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Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT02604576
Recruitment Status : Recruiting
First Posted : November 13, 2015
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
EMS

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Drug: FDC Bromopride 10 mg and Simethicone 80 mg Drug: Bromopride 10 mg Phase 3

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  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
Drug Information available for: Simethicone

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 Name: 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 Name: Digesan®




Primary Outcome Measures :
  1. 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 Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604576


Contacts
Contact: Roberto B. Amazonas, MD +551938879851 pesquisa.clinica@ems.com.br

Locations
Brazil
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Carlos Isaia Filho, MD         
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil
Contact: Carlos Fernando Francesconi, MD         
Hospital Ernesto Dornelles Recruiting
Porto Alegre, RS, Brazil, 90160-092
Contact: Guilherme B. Sander, MD         
UNIFAG Recruiting
Bragança Paulista, SP, Brazil, 129169000
Contact: José Pedrazzoli, MD         
Loema Recruiting
Campinas, SP, Brazil, 13010001
Contact: Fabio R Santos, MD       contato@loemaipc.com.br   
Principal Investigator: Fabio R Santos, MD         
Instituto de Pesquisa Clinica de Campinas Recruiting
Campinas, SP, Brazil, 13060-080
Contact: José Francisco K. Saraiva, MD         
Centro de Estudos Clínicos do Interior Paulista Recruiting
Jau, SP, Brazil, 17201-130
Contact: Paula Tokunaga, MD         
Faculdade de Medicina do ABC Recruiting
Santo André, SP, Brazil, 09060-650
Contact: Wilson Catapani, MD         
AFIP Recruiting
São Paulo, Sâo Paulo, Brazil, 04020-060
Contact: Edson Ide, MD         
Allergisa Recruiting
Campinas, São Paulo, Brazil
Contact: Mauro A Crippa, MD         
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: Carlos Fernando Francesconi, MD Hospital de Clínicas de Porto Alegre

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02604576     History of Changes
Other Study ID Numbers: BRDEMS1011
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by EMS:
functional dyspepsia

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Simethicone
Bromopride
Metoclopramide
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Dopamine D2 Receptor Antagonists