Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT00404534
Status:
COMPLETED
Last Update Posted:
2018-03-01
First Post:
2006-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Helicobacter Eradication Relief of Dyspeptic Symptoms
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEROES-12
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: