Status:
UNKNOWN
Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Conditions:
Common Cold
Flu-like Syndrome
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in hea...
Detailed Description
Upper respiratory infections are rather frequent in the population, and their treatment consists, in most cases, in the use of symptomatic drugs. Acetaminophen is widely used as an analgesic and antip...
Eligibility Criteria
Inclusion
- Age between 18 to 60 years old;
- Presenting with at least 6 and at max 72 hours of common cold symptoms (headache, muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;
- Proper anticonception, in the case of women in fertile age;
- Possibility to abstain from using any other drug for the treatment of the studied condition, except in emergencies, in wich case the responsible party must be immediately notified;
- Cooperation and understanding skills;
- Agreement to informed consent form.
Exclusion
- Pregnant or lactating women;
- Hypersensitivity to any of the drug's components;
- Alcohol or substance abuse;
- Use of MAO inhibitor or barbituric;
- Diagnosis of any acute disease in current activity or uncontrolled chronic disease;
- Clinical evidence of immunosuppression;
- Influenza vaccine less than a week prior to inclusion;
- Need for antibiotic treatment for the respiratory infection, in the opinion of the investigator;
- Having participated in other clinical trial less than one year prior to inclusion.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00940836
Start Date
June 1 2009
Last Update
July 16 2009
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903