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Fexofenadine M016455

Phase 3

Rhinitis Seasonal | Small molecule | Respiratory |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Fexofenadine M016455 · 1 trial · 1 indication

Phase 3 1
NCT03664882Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of PollutantsRhinitis Seasonal
COMPLETED240 Analytics
PHASE3COMPLETED
Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants
Rhinitis Seasonal
NCT03664882240
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Study Endpoints

Primary Endpoints

Total nasal symptom score (TNSS)
From hour 0 to hour 12 in Period 1 and Period 2

Assessed by measuring change in the area under the curve (AUC) of the TNSS during Period 1 and 2

TNSS
From hour 2 to hour 12 in Period 3

Assessed by measuring change in the AUC of the TNSS from hour 2 (planned time of investigational medicinal product administration) to hour 12 in Period 3

Secondary Endpoints

Total symptom score (TSS)
From hour 2 to hour 12 in Period 3
Individual symptom score
From hour 2 to hour 12 in Period 3
TNSS
From hour 2 to hour 12 in Period 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FexofenadineEXPERIMENTALFexofenadine, single administration
PlaceboPLACEBO_COMPARATORPlacebo, single administration

Interventions

NameTypeDescription
Fexofenadine M016455DRUGPharmaceutical form: tablet Route of administration: oral
PlaceboDRUGPharmaceutical form: tablet Route of administration: oral
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Males or females between the ages of 18 and 65 suffering from seasonal allergic rhinitis provoked by ragweed pollen. * Having a 2-year history of seasonal allergic rhinitis with positive skin prick test to ragweed allergen at screening with a wheal diameter at least 3 mm large...

Countries:Canada
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