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monofluorophosphate dentifrice

Phase 2

Dentine Hypersensitivity | Small molecule | Other |GSK plc|Last Updated: May 29, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01691560Exploratory Study to Evaluate an Occlusion Based Dentifrice in Relief of Dentinal HypersensitivityPHASE2 COMPLETED 140 — — Aug 1, 2012Nov 1, 2012May 29, 20141 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 4
Baseline to 4 weeks post administration of study treatment

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 4
Baseline to 4 weeks post administration of study treatment

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.

Change From Baseline in Evaporative Air Sensitivity Pain Response on Schiff Sensitivity Scale at Week 8
Baseline to 8 weeks post administration of study treatment

Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Change From Baseline in Tactile Sensitivity Pain Response (g) at Week 8
Baseline to 8 weeks post administration of study treatment

Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. In tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response was recorded or the maximum force was reached.

Change From Baseline in Evaporative Air Sensitivity Response on a Visual Rating Scale (VRS) at Week 4
Baseline to 4 weeks post administration of study treatment

Participants rated the intensity of their response to the stimulus using a 10 point Visual rating scale of 1 (no Pain) to 10 (intense pain).

Change From Baseline in Evaporative Air Sensitivity Response on VRS at Week 8
Baseline to 8 weeks post administration of study treatment

Participants rated the intensity of their response to the stimulus using a 10 point VRS of 1 (no Pain) to 10 (intense pain).

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5% calcium sodium phosphosilicate/sodium monofluorophosphateEXPERIMENTALDentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF).
0% calcium sodium phosphosilicate/sodium monofluorophosphateACTIVE_COMPARATORDentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Sodium monofluorophosphateACTIVE_COMPARATORDentifrice containing 1000 ppmF as sodium monofluorophosphate
Sodium fluorideACTIVE_COMPARATORDentifrice containing 1100 ppmF as sodium fluoride
Interventions
NameTypeDescription
5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifriceDRUGDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifriceDRUGDentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
Sodium monofluorophosphate dentifriceDRUGDentifrice containing 1000 ppmF as sodium monofluorophosphate
Sodium fluoride dentifriceDRUGDentifrice containing 1100 ppmF as sodium fluoride
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Participants between 18 and 55 years of age, in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity are required for entry into the study 2. Participants will be required to have at least four teeth with facial/cervical erosion, abr...

Countries:United States
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