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

• 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.

• Registration Number: EUCTR2004-001637-41-BE
• Lead Sponsor: Pfizer Consumer Healthcare cva/sca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-18
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
8. Any important intercurrent medical condition; The subject has given the answers under Medical History
8.1. Bronchial asthma, clinical bronchitis or other significant respiratory diseases such as chronic obstructive pulmonary disease (COPD), emphysema or diseases requiring any use of assisted ventilation or continuous Positive Airway Pressure. Allergies to household allergens (e.g. dust, pets, etc.) and active seasonal allergies, excepted: (1) non-active seasonal allergies, (2) drug allergies, and (3) food allergies.
8.2. Have significant nasal abnormalities such as significant nasal mucosa thickening or severe nasal septal deviation, polyps, or other known significant structural abnormalities of the nasal cavity (based on subject medical history)
8.3. History of nasal reconstructive surgery
8.4. Subjects with known hypertension (active or history)
8.5. Any male subjects with a positive history of Benign Prostatic Hypertrophy (BPH) who are symptomatic or who are not currently well-controlled
8.6. Have a history of alcohol and/or drug abuse within a 6-month period immediately
preceding the screening visit
8.7. Have conditions that might interfere with the drug studied e.g. cardiovascular (a gradation will be taken into account), respiratory, neurological, renal, urogenital, hepatic or malignant diseases, malnutrition or any chronic systemic infection (e.g. HIV)
9. Other severe acute or chronic medical or psychiatric condition or known laboratory
abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the sub-investigator, would make the subject inappropriate for entry into this study
10. Participation in other clinical trials the last three months and during study participation
11. Employees of the clinical research centers at Pfizer, the CRO’s contracted for this study, or their immediate family members, are not permitted to participate in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified