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

NCT01158326 | Completed Phase 3 DMC

• 1 other identifier: 09-542
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Common Cold; Influenza

Keywords

reducing symptoms; events; Common Cold; flu syndrome; Symptomatic treatment of the Common Cold and Flu syndrome

Outcome Measures

Primary Outcomes (1)

• Reduction global symptom score (0-none, 1-weak, 2-medium, 3-strong)

  emergence of adverse events

  48 hours

Secondary Outcomes (1)

• Use of rescue medication for relief of symptoms, treatment compliance, improvement of foot

  48 hours

Study Arms (2)

Resfenol Solution oral

ACTIVE COMPARATOR

Acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride active drug

Drug: Resfenol

Placebo

PLACEBO COMPARATOR

Placebo oral solution

Other: Placebo

Interventions

Resfenol DRUG

Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride. 10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours.

Also known as: Antigripal

Resfenol Solution oral

Placebo OTHER

10 ml of oral placebo every 6 hours for 48 hours

Also known as: Placebo Antigripal

Placebo

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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),
• 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:
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Officials

• Paulo D Picon, Doctor

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

• Luis Felipe C Schmidt, MD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

• Marisa B Costa, MS

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: July 8, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 28, 2011

Record last verified: 2011-11

Locations

BR (1)