CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Optimized bismuth quadruple therapy +1 moredrug
Likely dose
Not stated in 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/NCT05664685
NCT05664685Phase 4Completed

Optimized Bismuth Quadruple Therapy vs Triple Standard Therapy for Helicobacter Pylori Eradication: Clinical Efficacy Randomized Trial

Pontificia Universidad Catolica de Chile·interventional·Posted Dec 27, 2022·Updated Apr 12, 2024

In Brief

A Phase 4 clinical trial evaluating Optimized bismuth quadruple therapy and Control for Helicobacter Pylori Infection. Completed, enrolled 127 participants across 2 sites.

Detailed Summary

This study have as primary aim "To compare the H. pylori eradication rate between the quadruple bismuth therapy versus the standard triple therapy recommended by the AUGE Clinical Guidelines for Helicobacter pylori eradication treatment in peptic ulcer patients." Briefly, this is a randomized, multicenter, controlled, double-blind clinical trial with two parallel arms. The control group will receive the current Standard Triple Therapy for the eradication of H. pylori. It consists of omeprazole + amoxicillin + clarithromycin for 14 days. The intervention group will be administered Quadruple Therapy with Bismuth, which consists in esomeprazole + amoxicillin + metronidazole + bismuth subsalicylate for 14 days

Study Details

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

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 27, 2022
Enrollment StartOct 17, 2022
Primary CompletionOct 30, 2023
Study CompletionJan 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.5 years ago

Interventions

Optimized bismuth quadruple therapydrug

Scheme that have high dosage of amoxicillin, metronidazole and omeprazole, with bismuth. The rationale of this scheme is that in Chile, amoxicillin resistance is low, clinical metronidazole is low in the doses used and the high doses ob Proton Pump Inhibitor enhanced the antimicrobial drugs

Controldrug

Standard eradication therapy using omeprazole, clarithromycin and amoxicillin