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IFF flavor 316 282, Paracetamol, Pseudoephedrine

Phase 3

Upper Respiratory Infections | Small molecule | Other |Novartis AG|Last Updated: Aug 7, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01586962Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTIPHASE3 COMPLETED 56May 1, 2012May 1, 2012Aug 7, 20131 Canada
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Study Endpoints
Primary Endpoints
Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
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

Secondary Endpoints
Subject Acceptability of the Syrup
1 hour
Safety and Tolerability of the Syrup
1 hour
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Upper Respiratory InfectionsEXPERIMENTAL -
Interventions
NameTypeDescription
IFF flavor 316 282, Paracetamol, PseudoephedrineDRUGSingle dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1): * mild to moderate body pain, headache, fever or sore throat * nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Exclusion Crit...

Countries:Canada
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