Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.
Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride in the relief os dyspepsia symptoms on research participants diagnosed with functional dyspepsia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
339
Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
Bromopride 10 mg
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
Time frame: 4 weeks
Adverse events
Safety assessment will be performed by evaluating the incidence of adverse events in each group as well as the relationship of these events to the drug used, the amount and severity of reported events.
Time frame: 4 weeks
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AFIP
São Paulo, Sâo Paulo, Brazil
UNIFAG
Bragança Paulista, São Paulo, Brazil
Loema
Campinas, São Paulo, Brazil
Instituto de Pesquisa Clinica de Campinas
Campinas, São Paulo, Brazil
Allergisa
Campinas, São Paulo, Brazil
Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil