drugset / Trial / NCT06088316

Efficacy of Amoxicillin-Esomeprazole HDDT Compared to Levofloxacin Triple Therapy for H. Pylori Eradication: A RCT

NCT06088316

RandomizedParallel-groupSingle-blindTreatment

Summary

The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is - 1. To identify the percentage of H. pylori infection among dyspeptic patients 2. To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori. Participants will be screened on the basis of two different test (stool antigen test \& endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin \& esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin \& esomeprazole for 14 days in usual dose. Dyspeptic symptoms will be recorded before \& after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.

Timeline

Start
2023-02-10
Primary completion
2024-02
Completion
2024-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g
Subject Esomeprazole Small molecule 20 mg
Subject Esomeprazole Small molecule 40 mg
Comparator Levofloxacin Small molecule 500 mg