Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05726734
• Other study ID #: 2022150
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: February 6, 2026

Study information

• Verified date: February 2023
• Source: Shanghai East Hospital
• Contact: Yingjie Ji, M.D.
• Phone: +86-15800575527
• Email: jiyingjie39[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vonoprazan Amoxicillin and metronidazole based triple therapy had achieved a high cure rate in the rescue treatment of helicobacter pylori infection. This study aims to evaluate the efficacy and safety of the Vonoprazan, amoxicillin and metronidazole based triple therapy and the empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 6, 2026
• Est. primary completion date: February 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Participants with non-ulcer functional dyspepsia or peptic ulcer disease

• Ability and willingness to participate in the study and to sign and give informed consent

• Confirmed H. pylori infection and with no previous treatment experience

Exclusion Criteria:

• Less than 18 years old

• With previous gastric surgery

• Major systemic diseases

• Pregnancy or lactation

• Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Vonoprazan
potassium-competitive acid blocker
• Amoxicillin, Metronidazole
Antibiotics for H. pylori eradication
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
• Esomeprazole
Proton pump inhibitor

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).	Six weeks after completion of therapy
Secondary	Rate of adverse effects	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)	Within 7 days after completion of therapy
Secondary	Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication	Within 7 days after completion of therapy