ClinicalTrials.gg
CompletedNCT07179159Updated Oct 23, 2026

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

An interventional study of 14-day vonoprazan-amoxicillin dual therapy and 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy in HELICOBACTER PYLORI INFECTIONS, sponsored by Yanqing Li. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Yanqing Li · Not applicable, Interventional, and Treatment

Updated Oct 23, 2026Now CompletedStart date moved+3 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
372
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

02

Conditions studied

  • HELICOBACTER PYLORI INFECTIONS
03

In context

Lead sponsor

Yanqing Li is the lead sponsor of 13 studies on the registry; 3 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

  1. Aged 18-70 years, male or female
  2. Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal tissue)
  3. No prior Helicobacter pylori eradication therapy

Exclusion criteria

Exclusion Criteria:

  1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
  2. Active gastrointestinal bleeding
  3. History of upper gastrointestinal surgery
  4. History of drug
  5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
  6. Pregnant or lactating women
  7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
  8. Individuals unable or unwilling to provide
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
372 participants (actual)

Study arms

  • Experimental
    14-day vonoprazan-amoxicillin dual therapy

    Drug: 14-day vonoprazan-amoxicillin dual therapy

  • Active comparator
    14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

    Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

  • Active comparator
    14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

    Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

Interventions

  • Drug14-day vonoprazan-amoxicillin dual therapy

    vonoprazan 20mg bid + amoxicillin 1000mg bid

  • Drug14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

    vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid

  • Drug14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

    vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid

06

What researchers measure

Primary outcomes

  1. eradication rate

    Time frame: 6 weeks after treatment

Secondary outcomes

  1. adverse events

    Time frame: immediately after a 2-week treatment

  2. compliance

    Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.

    Time frame: immediately after a 2-week treatment

07

Study locations

2 sites
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
  • Qilu Hospital of Shandong University
    Jinan, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Sep 2025 to primary completion in Jun 2026, 9 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Aug 2026 → Jun 2026 and completion Dec 2026 → Jun 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2025
First posted
Sep 17, 2025
StartActual
Sep 20, 2025
Primary completionActual
Jun 30, 2026was Aug 2026
CompletionActual
Jun 30, 2026was Dec 2026
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 23, 2026
Start date
Sep 9, 2025→Sep 20, 2025
Oct 23, 2026
Primary completion
Aug 31, 2026→Jun 30, 2026 (actual)
Oct 23, 2026
Study completion
Dec 31, 2026→Jun 30, 2026 (actual)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Recruiting→Completed
    Start date Sep 9, 2025→Sep 20, 2025
    Primary completion Aug 31, 2026→Jun 30, 2026 (now actual)
    Study completion Dec 31, 2026→Jun 30, 2026 (now actual)
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07179159
Lead sponsor
Yanqing Li
Collaborators
Longkou People's Hospital, Qingdao Jimo People's Hospital, Shandong University of Traditional Chinese Medicine, Dezhou Hospital Qilu Hospital of Shandong University, Zibo Maternal and Child Health Hospital, Guanxian County People's Hospital, Yantai Zhifu Hospital, Dongying No. 2 People's Hospital, Qilu Hospital of Shandong University
Responsible party
Yanqing Li (Clinical Professor, Shandong University) — Sponsor-investigator
First posted
Sep 17, 2025
Start date
Sep 20, 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Oct 23, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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