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

NCT04907747 | Unknown Phase 4

• 1 other identifier: 2021-0446
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; vonoprazan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of Adverse Drug Reaction(ADR)

  Within 7 days after completion of therapy

• Compliance Rate

  Within 7 days after completion of therapy

Study Arms (3)

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

EXPERIMENTAL

Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 10days

Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone

Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days

EXPERIMENTAL

Vonoprazan 20mg qd, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days

Drug: Vonoprazan; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone

Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days

ACTIVE COMPARATOR

Esomeprazole 20 mg bid, Colloidal bismuth pectin 200mg bid, Amoxicillin 1.0g bid, Furazolidone 0.1g bid for 14days

Drug: Esomeprazole; Drug: Colloidal bismuth pectin; Drug: Amoxicillin; Drug: Furazolidone

Interventions

Vonoprazan DRUG

Potassium-competitive acid blocker

Group A: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 10 days; Group B: Vonoprazan taken with bismuth, amoxicillin, furazolidone for 14 days

Esomeprazole DRUG

Proton pump inhibitor

Group C: Esomeprazole taken with bismuth, amoxicillin, furazolidone for 14 days

Colloidal bismuth pectin DRUG

Gastric mucosal protective drug with anti-H. pylori effect

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

Amoxicillin DRUG

Antibiotic for H. pylori eradication

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

Furazolidone DRUG

Antibiotic for H. pylori eradication

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Related Publications (1)

• Lu L, Wang Y, Ye J, Han Y, Lou G, Li Y, Yan H, Du Q. Quadruple therapy with vonoprazan 20 mg daily as a first-line treatment for Helicobacter pylori infection: A single-center, open-label, noninferiority, randomized controlled trial. Helicobacter. 2023 Feb;28(1):e12940. doi: 10.1111/hel.12940. Epub 2022 Dec 1.

  PMID: 36458325 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Esomeprazole; Amoxicillin; Furazolidone

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans

Central Study Contacts

Qin Du, Master

CONTACT

+86 0571-89713734; duq518@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 1, 2021
• Study Start: May 18, 2021
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: June 1, 2021

Record last verified: 2021-04

Locations

CN (1)