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

NCT00967759 | Withdrawn Phase 3

• 1 other identifier: ACH-DCN-03(05/08)
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Keywords

common cold; treatment; inflammatory symptoms of superior air passages affection

Outcome Measures

Primary Outcomes (1)

• 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.

  04/2010

Secondary Outcomes (4)

• Patient adherence to the treatment.

  04/2010

• 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

Study Arms (3)

Decongex Plus

EXPERIMENTAL

Drug: Bronpheniramine and fenilefrine (Decongex Plus)

Bronpheniramine isolated

ACTIVE COMPARATOR

Drug: Bronpheniramine isolated

Fenilefrine isolated

ACTIVE COMPARATOR

Drug: Fenilefrine isolated

Interventions

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.

Decongex Plus

Bronpheniramine isolated DRUG

Oral Solution: Bronpheniramine (2mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.

Bronpheniramine isolated

Fenilefrine isolated DRUG

Oral Solution: Fenilefrine (2,5mg/ml) 2 drops/kg/day divided into 3 doses; maximum of 60 drops/day QID, during 5 days.

Fenilefrine isolated

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

UNIFESP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Luc Weckx, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Fabio Castro, MD

  Instituto de Medicina Avançada

  PRINCIPAL INVESTIGATOR

• Flavio Sano, MD

  Hospital Beneficência Nipo Brasileiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 28, 2009
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

BR (1)