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

NCT07179159 | Recruiting

• 1 other identifier: 202509
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• eradication rate

  6 weeks after treatment

Secondary Outcomes (2)

• adverse events

  immediately after a 2-week treatment

• compliance

  immediately after a 2-week treatment

Study Arms (3)

14-day vonoprazan-amoxicillin dual therapy

EXPERIMENTAL

Drug: 14-day vonoprazan-amoxicillin dual therapy

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

ACTIVE COMPARATOR

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

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

ACTIVE COMPARATOR

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

Interventions

14-day vonoprazan-amoxicillin dual therapy DRUG

vonoprazan 20mg bid + amoxicillin 1000mg bid

14-day vonoprazan-amoxicillin dual therapy

14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy DRUG

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

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

14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years, male or female
• 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)
• No prior Helicobacter pylori eradication therapy

You may not qualify if:

• Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
• Active gastrointestinal bleeding
• History of upper gastrointestinal surgery
• History of drug hypersensitivity
• Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
• Pregnant or lactating women
• Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
• Individuals unable or unwilling to provide informed consent

Sponsors & Collaborators

• Yanqing Li: lead
• Longkou People's Hospital: collaborator
• Qingdao Jimo People's Hospital: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator
• Zibo Maternal and Child Health Hospital: collaborator
• Yantai Zhifu Hospital: collaborator
• The 2nd People's Hospital of Dongying City: collaborator
• Qilu Hospital of Shandong University: collaborator
• Dezhou Hospital Qilu Hospital of Shandong University: collaborator
• Guanxian County People's Hospital: collaborator

Study Sites (2)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, China

NOT YET RECRUITING

Central Study Contacts

Yueyue Li

CONTACT

+8618560089751; lyynqj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 17, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-08

Locations

CN (2)