NCT01389518

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Flu

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2011-07-08
• Last updated: 2011-11-28