Health TrialsbyHealthPanel

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

ConditionHELICOBACTER PYLORI INFECTIONS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYanqing Li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours

Active gastrointestinal bleeding

History of upper gastrointestinal surgery

History of drug hypersensitivity

Trial design

Design model

Parallel

Treatments tested in this trial

  • 14-day vonoprazan-amoxicillin dual therapy

    Drug

    vonoprazan 20mg bid + amoxicillin 1000mg bid

  • 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-clarithromycin-bismuth quadruple therapy

    Drug

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

Treatment groups

372 Participants
are divided into 3 treatment groups
Group A: 14-day vonoprazan-amoxicillin dual therapyExperimental treatment 1 intervention
Group B: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapyActive comparator 1 intervention
Group C: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapyActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yanqing Li

Lead sponsor

Shandong University

Sponsor institution

Longkou People's Hospital

Collaborator

Qingdao Jimo People's Hospital

Collaborator

Shandong University of Traditional Chinese Medicine

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator

Zibo Maternal and Child Health Hospital

Collaborator

Guanxian County People's Hospital

Collaborator

Yantai Zhifu Hospital

Collaborator

Dongying No. 2 People's Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Source ClinicalTrials.gov
Apply now