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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05419674

Collaborator

(none)

393

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan Drug: Rabeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Colloidal bismuth pectin	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

393 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Ten-day Amoxicillin-containing Dual Therapy as First-line Helicobacter Pylori Treatment in Elderly Patients: a Randomized Trial

Anticipated Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: groupA: dual therapy (vonoprazan+amoxicillin) vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days	Drug: Vonoprazan Potassium-competitive acid blocker Drug: Amoxicillin Antibiotic for H. pylori eradication
Experimental: group B: dual therapy (rabeprazole+amoxicillin) rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days	Drug: Rabeprazole Proton pump inhibitor Drug: Amoxicillin Antibiotic for H. pylori eradication
Active Comparator: 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	Drug: Rabeprazole Proton pump inhibitor Drug: Amoxicillin Antibiotic for H. pylori eradication Drug: Clarithromycin Antibiotic for H. pylori eradication Drug: Colloidal bismuth pectin Gastric mucosal protective drug with anti-H. pylori effect

Arm

Intervention/Treatment

Experimental: groupA: dual therapy (vonoprazan+amoxicillin)

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

Drug: Vonoprazan

Potassium-competitive acid blocker

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Experimental: group B: dual therapy (rabeprazole+amoxicillin)

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

Drug: Rabeprazole

Proton pump inhibitor

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Active Comparator: 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

Drug: Rabeprazole

Proton pump inhibitor

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Drug: Clarithromycin

Antibiotic for H. pylori eradication

Drug: Colloidal bismuth pectin

Gastric mucosal protective drug with anti-H. pylori effect

Outcome Measures

Primary Outcome Measures

Helicobacter pylori Eradication Rate [Six to eight weeks after completion of the medication]
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test six to eight weeks after completion of the medication. The eradication rates will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.

Secondary Outcome Measures

Rate of Adverse Drug Reaction(ADR) [Within 7 days after completion of therapy]
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).
Compliance Rate [Within 7 days after completion of therapy]
Compliance was defined as poor when they had taken less than 80% of the total medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

having H. pylori related chronic gastritis confirmed by ¹³C-urea breath test, ¹⁴C-urea breath test and/or biopsy；
underwent gastroscopy within 1 year before treatment, liver and renal function tests and electrocardiogram within 3 months before treatment；
with no historical treatment for helicobacter pylori infection.

Exclusion Criteria:

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