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Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Primary Purpose

Dyspepsia

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
FDC Bromopride 10 mg and Simethicone 80 mg
Bromopride 10 mg
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring functional dyspepsia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent;
  • Participants aged 18- 70 years;
  • Clinical diagnosis of functional dyspepsia according to Rome III criteria;
  • Minimum score of 22 points in PADYQ questionnaire

Exclusion Criteria:

  • Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological;
  • Positive diagnosis for Helicobacter pylori;
  • Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization;
  • History of esophageal surgery, gastrointestinal or other intra-abdominal surgery;
  • Hypersensitivity to the components of the formulations;
  • Allergy tartrazine yellow dye;
  • Allergy to aspirin;
  • Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit;
  • Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms;
  • Pregnant women or women without adequate contraception;
  • Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it;
  • Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase;
  • Diagnosis of neurological or psychiatric diseases or decompensated diabetes;
  • Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers;
  • Alcoholism or sporadic use of alcohol and illicit drug use.

Sites / Locations

  • Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
  • Hospital de Clínicas de Porto Alegre
  • Hospital Ernesto Dornelles
  • UNIFAG
  • Loema
  • Instituto de Pesquisa Clinica de Campinas
  • Centro de Estudos Clínicos do Interior Paulista
  • Faculdade de Medicina do ABC
  • AFIP
  • Allergisa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

FDC Bromopride 10 mg and Simethicone 80 mg

Bromopride 10 mg (Digesan ® - Sanofi Aventis)

Outcomes

Primary Outcome Measures

Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2015
Last Updated
February 23, 2021
Sponsor
EMS
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1. Study Identification

Unique Protocol Identification Number
NCT02604576
Brief Title
Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia
Official Title
Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
functional dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
FDC Bromopride 10 mg and Simethicone 80 mg
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Bromopride 10 mg (Digesan ® - Sanofi Aventis)
Intervention Type
Drug
Intervention Name(s)
FDC Bromopride 10 mg and Simethicone 80 mg
Other Intervention Name(s)
Bromopride 10 mg and Simethicone 80 mg
Intervention Description
Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
Intervention Type
Drug
Intervention Name(s)
Bromopride 10 mg
Other Intervention Name(s)
Digesan®
Intervention Description
Bromopride 10 mg
Primary Outcome Measure Information:
Title
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent; Participants aged 18- 70 years; Clinical diagnosis of functional dyspepsia according to Rome III criteria; Minimum score of 22 points in PADYQ questionnaire Exclusion Criteria: Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological; Positive diagnosis for Helicobacter pylori; Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization; History of esophageal surgery, gastrointestinal or other intra-abdominal surgery; Hypersensitivity to the components of the formulations; Allergy tartrazine yellow dye; Allergy to aspirin; Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit; Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms; Pregnant women or women without adequate contraception; Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it; Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase; Diagnosis of neurological or psychiatric diseases or decompensated diabetes; Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers; Alcoholism or sporadic use of alcohol and illicit drug use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Fernando Francesconi, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
UNIFAG
City
Bragança Paulista
State/Province
SP
ZIP/Postal Code
129169000
Country
Brazil
Facility Name
Loema
City
Campinas
State/Province
SP
ZIP/Postal Code
13010001
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica de Campinas
City
Campinas
State/Province
SP
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Centro de Estudos Clínicos do Interior Paulista
City
Jau
State/Province
SP
ZIP/Postal Code
17201-130
Country
Brazil
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
SP
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
AFIP
City
São Paulo
State/Province
Sâo Paulo
ZIP/Postal Code
04020-060
Country
Brazil
Facility Name
Allergisa
City
Campinas
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

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Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

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