CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 132 enrolled
Drug / intervention
standard Clarithromycin triple therapy +2 moredrug
Likely dose
standard Clarithromycin triple therapy 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05614934
NCT05614934Phase 4Completed

Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management

Alexandria University·interventional·Posted Nov 14, 2022·Updated Feb 21, 2025

In Brief

A Phase 4 clinical trial evaluating standard Clarithromycin triple therapy, Vonoprazan triple therapy, and 1 other intervention for Helicobacter Pylori Infection. Completed, enrolled 132 participants across 1 site.

Detailed Summary

Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens. The aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartJun 11, 2022
Primary CompletionMay 1, 2023
Study CompletionMay 15, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.6 years ago

Interventions

standard Clarithromycin triple therapydrug

Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days

Vonoprazan triple therapydrug

Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days

Vonoprazan dual therapydrug

Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days