Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01576809
Recruitment Status : Completed
First Posted : April 12, 2012
Results First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Sponsor:
Collaborator:
Novartis Consumer Health
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Upper Respiratory Infections
Intervention Drug: IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin
Enrollment 51
Recruitment Details Study Start/End Dates 09 Mar 2012 to 27 Apr 2012
Pre-assignment Details  
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description 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
Period Title: Overall Study
Started 51
Completed 51
Not Completed 0
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description 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
Overall Number of Baseline Participants 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
<=18 years
1
   2.0%
Between 18 and 65 years
50
  98.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants
32.0  (12.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants
Female
26
  51.0%
Male
25
  49.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 51 participants
51
1.Primary Outcome
Title 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
Hide Description Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation
Time Frame 1 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: mm
34.6  (27.96)
2.Secondary Outcome
Title Subject Acceptability of the Syrup
Hide Description

In response to the question "How did you like the warming sensation you have experienced for this product?", the number of patients answering "Like extremely or Like very much or Like moderately or Like slightly"

Possible responses are :

Like extremely Like very much Like moderately Like slightly Neither like nor dislike Dislike slightly Dislike moderately Dislike very much Dislike extremely

Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
36
3.Secondary Outcome
Title Safety and Tolerability of the Syrup
Hide Description Number of participants with adverse events.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: participants
6
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Upper Respiratory Tract Infection
Hide Arm/Group Description 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
All-Cause Mortality
Upper Respiratory Tract Infection
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Upper Respiratory Tract Infection
Affected / at Risk (%) # Events
Total   0/51 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Upper Respiratory Tract Infection
Affected / at Risk (%) # Events
Total   2/51 (3.92%)    
General disorders   
Pyrexia   2/51 (3.92%)  2
Indicates events were collected by systematic assessment
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.
Preliminary agreement between Novartis Consumer Health and the investigator
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical project Leader
Organization: Novartis Consumer Health
Phone: 41223633111
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01576809    
Other Study ID Numbers: 147-A-302
First Submitted: March 29, 2012
First Posted: April 12, 2012
Results First Submitted: April 17, 2013
Results First Posted: November 11, 2013
Last Update Posted: November 11, 2013