Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu
Condition: Common Cold; Influenza
MeSH terms: Common Cold
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Infections of upper respiratory tract are common in the population, and its treatment, in
      most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and
      antipyretic, while chlorpheniramine is an antihistamine and a vasoconstrictor phenylephrine
      decongestant function. 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. Volunteers will be recruited through posters down at the Hospital
      de Clinicals de Porto Alegre, and care in the public hospital network, which will undergo a
      screening questionnaire on first contact. With a statistical power of 80% and the possibility
      of random error of 5% should be followed in this study 194 subjects. Whereas a loss of up to
      10% 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, characterizing one of the following conditions:
      Common Cold, which consists of at least 3 symptoms among the 10 following: sneezing,
      rhinorrhea, nasal congestion, headache, muscle pain, throat discomfort, pain throat,
      dysphonia, cough, fever, and these moderate or severe using a scale of severity of symptoms
      of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe) and / or Influenza consisting
      fever of at least 38.1 ° C and headache of moderate or severe or myalgia / arthralgia
      moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 =
      moderate , 3 = severe). Will be included only subjects who agree with the Terms of Consent.
      Not be included in the study pregnant women or infants with known hypersensitivity to
      components of the formula, or research subjects that are experiencing chronic active or
      exacerbated. 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. Be provided
      paracetamol rescue co-intervention. Study subjects will receive a diary containing
      questionnaires of symptoms. 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 scores of symptoms, rescue medication use, improvement of
      fever, subjective evaluation of palatability and tolerance and treatment compliance. To
      evaluate the safety of the drug will be accompanied by the emergence of adverse events
    

Intervention name(s): Resfenol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride.
10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours.; 10 ml of oral placebo every 6 hours for 48 hours
Other intervention name(s): Antigripal; Placebo Antigripal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: reducing symptoms; events; Common Cold; flu syndrome; Symptomatic treatment of the Common Cold and Flu syndrome