A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold
A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
Evaluation of Efficacy and Safety of Oral Solution Paracetamol, Maleate Chlorpheniramine and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu: a Double-blind
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza. After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention). The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.
Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults
The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
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