Helicobacter Eradication Relief of Dyspeptic Symptoms (HEROES-12)

This study has been completed.
Sponsor:
Collaborator:
Aché Laboratórios Farmacêuticos Ltda
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00404534
First received: November 27, 2006
Last updated: March 29, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
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:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PROF. LUIZ EDMUNDO MAZZOLENI, HOSPITAL DE CLINICAS DE PORTO ALEGRE
ClinicalTrials.gov Identifier: NCT00404534     History of Changes
Other Study ID Numbers: 05-422
Study First Received: November 27, 2006
Last Updated: March 29, 2010
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

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Clarithromycin
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014