Optimization of Vonoprazan-based Dual Therapy for Helicobacter Pylori

NCT05649540 | Completed Phase 4

• 1 other identifier: KY20221124-07
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; dual therapy; eradication rate; safety; microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse event

  Within 7 days after completion of therapy

• Compliance Rate

  Within 7 days after completion of therapy

• Microbiota influence

  baseline, within 1 day after completion of therapy, Within 6 weeks after completion of therapy

Study Arms (3)

high dose amoxicillin with vonoprazan group

ACTIVE COMPARATOR

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

Drug: Vonoprazan; Drug: Amoxicillin

standard dose amoxicillin with vonoprazan group

EXPERIMENTAL

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

Drug: Vonoprazan; Drug: Amoxicillin

low dose amoxicillin with vonoprazan group

EXPERIMENTAL

vonoprazan 20mg bid and amoxicillin 500mg tid for 14 days

Drug: Vonoprazan; Drug: Amoxicillin

Interventions

Vonoprazan DRUG

Potassium-competitive acid blocker

high dose amoxicillin with vonoprazan group; low dose amoxicillin with vonoprazan group; standard dose amoxicillin with vonoprazan group

Amoxicillin DRUG

Antibiotic for H. pylori eradication

high dose amoxicillin with vonoprazan group; low dose amoxicillin with vonoprazan group; standard dose amoxicillin with vonoprazan group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages between 18 and 70 years; Sexes eligible for study: both;
• patients who are diagnosed with Helicobacter pylori with 13C urea breath test or 14C urea breath test;
• 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

You may not qualify if:

• 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
• MALT lymphoma of stomach or malignant tumor

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (13)

Changshu No.1 People's Hospital

Changshu, Jiangsu, China

Location

Changzhou Traditional Chinese Medicine Hospital

Changzhou, Jiangsu, China

Location

The first people's hospital of Lianyungang

Lianyungang, Jiangsu, China

Location

Jiangsu Province Hospital on Integration of Chinese and Western Medicine

Nanjing, Jiangsu, China

Location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Nanjing Jiangbei Hospital

Nanjing, Jiangsu, China

Location

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Taixing People's Hospital

Taishing, Jiangsu, China

Location

The Fourth People's Hospital of Taizhou

Taizhou, Jiangsu, China

Location

The First People's Hospital of Xuzhou, Xuzhou Municipal Hospital Affiliated to Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

The Affiliated Zhangjiagang Hospital of Soochow University

Zhangjiagang, Jiangsu, China

Location

Related Publications (7)

• 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.

  PMID: 26187502 BACKGROUND

• 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.

  PMID: 35944925 BACKGROUND

• 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.

  PMID: 19109870 BACKGROUND

• 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.

  PMID: 32314468 BACKGROUND

• 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.

  PMID: 17215846 BACKGROUND

• 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.

  PMID: 35075679 BACKGROUND

• Peng R, Cai P, Zhang Z, Lv S, Chen G, Xu Y, He B, Sun M, Dai X, Yan K, Shen L, Wang J, Li W, Yin R, Ge J, Hu D, Hu K, Xu X, Li H, Pan C, Duan Z, Gao X, Zhang Z, Liu W. Efficacy of Three Amoxicillin Doses in Vonoprazan Dual Therapy for Helicobacter pylori Eradication: A Randomized Noninferiority Trial. Helicobacter. 2025 May-Jun;30(3):e70050. doi: 10.1111/hel.70050.

  PMID: 40481714 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zhenyu Zhang

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 20, 2023
• Primary Completion: July 6, 2024
• Study Completion: November 5, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)