CClinicalTrials.gg
Sign In
RecruitingNCT07179159Updated Apr 15, 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. Recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-15.

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

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

Who can participate

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

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 biopsy 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 hypersensitivity
  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 informed consent
04

Study design

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

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

05

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

06

Study locations

1 of 2 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    Recruiting
  • Qilu Hospital of Shandong University
    Jinan, China
    Not yet recruiting
07

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 9, 2025
Primary completion
Aug 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 15, 2026

Study contacts

Yueyue Li
Contact
lyynqj@126.com
+8618560089751

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Yanqing Li

Start the discussion