Ineffectiveness of 14-day Vonoprazan-based dual therapy and Vonoprazan-based triple therapy for Helicobacter pylori Eradication in area of high Clarithromycin resistance: A prospective randomized study

Phase 1

Active, not recruiting

• Conditions: /A; Helicobacter Pylori Infection

• Registration Number: TCTR20191219003
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-19
• Study Completion: 2020-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Thai patients with the age between 18 and 75 years
Detecting for H.pylori infection with positive urease test and/or pathological findings of H.pylori and/or positive

Exclusion Criteria

Any cases with upper gastrointestinal bleeding
Being treated with medications affecting the research outcome, for example, by using antibiotics including amoxicillin, clarithromycin, metronidazole or fluoroquinolone within 1 month before the enrollment.
Contraindicated for gastric biopsy such as coagulopathy.
Any history of drug allergy for amoxicillin, clarithromycin or vonoprazan.
Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks.
Being pregnant or raising children with lactation.
Having history of H.pylori eradication treatment.
Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immunocompromised host with AIDS, malignancy and/or bed ridden cerebrovascular disease.
Any cases who receiving anticoagulant.
Having previous gastric surgery.
Unwilling to participate into research.
Having history of taking previous medications which interacted with the research treatment.
Having underlying heart disease including congenital long QT syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eradication rate of Helicobacter pylori infection 4 weeks after last dose eradication rate of 14-day vonoprazan-based dual therapy and 14-day vonoprazan-based triple therapy

Secondary Outcome Measures

Name	Time	Method
Adverse effect ุุ6 month To measure the adverse effect reaction of 14-day vonoprazan-based dual therapy and 14-day vonoprazan