Back to results

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

Primary Purpose

Helicobacter Pylori Infection

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Vonoprazan

Rabeprazole

Amoxicillin

Clarithromycin

Colloidal bismuth pectin

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Second Affiliated Hospital of Zhejiang University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

groupA: dual therapy (vonoprazan+amoxicillin)

group B: dual therapy (rabeprazole+amoxicillin)

group C: bismuth-containing quadruple therapy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Compliance Rate

Compliance was defined as poor when they had taken less than 80% of the total medication.

Full Information

NCT ID

NCT05419674

First Posted

June 10, 2022

Last Updated

February 14, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT05419674

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

Keywords

dual therapy, bismuth-containing quadruple therapy, Helicobacter Pylori

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

393 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

groupA: dual therapy (vonoprazan+amoxicillin)

Arm Type

Experimental

Arm Description

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

Arm Title

group B: dual therapy (rabeprazole+amoxicillin)

Arm Type

Experimental

Arm Description

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

Arm Title

group C: bismuth-containing quadruple therapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Vonoprazan

Intervention Description

Potassium-competitive acid blocker

Intervention Type

Drug

Intervention Name(s)

Rabeprazole

Intervention Description

Proton pump inhibitor

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

Antibiotic for H. pylori eradication

Intervention Type

Drug

Intervention Name(s)

Clarithromycin

Intervention Description

Antibiotic for H. pylori eradication

Intervention Type

Drug

Intervention Name(s)

Colloidal bismuth pectin

Intervention Description

Gastric mucosal protective drug with anti-H. pylori effect

Primary Outcome Measure Information:

Title

Helicobacter pylori Eradication Rate

Description

Time Frame

Six to eight weeks after completion of the medication

Secondary Outcome Measure Information:

Title

Rate of Adverse Drug Reaction(ADR)

Description

Time Frame

Within 7 days after completion of therapy

Title

Compliance Rate

Description

Compliance was defined as poor when they had taken less than 80% of the total medication.

Time Frame

Within 7 days after completion of therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qin Du, Master

Phone

+86 0571-89713734

duq518@163.com

Facility Information:

Facility Name

Second Affiliated Hospital of Zhejiang University, School of Medicine

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qin Du, Master

Phone

+86 0571-89713734

duq518@163.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs