NCT02604576

Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-17
• Primary completion: 2018-03-13
• Completion: 2019-03-11
• First posted: 2015-11-13
• Last updated: 2021-02-24

Locations

10 sites across 1 country: Brazil