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

This study has suspended participant recruitment.
(The study was designed again in compliance with the regulatory agency.)
Sponsor:
Information provided by:
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT00967759
First received: August 26, 2009
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Common Cold
Drug: Bronpheniramine and fenilefrine (Decongex Plus)
Drug: Bronpheniramine isolated
Drug: Fenilefrine isolated
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient adherence to the treatment. [ Time Frame: 04/2010 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluate the intensity of the symptoms during the treatment [ Time Frame: Assessed during the treatment ] [ Designated as safety issue: No ]
  • Adverse effect appearance during the study and tolerability [ Time Frame: Assessed during the treatment and at the final visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Arms Assigned Interventions
Experimental: Decongex Plus Drug: 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.
Active Comparator: Bronpheniramine isolated Drug: 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 Drug: 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.

  Eligibility

Ages Eligible for Study:   2 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between 2 and 6 years old, according to dosage information provided in the product package insert.
  2. Patient with a relative available for observation of symptoms during the night.
  3. 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.
  4. Patients facing at least a 7 points score in the addition of general symptoms (rhinorrhea, sneeze, itching, nose obstruction and coughing).
  5. At least two symptoms must be moderated in scale, for specific evaluation.
  6. Presence of fluid and/or sputum verified through a rhinoscopy.

Exclusion Criteria:

  1. Children younger than 2 years old or a weight and/or height percentual inferior to 10.
  2. Children with corporal weight superior to 30Kg.
  3. Suggestive signs of superior air passages bacterial infection to the rhinoscopy, otoscopy and oropharingoscopy.
  4. Chronic oral breath with a 6 months history.
  5. 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.
  6. Patients in a chronic medication treatment for allergy.
  7. Patients with an asthma clinical history confirmed (diagnosed).
  8. Personal preceding of nasal surgery that in the opinion of the investigator can influence in the resistance to the air nose flow.
  9. Children older than 5 years old that are not registered in the school.
  10. Children that don´t have vaccination notebook.
  11. Patient that had used prohibited medication, during the established period before V0 - Randomization Visit (See Picture 1).
  12. Hypersensitive history to the study drug or its components.
  13. 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).
  14. Relatives of sponsor´s or study site´s employee.
  15. Patients with gastroesofagic reflux disease.
  16. Presence of psychiatry diseases.
  17. Presence of mental disorder of any etiology.
  18. Renal and hepatic insufficiency.
  19. 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.
  20. Patients with genetic diseases.
  21. Any finding of clinical observation (anamneses and physical evaluation) that be understood by the investigator as risk to the patient participation in the study.
  22. Any finding of lab result that the investigator judges as a risk to the patient, considering the participation in the study.
  23. 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.
  24. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967759

Locations
Brazil
UNIFESP
São Paulo, SP, Brazil
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Carla Rosana Goulart Silva Peron, MD, Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT00967759     History of Changes
Other Study ID Numbers: ACH-DCN-03(05/08)
Study First Received: August 26, 2009
Last Updated: July 12, 2011
Health Authority: Brazil: ANVISA

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
common cold
treatment
inflammatory symptoms of superior air passages affection

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
Respiratory Tract Diseases
Respiratory Tract Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014