Status:
UNKNOWN
14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication
Lead Sponsor:
Infante, Javier Molina, M.D.
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Helicobacter pylori (H. pylori) infects approximately 50% of the adult population and is well recognized as the main cause of gastritis, peptic ulcer disease and gastric cancer. The cure of the H. pyl...
Detailed Description
Justification of the study: Several non-bismuth quadruple clarithromycin-containing regimens have raised over the last decade aiming to substitute standard triple therapy (STT) for first-line H. pylo...
Eligibility Criteria
Inclusion
- Patients with dyspepsia or peptic gastroduodenal ulcer for whom eradication treatment is indicated.
- Requirement of confirmation of the diagnosis of H. pylori infection by at least one positive test out of the following: breath test, histology, rapid urease test or culture.
Exclusion
- Age less than 18 years.
- Advanced chronic disease or any other pathology that prevents attending controls and follow up.
- Allergy to any of the antibiotics in the treatment.
- Previous gastric surgery
- Pregnancy and lactation.
- History of alcohol or drug abuse.
- Previous eradication treatment.
- Consumption of antibiotics or bismuth salts during the last 4 weeks
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01464060
Start Date
September 1 2011
End Date
January 1 2013
Last Update
December 31 2012
Active Locations (4)
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1
Azienda Ospedaliera Universitaria
Napoli, Napoli, Italy
2
Hospital de Merida
Mérida, Badajoz, Spain
3
Hospital San Pedro de Alcantara
Cáceres, Caceres, Spain, 10003
4
Hospital Virgen del Puerto
Plasencia, Caceres, Spain