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Epinastine

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 12, 2015

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment571
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00407927A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic RhinitisPHASE2 COMPLETED 571 — — Dec 1, 2006Mar 1, 2007Oct 12, 20157 United States
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Study Endpoints
Primary Endpoints
Change in nasal symptom scores
Secondary Endpoints
Change in non-nasal symptom scores and quality of life scores
Standard safety assessments
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Epinastine Nasal SprayDRUG -
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * A documented history of seasonal allergic rhinitis to mountain cedar pollen Exclusion Criteria: * Significant medical condition * Cardiovascular abnormality * Have a significant physical obstruction in the nose * Started or had a change in immunotherapy within the 30 days pr...

Countries:United States
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