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nitrate and fluoride

Phase 2

Dentin Sensitivity | Small molecule | Other |GSK plc|Last Updated: Aug 27, 2018

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment191
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02226562Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal HypersensitivityPHASE2 COMPLETED 191Sep 2, 2014Dec 5, 2014Aug 27, 20181 United States
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Study Endpoints
Primary Endpoints
Mean Change From Baseline in Schiff Sensitivity Score at Week 8
Baseline to 8 week

The examiner indicated the participant's response to an evaporaitve air stimulus for each tooth using the Schiff Sensitivity Scale scored as follows - 0: Participant does not respond to air stimulation; 1: responds to air stimulus but does not request discontinuation of stimulus; 2: Participant responds to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score is indicative of an imrpovement in sensitivity.

Secondary Endpoints
Mean Change From Baseline in Schiff Sensitivity Score at Week 4
Baseline to 4 week
Mean Change From Baseline in Tactile Threshold at Week 8
Baseline to 8 week
Mean Change From Baseline in Tactile Threshold at Week 4
Baseline to 4 week
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Potassium nitrate and sodium fluorideEXPERIMENTAL3.0% weight by weight (w/w) potassium nitrate mouthwash with 0.02% sodium fluoride
Standard fluoride dentifriceOTHERStandard fluoride dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate (SMFP)
Interventions
NameTypeDescription
Potassium nitrate and sodium fluorideDRUG3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
Standard fluoride dentifriceDRUGStandard fluoride dentifrice containing 1000 ppm fluoride as SMFP
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants in good general health, with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years. * Participants with minimum of 20 natural teeth. * At screening, a minimum of four, non-adjacent teeth. 1. Teeth showing signs...

Countries:United States
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