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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Amoxicillin; Drug: Vonoprazan; Drug: Clarithromycin; Drug: Colloidal bismuth pectin; Drug: Rabeprazole

• Study Type: Interventional
• Enrollment (Anticipated): 393
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: groupA: dual therapy (vonoprazan+amoxicillin); vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Vonoprazan; Potassium-competitive acid blocker
Experimental: group B: dual therapy (rabeprazole+amoxicillin); rabeprazole 10mg tid and amoxicillin 1000mg tid for 10 days	Drug: Amoxicillin; Antibiotic for H. pylori eradication; Drug: Rabeprazole; Proton pump inhibitor
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: 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; Drug: Rabeprazole; Proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori Eradication Rate	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.	Six to eight weeks after completion of the medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: dual therapy; bismuth-containing quadruple therapy; Helicobacter Pylori
• Additional Relevant MeSH Terms: Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Rabeprazole; Amoxicillin; Clarithromycin; Bismuth
• Other Study ID Numbers: 2022-0323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No