7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
NCT ID: NCT06576882
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2024-06-30
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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14-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 14 days .
Vonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Amoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
Clarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].
7-days Vonoprazan-based triple therapy
Vonoprazan tablets 20 mg twice daily plus Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose 2 g\] plus Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose 1 g\]. The triple combination will be given for 7 days.
Vonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Amoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
Clarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].
Interventions
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Vonoprazan
Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
Amoxicillin
Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
Clarithromycin
Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .
Exclusion Criteria
2. previous attempts to eradicate H.P.
3. receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
4. Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
5. hepatic impairment or kidney failure.
6. symptoms suggestive of functional disorders.
10 Years
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Sameh A. Lashen
Assistant Professor
Principal Investigators
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Sameh A Lashen, MD
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Faculty of Medicine, Alexandria University.
Alexandria, , Egypt
Countries
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Other Identifiers
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0306630
Identifier Type: -
Identifier Source: org_study_id
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