Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori:a Prospective, Multicenter, Open Label, Randomized Controlled Study:

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649540
• Other study ID #: KY20221124-07
• Status: Recruiting
• Phase: Phase 4
• Start date: January 20, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Zhenyu Zhang
• Phone: +86 025-87726248
• Email: zzy6565[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy and safety of vonoprazan with different doses of amoxicillin for Helicobacter Pylori.

Description:

This study intends to select the patients with Hp infection in 13 tertiary hospitals across our country, and randomly give the three 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Ages between 18 and 70 years; Sexes eligible for study: both;

2. patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;

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

10. MALT lymphoma of stomach or malignant tumor

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Vonoprazan
Potassium-competitive acid blocker
• Amoxicillin
Antibiotic for H. pylori eradication

Locations

Country	Name	City	State
China	Changshu No.1 People's Hospital	Changshu	Jiangsu
China	Changzhou Traditional Chinese medical hospital,Affiliated to Nanjing University of Chinese Medicine	Changzhou	Jiangsu
China	The first people's hospital of Lianyungang	Lianyungang	Jiangsu
China	Jiangsu Province Hospital on Integration of Chinese and Western Medicine	Nanjing	Jiangsu
China	Nanjing First Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	Nanjing Jiangbei Hospital	Nanjing	Jiangsu
China	Sir Run Run Hospital, Nanjing Medical University	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Soochow	Suzhou	Jiangsu
China	Taixing People's Hospital	Taixing	Jiangsu
China	The Fourth People's Hospital of Taizhou	Taizhou	Jiangsu
China	The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University	Xuzhou	Jiangsu
China	Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu
China	Zhangjiagang First people's Hospital	Zhangjiagang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

Furuta T, Shirai N, Kodaira M, Sugimoto M, Nogaki A, Kuriyama S, Iwaizumi M, Yamade M, Terakawa I, Ohashi K, Ishizaki T, Hishida A. Pharmacogenomics-based tailored versus standard therapeutic regimen for eradication of H. pylori. Clin Pharmacol Ther. 2007 Apr;81(4):521-8. doi: 10.1038/sj.clpt.6100043. Epub 2007 Jan 10. — View 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. — View Citation

Guan JL, Hu YL, An P, He Q, Long H, Zhou L, Chen ZF, Xiong JG, Wu SS, Ding XW, Luo HS, Li PY. Comparison of high-dose dual therapy with bismuth-containing quadruple therapy in Helicobacter pylori-infected treatment-naive patients: An open-label, multicenter, randomized controlled trial. Pharmacotherapy. 2022 Mar;42(3):224-232. doi: 10.1002/phar.2662. Epub 2022 Feb 5. — View Citation

Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Online ahead of print. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	four to eight weeks after completion of the medication
Secondary	Adverse event	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
Secondary	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
Secondary	Microbiota influence	Collect the tongue coating and feces of some patients for flora analysis	baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy