Common ColdPhase 3NCT00967759
Study Comparing 3 Formulations to Evaluate the Efficacy and Safety of the Inflammatory Symptoms of the Upper Respiratory Tract, in Children Between 2 and 6 Years Old
A Phase 3 study testing Bronpheniramine and fenilefrine (Decongex Plus), Bronpheniramine isolated and Fenilefrine isolated in people with Common Cold, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed combination and each drug, that composes it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Bronpheniramine and fenilefrine (Decongex Plus), Bronpheniramine isolated and Fenilefrine isolated
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 2 and 6 years old, according to dosage information provided in the product package insert.
- Patient with a relative available for observation of symptoms during the night.
- Patients with acute symptoms of air passages jeopardizing, initiated, at least, 24 hours before patient inclusion in this protocol and, at most, in the 3 days before patient inclusion.
- Patients facing at least a 7 points score in the addition of general symptoms (rhinorrhea, sneeze, itching, nose obstruction and coughing).
- At least two symptoms must be moderated in scale, for specific evaluation.
- Presence of fluid and/or sputum verified through a rhinoscopy.
Who cannot join
- Children younger than 2 years old or a weight and/or height percentual inferior to 10.
- Children with corporal weight superior to 30Kg.
- Suggestive signs of superior air passages bacterial infection to the rhinoscopy, otoscopy and oropharingoscopy.
- Chronic oral breath with a 6 months history.
- Presence of degree II and III of nasal septal deviation (in any region and in any nasal fossa) and/or presence of nasal polyp or other conditions that determine nasal obstruction.
- Patients in a chronic medication treatment for allergy.
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- Patients with an asthma clinical history confirmed (diagnosed).
- Personal preceding of nasal surgery that in the opinion of the investigator can influence in the resistance to the air nose flow.
- Children older than 5 years old that are not registered in the school.
- Children that don´t have vaccination notebook.
- Patient that had used prohibited medication, during the established period before V0 - Randomization Visit (See Picture 1).
- Hypersensitive history to the study drug or its components.
- Patient that have participated in, during the last 12 months, study protocols (according to Resolution 251, dated of August, 7th 1997, item III, sub-item J, "Investigator Responsibility", its recommended that the same person does not be subject of a clinical study in a new project before have elapsed 1(one) year from previous study participation, unless there is a direct benefit to the study patient).
- Relatives of sponsor´s or study site´s employee.
- Patients with gastroesofagic reflux disease.
- Presence of psychiatry diseases.
- Presence of mental disorder of any etiology.
- Renal and hepatic insufficiency.
- Patient with current evidence of clinically significant diseases, of origin: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrinological, psychiatric, self immune, pulmonary, or other that preclude, according to the investigator criteria, the subject participation.
- Patients with genetic diseases.
- Any finding of clinical observation (anamneses and physical evaluation) that be understood by the investigator as risk to the patient participation in the study.
- Any finding of lab result that the investigator judges as a risk to the patient, considering the participation in the study.
- Patients with AST and ALT levels higher than 20% related to the upper normal limits; total bilirubins with an increase of 10% related to the upper normal limits; fasting serum/blood glucose >99mg/dl or postprandial serum/blood glucose >140mg/dl; Hb <10g/dl ou Hb >15 g/dl; serum creatinine with levels over than 10% of upper limit; serum potassium under 3,5 mEq/L, or upper 5,1 mEq/L; serum sodium under 136 mEq/L, or upper 145 mEq/L.
- Presence of hematogenous or meliceric, purulent or mucus purulent secretion, bulging or malformation (leporine lips and nasolabial fissure surgically corrected or not) in the region of the nasal vestibule.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Multicenter Phase III Study Comparing 3 Formulations: Dose Fixed Combination of Bronpheniramine and Fenilefrine, Bronpheniramine Isolated and Fenilefrine Isolated, to Evaluate the Efficacy and Safety of the Treatment of the Inflammatory Symptoms of Upper Respiratory Tract, in Children Between 2 and 6 Years Old.
The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed combination and each drug, that composes it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.
- Conditions
- Common Cold
- Being tested
- Bronpheniramine and fenilefrine (Decongex Plus), Bronpheniramine isolated, Fenilefrine isolated
- Keywords
- common cold, treatment, inflammatory symptoms of superior air passages affection
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronpheniramine and fenilefrine (Decongex Plus)Drug
Oral Solution: Bronpheniramine (2mg/ml) and fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
Bronpheniramine isolatedDrug
Oral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
Fenilefrine isolatedDrug
Oral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Decongex Plus | Experimental | Not described Receives: Drug: Bronpheniramine and fenilefrine (Decongex Plus) |
| Bronpheniramine isolated | Active comparator | Not described Receives: Drug: Bronpheniramine isolated |
| Fenilefrine isolated | Active comparator | Not described Receives: Drug: Fenilefrine isolated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical efficacy of the dose fixed combination and each drug, that compose it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.
