Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu
Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu
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.
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
Inclusion Criteria:

 -  Men or women older than 12 years and less than or equal to 60 years, without
 distinction of color and / or race.

 -  Presenting 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, discomfort in the throat, sore throat,
 dysphonia, cough, fever, and these moderate or severe by a scale of severity of symptoms of
 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe),

 OR

 Flu-like symptoms consisting of 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).

 -  Adequate contraception, a woman of childbearing age.

 -  Do not use any other drugs for the treatment of clinical symptoms, except in cases of
 urgency, and immediate notification to the investigator. Patients with chronic
 diseases being treated with monotherapy, stable over the last three months, may be
 included after medical evaluation.

 -  Good ability of understanding and cooperation.

 -  Agreement with the informed consent consent (IC).

 -  Assessment exams, the medical criteria:

 -  Pregnancy test (rapid urine), a woman of childbearing age, performed prior to
 inclusion;

 -  12-lead electrocardiogram performed during the consultation

 -  Complete blood count and platelet count, serum creatinine, serum urea, serum
 sodium, serum potassium, total bilirubin and fractions,
 gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase
 (AST), alanine aminotransferase (ALT), prothrombin time , amylase, blood glucose
 (if possible in eight hours of fasting), TSH, urinalysis I, chorionic
 gonadotropin (β-HCG)

 Exclusion Criteria:

 -  Pregnant or lactating women

 -  Known hypersensitivity to components of the formula of the drug solution active

 -  Use of alcohol or illicit drug use

 -  Use of monoamine oxidase (MAO) or barbiturates

 -  Diagnosis of allergic rhinitis or perennial activity

 -  Presenting the diagnosis of any disease or active acute exacerbated chronic disease
 (not compensated), including hypertension, ischemic heart disease, narrow-angle
 glaucoma, symptomatic prostatic hyperplasia, chronic renal failure, liver diseases,
 infectious tracheobronchitis presumably bacterial pneumonia, streptococcal pharyngitis
 , asthma or chronic obstructive pulmonary disease and any disease or condition that in
 the opinion of the investigator can modify the results of their study is not due to
 the drug under investigation or that puts the patient at significant risk

 -  Clinical evidence of immunosuppression (AIDS, hematologic malignancies, use of
 immunosuppressive drugs and others)

 -  Patients who received influenza vaccine for the week before inclusion;

 -  Patients who in the opinion of the attending physician and / or the investigator may
 need to receive antiviral drugs for treatment of infection with influenza virus A or B
 (eg, amantadine, rimantadine, oseltamivir, zanamivir)

 -  Patients who in the opinion of the attending physician and / or the investigator need
 receive antibacterial drugs for the treatment of acute respiratory infection

 -  Drug use prior to inclusion by time less than two dose ranges of these drugs (in the
 case of associations, considered as the reference half-life longer): analgesics,
 NSAIDs, glucocorticoids and other immunosuppressants, antihistamines, decongestants
 topical and systemic, as well as any medications that in the opinion of the
 investigator can modify the results of their study is not due to the drug under
 investigation or that the interaction place the patient at significant risk

 -  Having participated in another clinical research for less than a year.