Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome

Last updated: July 15, 2009
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Trial Status Unknown

Phase

3

Condition

Acute Rhinitis

Common Cold

Treatment

N/A

Clinical Study ID

NCT00940836
05492
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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 healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 inan 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 studiedcondition, except in emergencies, in wich case the responsible party must beimmediately notified;

  • Cooperation and understanding skills;

  • Agreement to informed consent form.

Exclusion

Exclusion Criteria:

  • 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 theinvestigator;

  • Having participated in other clinical trial less than one year prior to inclusion.

Study Design

Total Participants: 146
Study Start date:
June 01, 2009
Estimated Completion Date:

Study 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 antipyretic, whereas chlorpheniramine is an antihistaminic and phenylephrine is a vasoconstrictor with decongestioning activity. The aim of this study is to assess the efficacy and safety of an anti-cold preparation, currently commercialized in Brazil by the name Resfenol, compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Healthy volunteers are recruited through panels fixated at Hospital de Clínicas de Porto Alegre, in Brazil, and must answer a screening questionnaire at first contact. One hundred and forty six patients who met the inclusion criteria were included and, after baseline clinical and laboratory evaluation, were randomized to receive either the active intervention or placebo, 5 times a day, at 4 hour intervals, during 48 to 72 hours, depending on patient availability to show up for re-evaluation. Patients also received acetaminophen as a co intervention, to be taken only in case of persisting symptoms.

Patients answered, during treatment, several symptom questionnaires contained in a diary, and followup was performed at days 3 or 4 (clinical and laboratory evaluation) and 10 or 11 (clinical followup). Axillary temperature was assessed along with every dose with a thermometer provided by the study and registered in the diary.

Primary endpoint consists in the mean symptom scores, assessed through questionnaires in patient diary, baseline and followup. Secondary endpoints are global duration of symptoms, time of return to usual activities, use of co intervention for symptom relief, improval of fever and adverse effect evaluation.

Connect with a study center

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul 90035-903
    Brazil

    Active - Recruiting

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