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Nitrate

Phase 1

Dentinal Hypersensitivity | Small molecule | Pain |GSK plc|Last Updated: Apr 28, 2015

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 Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01587950The Effects of Potassium Nitrate in Reducing Dentinal HypersensitivityPHASE1 COMPLETED 12Feb 1, 2009Apr 1, 2009Apr 28, 20151 United States
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Study Endpoints
Primary Endpoints
Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a Visual Analogue Scale (VAS) Immediately Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Baseline, immediately post administration of treatment

Response to a constant jet of air applied to a hypersensitive tooth was evaluated using a 100 millimeter (mm) VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score immediately post treatment.

Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 10 Minutes Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Baseline, 10 minutes post administration of treatment

Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 10 minutes post treatment.

Adjusted Mean Change From Baseline in Evaporative Sensitivity Pain Response of Hypersensitive Tooth on a VAS, 20 Minute Post Application of 5% KNO3 Solution, 2.5% KNO3 Solution and Sterile Water
Baseline, 20 minutes post administration of treatment

Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using a 100 mm VAS pain response scale. According to this analog scale, pain response for stimulated tooth ranged from 0 (no pain) to 100 (intense pain). Change from baseline in pain response was calculated using VAS score at 20 minutes post treatment.

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sterile waterPLACEBO_COMPARATORParticipants to receive 250 microlitres (μL) of sterile water.
Potassium nitrate 5% solutionEXPERIMENTALParticipants to receive 250 μL of potassium nitrate 5% solution.
Potassium nitrate 2.5% solutionEXPERIMENTALParticipants to receive 250 μL of potassium nitrate 2.5% solution.
Interventions
NameTypeDescription
Potassium NitrateDRUG250 μL of Potassium nitrate solution (either 5% or 2.5%)
PlaceboDRUGSterile Water
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * General Health and Oral Heath: Good general health and oral health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. * Teeth: Presence of teeth in various locations in the mouth to determine stent success. Requir...

Countries:United States
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