Trial Outcomes & Findings for 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) (NCT NCT01576809)

Results Overview

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

51 participants

Primary outcome timeframe

1 minutes

Results posted on

2013-11-11

Participant Flow

Study Start/End Dates 09 Mar 2012 to 27 Apr 2012

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Upper Respiratory Tract Infection n=51 Participants 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
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	32.0 years STANDARD_DEVIATION 12.65 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Canada	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minutes

Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0= no warming sensation and 100= strongest possible warming sensation

Outcome measures

Outcome measures
Measure	Upper Respiratory Tract Infection n=51 Participants 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
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	34.6 mm Standard Deviation 27.96

SECONDARY outcome

Timeframe: 1 hour

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

Outcome measures

Outcome measures
Measure	Upper Respiratory Tract Infection n=51 Participants 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
Subject Acceptability of the Syrup	36 participants

SECONDARY outcome

Timeframe: 1 hour

Number of participants with adverse events.

Outcome measures

Outcome measures
Measure	Upper Respiratory Tract Infection n=51 Participants 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
Safety and Tolerability of the Syrup	6 participants

Adverse Events

Upper Respiratory Tract Infection

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Upper Respiratory Tract Infection n=51 participants at risk 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
General disorders Pyrexia	3.9% 2/51 • Number of events 2

Additional Information

Clinical project Leader

Novartis Consumer Health

Phone: 41223633111

Results disclosure agreements

Principal investigator is a sponsor employee Preliminary agreement between Novartis Consumer Health and the investigator
Publication restrictions are in place

Restriction type: OTHER