Back to resultsEfficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
Primary Purpose
Common Cold, Headache, Nasal Congestion
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Pseudoephedrine/Paracetamol
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
Eligibility Criteria
Inclusion Criteria:
- age 18 years or more
- reported cold symptoms beginning ≤ 48 hours prior to visit 1
- scored ≥ 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
- willing and able to comply with scheduled visits, treatment plan, and other study procedures
- evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
Exclusion Criteria:
- patients without an electronic medication record in the pharmacy
- history of hypersensitivity to paracetamol or pseudoephedrine or lactose
- fever more than 38.0°C (measured by pharmacist)
- women in the fertile years who do not use a hormonal contraception or an intra-uterine device
- use of concomitant drugs, medications or treatments that could interfere with the study drug
- important intercurrent medical condition based on the available medication record of the patient. (cf. exclusion criterium 1)
- history of nasal reconstructive surgery
- alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit
- any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
- participation in other clinical trials the last three months and during study participation.
- employees of the clinical research centers, sponsor, the CRO's contracted for this study, or their immediate family members
Sites / Locations
- JJCPPW Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Pseudoephedrine/Paracetamol
Outcomes
Primary Outcome Measures
Change from baseline in the sum of nasal congestion and headache sign/symptom scores
Secondary Outcome Measures
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
Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes
Number of lost days at work or school
Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only
Safety evaluation by adverse event recording
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00378144
Brief Title
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and safety for a marketed sinus allergy product, Sinutab, in the treatment of nasal congestion and headache.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold, Headache, Nasal Congestion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
469 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pseudoephedrine/Paracetamol
Intervention Type
Drug
Intervention Name(s)
Pseudoephedrine/Paracetamol
Other Intervention Name(s)
Sinutab
Intervention Description
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)]
Primary Outcome Measure Information:
Title
Change from baseline in the sum of nasal congestion and headache sign/symptom scores
Time Frame
7 days
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Number of lost days at work or school
Time Frame
7 Days
Title
Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only
Time Frame
7 days
Title
Safety evaluation by adverse event recording
Time Frame
7 days
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years or more
reported cold symptoms beginning ≤ 48 hours prior to visit 1
scored ≥ 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
willing and able to comply with scheduled visits, treatment plan, and other study procedures
evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
Exclusion Criteria:
patients without an electronic medication record in the pharmacy
history of hypersensitivity to paracetamol or pseudoephedrine or lactose
fever more than 38.0°C (measured by pharmacist)
women in the fertile years who do not use a hormonal contraception or an intra-uterine device
use of concomitant drugs, medications or treatments that could interfere with the study drug
important intercurrent medical condition based on the available medication record of the patient. (cf. exclusion criterium 1)
history of nasal reconstructive surgery
alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit
any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion
participation in other clinical trials the last three months and during study participation.
employees of the clinical research centers, sponsor, the CRO's contracted for this study, or their immediate family members
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth A Kruse, PhD
Organizational Affiliation
JJCPPW
Official's Role
Study Director
Facility Information:
Facility Name
JJCPPW Investigational Site
City
Wilrijk
State/Province
Antwerp
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
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