People's Hospital

    Suzhou, Jiangsu

  • Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Taixing People's Hospital

    Taizhou, Jiangsu

  • Taizhou Fourth People's Hospital

    Taizhou, Jiangsu

  • Wuxi People's Hospital Affiliated to Nanjing Medical University

    Wuxi, Jiangsu

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

    Xuzhou, Jiangsu

  • Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School

    Yancheng, Jiangsu

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu

Other trials in China

About this study

Official title: Efficacy and Safety of Vonoprazan- Amoxicillin Dual Therapy for Helicobacter Pylori Eradication : a Prospective, Multicenter, Randomized Controlled Trial

The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication

Read the detailed description

This study intends to select the patients with Hp infection in 11 tertiary hospitals across our country, and randomly give the two 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, infection eradication, safety

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 NCT05469685
Study groupRoleWhat they receive
10-day treatment groupExperimentalvonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
Receives: Drug: Vonoprazan; Drug: Amoxicillin
14-day treatment groupActive comparatorvonoprazan 20mg bid and amoxicillin 1000mg 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 six weeks after completion of the medication

Secondary outcomes (2)

  1. Adverse events

    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

Timeline

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

  1. First posted22 Jul 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Aug 2023
  4. Study completion30 Sep 2023

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
914 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05469685
Sponsor's protocol ID
KY20220701-06
Status last verified
Jun 2024
First submitted
19 Jul 2022
Last updated
13 Jun 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

  • 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

  • Rimbara E, Noguchi N, Kawai T, Sasatsu M. Mutations in penicillin-binding proteins 1, 2 and 3 are responsible for amoxicillin resistance in Helicobacter pylori. J Antimicrob Chemother. 2008 May;61(5):995-8. doi: 10.1093/jac/dkn051. Epub 2008 Feb 14.

    PubMed 18276599

  • Furuta T, Graham DY. Pharmacologic aspects of eradication therapy for Helicobacter pylori Infection. Gastroenterol Clin North Am. 2010 Sep;39(3):465-80. doi: 10.1016/j.gtc.2010.08.007.

    PubMed 20951912

  • 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

  • Berry V, Jennings K, Woodnutt G. Bactericidal and morphological effects of amoxicillin on Helicobacter pylori. Antimicrob Agents Chemother. 1995 Aug;39(8):1859-61. doi: 10.1128/AAC.39.8.1859.

    PubMed 7486933

  • Dong Y, Duan Z, Liu M, Ding Y, Chen G, Wang R, Xu X, Ding L, Zhan Q, Pan C, Li H, Yang F, Dai X, Li X, Wu X, Peng P, Wang J, Hu K, Hu D, Jie Q, Zhang Z. Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial. Front Pharmacol. 2025 Mar 24;16:1543352. doi: 10.3389/fphar.2025.1543352. eCollection 2025.

    PubMed 40196374

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 10 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 9 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 six 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 NCT05469685, 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 13 Jun 2024.

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