NCT06576882

7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication

7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.

Detailed description

After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.

Conditions

• Helicobacter Pylori Infection
• Gastritis
• Vonoprazan
• Adolescents

Interventions

Type	Name	Description
DRUG	Vonoprazan	Participants will receive Vonoprazan 20 mg tablets twice daily before meals.
DRUG	Amoxicillin	Participants will receive Amoxicillin 50 mg/kg/day capsules or suspension \[maximum daily dose: 2 g\].
DRUG	Clarithromycin	Participants will receive Clarithromycin 20 mg/kg/day tablets or suspension \[maximum daily dose: 1 g\].

Timeline

• Start date: 2024-06-30
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2024-08-29
• Last updated: 2025-02-11

Locations

1 site across 1 country: Egypt