Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604576
• Other study ID #: BRDEMS1011
• Status: Completed
• Phase: Phase 3
• Start date: January 17, 2017
• Est. completion date: March 11, 2019

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: March 11, 2019
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia

Intervention

Drug:
• FDC Bromopride 10 mg and Simethicone 80 mg
Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
• Bromopride 10 mg
Bromopride 10 mg

Locations

Country	Name	City	State
Brazil	UNIFAG	Bragança Paulista	SP
Brazil	Allergisa	Campinas	São Paulo
Brazil	Instituto de Pesquisa Clinica de Campinas	Campinas	SP
Brazil	Loema	Campinas	SP
Brazil	Centro de Estudos Clínicos do Interior Paulista	Jau	SP
Brazil	Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Ernesto Dornelles	Porto Alegre	RS
Brazil	Faculdade de Medicina do ABC	Santo André	SP
Brazil	AFIP	São Paulo	Sâo Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ		4 weeks
Secondary	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.	4 weeks