Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis

NCT ID: NCT01177852

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31

Brief Summary

Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

Conditions

Inflammation; Cough; Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Notuss® syrup

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Group Type: EXPERIMENTAL

diphenhydramine + dropropizine + pseudoephedrine

Intervention Type: DRUG

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Posology: The medicine treat will be as follows:

• Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml

Dropropizine + Pseudoephedrine and brompheniramine

Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate.

Group Type: ACTIVE_COMPARATOR

Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

Intervention Type: DRUG

Dropropizine:

Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml

Pseudoephedrine hydrochloride + brompheniramine maleate:

Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml

Interventions

diphenhydramine + dropropizine + pseudoephedrine

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Posology: The medicine treat will be as follows:

• Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml

Intervention Type: DRUG

Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

Dropropizine:

Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml

Pseudoephedrine hydrochloride + brompheniramine maleate:

Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients between 2 and 12 years old, of both sexes;

2. Clinical condition compatible with acute rhinitis accompanied by nasal obstruction;

3. Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;

4. Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);

5. Score greater than or equal to 2 points on the nasal obstruction severity score (As per item 4.1.3);

6. ICF signed by a parent/caregiver/representant;

7. Parent/Caregiver/Representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria

1. Non-productive cough with purulent smear, fever (axillar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;

2. Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;

3. Previous diagnosis of asthma;

4. Patients under treatment for chronic allergy;

5. Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;

6. Current use of systemic antibiotics for any reason;

7. Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;

8. Participation in last one year of clinical protocols;

9. Any psychiatric diseases, including major depression;

10. Presence of mental retardation from any cause;

11. Diagnosis of renal or hepatic failure;

12. History of hypersensitivity to any component of the study drugs;

13. Relatives of sponsor´s or study site´s employee;

14. Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;

15. Patient or parent/caregiver/representant with a history of lack of compliance to treatment or previous treatment protocols;

16. Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ache Laboratorios Farmaceuticos S.A

Other Identifiers

ACH-NTS-03(02/10)

Identifier Type: -

Identifier Source: org_study_id