Helicobacter Eradication Relief of Dyspeptic Symptoms

Functional Dyspepsia Clinical Trial

— HEROES-12  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404534
• Other study ID #: 05-422
• Status: Completed
• Phase: Phase 3
• First received: November 27, 2006
• Last updated: February 27, 2018
• Start date: October 2006
• Est. completion date: June 2009

Study information

• Verified date: March 2010
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Aché Laboratórios Farmacêuticos Ltda

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Mazzoleni LE, Sander GB, Ott EA, Barros SG, Francesconi CF, Polanczyk CA, Wortmann AC, Theil AL, Fritscher LG, Rivero LF, Cartell A, Edelweiss MI, Uchôa DM, Prolla JC. Clinical outcomes of eradication of Helicobacter pylori in nonulcer dyspepsia in a population with a high prevalence of infection: results of a 12-month randomized, double blind, placebo-controlled study. Dig Dis Sci. 2006 Jan;51(1):89-98. — View Citation

Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchôa DM, Francesconi CF, Prolla JC. Helicobacter pylori eradication does not cause reflux oesophagitis in functional dyspeptic patients: a randomized, investigator-blinded, placebo-controlled trial. Aliment Pharmacol Ther. 2005 May 15;21(10):1231-9. — View Citation

Sander GB, Mazzoleni LE, Francesconi CF, Wortmann AC, Ott EA, Theil A, Da Cruz PV, Da Silva AC, Oliveira L, Beheregaray S, Matioti S, Somm G, Goldim JR. Development and validation of a cross-cultural questionnaire to evaluate nonulcer dyspepsia: the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ). Dig Dis Sci. 2004 Nov-Dec;49(11-12):1822-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Need of rescue medication		4, 8 and 12 months
Secondary	Median difference of score between groups		the last visit among the antecipated visits (4, 8 and 12 months)
Secondary	Mean SF-36 scores evolution between groups		12 months
Secondary	Lost of productivity measured by WPAI between groups		12 months
Secondary	Adverse Events		4 , 8 and 12 months

External Links

•   Official Homepage of Site that is Conducting the Study