Helicobacter Eradication Relief of Dyspeptic Symptoms

Condition(s) targeted: Functional Dyspepsia

Intervention: Amoxicillin, Clarythromycin, Omeprazole for ten days (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hospital de Clinicas de Porto Alegre

Official(s) and/or principal investigator(s):
Luiz E Mazzoleni, MD, MsC, PhD, Principal Investigator, Affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Carlos F Francesconi, MD, PhD, Study Chair, Affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul
Guilherme B Sander, MD, MsC, Study Chair, Affiliation: Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

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

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

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

Primary outcome: Proportion of patients with 50% reduction of baseline symptoms score measured by the validated Porto Alegre Dyspeptic Symptoms Questionnaire

Secondary outcome:

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

Adverse Events

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903, Brazil

Official Homepage of Site that is Conducting the Study

Related publications:

Mazzoleni LE, Sander GB, Ott EA, Barros SG, Francesconi CF, Polanczyk CA, Wortmann AC, Theil AL, Fritscher LG, Rivero LF, Cartell A, Edelweiss MI, Uchoa 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.

Ott EA, Mazzoleni LE, Edelweiss MI, Sander GB, Wortmann AC, Theil AL, Somm G, Cartell A, Rivero LF, Uchoa 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.

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.

Starting date: November 2006
Ending date: May 2009
Last updated: June 19, 2008