Status:
UNKNOWN
Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study aims to evaluate the efficacy of vonoprazan compared with esomeprazole as first-line treatment for Helicobacter Pylori(Hp) eradication, as well as the safety and economic benefits.
Detailed Description
Vonoprazan, a novel potassium-competitive acid blocker, is proved to be superior to proton pump inhibitor in gastric acid-related diseases such as reflux esophagitis, as the increase of intragastric p...
Eligibility Criteria
Inclusion
- Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹⁴C-urea breath test, HE stain or bacterium culture
- With no historical treatment for helicobacter pylori infection.
Exclusion
- Administration of antibiotics, bismuth in 4 weeks prior to inclusion or antacids including H2 receptor antagonist, proton pump inhibitor and potassium-competitive acid blocker in 2 weeks prior to inclusion
- Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.
- With previous esophageal or gastric surgery
- With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
- Allergy to any of the study drugs
- Pregnancy or in lactation
- Participated in other research within 3 months，cannot express his/her own ideas correctly or cannot cooperate with the researcher
Key Trial Info
Start Date :
May 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 13 2022
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT04907747
Start Date
May 18 2021
End Date
April 13 2022
Last Update
June 1 2021
Active Locations (1)
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1
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China, 310009