Clinical trial NCT02604576: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: functional dyspepsia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
timeFrame: 4 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: RS
city: Bragança Paulista
country: Brazil
facility: UNIFAG
state: SP
city: Campinas
country: Brazil
facility: Loema
state: SP
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clinica de Campinas
state: SP
city: Jau
country: Brazil
facility: Centro de Estudos Clínicos do Interior Paulista
state: SP
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: SP
city: São Paulo
country: Brazil
facility: AFIP
state: Sâo Paulo
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Carlos Fernando Francesconi, MD
role: PRINCIPAL_INVESTIGATOR
References: