Status:
COMPLETED
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
Lead Sponsor:
McNeil AB
Conditions:
Common Cold
Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
469 Patients enrolled
Trial Details
Trial ID
NCT00378144
Start Date
January 1 2007
End Date
March 1 2008
Last Update
July 10 2012
Active Locations (1)
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1
JJCPPW Investigational Site
Wilrijk, Antwerp, Belgium