Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Drug: FDC Bromopride 10 mg and Simethicone 80 mg; Drug: Bromopride 10 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90160-092
      • Hospital Ernesto Dornelles
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
  • SP
    • Bragança Paulista, SP, Brazil, 129169000
      • UNIFAG
    • Campinas, SP, Brazil, 13010001
      • Loema
    • Campinas, SP, Brazil, 13060-080
      • Instituto de Pesquisa Clinica de Campinas
    • Jau, SP, Brazil, 17201-130
      • Centro de Estudos Clínicos do Interior Paulista
    • Santo André, SP, Brazil, 09060-650
      • Faculdade de Medicina do ABC
  • Sâo Paulo
    • São Paulo, Sâo Paulo, Brazil, 04020-060
      • AFIP
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Allergisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; FDC Bromopride 10 mg and Simethicone 80 mg	Drug: FDC Bromopride 10 mg and Simethicone 80 mg; Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg; Other Names: Bromopride 10 mg and Simethicone 80 mg
ACTIVE_COMPARATOR: Group 2; Bromopride 10 mg (Digesan ® - Sanofi Aventis)	Drug: Bromopride 10 mg; Bromopride 10 mg; Other Names: Digesan®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: EMS
• Investigators: Principal Investigator: Carlos Fernando Francesconi, MD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2017
• Primary Completion (ACTUAL): March 13, 2018
• Study Completion (ACTUAL): March 11, 2019

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: November 12, 2015
• First Posted (ESTIMATE): November 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: functional dyspepsia
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Antifoaming Agents; Emollients; Simethicone; Metoclopramide; Bromopride
• Other Study ID Numbers: BRDEMS1011