Official Title: “Dyspeptic Symptoms Evolution After Eradication of Helicobacter Pylori in Patients With Different Endoscopic Findings: a Randomized Double-Blind Placebo-Controlled Clinical Trial With 12 Months of Follow-up”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

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

Intervention(s) in this Clinical Trial

• Drug: Amoxicillin, 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
• Placebo Comparator: 2
  • Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days

Primary Measures

• Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
  • Time Frame: the last visit among the antecipated visits (4, 8 and 12 months)
    Safety Issue?: No

Secondary Measures

• Proportion of patients with 100% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire
  • Time Frame: the last visit among the antecipated visits (4, 8 and 12 months)
    Safety Issue?: No
• Need of rescue medication
  • Time Frame: 4, 8 and 12 months
    Safety Issue?: Yes
• Median difference of score between groups
  • Time Frame: the last visit among the antecipated visits (4, 8 and 12 months)
    Safety Issue?: No
• Mean SF-36 scores evolution between groups
  • Time Frame: 12 months
    Safety Issue?: Yes
• Lost of productivity measured by WPAI between groups
  • Time Frame: 12 months
    Safety Issue?: Yes
• Adverse Events
  • Time Frame: 4 , 8 and 12 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Overall Clinical Trial Officials and Contacts

Luiz E Mazzoleni, MD, MsC, PhD Principal Investigator Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00404534

Study ID Number: 05-422

ClinicalTrials.gov Identifier: NCT00404534

Health Authority: Brazil: National Committee of Ethics in Research

Official Homepage of Site that is Conducting the Study