Efficacy of Low-dose Vonoprazan for Helicobacter Pylori E... | NCT06037122

Studies
Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

NCT06037122

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Sep 14, 2023Actual

Enrollment

558Estimated

Phase

Not provided

Conditions

Helicobacter Pylori Infection

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2023Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Jun 2024Estimated

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 7, 2023

First Posted Date

Sep 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2023

Last Update Posted Date

Sep 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this retrospective study was to assess the efficacy and safety of a bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori infection.

Detailed Description

Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB) vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ 20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as initial treatment for H. pylori infection. Our study will provide clinical evidence for the necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize the treatment regimen for H. pylori infection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

558Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group R-BID		rabeprazole 10mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days
group V-BID		vonoprazan 20mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days
group V-QD		vonoprazan 20mg once daily, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Helicobacter H. pylori eradication rate	number of patients successfully eradicated / the total number participants	after eradication therapy at least 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
safety of regimens	comparison of the incidence of adverse events in each group	Within 4 weeks from the beginning to the end of therapy
compliance	percentage of correctly administered drugs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture;
No previous eradication therapy for H. pylori;
Age and gender are not restricted.

Exclusion Criteria:

Use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks prior to treatment;
Known hypersensitivity to the drugs used in this study;
History of esophageal or gastric surgery;
Pregnant or lactating women;
Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer);
Patients unable to express their main complaints.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study population consisted of patients undergoing initial treatment for H. pylori infection who attended the outpatient clinic of the Department of Gastroenterology at the Second Hospital of Zhejiang University School of Medicine from January 1, 2021 to December 31, 2021. Only patients using a quadruple regimen based on rabeprazole or vonoprazan combined with amoxicillin and clarithromycin with bismuth were included in the study.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Qin DU	Contact	+86 0571-89713734		duqin@zju.edu.cn

Name	Affiliation	Role
Qin DU	Second Affiliated Hospital of Zhejiang University, School of Medicine	Study Chair

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

IPD Sharing will be available from June 30th 2024.

Access Criteria

After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.

URL

Not provided