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

NCT02959255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2018-03-29

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Esomeprazole

dosage difference

Sponsors & Collaborators

  • Elpen Pharmaceutical Co. Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2017-12-30
Completion
2017-12-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02959255 on ClinicalTrials.gov