- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05469685
Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication
Efficacy and Safety of Vonoprazan- Amoxicillin Dual Therapy for Helicobacter Pylori Eradication : a Prospective, Multicenter, Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Jiangsu
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Jiangyin, Jiangsu, China
- Withdrawn
- Jiangyin Clinical College of Xuzhou Medical University
-
Nanjing, Jiangsu, China
- Recruiting
- Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine
-
Contact:
- Yaozhou Tian
- Phone Number: +86 025-52362072
- Email: tianyaozhou1960@163.com
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Principal Investigator:
- Yaozhou Tian
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Principal Investigator:
- Hui Li
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Nanjing, Jiangsu, China
- Recruiting
- Nanjing First Hospital, Nanjing Medical University
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Sub-Investigator:
- Ximei Zhang
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Suzhou, Jiangsu, China
- Recruiting
- Changshu No.1 People's Hospital
-
Contact:
- Xiaodan Xu
- Phone Number: +86 0512-52727072
- Email: xxd20@163.com
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Suzhou, Jiangsu, China
- Recruiting
- Second Affiliated Hospital of Soochow University
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Contact:
- Duanmin Hu
- Phone Number: +86 51267784809
- Email: huduanmin@163.com
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Principal Investigator:
- Duanmin Hu
-
Sub-Investigator:
- Xuexin Xu
-
Sub-Investigator:
- Kewei Hu
-
Taizhou, Jiangsu, China
- Recruiting
- Taixing People's Hospital
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Contact:
- Xiaorong Dai
- Phone Number: +86 13905265377
- Email: 1030498110@qq.com
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Principal Investigator:
- Xiaorong Dai
-
Sub-Investigator:
- Faming Yang
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Sub-Investigator:
- Weiwei Rong
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Taizhou, Jiangsu, China
- Recruiting
- Taizhou Fourth People's Hospital
-
Contact:
- Jianrong Wang
- Phone Number: +86 0523-80185110
- Email: jstzwjr@sina.com
-
Principal Investigator:
- Jianrong Wang
-
Sub-Investigator:
- Peng Peng
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Wuxi, Jiangsu, China
- Recruiting
- Wuxi People's Hospital Affiliated to Nanjing Medical University
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Contact:
- Qiang Zhan
- Email: zhanq33@163.com
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Xuzhou, Jiangsu, China
- Recruiting
- The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University
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Contact:
- Guangxia Chen
- Phone Number: +86 13685135997
- Email: gx_chen2010@163.com
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Contact:
- Xinxin Xu
- Phone Number: +86 18895644998
- Email: xuxinxin97@163.com
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Sub-Investigator:
- Qingchun Jin
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Yancheng, Jiangsu, China
- Recruiting
- Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School
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Contact:
- Xundong Wu
- Phone Number: +86 51588507926
- Email: hnjsycwxd@163.com
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Yangzhou, Jiangsu, China
- Recruiting
- Affiliated Hospital of Yangzhou University
-
Contact:
- Yanbing Ding
- Phone Number: +86 0514-82981199-81905
- Email: ybding@yzu.edu.cn
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Sub-Investigator:
- Xin Jiang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 10-day treatment group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 10 days
|
Antibiotic for H. pylori eradication
Potassium-competitive acid blocker
|
Active Comparator: 14-day treatment group
vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days
|
Antibiotic for H. pylori eradication
Potassium-competitive acid blocker
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Helicobacter pylori eradication rate
Time Frame: 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.
|
four to six weeks after completion of the medication
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 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.
|
Within 7 days after completion of therapy
|
Compliance Rate
Time Frame: Within 7 days after completion of therapy
|
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
Publications and helpful links
General Publications
- 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.
- 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. Review.
- 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.
- 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.
- 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.
- Berry V, Jennings K, Woodnutt G. Bactericidal and morphological effects of amoxicillin on Helicobacter pylori. Antimicrob Agents Chemother. 1995 Aug;39(8):1859-61.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20220701-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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