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Sponsors and Collaborators: |
Hospital de Clinicas de Porto Alegre Aché Laboratórios Farmacêuticos Ltda |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00404534 |
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
Condition | Intervention | Phase |
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Functional Dyspepsia |
Drug: Amoxicillin, Clarythromycin, Omeprazole for ten days |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 407 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Amoxicillin 1000 mg BID, clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
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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.
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2: Placebo Comparator
Placebo of Amoxicillin 1000 mg BID, placebo of clarythromycin 500 mg BID and Omeprazole 20 mg BID for ten days
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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.
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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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Rio Grande do Sul | |
Hospital de Clinicas de Porto Alegre | |
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 |
Principal Investigator: | Luiz E Mazzoleni, MD, MsC, PhD | Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul |
Study Chair: | Carlos F Francesconi, MD, PhD | Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul |
Study Chair: | Guilherme B Sander, MD, MsC | Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul |
Responsible Party: | HOSPITAL DE CLINICAS DE PORTO ALEGRE ( PROF. LUIZ EDMUNDO MAZZOLENI ) |
Study ID Numbers: | 05-422 |
Study First Received: | November 27, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00404534 |
Health Authority: | Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health |
functional dyspepsia Helicobacter pylori Anti-Inflammatory Agents, Non-Steroidal Gastritis |
Clarithromycin Signs and Symptoms Amoxicillin Stomach Diseases Digestive System Diseases Signs and Symptoms, Digestive |
Gastrointestinal Diseases Omeprazole Gastroenteritis Dyspepsia Gastritis |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |