Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome

This study has been completed.
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01389518
First received: February 15, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators included 146 healthy study subjects aged between 18 and 60 years who presented flu or common cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory evaluation were randomized to receive active drug or placebo, five capsules a day, every 4 hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom scores, overall duration of symptoms, return to usual activities, use of rescue medication, improvement of the fever.


Condition Intervention Phase
Flu
Drug: Active
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and Safety of Fixed Combination of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Symptomatic Common Cold and Flu Syndrome in Adults

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Symptom score [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    We assessed symptoms of common cold or flu-like illness with symptoms of global scale for assessing efficacy in clinical trial. The scale consists of 10 symptoms (sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough and fever). We used a Likert scale of intensity of 4 points where 0 no symptoms, 1 mild symptom, 2 moderate symptom, 3 severe symptom intensity.Overall duration of symptoms. Return to normal activity. Use of rescue medication for relief of symptoms. Improves fever by reducing the axillary temperature below 38.1 ° C


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    The safety of the product will be accompanied by subjective report of patients, the emergence of adverse effects such as drowsiness, nausea, eye pain, dizziness and palpitations. In addition, there will be accompanied by clinical laboratory parameters.


Enrollment: 146
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paracetamol,Chlorpheniramin,Phenylephrin Drug: Active
1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
Other Name: Active Flu
Placebo Comparator: Placebo Drug: Placebo
1 capsule administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
Other Name: Placebo Comparator Flu

Detailed Description:

The upper respiratory infections are frequent in the population, and its treatment, in most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and antipyretic, whereas chlorpheniramine and phenylephrine is an antihistamine with a vasoconstrictor decongestant function. The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between 18 and 60;
  • Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions:

the common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).

the flu syndrome, which consists of fever of at least 38.1 ° C and headache of moderate or severe intensity 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 if women of childbearing age.
  • Ability to not use any other drugs for the treatment of clinical symptoms, except in cases of urgency, and immediate communication with the investigator, patients with chronic diseases being treated with monotherapy, stable over the past three months, could be included.
  • Good understanding capacity and collaboration.
  • Compliance with the informed consent form had been signed.

Exclusion Criteria:

  • Pregnant women or nursing mothers
  • Known hypersensitivity to components of the formula of anti-flu drug
  • Use of alcohol or illicit drug use
  • Use of monoamine oxidase inhibitors or barbiturates
  • Diagnosis of seasonal or perennial allergic rhinitis in activity
  • Presenting the diagnosis of any disease activity in acute or chronic disease exacerbated (uncompensated), including hypertension, ischemic heart disease, narrow-angle glaucoma, symptomatic prostatic hyperplasia, chronic renal failure, liver diseases, infectious tracheobronchitis presumably bacterial pneumonia, pharyngitis strep, 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;
  • Patients who received influenza vaccine for the week prior to 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
  • Use of drugs prior to inclusion by time intervals of less than two doses of these drugs (in the case of associations, considered as the reference half-life longer): analgesics, nonsteroidal anti-inflammatory drugs, glucocorticoids and other immunosuppressants, antihistamines, Topical and systemic decongestants, and any medication that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or by an interaction that place the patient at significant risk
  • Participation in another clinical research for less than a year.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01389518

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Paulo D Piccon, Prof. Dr. Federal University of Rio Grande do Sul (UFRGS) / Hospital de Clinicas de Porto Alegre
Study Director: Marisa B Costa, MS Federal University of Rio Grande do Sul
Study Director: Luis Felipe C Schmidt, MD Hospital de Clinicas de Porto Alegre
  More Information

No publications provided by Hospital de Clinicas de Porto Alegre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paulo Dornelles Picon, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01389518     History of Changes
Other Study ID Numbers: 05-492
Study First Received: February 15, 2011
Last Updated: November 24, 2011
Health Authority: Brazil: National Health Surveillance Agency
Brazil: Ethics Committee

Keywords provided by Hospital de Clinicas de Porto Alegre:
Symptomatic treatment
Common Cold
flu syndrome

Additional relevant MeSH terms:
Syndrome
Common Cold
Influenza, Human
Disease
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Orthomyxoviridae Infections
Phenylephrine
Oxymetazoline
Chlorpheniramine
Acetaminophen
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on October 19, 2014