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NCT05649709
Helicobacter Pylori and Vonoprazan Dual Therapy
Conditions: Helicobacter Pylori
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 504
Sponsor: The First Affiliated Hospital of Nanchang University
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication historyExclusion Criteria: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
Source: ClinicalTrials.gov (NCT05649709). StuddyBuddy aggregates publicly available trial information.