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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Reduction global symptom score (0-none, 1-weak, 2-medium, 3-strong) [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]emergence of adverse events
- Use of rescue medication for relief of symptoms, treatment compliance, improvement of foot [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]Subjective evaluation of the research subject and the physician
|Study Start Date:||August 2010|
|Study Completion Date:||November 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Resfenol Solution oral
Acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride active drug
Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride.
10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours.
Other Name: Antigripal
Placebo Comparator: Placebo
Placebo oral solution
10 ml of oral placebo every 6 hours for 48 hours
Other Name: Placebo Antigripal
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158326
|Hospital de Clinicas de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil|
|Principal Investigator:||Paulo D Picon, Doctor||Federal University of Health Science of Porto Alegre|
|Study Director:||Luis Felipe C Schmidt, MD||Hospital de Clinicas de Porto Alegre|
|Study Director:||Marisa B Costa, MS||Federal University of Rio Grande do Sul|