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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

NCT01177852 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-10-19

No results posted yet for this study

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

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01177852 on ClinicalTrials.gov