Helicobacter Pylori and Vonoprazan Dual Therapy

NCT05649709 | Completed Phase 4

• 1 other identifier: Hp therapy of NCU
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., \<90%) when given as first-line treatment for H. pylori infection. This study evaluated the efficacy and safety of low-and high-dose amoxicillin-vonoprazan dual therapy for 14 days as first-line treatment for H. pylori in China.

Conditions

Helicobacter Pylori

Keywords

Helicobacter pylori; vonoprazan; amoxicillin; eradication

Outcome Measures

Primary Outcomes (1)

• The efficacy of VA dual therapy

  The confirmation of H. pylori status was evaluated by urea breath test

  6-8 weeks after treatment

Secondary Outcomes (4)

• treatment-emergent adverse events

  1 day after eradication

• compliance

  1 day after eradication

• resistance of antibiotics

  before the eradication

• the alteration of gut microbiota

  before eradication，1 day after eradication and confirmation（6-8 weeks after treatment）

Study Arms (2)

vonoprazan and low-dose amoxicillin dual therapy

EXPERIMENTAL

1000 mg amoxicillin capsules twice daily and 20 mg vonoprazan Fumarate Tablets twice daily for 14 days

Drug: L-VA dual therapy

vonoprazan and high-dose amoxicillin dual therapy

ACTIVE COMPARATOR

1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days

Drug: H-VA dual therapy

Interventions

L-VA dual therapy DRUG

1000mg amoxicillin capsules twice times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days

Also known as: L-VA

vonoprazan and low-dose amoxicillin dual therapy

H-VA dual therapy DRUG

1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 14 days

Also known as: H-VA

vonoprazan and high-dose amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history

You may not qualify if:

• allergy to amoxicillin or vonoprazan;
• acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;
• serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;
• pregnancy or breast feeding;
• proton pump inhibitors and antibiotics use within one month;
• not willing to participate in the study

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Related Publications (1)

• Hu Y, Zhang ZY, Wang F, Zhuang K, Xu X, Liu DS, Fan HZ, Yang L, Jiang K, Zhang DK, Xu L, Tang JH, Liu XM, He C, Shu X, Xie Y, Lau JYW, Zhu Y, Du YQ, Graham DY, Lu NH. Effects of amoxicillin dosage on cure rate, gut microbiota, and antibiotic resistome in vonoprazan and amoxicillin dual therapy for Helicobacter pylori: a multicentre, open-label, non-inferiority randomised controlled trial. Lancet Microbe. 2025 Mar;6(3):100975. doi: 10.1016/j.lanmic.2024.100975. Epub 2024 Dec 18.

  PMID: 39708826 DERIVED

Study Officials

• Nong-Hua Lu, phD

  The First Affiliated Hospital of Nanchang University

  PRINCIPAL INVESTIGATOR

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: Professor

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 14, 2022
• Study Start: February 13, 2023
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)