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Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold

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ClinicalTrials.gov Identifier: NCT00378144
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )

September 5, 2006
September 19, 2006
July 10, 2012
January 2007
March 2008   (Final data collection date for primary outcome measure)
Change from baseline in the sum of nasal congestion and headache sign/symptom scores [ Time Frame: 7 days ]
Change in nasal congestion and headache.
Complete list of historical versions of study NCT00378144 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Number of lost days at work or school [ Time Frame: 7 Days ]
  • Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only [ Time Frame: 7 days ]
  • Safety evaluation by adverse event recording [ Time Frame: 7 days ]
  • 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 ]
Change in additional symptoms of common cold. (e.g. sore throat) Number of lost days at work/school.
Not Provided
Not Provided
 
Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Common Cold
  • Headache
  • Nasal Congestion
Drug: Pseudoephedrine/Paracetamol
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
Experimental: 1
Pseudoephedrine/Paracetamol
Intervention: Drug: Pseudoephedrine/Paracetamol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
469
300
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00378144
A7801002
2006-000058-35 ( EudraCT Number )
No
Not Provided
Not Provided
Johnson & Johnson Consumer and Personal Products Worldwide ( McNeil AB )
McNeil AB
Not Provided
Study Director: Elisabeth A Kruse, PhD JJCPPW
Johnson & Johnson Consumer and Personal Products Worldwide
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP