Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 26, 2009
July 12, 2011
Not Provided
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00967759 on ClinicalTrials.gov Archive Site
  • 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 ]
Patient adherence to the treatment, Evaluation of the other medication need, intensity of each symptom, the velocity of symptoms relief, rescue medication need (frequency) and tolerability. [ Time Frame: 04/2010 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Common Cold
  • 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.
  • 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.
  • 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.
  • Experimental: Decongex Plus
    Intervention: Drug: Bronpheniramine and fenilefrine (Decongex Plus)
  • Active Comparator: Bronpheniramine isolated
    Intervention: Drug: Bronpheniramine isolated
  • Active Comparator: Fenilefrine isolated
    Intervention: Drug: Fenilefrine isolated
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
300
Not Provided
Not Provided

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.
Both
2 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00967759
ACH-DCN-03(05/08)
No
Carla Rosana Goulart Silva Peron, MD, Ache Laboratorios Farmaceuticos S.A.
Ache Laboratorios Farmaceuticos S.A.
Not Provided
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
Ache Laboratorios Farmaceuticos S.A.
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP