NCT06162949

Vonoprazan for Helicobacter Pylori Eradication in Adolescents

Vonoprazan-based Triple Therapy vs. Standard Triple Therapy for Helicobacter Pylori Eradication in Adolescents: A Randomized, Double-blinded Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The trial tends to evaluate the efficacy of vonoprazan-based triple therapy in eradicating H. Pylori infection in adolescent patients in Egypt, in comparison to standard treatment regimens to determine if it offers superior eradication rates (VONTAPE trial).

Detailed description

The VONTAPE trial will compare two treatment regimens for Helicobacter pylori eradication among adolescent patients presented to the gastroenterology department in an Egyptian institute. the eligible subjects will be randomly assigned to one of the two protocols (vonoprazan based vs. proton pump inhibitor-based triple therapy) for two weeks. then the eradication rates will be compared between the two study groups to see if there is a difference in efficacy. The currently available eradication regimens in our country show a low to intermediate eradication rate (50-75%). At the same time, H. pylori infection is prevalent. Recently, the FDA approved vonoprazan-based regimens for adult H. pylori infection with high eradication rates even in the settings of clarithromycin antibiotic resistance. In the VOTSAPE trial, we will test this efficacy in the \< 18 years adolescents.

Conditions

• Treatment Effectiveness

Interventions

Type	Name	Description
DRUG	Vonoprazan	an acid suppressor therapy that inhibits the H+, K+-ATPase enzyme system in a potassium-competitive manner.
DRUG	Amoxicillin	An antibiotic of penicillins antibiotic group
DRUG	Clarithromycin	An antibiotic of macrolide group
DRUG	Esomeprazole	An acid suppressor therapy that blocks the proton pump.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-12-08
• Last updated: 2024-08-28

Locations

1 site across 1 country: Egypt