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Cetylpyridinium chloride

Phase 3

Healthy | Small molecule | Other |Sanofi|Last Updated: Feb 13, 2009

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
UNCONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00687037Safety Oral Mucosa Evaluation - Acceptability With Odontological Follow up - Cepacol Canela PowerPHASE3 COMPLETED 30 — — Jan 1, 2008 -Feb 13, 20091 Brazil
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Study Endpoints
Primary Endpoints
Patients will be evaluated according to the adverse reactions and the intensity of them. The volunteers will also answer a questionnaire about the physical attributes of the product.
21 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
IEXPERIMENTALCetylpyridinium chloride during 21 days.
Interventions
NameTypeDescription
Cetylpyridinium chlorideDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Integral buccal mucous (without oral pathologies); * Normal odontological exams; Exclusion Criteria: * Lactation or gestational risk or gestation; * Use of Anti-inflammatory or immunosuppression drugs 15 days before the study; * Being in odontological treatment; * Pathologic...

Countries:Brazil
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