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N-acetylcysteine

Phase 2

Common Cold Associated With Cough | Small molecule | Other |Novartis AG|Last Updated: Jul 11, 2016

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02379637Study to Evaluate the Efficacy of N-acetylcysteine (NAC) in the Treatment of the Common Cold and CoughPHASE2 COMPLETED 70Jan 1, 2015Apr 1, 2015Jul 11, 20165 Canada
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Study Endpoints
Primary Endpoints
Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours)
72 hours

Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours

Secondary Endpoints
Safety of Daily Dose of NAC (Number of Patients With Adverse Advents)
7 Days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A N-acetylcysteineEXPERIMENTALN-acetylcysteine
B PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
N-acetylcysteineDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Cold/URTI symptoms occurring no more than 4 days * cough due to a cold or acute viral (URTI) with an onset of no more than 3 days * cough frequency with specified cut-off Exclusion Criteria: * A subchronic, or chronic cough (cough duration \> 2 months) due to any condition o...

Countries:Canada
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