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

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ClinicalTrials.gov Identifier: NCT01389518
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : November 28, 2011
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Tracking Information
First Submitted Date  ICMJE February 15, 2011
First Posted Date  ICMJE July 8, 2011
Last Update Posted Date November 28, 2011
Study Start Date  ICMJE May 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
Symptom score [ Time Frame: 72 hours ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2011)
Adverse events [ Time Frame: 72 hours ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Flu
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Paracetamol,Chlorpheniramin,Phenylephrin
    Intervention: Drug: Active
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013 Nov 22;13:556. doi: 10.1186/1471-2334-13-556.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 6, 2011)
146
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01389518
Other Study ID Numbers  ICMJE 05-492
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paulo Dornelles Picon, Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP