Efficacy and Safety of Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy and Safety of Furazolidone-based Quadruple Therapy With Vonoprazan as First-line Treatment for Helicobacter Pylori Eradication: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04907747
• Other study ID #: 2021-0446
• Status: Recruiting
• Phase: Phase 4
• Start date: May 18, 2021
• Est. completion date: April 13, 2022

Study information

• Verified date: April 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Qin Du, Master
• Phone: +86 0571-89713734
• Email: duq518[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 pH maintains for a longer period. Vonoprazan, therefore, is a promising candidate in helicobacter pylori eradication as the antibiotic resistance is rising.

This study will enroll 234 patients, and randomly assigned by computer to one of the three treatment groups.

Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days Group B:

Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days Participants will visit the clinic for a follow-up assessment 6-8 weeks after the course of treatments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Helicobacter pylori-positive participants determined by ¹³C-urea breath test, ¹4C-urea breath test, HE stain or bacterium culture

2. With no historical treatment for helicobacter pylori infection.

Exclusion Criteria:

1. 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

2. Active peptic ulcer with complications such as hemorrhage, perforation, obstruction, cancerization, etc.

3. With previous esophageal or gastric surgery

4. With severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases

5. Allergy to any of the study drugs

6. Pregnancy or in lactation

7. Participated in other research within 3 months,cannot express his/her own ideas correctly or cannot cooperate with the researcher

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Vonoprazan
Potassium-competitive acid blocker
• Esomeprazole
Proton pump inhibitor
• Colloidal bismuth pectin
Gastric mucosal protective drug with anti-H. pylori effect
• Amoxicillin
Antibiotic for H. pylori eradication
• Furazolidone
Antibiotic for H. pylori eradication

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University, School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori Eradication Rate	Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication.	Six to eight weeks after completion of the medication
Secondary	Rate of Adverse Drug Reaction(ADR)	Adverse drug reactions are classified into six types (with mnemonics): dose-related (Augmented), non-dose-related (Bizarre), dose-related and time-related (Chronic), time-related (Delayed), withdrawal (End of use), and failure of therapy (Failure).	Within 7 days after completion of therapy
Secondary	Compliance Rate	Compliance was defined as poor when they had taken less than 80% of the total medication.	Within 7 days after completion of therapy