Helicobacter Eradication Relief of Dyspeptic Symptoms - Full Text View

Sponsors and Collaborators:	Hospital de Clinicas de Porto Alegre Aché Laboratórios Farmacêuticos Ltda
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00404534

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Indigestion

Drug Information available for: Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Omeprazole Clarithromycin Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome 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) ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as safety issue: No ]
Need of rescue medication [ Time Frame: 4, 8 and 12 months ] [ Designated as safety issue: Yes ]
Median difference of score between groups [ Time Frame: the last visit among the antecipated visits (4, 8 and 12 months) ] [ Designated as safety issue: No ]
Mean SF-36 scores evolution between groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Lost of productivity measured by WPAI between groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 4 , 8 and 12 months ] [ Designated as safety issue: Yes ]

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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404534

Locations

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

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Aché Laboratórios Farmacêuticos Ltda

Investigators

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

More Information

Additional Information:

Official Homepage of Site that is Conducting the Study This link exits the ClinicalTrials.gov site

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.

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:	July 3, 2009
ClinicalTrials.gov Identifier:	NCT00404534 History of Changes
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:

functional dyspepsia
Helicobacter pylori
Anti-Inflammatory Agents, Non-Steroidal
Gastritis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Anti-Infective Agents
Amoxicillin
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Omeprazole
Dyspepsia
Anti-Bacterial Agents
Signs and Symptoms
Clarithromycin

Digestive System Diseases
Stomach Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Gastroenteritis
Gastritis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Omeprazole
Anti-Bacterial Agents
Clarithromycin
Signs and Symptoms
Stomach Diseases
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Amoxicillin
Gastrointestinal Agents
Enzyme Inhibitors
Dyspepsia
Pharmacologic Actions
Protein Synthesis Inhibitors
Digestive System Diseases
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Gastroenteritis
Antirheumatic Agents
Gastritis

ClinicalTrials.gov processed this record on September 03, 2009