Clinical Trial: Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: EMS

Current Primary Outcome: Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ [ Time Frame: 4 weeks ]

Original Primary Outcome: Symptoms assessed by proportion of participants who have reduction equal to or greater than 20% in symptoms through questionnaire PADYQ [ Time Frame: 4 weeks ]

Current Secondary Outcome: Adverse events [ Time Frame: 4 weeks ]

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.


Original Secondary Outcome:

  • Quality of Life [ Time Frame: 4 weeks ]
    Score of quality of life
  • Individual Symptoms Score [ Time Frame: 4 weeks ]
    Scores of symptoms of pain, nausea / vomiting, bloating / fullness, through questionnaire.
  • Participant satisfaction [ Time Frame: 4 weeks ]
    Satisfaction of participants with treatment through questionnaire.
  • Adverse events [ Time Frame: 4 weeks ]
    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.


Information By: EMS

Dates:
Date Received: November 11, 2015
Date Started: December 2016
Date Completion: October 2017
Last Updated: January 17, 2017
Last Verified: January 2017