Functional Dyspepsia
Conditions
Keywords
functional dyspepsia, Helicobacter pylori, Anti-Inflammatory Agents, Non-Steroidal, Gastritis
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 Helicobacter eradication than the placebo control group
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 eradication than the placebo control group Design: A randomized double-blind placebo controlled clinical trial 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 Interventions: amoxicillin, clarythromycin, omeprazole for 10 days Control: Placebo Outcomes: Primary: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire Secondary: Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire; Need of rescue medication; Median difference of score between groups; Mean SF-36 scores evolution between groups; Lost of productivity measured by WPAI between groups Visits: screening, baseline, 4, 8, 12 months Endoscopic evaluation: screening, 12 months Helicobacter detection methods: urease, histology (3 pathologists) performed at screening and 12 months
Interventions
DRUGAmoxicillin, Clarythromycin, Omeprazole for ten days
Amoxicillin 1000 mg BID, clarythromycin 500 mg BID for ten days in the experimental group and placebo of Amoxicillin 1000 mg BID and placebo of clarythromycin 500 mg BID in the placebo comparator. Both groups receive omeprazole 20 mg bid for 10 days.
Sponsors
Aché Laboratórios Farmacêuticos Ltda
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire | the last visit among the antecipated visits (4, 8 and 12 months) |
Secondary
| Measure | Time frame |
|---|---|
| Mean SF-36 scores evolution between groups | 12 months |
| Lost of productivity measured by WPAI between groups | 12 months |
| Median difference of score between groups | the last visit among the antecipated visits (4, 8 and 12 months) |
| Need of rescue medication | 4, 8 and 12 months |
| Adverse Events | 4 , 8 and 12 months |
| Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire | the last visit among the antecipated visits (4, 8 and 12 months) |
Countries
Brazil
Outcome results
None listed