Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06037122

Collaborator

(none)

558

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

558 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy and Safety Evaluation of Bismuth-containing Quadruple Therapies Based on Low-dose Vonoprazan in the Initial Treatment of Helicobacter Pylori Infection: a Retrospective Study

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Helicobacter H. pylori eradication rate [after eradication therapy at least 4 weeks]
number of patients successfully eradicated / the total number participants

Secondary Outcome Measures

safety of regimens [Within 4 weeks from the beginning to the end of therapy]
comparison of the incidence of adverse events in each group
compliance [4 weeks after therapy completion]
percentage of correctly administered drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Qin DU, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT06037122

Other Study ID Numbers:

2023-0674

First Posted:

Sep 14, 2023

Last Update Posted:

Sep 14, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Helicobacter Pylori

quadruple regimen

vonoprazan

Additional relevant MeSH terms:

Infections

Helicobacter Infections

Study Results

No Results Posted as of Sep 14, 2023