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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02045251
Recruitment Status : Withdrawn (Unavailability of clarithromycin 250 mg in the market)
First Posted : January 24, 2014
Last Update Posted : January 15, 2015
Information provided by (Responsible Party):
American University of Beirut Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Treatment of H. Pylori Infection Drug: Pylera based reduced regimen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Helicobacter pylori eradication [ Time Frame: Eradication ]
    The rate of eradication of H. pylori using the proposed regimen

Secondary Outcome Measures :
  1. Side effects of treatment [ Time Frame: Day 10 (at the end of treatment) ]
    Assessment of side effects of the new regimen

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with either positive CLO tests, urea breath tests, or histopathologic documention of H. pylori infection, and agreeing to the study by signing the informed consent.

Exclusion Criteria:

  • Age under 18 or older than 80 years
  • Allergies to any of the drugs used
  • Recent antibiotic therapy (within 2 weeks of enrollement)
  • Severe ulcers or bleeding
  • Gastric perforation or obstruction
  • Previous gastrectomy
  • Gastric cancer
  • Pregnancy or lactation
  • Prior eradication therapy for H. pylori
  • Severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02045251

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American University of Beirut Medical Center
Beirut, Lebanon, 00961
Sponsors and Collaborators
American University of Beirut Medical Center
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Responsible Party: American University of Beirut Medical Center Identifier: NCT02045251    
Other Study ID Numbers: IM.AS1.33
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: March 2013
Keywords provided by American University of Beirut Medical Center:
Helicobacter pylori
H. pylori
Additional relevant MeSH terms:
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Communicable Diseases