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

NCT ID: NCT07179159

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HELICOBACTER PYLORI INFECTIONS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

14-day vonoprazan-amoxicillin dual therapy

Group Type EXPERIMENTAL

14-day vonoprazan-amoxicillin dual therapy

Intervention Type DRUG

vonoprazan 20mg bid + amoxicillin 1000mg bid

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

14-day vonoprazan-amoxicillin dual therapy

vonoprazan 20mg bid + amoxicillin 1000mg bid

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18-70 years, male or female
2. Current Helicobacter pylori infection (positive 13C-urea breath test)
3. No prior Helicobacter pylori eradication therapy

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Longkou People's Hospital

UNKNOWN

Sponsor Role collaborator

Qingdao Jimo People's Hospital

OTHER

Sponsor Role collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Dezhou Hospital Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Zibo Maternal and Child Health Hospital

UNKNOWN

Sponsor Role collaborator

Guanxian People's Hospital

UNKNOWN

Sponsor Role collaborator

Yantai Zhifu Hospital

UNKNOWN

Sponsor Role collaborator

The 2nd People's Hospital of Dongying City

UNKNOWN

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanqing Li

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Qilu Hospital of Shandong University

Jinan, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yueyue Li

Role: CONTACT

+8618560089751

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yueyue Li

Role: primary

+8618560089751

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

202509

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.