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IFF flavor 316 282, Paracetamol, Pseudoephedrine

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

IFF flavor 316 282, Paracetamol, Pseudoephedrine · 1 trial · 1 indication

Phase 3 1
NCT01586962Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTIUpper Respiratory Infections
COMPLETED56 Analytics
PHASE3COMPLETED
Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI
Upper Respiratory Infections
NCT0158696256
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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 to 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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Frequently asked questions about IFF flavor 316 282, Paracetamol, Pseudoephedrine

What is IFF flavor 316 282, Paracetamol, Pseudoephedrine used for?

IFF flavor 316 282, Paracetamol, Pseudoephedrine is a small molecule combination being studied for the treatment of Upper Respiratory Infections (URTIs). It is formulated as a syrup containing paracetamol 500 mg and pseudoephedrine 30 mg, and is being developed by Novartis AG.

Who makes IFF flavor 316 282, Paracetamol, Pseudoephedrine?

Novartis AG (ticker: NVS) is developing IFF flavor 316 282, Paracetamol, Pseudoephedrine. The drug is a small molecule combination syrup intended for patients with Upper Respiratory Infections.

What phase is IFF flavor 316 282, Paracetamol, Pseudoephedrine in?

IFF flavor 316 282, Paracetamol, Pseudoephedrine is in Phase 3 clinical development. It is an investigational drug and is not approved by the FDA. The Phase 3 trial has been completed.

What clinical trials is IFF flavor 316 282, Paracetamol, Pseudoephedrine in?

IFF flavor 316 282, Paracetamol, Pseudoephedrine has one completed Phase 3 trial, NCT01586962, titled 'Warming Sensation Intensity and Acceptability of the Flavour, Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup in Patients Suffering a URTI'. The trial enrolled 56 patients in Canada.

Is IFF flavor 316 282, Paracetamol, Pseudoephedrine the same as Paracetamol and Pseudoephedrine?

IFF flavor 316 282, Paracetamol, Pseudoephedrine is a combination product containing paracetamol 500 mg and pseudoephedrine 30 mg. The name includes the flavor identifier 'IFF flavor 316 282' to distinguish this specific formulation of the syrup.