An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection
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|ClinicalTrials.gov Identifier: NCT02045251|
Recruitment Status : Withdrawn (Unavailability of clarithromycin 250 mg in the market)
First Posted : January 24, 2014
Last Update Posted : January 15, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Treatment of H. Pylori Infection||Drug: Pylera based reduced regimen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AN OPEN-LABEL TRIAL OF REDUCED- DOSE PYLERA (BISMUTH, METRONIDAZOLE, TETRACYCLINE), AMOXICILLIN, AND ESOMEPRAZOLE IN THE TREATMENT OF HELICOBACTER PYLORI INFECTION|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2016|
Experimental: Interventional Arm
This arm will have 100 patients receiving the proposed Pylera based regimen for 10 days.
Drug: Pylera based reduced regimen
Patients with H. pylori infection will be treated with a 10 day course of reduced Pylera based regimen.
- Helicobacter pylori eradication [ Time Frame: Eradication ]The rate of eradication of H. pylori using the proposed regimen
- Side effects of treatment [ Time Frame: Day 10 (at the end of treatment) ]Assessment of side effects of the new regimen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045251
|American University of Beirut Medical Center|
|Beirut, Lebanon, 00961|