Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dyspepsia

Intervention / Treatment
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* Drug: FDC Bromopride 10 mg and Simethicone 80 mg
* Drug: Bromopride 10 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>FDC Bromopride 10 mg and Simethicone 80 mg | Drug: FDC Bromopride 10 mg and Simethicone 80 mg<br>* Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg<br>* Other names: Bromopride 10 mg and Simethicone 80 mg;|
| Active Comparator: Group 2<br>Bromopride 10 mg (Digesan ® - Sanofi Aventis) | Drug: Bromopride 10 mg<br>* Bromopride 10 mg<br>* Other names: Digesan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia