NCT00967759
Withdrawn
Phase 3
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.
Ache Laboratorios Farmaceuticos S.A.1 site in 1 countryAugust 28, 2009
ConditionsCommon Cold
Overview
- Phase
- Phase 3
- Intervention
- Bronpheniramine and fenilefrine (Decongex Plus)
- Conditions
- Common Cold
- Sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
- •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.
Arms & Interventions
Decongex Plus
Intervention: Bronpheniramine and fenilefrine (Decongex Plus)
Bronpheniramine isolated
Intervention: Bronpheniramine isolated
Fenilefrine isolated
Intervention: Fenilefrine isolated
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Use of co intervention for symptom relief during treatment(Assessed during the treatment in the diary and questioned by the Investigator at the visits)
- Evaluate the intensity of the symptoms during the treatment(Assessed during the treatment)
- Adverse effect appearance during the study and tolerability(Assessed during the treatment and at the final visit)
- Patient adherence to the treatment.(04/2010)
Study Sites (1)
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