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A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

NCT03908619 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2020-10-08

No results posted yet for this study

Summary

Helicobacter pylori (H. pylori) gastritis is a common bacterial infection among the elderly population. H. pylori infection causes chronic progressive gastric inflammation, peptic ulcer disease and gastric cancer. Gastric cancer is a significant contributor of cancer-related mortality. The eradication of H. pylori reduces the incidence of gastric cancer. However, the efficacy of H. pylori eradication has decreased dramatically because of antibiotic resistance. This study aims to (i) compare the eradication rates of H. pylori by triple therapy with vonoprazan for the treatment of H. pylori gastritis) (TTV regimen), with triple therapy with conventional proton pump inhibitor (PPI) (TTP regimen) in a multi-racial Asian cohort, (ii) evaluate the prevalence of antibiotic (klacid/amoxicillin/levofloxacin/tetracycline) resistance in H. pylori infected patients, and (iii) assess the safety of the TTV regimen. Diagnosed H. pylori-infected patients (n=252) will be enrolled and randomized 1:1 to TTV or TTP regimen. Gastric biopsies will be cultured and antibiotic sensitivity evaluated using E-test/agar dilution method. The safety of TTV regimen will be assessed using adverse effect questionnaire. This study may potentially impact on prescribing policies and management of H. pylori infections for improved therapeutic outcome.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Omeprazole 20mg

Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

DRUG

Esomeprazole 20mg

Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

DRUG

Rabeprazole Sodium 20mg

Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

DRUG

Vonoprazan

Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days

Sponsors & Collaborators

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Daphne Shih Wen Ang, MD · Changi General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908619 on ClinicalTrials.gov