Efficacy and Safety of Dual Therapy as First-line Treatment for Hp Infection

NCT ID: NCT05419674

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-01

Brief Summary

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This study aims to evaluate the efficacy of dual therapy compared with bismuth-containing quadruple therapy as first-line treatment for Helicobacter Pylori eradication, as well as the safety and economic benefits.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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groupA: dual therapy (vonoprazan+amoxicillin)

vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days

Group Type EXPERIMENTAL

Vonoprazan

Intervention Type DRUG

Potassium-competitive acid blocker

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

group B: dual therapy (rabeprazole+amoxicillin)

rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days

Group Type EXPERIMENTAL

Rabeprazole

Intervention Type DRUG

Proton pump inhibitor

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

group C: bismuth-containing quadruple therapy

rabeprazole 10 mg bid, colloidal bismuth pectin 200mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 10 days

Group Type ACTIVE_COMPARATOR

Rabeprazole

Intervention Type DRUG

Proton pump inhibitor

Amoxicillin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Clarithromycin

Intervention Type DRUG

Antibiotic for H. pylori eradication

Colloidal bismuth pectin

Intervention Type DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Interventions

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Vonoprazan

Potassium-competitive acid blocker

Intervention Type DRUG

Rabeprazole

Proton pump inhibitor

Intervention Type DRUG

Amoxicillin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Clarithromycin

Antibiotic for H. pylori eradication

Intervention Type DRUG

Colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy;
2. underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment;
3. 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. with previous esophageal or gastric surgery
3. with severe systemic diseases, major organ like heart, lung, brain diseases, liver or kidney insufficiency, malignant tumor or other diseases
4. allergy to any of the study drugs
5. participated in other research within 3 months,cannot express his/her own ideas correctly or cannot cooperate with the researcher
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qin Du, Master

Role: CONTACT

+86 0571-89713734

Facility Contacts

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Qin Du, Master

Role: primary

+86 0571-89713734

Other Identifiers

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2022-0323

Identifier Type: -

Identifier Source: org_study_id

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