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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00940836
First received: July 15, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 15, 2009
July 15, 2009
June 2009
November 2009   (final data collection date for primary outcome measure)
Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe. [ Time Frame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Global duration of symptoms, assessed by the investigator through direct questioning at followup visits. [ Time Frame: Day 3/4 and, if no relief yet, day 10/11. ] [ Designated as safety issue: No ]
  • Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits. [ Time Frame: Day 3/4 and, if no relief yet, day 10/11. ] [ Designated as safety issue: No ]
  • Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion. [ Time Frame: Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit. ] [ Designated as safety issue: No ]
  • Improval of fever by reduction of axillary temperature to less than 38,1°C. [ Time Frame: Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary. ] [ Designated as safety issue: No ]
  • Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams. [ Time Frame: Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome
Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Common Cold
  • Flu-like Syndrome
  • Drug: Resfenol
    Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine. Patients will receive up to five capsules a day.
    Other Names:
    • Anti-cold preparation
    • Acetaminophen
    • Chlorpheniramine
    • Phenylephrine
  • Drug: Placebo
    Patients in this group will receive placebo capsules up to five times a day, with the exact same taste and appearance as the active comparator.
  • Drug: Co interventional acetaminophen
    All patients received, along with the assigned intervention, 12 acetaminophen 500mg pills, that they were instructed to take only in case of persisting PAIN or FEVER, up to 4 times a day.
    Other Names:
    • Rescue medication
    • Acetaminophen
    • Paracetamol
    • Co intervention
  • Active Comparator: Resfenol

    Patients in this arm will receive 15 capsules containing a combination described below. They are instructed to take one capsule at 7, 11, 15, 19 and 23h every day, starting after baseline evaluation. The duration of the treatment goes from 48 to 72 hours, depending on patient availability for the second evaluation.

    Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day.

    Interventions:
    • Drug: Resfenol
    • Drug: Co interventional acetaminophen
  • Placebo Comparator: Placebo

    Patients in this arm will receive 15 capsules of placebo, that they are instructed to take in the same posology and in the same duration than the active comparator.

    Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day.

    Interventions:
    • Drug: Placebo
    • Drug: Co interventional acetaminophen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
146
Not Provided
November 2009   (final data collection date for primary outcome measure)

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 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 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 the investigator;
  • Having participated in other clinical trial less than one year prior to inclusion.
Both
18 Years to 60 Years
Yes
Contact: Paulo D Picon, MD, PhD 55 xx 51 33598752 paulopicon@gmail.com
Brazil
 
NCT00940836
05492
No
Paulo Dornelles Picon, Hospital de Clínicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
Not Provided
Not Provided
Hospital de Clinicas de Porto Alegre
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP