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Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

Primary Purpose

Helicobacter Pylori Infection

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vonoprazan
Amoxicillin
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, dual therapy, infection eradication, safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Ages between 18 and 65 years; Sexes eligible for study: both;
  2. patients who are diagnosed with Helicobacter pylori;
  3. 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;
  4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

  1. allergic reactions to the study drugs;
  2. patients with peptic ulcer;
  3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
  4. 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;
  5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
  6. patients who have history of esophageal or gastric surgery;
  7. pregnant or lactating women;
  8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
  9. Alcohol abusers

Sites / Locations

  • Jiangyin Clinical College of Xuzhou Medical University
  • Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese MedicineRecruiting
  • Nanjing First Hospital, Nanjing Medical UniversityRecruiting
  • Changshu No.1 People's HospitalRecruiting
  • Second Affiliated Hospital of Soochow UniversityRecruiting
  • Taixing People's HospitalRecruiting
  • Taizhou Fourth People's HospitalRecruiting
  • Wuxi People's Hospital Affiliated to Nanjing Medical UniversityRecruiting
  • The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical UniversityRecruiting
  • Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • Affiliated Hospital of Yangzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

10-day treatment group

14-day treatment group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Helicobacter pylori eradication rate
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
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
Compliance was defined as poor when they had taken less than 80% of the total medication

Full Information

First Posted
July 19, 2022
Last Updated
December 6, 2022
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05469685
Brief Title
Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication
Official Title
Efficacy and Safety of Vonoprazan- Amoxicillin Dual Therapy for Helicobacter Pylori Eradication : a Prospective, Multicenter, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, dual therapy, infection eradication, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
10-day treatment group
Arm Type
Experimental
Arm Description
vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
Arm Title
14-day treatment group
Arm Type
Active Comparator
Arm Description
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
Intervention Type
Drug
Intervention Name(s)
Vonoprazan
Intervention Description
Potassium-competitive acid blocker
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
Antibiotic for H. pylori eradication
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication rate
Description
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.
Time Frame
four to six weeks after completion of the medication
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
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
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenyu Zhang
Phone
+86 025-87726248
Email
zzy6565@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunfan Dong
Phone
+86 18795993220
Email
dyf967878@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Jiangyin Clinical College of Xuzhou Medical University
City
Jiangyin
State/Province
Jiangsu
Country
China
Individual Site Status
Withdrawn
Facility Name
Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaozhou Tian
Phone
+86 025-52362072
Email
tianyaozhou1960@163.com
First Name & Middle Initial & Last Name & Degree
Yaozhou Tian
First Name & Middle Initial & Last Name & Degree
Hui Li
Facility Name
Nanjing First Hospital, Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
Phone
+86 025-87726248
Email
zzy6565@sina.com
First Name & Middle Initial & Last Name & Degree
Zhenyu Zhang
First Name & Middle Initial & Last Name & Degree
Ximei Zhang
First Name & Middle Initial & Last Name & Degree
Yunfan Dong
Facility Name
Changshu No.1 People's Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodan Xu
Phone
+86 0512-52727072
Email
xxd20@163.com
First Name & Middle Initial & Last Name & Degree
Xiaodan Xu
First Name & Middle Initial & Last Name & Degree
Ruifang Wang
Facility Name
Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duanmin Hu
Phone
+86 51267784809
Email
huduanmin@163.com
First Name & Middle Initial & Last Name & Degree
Duanmin Hu
First Name & Middle Initial & Last Name & Degree
Xuexin Xu
First Name & Middle Initial & Last Name & Degree
Kewei Hu
Facility Name
Taixing People's Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaorong Dai
Phone
+86 13905265377
Email
1030498110@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaorong Dai
First Name & Middle Initial & Last Name & Degree
Faming Yang
First Name & Middle Initial & Last Name & Degree
Weiwei Rong
Facility Name
Taizhou Fourth People's Hospital
City
Taizhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianrong Wang
Phone
+86 0523-80185110
Email
jstzwjr@sina.com
First Name & Middle Initial & Last Name & Degree
Jianrong Wang
First Name & Middle Initial & Last Name & Degree
Peng Peng
Facility Name
Wuxi People's Hospital Affiliated to Nanjing Medical University
City
Wuxi
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Zhan
Email
zhanq33@163.com
First Name & Middle Initial & Last Name & Degree
Qiang Zhan
First Name & Middle Initial & Last Name & Degree
Lixia Ding
Facility Name
The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guangxia Chen
Phone
+86 13685135997
Email
gx_chen2010@163.com
First Name & Middle Initial & Last Name & Degree
Xinxin Xu
Phone
+86 18895644998
Email
xuxinxin97@163.com
First Name & Middle Initial & Last Name & Degree
Guangxia Chen
First Name & Middle Initial & Last Name & Degree
Xinxin Xu
First Name & Middle Initial & Last Name & Degree
Qingchun Jin
Facility Name
Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School
City
Yancheng
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xundong Wu
Phone
+86 51588507926
Email
hnjsycwxd@163.com
First Name & Middle Initial & Last Name & Degree
Xundong Wu
First Name & Middle Initial & Last Name & Degree
Xiangsu Li
Facility Name
Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbing Ding
Phone
+86 0514-82981199-81905
Email
ybding@yzu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanbing Ding
First Name & Middle Initial & Last Name & Degree
Zhaotao Duan
First Name & Middle Initial & Last Name & Degree
Xin Jiang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26187502
Citation
Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.
Results Reference
background
PubMed Identifier
19109870
Citation
Ford AC, Malfertheiner P, Giguere M, Santana J, Khan M, Moayyedi P. Adverse events with bismuth salts for Helicobacter pylori eradication: systematic review and meta-analysis. World J Gastroenterol. 2008 Dec 28;14(48):7361-70. doi: 10.3748/wjg.14.7361.
Results Reference
background
PubMed Identifier
18276599
Citation
Rimbara E, Noguchi N, Kawai T, Sasatsu M. Mutations in penicillin-binding proteins 1, 2 and 3 are responsible for amoxicillin resistance in Helicobacter pylori. J Antimicrob Chemother. 2008 May;61(5):995-8. doi: 10.1093/jac/dkn051. Epub 2008 Feb 14.
Results Reference
background
PubMed Identifier
20951912
Citation
Furuta T, Graham DY. Pharmacologic aspects of eradication therapy for Helicobacter pylori Infection. Gastroenterol Clin North Am. 2010 Sep;39(3):465-80. doi: 10.1016/j.gtc.2010.08.007.
Results Reference
background
PubMed Identifier
32314468
Citation
Gao CP, Zhang D, Zhang T, Wang JX, Han SX, Graham DY, Lu H. PPI-amoxicillin dual therapy for Helicobacter pylori infection: An update based on a systematic review and meta-analysis. Helicobacter. 2020 Aug;25(4):e12692. doi: 10.1111/hel.12692. Epub 2020 Apr 20.
Results Reference
background
PubMed Identifier
7486933
Citation
Berry V, Jennings K, Woodnutt G. Bactericidal and morphological effects of amoxicillin on Helicobacter pylori. Antimicrob Agents Chemother. 1995 Aug;39(8):1859-61. doi: 10.1128/AAC.39.8.1859.
Results Reference
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Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

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