Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Sponsor

Nanjing First Hospital, Nanjing Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05469685

Collaborator

(none)

1,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

90.9

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the Efficacy and Safety of Vonoprazan- amoxicillin dual therapy for Helicobacter Pylori eradication

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan Drug: Amoxicillin	Phase 4

Detailed Description

This study intends to select the patients with Hp infection in 11 tertiary hospitals across our country, and randomly give the two therapies to compare the eradication rate, compliance, the rate of adverse events, so as to provide some advices for the selection of appropriate eradication therapy, then collect an efficient, convenient and safe therapy for patients with H.pylori infection.

Before receiving the treatment plan, general information and relevant medical history of the subjects were collected through electronic questionnaires.The experimental data will be collected and recorded through follow-up by phone or WeChat during the experiment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Vonoprazan- Amoxicillin Dual Therapy for Helicobacter Pylori Eradication : a Prospective, Multicenter, Randomized Controlled Trial

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10-day treatment group vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days	Drug: Vonoprazan Potassium-competitive acid blocker Drug: Amoxicillin Antibiotic for H. pylori eradication
Active Comparator: 14-day treatment group vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days	Drug: Vonoprazan Potassium-competitive acid blocker Drug: Amoxicillin Antibiotic for H. pylori eradication

Arm

Intervention/Treatment

Experimental: 10-day treatment group

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

Drug: Vonoprazan

Potassium-competitive acid blocker

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Active Comparator: 14-day treatment group

vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days

Drug: Vonoprazan

Potassium-competitive acid blocker

Drug: Amoxicillin

Antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [four to six weeks after completion of the medication]
Helicobacter pylori Eradication will be determined by ¹³C-urea breath test four to six 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

Adverse events [Within 7 days after completion of therapy]
Adverse drug reactions are classified into six types: dose-related, non-dose-related, dose-related and time-related, time-related, withdrawal, and failure of therapy.
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:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages between 18 and 65 years; Sexes eligible for study: both;
patients who are diagnosed with Helicobacter pylori;
treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

allergic reactions to the study drugs;
patients with peptic ulcer;
patients who underwent eradication therapy for Helicobacter pylori during the last six months;
patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
patients who have history of esophageal or gastric surgery;
pregnant or lactating women;
patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
Alcohol abusers

Contacts and Locations

Locations

	Site	City	State	Country
1	Jiangyin Clinical College of Xuzhou Medical University	Jiangyin	Jiangsu	China
2	Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine	Nanjing	Jiangsu	China
3	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu	China
4	Changshu No.1 People's Hospital	Suzhou	Jiangsu	China
5	Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China
6	Taixing People's Hospital	Taizhou	Jiangsu	China
7	Taizhou Fourth People's Hospital	Taizhou	Jiangsu	China
8	Wuxi People's Hospital Affiliated to Nanjing Medical University	Wuxi	Jiangsu	China
9	The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University	Xuzhou	Jiangsu	China
10	Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School	Yancheng	Jiangsu	China
11	Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu	China