Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Syrup in Patients Suffering a Upper Respiratory Tract Infection (URTI)

This study has been completed.
Sponsor:
Collaborator:
Novartis Consumer Health
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01576809
First received: March 29, 2012
Last updated: October 18, 2013
Last verified: October 2013
Results First Received: April 17, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Upper Respiratory Infections
Intervention: Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study Start/End Dates 09 Mar 2012 to 27 Apr 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Upper Respiratory Tract Infection IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup

Participant Flow:   Overall Study
    Upper Respiratory Tract Infection  
STARTED     51  
COMPLETED     51  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Upper Respiratory Tract Infection IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup

Baseline Measures
    Upper Respiratory Tract Infection  
Number of Participants  
[units: participants]
  51  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     50  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.0  ± 12.65  
Gender  
[units: participants]
 
Female     26  
Male     25  
Region of Enrollment  
[units: participants]
 
Canada     51  



  Outcome Measures
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1.  Primary:   Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Phenylephrine 10mg + Guaifenesin 200 mg Per 30 ml Syrup   [ Time Frame: 1 minutes ]

2.  Secondary:   Subject Acceptability of the Syrup   [ Time Frame: 1 hour ]

3.  Secondary:   Safety and Tolerability of the Syrup   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical project Leader
Organization: Novartis Consumer Health
phone: 41223633111


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01576809     History of Changes
Other Study ID Numbers: 147-A-302
Study First Received: March 29, 2012
Results First Received: April 17, 2013
Last Updated: October 18, 2013
Health Authority: Canada: Health Canada