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Clinical Trials/EUCTR2006-000058-35-BE
EUCTR2006-000058-35-BE
Active, not recruiting
Not Applicable

A community pharmacy based investigation in the self-medication areaEfficacy and safety of Sinutab® [Paracetamol (500mg) and Pseudoephedrine (30mg)] on subjects with nasal congestion accompanied by headache in the setting of a common cold

Pfizer Consumer Healthcare Comm. VA/SCA0 sitesApril 14, 2006
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ConditionsThe medical rationale = to investigate this combination drug in the symptomatic relief of common cold with nasal symptoms. The reduction of symptom severity may allow subjects receiving active medication to return to work or school earlier than those receiving placebo. To study the drug in it’s ‘natural environment’, community pharmacists will function as local investigators. They will include subjects with early (= 48 hours) cold symptoms of blocked nose with headache.

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
The medical rationale = to investigate this combination drug in the symptomatic relief of common cold with nasal symptoms. The reduction of symptom severity may allow subjects receiving active medication to return to work or school earlier than those receiving placebo. To study the drug in it’s ‘natural environment’, community pharmacists will function as local investigators. They will include subjects with early (= 48 hours) cold symptoms of blocked nose with headache.
Sponsor
Pfizer Consumer Healthcare Comm. VA/SCA
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 14, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Pfizer Consumer Healthcare Comm. VA/SCA

Eligibility Criteria

Inclusion Criteria

  • •Only subjects asking for Sinutab® in the pharmacy can participate in the study. These subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
  • •1\. Age 18 years or more
  • •2\. Reported cold symptoms begin \= 48 hours prior to visit 1
  • •3\. Scored \> or \= 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
  • •4\. Willing and able to comply with scheduled visits, treatment plan, and other study procedures
  • •5\. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Patients without an electronic medication record in the pharmacy
  • •2\. Have a history of hypersensitivity to paracetamol or pseudoephedrine or lactose
  • •3\. Have a fever more than 38\.0°C (measured by pharmacist)
  • •4\. Women in the fertile years who do not practise a hormonal contraception or an intra\-uterine device
  • •5\. Use of concomitant drugs that could interfere with the study drug; See concomitant medication Questionnaire.
  • •Not allowed is current use (nasal, oral or inhalation) of:
  • •Antipyretics
  • •Cough medicines
  • •Antihistaminics
  • •Corticosteroids

Outcomes

Primary Outcomes

Not specified

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A community pharmacy based investigation in the self-medication areaEfficacy and safety of Sinutab® (Paracetamol (500mg)/Pseudoephedrine (30mg)) on subjects with nasal congestion accompanied by headache and/or fever in the setting of a common coldMedical rationale= Investigation of combination drug Sinutab in symptomatic relief of common cold with nasal symptoms. Community pharmacists are considered as local investigators including subjects with early (= 48 hours) cold symptoms of blocked nose with headache and/or fever.
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