Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu

Summary

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.

Timeline

Start

2010-08

Primary completion

2011-09

Completion

2011-11

Drugs

Indications