National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen. The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect. The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart. The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
01 tablet, orally, every 12 hours.
01 tablet, orally, every 12 hours.
Allergisa Pesquisa Dermato Cosmética Ltda.
Campinas, São Paulo, Brazil
Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo
To evaluate the association of the superiority fixed dose of desloratadine 2.5mg, 20mg phenylephrine hydrochloride and ibuprofen 400 mg compared to placebo in the treatment of symptoms related to the common cold / flu syndrome by varying the intensity total score of symptoms, three (03 ) hours after the first dose of investigational product.
Time frame: 03 hours after the first dose
Evaluation of the symptoms related to the common cold / flu syndrome.
Absolute variation in total score intensity of symptoms related to the common cold / flu-like symptoms 02 days after the start of treatment compared to baseline.
Time frame: 02 days after initiation of treatment, compared to baseline.
Satisfaction of the quality of sleep
Distribution of subjects in each treatment group as their perception to the sleep quality, assessed at baseline by answering the following statement: " Last night, with this cold, I did not sleep as well as I usually sleep "based on a scale of 0 to 4 points (0 = strongly disagree, 1 = disagree, 2 = neither agree nor disagree, 3 = agree and 4 = I totally agree).
Time frame: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication measured through the subject's diary.
Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, measured through the subject's diary.
Time frame: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication according to accounting of rescue medication returned.
Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, accounting of rescue medication (Tylenol®) returned.
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Time frame: On the first day and on the second day after the start of treatment.