Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold|
- Change from baseline in the sum of nasal congestion and headache sign/symptom scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Change from baseline in the mean MSC score over the treatment days. The MSC score is defined as the sum of nasal congestion, headache, sore throat, and pressure around the eyes sign/symptom scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Number of lost days at work or school [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
- Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Safety evaluation by adverse event recording [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Exploratory Endpoint: time to reach the first of two consecutive total Modified Jackson Subject Evaluation Scale (MJS) scores (defined as sum of 8 signs/symptoms) ≤ 1 [ Time Frame: Up to seven days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Fixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)]
Other Name: Sinutab
In response to a mandated requirement from the Belgium Medicines Agency - rising from the perforce switch of Sinutab® to a 2 active ingredients Pseudoephedrine+Paracetamol combination - we have made a commitment to demonstrate the safety and efficacy of Sinutab®.
In agreement with the Medicines Agency, an in-use Pharmacy-based study has been designed to demonstrate efficacy and safety of Sinutab® for the approved indications (symptomatic relief in the common cold).
This will be a randomized, double blind, placebo-controlled, comparative phase 4, multi-centre study in parallel groups between Sinutab and placebo. To study the drug in it's 'natural environment', community pharmacists will function as local investigators. Approximately 25 community pharmacists will be carefully selected, and only be taken into consideration if appropriate software programs are used in their pharmacy.
This implicates that the pharmacist has a medication record of his patients at his disposal which he will use to check the exclusion criteria. They will include subjects with early (≤ 48 hours) cold symptoms of blocked nose with headache. Subjects fulfilling the inclusion/exclusion criteria will be assigned to one of the two treatment groups, according to a computer-generated randomization list. A sufficient number of subjects will be randomized in the order of their enrolment, targeting at 300 evaluable subjects at the conclusion of study.
The following information will be collected every evening from subjects during 7 days: symptom assessment, compliance, adverse events and the ability to go to work or school.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00378144
|JJCPPW Investigational Site|
|Wilrijk, Antwerp, Belgium|
|Study Director:||Elisabeth A Kruse, PhD||JJCPPW|