Efficacy and Safety of Dual Therapy for Helicobacter Pylori Eradication

NCT05469685 | Completed Phase 4

• 1 other identifier: KY20220701-06
• Study Type: interventional
• Target: 914
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; dual therapy; infection eradication; safety

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 six weeks after completion of the medication

Secondary Outcomes (2)

• Adverse events

  Within 7 days after completion of therapy

• Compliance Rate

  Within 7 days after completion of therapy

Study Arms (2)

10-day treatment group

EXPERIMENTAL

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

Drug: Vonoprazan; Drug: Amoxicillin

14-day treatment group

ACTIVE COMPARATOR

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

Drug: Vonoprazan; Drug: Amoxicillin

Interventions

Vonoprazan DRUG

Potassium-competitive acid blocker

10-day treatment group; 14-day treatment group

Amoxicillin DRUG

Antibiotic for H. pylori eradication

10-day treatment group; 14-day treatment group

Eligibility Criteria

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

You may qualify if:

• 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

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (10)

Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Changshu No.1 People's Hospital

Suzhou, Jiangsu, China

Location

Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Taixing People's Hospital

Taizhou, Jiangsu, China

Location

Taizhou Fourth People's Hospital

Taizhou, Jiangsu, China

Location

Wuxi People's Hospital Affiliated to Nanjing Medical University

Wuxi, Jiangsu, China

Location

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

Xuzhou, Jiangsu, China

Location

Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School

Yancheng, Jiangsu, China

Location

Affiliated Hospital of Yangzhou University

Yangzhou, 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

• 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

• 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.

  PMID: 18276599 BACKGROUND

• 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.

  PMID: 20951912 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

• 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.

  PMID: 7486933 BACKGROUND

• Dong Y, Duan Z, Liu M, Ding Y, Chen G, Wang R, Xu X, Ding L, Zhan Q, Pan C, Li H, Yang F, Dai X, Li X, Wu X, Peng P, Wang J, Hu K, Hu D, Jie Q, Zhang Z. Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial. Front Pharmacol. 2025 Mar 24;16:1543352. doi: 10.3389/fphar.2025.1543352. eCollection 2025.

  PMID: 40196374 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: July 19, 2022
• First Posted: July 22, 2022
• Study Start: August 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)