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Helicobacter Eradication Relief of Dyspeptic Symptoms

NCT00404534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2018-03-01

No results posted yet for this study

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

Conditions

  • Functional Dyspepsia

Interventions

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.

Sponsors & Collaborators

  • Aché Laboratórios Farmacêuticos Ltda

    collaborator INDUSTRY

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Luiz E Mazzoleni, MD, MsC, PhD · Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

  • Carlos F Francesconi, MD, PhD · Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

  • Guilherme B Sander, MD, MsC · Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00404534 on ClinicalTrials.gov