A community pharmacy based investigation in the self-medication area

INTERVENTION: 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) Concentration type: equal INN or Proposed INN: pseudoephedrine CAS Number: 345‐78‐8 Concentration unit: mg milligram(s) Concentration type: equal Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: 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. PRIMARY OUTCOME: Main Objective: To assess the effectiveness of Sinutab on the symptom relief of nasal congestion and headache in the setting of a common cold. 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. 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; 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