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
Withdrawn
Ache Laboratorios Farmaceuticos S.A.
Phase 3
2011-10-01
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.
Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis
Withdrawn
Ache Laboratorios Farmaceuticos S.A.
Phase 3
2011-08-01
Multicenter clinical trial, phase III, controlled by active medicine, double-blind,
randomized, enroll 208 subjects, above 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.
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