Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

EMS

Status and phase

Completed

Phase 3

Conditions

Dyspepsia

Treatments

Drug: FDC Bromopride 10 mg and Simethicone 80 mg

Drug: Bromopride 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02604576

BRDEMS1011

Details and patient eligibility

About

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.

Full 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.

Enrollment

339 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.