Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

NCT02604576 | Completed Phase 3

• 1 other identifier: BRDEMS1011
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 10

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.

Conditions

Dyspepsia

Keywords

functional dyspepsia

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Secondary Outcomes (1)

• Adverse events

  4 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

FDC Bromopride 10 mg and Simethicone 80 mg

Drug: FDC Bromopride 10 mg and Simethicone 80 mg

Group 2

ACTIVE COMPARATOR

Bromopride 10 mg (Digesan ® - Sanofi Aventis)

Drug: Bromopride 10 mg

Interventions

FDC Bromopride 10 mg and Simethicone 80 mg DRUG

Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg

Also known as: Bromopride 10 mg and Simethicone 80 mg

Group 1

Bromopride 10 mg DRUG

Bromopride 10 mg

Also known as: Digesan®

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• EMS: lead

Study Sites (10)

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-092, Brazil

Location

Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

AFIP

São Paulo, Sâo Paulo, 04020-060, Brazil

Location

UNIFAG

Bragança Paulista, São Paulo, 129169000, Brazil

Location

Loema

Campinas, São Paulo, 13010001, Brazil

Location

Instituto de Pesquisa Clinica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

Allergisa

Campinas, São Paulo, Brazil

Location

Centro de Estudos Clínicos do Interior Paulista

Jaú, São Paulo, 17201-130, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-650, Brazil

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Simethicone; bromopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Carlos Fernando Francesconi, MD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 13, 2015
• Study Start: January 17, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 11, 2019
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

BR (10)