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

Sponsor

Shanghai East Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05726734

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan Drug: Amoxicillin, Metronidazole Drug: Bismuth Potassium Citrate Drug: Esomeprazole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 6, 2023

Anticipated Primary Completion Date :

Feb 6, 2025

Anticipated Study Completion Date :

Feb 6, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vonoprazan-containing Triple Therapy Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days	Drug: Vonoprazan potassium-competitive acid blocker Drug: Amoxicillin, Metronidazole Antibiotics for H. pylori eradication
Experimental: Empiric Bismuth Quadruple Therapy Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days	Drug: Amoxicillin, Metronidazole Antibiotics for H. pylori eradication Drug: Bismuth Potassium Citrate Gastric mucosal protective drug with anti-H. pylori effect Drug: Esomeprazole Proton pump inhibitor

Arm

Intervention/Treatment

Active Comparator: Vonoprazan-containing Triple Therapy

Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Drug: Vonoprazan

potassium-competitive acid blocker

Drug: Amoxicillin, Metronidazole

Antibiotics for H. pylori eradication

Experimental: Empiric Bismuth Quadruple Therapy

Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Drug: Amoxicillin, Metronidazole

Antibiotics for H. pylori eradication

Drug: Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Esomeprazole

Proton pump inhibitor

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [Six weeks after completion of therapy]
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).

Secondary Outcome Measures

Rate of adverse effects [Within 7 days after completion of therapy]
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)
Compliance rate [Within 7 days after completion of therapy]
Compliance was defined as poor when they had taken less than 80% of the total medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai East Hospital	Shanghai	Shanghai	China	200120

Sponsors and Collaborators

Shanghai East Hospital

Investigators

Principal Investigator: Yingjie Ji, M.D., Shanghai East Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yingjie Ji, Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital, Shanghai East Hospital

ClinicalTrials.gov Identifier:

NCT05726734

Other Study ID Numbers:

2022150

First Posted:

Feb 14, 2023

Last Update Posted:

Feb 14, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yingjie Ji, Medical Doctor of Division of Endoscopy Center, Department of Gastroenterology of Shanghai East Hospital, Shanghai East Hospital

Helicobacter Pylori Infection

Additional relevant MeSH terms:

Infections

Helicobacter Infections

Study Results

No Results Posted as of Feb 14, 2023