DyspepsiaPhase 3NCT02604576
Efficacy of Bromopride and Simethicone Versus Bromopride in Functional Dyspepsia
A Phase 3 study testing FDC Bromopride 10 mg and Simethicone 80 mg and Bromopride 10 mg in people with Dyspepsia, run by EMS at 10 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- FDC Bromopride 10 mg and Simethicone 80 mg and Bromopride 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 339 participants
- Where
- 10 sitesBrazil
- Study dates
- 17 Jan 2017to 11 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
UNIFAG
Bragança Paulista, São Paulo, 129169000
Loema
Campinas, São Paulo, 13010001
Instituto de Pesquisa Clinica de Campinas
Campinas, São Paulo, 13060-080
Allergisa
Campinas, São Paulo
Centro de Estudos Clínicos do Interior Paulista
Jaú, São Paulo, 17201-130
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-092
Centro de Medicina Reprodutiva Carlos Isaia Filho Ltda
Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-650
AFIP
São Paulo, Sâo Paulo, 04020-060
About this study
Official title: Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.
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.
Read the 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.
- Conditions
- Dyspepsia
- Being tested
- FDC Bromopride 10 mg and Simethicone 80 mg, Bromopride 10 mg
- Keywords
- functional dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDC Bromopride 10 mg and Simethicone 80 mgDrug
Also called Bromopride 10 mg and Simethicone 80 mg
Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
Bromopride 10 mgDrug
Also called Digesan®
Bromopride 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | FDC Bromopride 10 mg and Simethicone 80 mg Receives: Drug: FDC Bromopride 10 mg and Simethicone 80 mg |
| Group 2 | Active comparator | Bromopride 10 mg (Digesan ® - Sanofi Aventis) Receives: Drug: Bromopride 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start17 Jan 2017
- Primary completion13 Mar 2018
- Study completion11 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Fernando Francesconi, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604576
- Sponsor's protocol ID
- BRDEMS1011
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2015
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.
- ClinicalTrials.gov ID
- NCT02604576
- Acronym / sponsor ID
- BRDEMS1011
- Conditions
- Dyspepsia
- Keywords
- functional dyspepsia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: FDC Bromopride 10 mg and Simethicone 80 mgFDC Bromopride 10 mg and Simethicone 80 mg |
| Group 2 | Active comparator | Drug: Bromopride 10 mgBromopride 10 mg (Digesan ® - Sanofi Aventis) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDC Bromopride 10 mg and Simethicone 80 mgAlso: Bromopride 10 mg and Simethicone 80 mgFixed-dose combination of Bromopride 10 mg and Simethicone 80 mg | Drug | Group 1 |
| Bromopride 10 mgAlso: Digesan®Bromopride 10 mg | Drug | Group 2 |
Primary outcome
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
Time frame: 4 weeks
1 secondary outcome
Adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Related trials for Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Fernando Francesconi, MD principal investigator
Hospital de Clinicas de Porto Alegre
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FDC Bromopride 10 mg and Simethicone 80 mg and Bromopride 10 mg in people with Dyspepsia, run by EMS at 10 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.