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Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

NCT02604576 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2021-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Dyspepsia

Interventions

DRUG

FDC Bromopride 10 mg and Simethicone 80 mg

Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg

DRUG

Bromopride 10 mg

Bromopride 10 mg

Sponsors & Collaborators

  • EMS

    lead INDUSTRY

Principal Investigators

  • Carlos Fernando Francesconi, MD · Hospital de Clínicas de Porto Alegre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2018-03-13
Completion
2019-03-11

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 NCT02604576 on ClinicalTrials.gov