Trial Outcomes & Findings for Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI (NCT NCT01586962)

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

56 participants

Primary outcome timeframe

1 minute

Results posted on

2013-08-07

Participant Flow

Study Start/End Dates 07 May 2012 to 17 May 2012

Participant milestones

Participant milestones
Measure	Upper Respiratory Infections IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Overall Study STARTED	56
Overall Study COMPLETED	56
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 + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Upper Respiratory Infections n=56 Participants IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	32.8 years STANDARD_DEVIATION 12.61 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Canada	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minute

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 Infections n=56 Participants IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup	34.2 mm Standard Deviation 25.51

SECONDARY outcome

Timeframe: 1 hour

How do you like the warming sensation you have experienced for this product? 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 Infections n=56 Participants IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Subject Acceptability of the Syrup	39 Participants

SECONDARY outcome

Timeframe: 1 hour

Number of participants with adverse events.

Outcome measures

Outcome measures
Measure	Upper Respiratory Infections n=56 Participants IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Safety and Tolerability of the Syrup	9 Participants

Adverse Events

Upper Respiratory Infections

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Upper Respiratory Infections n=56 participants at risk IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
Nervous system disorders Somnolence	7.1% 4/56

Additional Information

Clinical Project Leader

Novartis

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