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NOT YET RECRUITING
NCT07624422
PHASE4

Vonoprazan High-Dose Dual VS Levofloxacin Concomitant

Sponsor: Damascus Hospital

View on ClinicalTrials.gov

Summary

This is a randomized controlled trial comparing the efficacy and safety of two vonoprazan-based regimens: high-dose dual therapy (vonoprazan plus a single antibiotic) versus triple therapy (vonoprazan plus two antibiotics) for the treatment of H. pylori infection). Participants will be randomly assigned to receive either regimen for 14 days. The primary outcome is eradication rate , and secondary outcomes include adverse events and treatment adherence.

Official title: Efficacy and Safety of Vonoprazan High-Dose Dual Therapy Compared to Levofloxacin Concomitant Therapy for H. Pylori Eradication: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-11-01

Completion Date

2027-12-31

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

Vonoprazan

Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose adjustments permitted during the 14-day treatment period.

DRUG

Levofloxacin 500mg

Oral medications dispensed at enrollment in blinded (to outcome assessor) packaging. Patients complete a daily medication diary. Adherence assessed by pill count at day 14. No dose

Locations (1)

General Assembly of Damascus Hospital

Damascus, Syria