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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||364 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- Helicobacter Pylori eradication [ Time Frame: 10 days - 14 days ]
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