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Xylometazoline

Phase 3

Common Cold | Small molecule | Other |Novartis AG|Last Updated: May 3, 2007

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00452270Decongestant Effect, Timing of Effect and Impact on Sleep and General Well-Being of Xylometazoline in Subjects With a Common ColdPHASE3 COMPLETED 60 — — Mar 1, 2007Apr 1, 2007May 3, 20071 United Kingdom
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Study Endpoints
Primary Endpoints
To evaluate the decongestant effect of xylometazoline in subjects with
common cold compared to placebo treatment by means of rhinomanometry over a period of 12 hours.
Secondary Endpoints
To measure the peak subjective effect, time to onset of subjective relief of nasal obstruction
and duration of relief of nasal obstruction
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
XylometazolineDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Over 18 years * Have had moderate common cold symptoms for less than 36 hours. Exclusion Criteria: * Congested/runny nose for more than two continuous weeks in the previous 12 months * Deviated septum or nasal polyps * Recent use of antibiotics * Recent sinusitis Other prot...

Countries:United Kingdom
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