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 cold

Pfizer Consumer Healthcare cva/sca0 sitesAugust 18, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Medical 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.
Sponsor: Pfizer Consumer Healthcare cva/sca
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

August 18, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Pfizer Consumer Healthcare cva/sca

•1\. Age 18 years or more
•2\. Reported cold symptoms begin \= 48 hours prior to visit 1
•3\. Scored \= 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
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Have a history of hypersensitivity to paracetamol or pseudoephedrine or lactose
•2\. Have a fever more than 38\.0°C (measured by pharmacist)
•3\. Pregnancy, lactation or intended pregnancy
•4\. Are unwilling or unable to abstain from the use of antihistamines or cold/cough/pain preparations during the treatment period
•5\. Use of concomitant drugs that could interfere with the study drug; See concomitant medication Questionnaire
•Drugs not allowed are: Analgesics, Antipyretics, Cough medicines, Antihistaminics,
•Corticosteroids (inhalation corticosteroids included), Sympathomimetics and
•Anticholinergic drugs
•6\. Take or have taken monoamine oxidase inhibitors within the past 2 weeks
•7\. Respiratory and/or bacterial sinusitis infection or have used antibiotics during the past 2 weeks