Helicobacter Pylori and Vonoprazan Dual Therapy

NCT05649709 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2024-08-23

No results posted yet for this study

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

Interventions

DRUG

L-VA dual therapy

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

DRUG

H-VA dual therapy

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Nanchang University

    lead OTHER

Principal Investigators

  • Nong-Hua Lu, phD · The First Affiliated Hospital of Nanchang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-01-25
Completion
2024-01-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649709 on ClinicalTrials.gov