Dyspepsia
Conditions
Keywords
functional dyspepsia
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.
Interventions
DRUGFDC Bromopride 10 mg and Simethicone 80 mg
Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
DRUGBromopride 10 mg
Bromopride 10 mg
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 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. |
Countries
Brazil
Outcome results
None listed