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Marketed Strip, Prototype Dilator

Phase 1

Healthy Subjects | Unknown | Other |GSK plc|Last Updated: Nov 24, 2014

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01495494A Multiple Use Tolerability Study of a Breathe Right Nasal Strip PrototypePHASE1 COMPLETED 80Nov 1, 2009Nov 1, 2009Nov 24, 20141 United States
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Study Endpoints
Primary Endpoints
Dermal response score of the application site of the nasal strip
Baseline through 7 days
Secondary Endpoints
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Marketed nasal stripACTIVE_COMPARATORMarketed nasal strip
Prototype nasal dilatorEXPERIMENTALPrototype nasal dilator
Interventions
NameTypeDescription
Marketed Nasal StripDEVICEBreathe Right Nasal Strips - Clear small/medium strip
Prototype Nasal DilatorDEVICEPrototype Nasal Dilator AB2R11
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects

Countries:United States
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