Back to resultsVonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
Primary Purpose
Helicobacter Pylori Infection
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vonoprazan
Amoxicillin, Metronidazole
Bismuth Potassium Citrate
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori Infection
Eligibility Criteria
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
Sites / Locations
- Shanghai East Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vonoprazan-containing Triple Therapy
Empiric Bismuth Quadruple Therapy
Arm Description
Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Full Information
NCT ID
NCT05726734
First Posted
February 3, 2023
Last Updated
February 3, 2023
Sponsor
Shanghai East Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05726734
Brief Title
Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 6, 2023 (Anticipated)
Primary Completion Date
February 6, 2025 (Anticipated)
Study Completion Date
February 6, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter Pylori Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vonoprazan-containing Triple Therapy
Arm Type
Active Comparator
Arm Description
Vonoprazan 20mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Arm Title
Empiric Bismuth Quadruple Therapy
Arm Type
Experimental
Arm Description
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Intervention Description
potassium-competitive acid blocker
Intervention Type
Drug
Intervention Name(s)
Amoxicillin, Metronidazole
Intervention Description
Antibiotics for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium Citrate
Intervention Description
Gastric mucosal protective drug with anti-H. pylori effect
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Proton pump inhibitor
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
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).
Time Frame
Six weeks after completion of therapy
Secondary Outcome Measure Information:
Title
Rate of adverse effects
Description
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)
Time Frame
Within 7 days after completion of therapy
Title
Compliance rate
Description
Compliance was defined as poor when they had taken less than 80% of the total medication
Time Frame
Within 7 days after completion of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjie Ji, M.D.
Phone
+86-15800575527
Email
jiyingjie39@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingjie Ji, M.D.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjie Ji, M.D.
Phone
86+15800575527
Email
jiyingjie39@outlook.com
First Name & Middle Initial & Last Name & Degree
Qinwei Xu
First Name & Middle Initial & Last Name & Degree
Xinyan Zhu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vonoprazan-containing Triple Therapy Versus Empiric Bismuth Quadruple Therapy for First-line Helicobacter Pylori Treatment: a Randomized Clinical Trial
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