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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Completed

CT.gov ID

NCT01389518

Collaborator

(none)

146

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flu	Drug: Active Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Placebo Comparator Flu

Arm

Intervention/Treatment

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 Names:

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 Names:

Placebo Comparator Flu

Outcome Measures

Primary Outcome Measures

Symptom score [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

Secondary Outcome Measures

Adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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