Measured: 04/2010
Secondary outcomes (4)
Patient adherence to the treatment.
Measured: 04/2010
Use of co intervention for symptom relief during treatment
Measured: Assessed during the treatment in the diary and questioned by the Investigator at the visits
Evaluate the intensity of the symptoms during the treatment
Measured: Assessed during the treatment
Adverse effect appearance during the study and tolerability
Measured: Assessed during the treatment and at the final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
Why it stopped: The study was designed again in compliance with the regulatory agency.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luc Weckx, MD, Principal investigator, Federal University of São PauloFabio Castro, MD, Principal investigator, Instituto de Medicina AvançadaFlavio Sano, MD, Principal investigator, Hospital Beneficência Nipo Brasileiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967759
- Sponsor's protocol ID
- ACH-DCN-03(05/08)
- Status last verified
- Oct 2016
- First submitted
- 26 Aug 2009
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Multicenter Phase III Study Comparing 3 Formulations: Dose Fixed Combination of Bronpheniramine and Fenilefrine, Bronpheniramine Isolated and Fenilefrine Isolated, to Evaluate the Efficacy and Safety of the Treatment of the Inflammatory Symptoms of Upper Respiratory Tract, in Children Between 2 and 6 Years Old.
- ClinicalTrials.gov ID
- NCT00967759
- Acronym / sponsor ID
- ACH-DCN-03(05/08)
- Conditions
- Common Cold
- Keywords
- common cold, treatment, inflammatory symptoms of superior air passages affection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was designed again in compliance with the regulatory agency.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- First posted
- 28 Aug 2009 (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.
The primary outcome of this study is to evaluate the clinical efficacy of the dose fixed combination and each drug, that composes it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Decongex Plus | Experimental | Drug: Bronpheniramine and fenilefrine (Decongex Plus) |
| Bronpheniramine isolated | Active comparator | Drug: Bronpheniramine isolated |
| Fenilefrine isolated | Active comparator | Drug: Fenilefrine isolated |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients between 2 and 6 years old, according to dosage information provided in the product package insert.
- Patient with a relative available for observation of symptoms during the night.
- Patients with acute symptoms of air passages jeopardizing, initiated, at least, 24 hours before patient inclusion in this protocol and, at most, in the 3 days before patient inclusion.
- Patients facing at least a 7 points score in the addition of general symptoms (rhinorrhea, sneeze, itching, nose obstruction and coughing).
- At least two symptoms must be moderated in scale, for specific evaluation.
Key exclusion criteria (24 listed)
- Children younger than 2 years old or a weight and/or height percentual inferior to 10.
- Children with corporal weight superior to 30Kg.
- Suggestive signs of superior air passages bacterial infection to the rhinoscopy, otoscopy and oropharingoscopy.
- Chronic oral breath with a 6 months history.
- Presence of degree II and III of nasal septal deviation (in any region and in any nasal fossa) and/or presence of nasal polyp or other conditions that determine nasal obstruction.
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 |
|---|---|---|
| Bronpheniramine and fenilefrine (Decongex Plus)Oral Solution: Bronpheniramine (2mg/ml) and fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days. | Drug | Decongex Plus |
| Bronpheniramine isolatedOral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days. | Drug | Bronpheniramine isolated |
| Fenilefrine isolatedOral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days. | Drug | Fenilefrine isolated |
Primary outcome
Evaluate the clinical efficacy of the dose fixed combination and each drug, that compose it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old.
Time frame: 04/2010
4 secondary outcomes
Patient adherence to the treatment.
Time frame: 04/2010
Use of co intervention for symptom relief during treatment
Time frame: Assessed during the treatment in the diary and questioned by the Investigator at the visits
Evaluate the intensity of the symptoms during the treatment
Time frame: Assessed during the treatment
Adverse effect appearance during the study and tolerability
Time frame: Assessed during the treatment and at the final visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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.
Luc Weckx, MD principal investigator
Federal University of São Paulo
Fabio Castro, MD principal investigator
Instituto de Medicina Avançada
Flavio Sano, MD principal investigator
Hospital Beneficência Nipo Brasileiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bronpheniramine and fenilefrine (Decongex Plus), Bronpheniramine isolated and Fenilefrine isolated in people with Common Cold, run by Ache Laboratorios Farmaceuticos S.A. at 1 site 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 6 inclusion and 24 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: withdrawn, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the clinical efficacy of the dose fixed combination and each drug, that compose it, isolated, regarding the respiratory symptoms improvement in superior air passages acute affection in children between 2 and 6 years old. (time frame: 04/2010). 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 19 Oct 2016.