Helicobacter Eradication Relief of Dyspeptic Symptoms

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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 Helicobacter eradication than the placebo control group

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborator: Aché Laboratórios Farmacêuticos Ltda
• Treatments: Amoxicillin; Anti-Inflammatory Agents, Non-Steroidal; Clarithromycin; Omeprazole

Criteria

Inclusion Criteria:

• Patients with more than 18 years

• Functional dyspepsia accordingly Rome III criteria

• Helicobacter pylori infection by two diagnostic tests

Exclusion Criteria:

• 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