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

NCT01389518 | Completed Phase 3 DMC

• 1 other identifier: 05-492
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Flu

Keywords

Symptomatic treatment; Common Cold; flu syndrome

Outcome Measures

Primary Outcomes (1)

• Symptom score

  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

  72 hours

Secondary Outcomes (1)

• Adverse events

  72 hours

Study Arms (2)

Paracetamol,Chlorpheniramin,Phenylephrin

ACTIVE COMPARATOR

Drug: Active

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Active DRUG

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

Also known as: Active Flu

Paracetamol,Chlorpheniramin,Phenylephrin

Placebo DRUG

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

Also known as: Placebo Comparator Flu

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• Participation in another clinical research for less than a year.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Related Publications (1)

• 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.

  PMID: 24261438 DERIVED

MeSH Terms

Conditions

Influenza, Human; Common Cold

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paulo D Piccon, Prof. Dr.

  Federal University of Rio Grande do Sul (UFRGS) / Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Marisa B Costa, MS

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Luis Felipe C Schmidt, MD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: July 8, 2011
• Study Start: May 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: November 28, 2011

Record last verified: 2011-11