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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06037122
Other study ID # 2023-0674
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date June 2024

Study information

Verified date August 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Qin DU
Phone +86 0571-89713734
Email duqin@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 558
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal antigen test, endoscopic biopsy histopathology, or bacterial culture; 2. No previous eradication therapy for H. pylori; 3. Age and gender are not restricted. Exclusion Criteria: 1. 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; 2. Known hypersensitivity to the drugs used in this study; 3. History of esophageal or gastric surgery; 4. Pregnant or lactating women; 5. Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs, hepatic or renal insufficiency or malignant tumors (except gastric cancer); 6. Patients unable to express their main complaints.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome

Type Measure Description Time frame Safety issue
Primary Helicobacter H. pylori eradication rate number of patients successfully eradicated / the total number participants after eradication therapy at least 4 weeks
Secondary safety of regimens comparison of the incidence of adverse events in each group Within 4 weeks from the beginning to the end of therapy
Secondary compliance percentage of correctly administered drugs 4 weeks after therapy completion
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