NCT02660372

Efficacy and Safety of Two Simeticone Brands in Adults With Functional Dyspepsia

A Multi-center, Randomized, Observer-blind, Parallel Group, 8-weeks Non-inferiority Clinical Trial to Compare the Efficacy and Safety of Two Brands of Simeticone for Symptomatic Treatment of Functional Dyspepsia in Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to show non-inferiority of two brands of simeticone in adult patients suffering from functional dyspepsia.

Detailed description

This is a multi-center, randomized, observer-blind, parallel-group, 8-weeks, non-inferiority clinical trial to compare the efficacy and safety of two brands of Simeticone for symptomatic treatment of functional dyspepsia in adults.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Imonogas	Simethicone 120 mg in gel capsules
DRUG	Espumisan	Simethicone 40 mg in gel capsules

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-10-01
• Completion: 2016-12-01
• First posted: 2016-01-21
• Last updated: 2016-12-15

Locations

1 site across 1 country: Russia