Status:
COMPLETED
Helicobacter Eradication Relief of Dyspeptic Symptoms
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Aché Laboratórios Farmacêuticos Ltda
Conditions:
Functional Dyspepsia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A double-blind clinical trial investigating if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after...
Detailed Description
Objective: investigate if a sub-group of functional dyspeptic patients without any use of NSAID or gastric erosions could have a better evolution of their dyspeptic symptoms after Helicobacter eradica...
Eligibility Criteria
Inclusion
- Patients with more than 18 years
- Functional dyspepsia accordingly Rome III criteria
- Helicobacter pylori infection by two diagnostic tests
Exclusion
- No concordance with informed consent
- Pregnant woman or breast feeding or no trust anticonceptional method
- Structural gastrointestinal abnormalities except gastritis, duodenitis or hiatal hernia
- Previous treatment for Helicobacter pylori infection
- Previous surgery on esophagus, stomach or duodenum
- Hypersensitivity to the drugs in study
- Proton pump inhibitor use in the previous 15 days
- H2-antagonists use in the previous 07 days
- Antibiotics use in the previous 30 days
- Patients unable to answer the study questionnaires
- Alcohol abuse
- Drug use
- Serious comorbidities
- Biliary colic
- Irritable bowel syndrome
- Gastroesophageal Reflux Disease
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00404534
Start Date
October 1 2006
End Date
June 1 2009
Last Update
March 1 2018
Active Locations (1)
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1
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903