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xylo+dex

Phase 3

Nasal Congestion | Small molecule | ENT |Johnson & Johnson|Last Updated: Oct 18, 2018

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03439436A Study to Compare Two Formulations of Xylometazoline/Dexpanthenol Nasal Spray for the Treatment of Nasal Congestion.PHASE3 COMPLETED 140 — — Feb 26, 2018May 2, 2018Oct 18, 20185 Russia
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Study Endpoints
Primary Endpoints
Change from baseline in self-assessment of nasal congestion after 72 hours of treatment.
After 72 hours of treatment.
Secondary Endpoints
Change from baseline in self-assessment of nasal congestion at 24 and 120 hours post dose.
At 24 and 120 hours post dose.
Change from baseline in self-assessment of rhinorrhea after 24 hours, 72 and 120 hours post dose.
At 24 hours, 72 and 120 hours post dose
Assessment of nasal crusting after 24 hours, 72 hours and 120 hours post dose.
At 24 hours, 72 hours and 120 hours post dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
xylo+dex nasal spray (0.1 mg+5 mg/dose)EXPERIMENTALXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
NasicACTIVE_COMPARATORXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
Interventions
NameTypeDescription
xylo+dex nasal spray (0.1 mg+5 mg/dose)DRUGXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
NasicDRUGXylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria * Subjects of 18 years of age or older; * Subjects suffering from nasal congestion with a clinical diagnosis of acute upper respiratory tract infection where symptoms of nasal congestion have persisted for minimum of 3 hours and maximum of 36 hours; * Body mass index (BMI) 18.5 t...

Countries:Russia
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