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 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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Phase
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- UNIFESP
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: Bronpheniramine isolated
|
Oral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
|
|
Active Comparator: Fenilefrine isolated
|
Oral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
04/2010
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Patient adherence to the treatment.
Time Frame: 04/2010
|
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
|
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
|
Assessed during the treatment
|
|
Adverse effect appearance during the study and tolerability
Time Frame: Assessed during the treatment and at the final visit
|
Assessed during the treatment and at the final visit
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Luc Weckx, MD, Federal University of São Paulo
- Principal Investigator: Fabio Castro, MD, Instituto de Medicina Avancada
- Principal Investigator: Flavio Sano, MD, Hospital Beneficência Nipo Brasileiro
Study record dates
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- ACH-DCN-03(05/08)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Common Cold
-
NCT00495976Completed
-
NCT01744106CompletedNasal Congestion Associated With the Common Cold
-
NCT07626437RecruitingNasal Obstruction | Nasal Congestion | Common Cold/Flu
-
NCT02379637CompletedCommon Cold Associated With Cough
-
NCT05118672Completed
-
NCT07642648Not yet recruiting
-
NCT05822141Recruiting
-
NCT02640352CompletedAcute Upper Respiratory Tract Infections (Common Cold)
-
NCT03089138Unknown
Clinical Trials on Bronpheniramine and fenilefrine (Decongex Plus)
-
NCT02414438CompletedIntellectual Disability | Developmental Delay
-
NCT03792737Completed
-
NCT02154893Completed
-
NCT01342653SuspendedGastric Cancer | Peritoneal Carcinomatosis
-
NCT01612013Completed
-
NCT00697047Completed
-
NCT07314372Not yet recruitingHepatocellular Carcinoma (HCC) | Unresectable Hepatocellular Carcinoma (HCC) | Liver Cancer Adult
-
NCT03653650RecruitingPersistent Epithelial Defect
-
NCT06467539RecruitingAlzheimer Disease | Mild Cognitive Impairment