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.
Conditions
Interventions
Trade Name: Sinutab 500/30mg tablets
Product Name: Sinutab 500/30mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: paracetamol
CAS Number: 103-90-2
Concentration unit: mg milligram(s)
Concen
Sponsors
Pfizer Consumer Healthcare cva/sca
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effectiveness of Sinutab on the symptom relief of nasal congestion and headache in the setting of a common cold.;Secondary Objective: 1. To assess the effectiveness of Sinutab on the major symptom complex (MSC) of common cold which consists of 4 signs/symptoms: nasal congestion, headache, sore throat, and pressure around the eyes. 2. To assess the effectiveness of Sinutab on the symptom relief of individual sign/symptoms, including nasal congestion, headache, sore throat, and pressure around the eyes 3. To assess the number of days lost at work or school 4. To assess the effect of Sinutab on the quality of life (day/night) 5. To assess time-to-resolution of common cold 6. Overall safety evaluation ;Primary end point(s): Change from baseline in the sum of nasal congestion and headache sign/symptom scores during the treatment period. The nasal congestion and headache scores will be summed by day; the daily sums will be averaged over the treatment days; and the change from the baseline will be calculated. | — |
Countries
Belgium
Outcome results
None listed