drugset / Trial / NCT02045251

An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection

NCT02045251

NaSingle-groupOpen-labelTreatment

Summary

Over the years, it has become clear that the first-line triple therapy is losing efficacy worldwide. A capsule containing 3 agents (Pylera®) containing 125mg metronidazole, 140mg bismuth subcitrate potassium, and 125mg tetracycline was made available. The efficacy of the Pylera capsule was studied in a randomized control trial, in which a quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple regimen. In the study, 3 three-in-one capsules were taken four times daily (after meals and at bedtime). Given the above, we aim at assessing the effectiveness of fewer pills per day of the Pylera capsule (3 Pylera capsules supplemented with the addition of amoxicillin and esomeprazole twice daily; sum of 10 pills/day for 10 days) in the eradication of H. pylori.

Timeline

Start
2013-06
Primary completion
2016-07
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 500 mg Oral
Subject Esomeprazole Small molecule 20 mg Oral
Subject Metronidazole Small molecule 250 mg Oral
Subject Tetracycline Unknown 250 mg Oral
Subject bismuth subcitrate Unknown 280 mg Oral

Indications

No indication recorded.