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10-day Versus 14-day Concomitant PAMC as First-line Treatment Strategy for the Eradication of H. Pylori Infection

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ClinicalTrials.gov Identifier: NCT02959255
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Study Description
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Brief Summary:

Helicobacter pylori (H. pylori) infection is highly associated with gastrointestinal disorders, including peptic ulcer disease, gastric cancer, and gastric mucosa associated lymphoid tissue lymphoma.1 In 1994, H. pylori was classified as a group carcinogen by the International Agency for Research on Cancer. Since then, many consensus conferences and clinical guidelines worldwide have been established for the treatment of H. pylori infection.

Despite H. pylori infecting an estimated 50% of the global population,there is no universally effective regimen in everyday clinical practice. The current European Helicobacter Study Group Guidelines for the first line empirical treatment of the H. pylori infection propose a variety of treatment strategies, as optimal treatment of H. pylori infection requires careful attention to local antibiotic resistance and eradication patterns. Most recently, the Toronto Consensus for the Treatment of Helicobacter pylori Infection in Adults strongly recommended that all H. pylori eradication regimens now be given for 14 days. Recommended first-line strategies include concomitant nonbismuth quadruple therapy (proton pump inhibitor [PPI] + amoxicillin + metronidazole + clarithromycin [PAMC]) and traditional bismuth quadruple therapy (PPI + bismuth + metronidazole + tetracycline [PBMT]).The aforementioned statement by an international working group of specialists chosen by the Canadian Association of Gastroenterology is of the outmost importance, especially in countries with increased antibiotic resistance, like Greece, with resistance rates >20% to clarithromycin and >40% to metronidazole.


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Esomeprazole Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Greek, Single Center, Randomized, Double Blind Controlled Clinical Study Comparing the 10-day Versus the 14-day Concomitant Proton Pump Inhibitor [PPI] + Amoxicillin + Metronidazole + Clarithromycin (PAMC) Therapeutic Scheme as First-line Treatment Strategy for the Eradication of H. Pylori Infection
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 10-day concomitant PAMC
40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 10 days
 Drug: Esomeprazole
dosage difference
Active Comparator: 14-day concomitant PAMC
(40mg esomeprazole twice daily, 500mg clarithromycin twice daily, 1gr amoxicillin twice daily, and 500mg metronidazole twice daily for 14 days.
 Drug: Esomeprazole
dosage difference


Outcome Measures
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Primary Outcome Measures :
  1. Helicobacter Pylori eradication [ Time Frame: 10 days - 14 days ]

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • age >18 or <80 years
  • consecutive newly diagnosed H. pylori-infected patients
  • endoscopically proven peptic ulcer disease or non-ulcer dyspepsia
  • H. pylori infection will be established by at least one positive test among C13-urea breath test (UBT), rapid urease test, and gastric histology.
  • patients who have signed the Informed Consent
  • patients who will be compliant to study procedures

Exclusion Criteria:

  • age <18 or >80 years.
  • previous H. pylori eradication therapy
  • known allergic history to any of the medications used in our study
  • pregnancy or lactation
  • ingestion of antibiotics within the prior 4 weeks
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness which would not allow patients' compliance (i.e., malignant neoplasms)
  • addiction to alcohol or illicit and recreational drugs
  • patients who have not signed Informed Consent
  • patients who will not comply with study procedures
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02959255


Locations
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Greece
Army Hospital
Athens, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
More Information
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Publications:

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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT02959255     History of Changes
Other Study ID Numbers: IIS-EL-ESO-2016
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
 Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors