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.
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
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Common Cold
Intervention
Resfenol, Placebo
Status
Not yet recruiting
Source
Hospital de Clinicas de Porto Alegre
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01158326
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:12:23-0400
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Medical and Biotech [MESH] Definitions
Multi-ingredient Cold, Flu, And Allergy Medications
A broad category of multi-ingredient preparations that are marketed for the relief of upper respiratory symptoms resulting from the COMMON COLD; ALLERGIES; or HUMAN INFLUENZA. While the majority of these medications are available as OVER-THE-COUNTER DRUGS some of them contain ingredients that require them to be sold as PRESCRIPTION DRUGS or as BEHIND-THE COUNTER DRUGS.
Rhinovirus
A genus of PICORNAVIRIDAE inhabiting primarily the respiratory tract of mammalian hosts. It includes over 100 human serotypes associated with the COMMON COLD.
Common Cold
A catarrhal disorder of the upper respiratory tract, which may be viral or a mixed infection. It generally involves a runny nose, nasal congestion, and sneezing.
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Cold-shock Response
A constellation of responses that occur when an organism is exposed to excessive cold. In humans, a fall in skin temperature triggers gasping, hypertension, and hyperventilation.
