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nitrate and fluoride

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment191

FDA Designations

No designations recorded

Clinical trial landscape

nitrate and fluoride · 1 trial · 1 indication

Phase 2 1
NCT02226562Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal HypersensitivityDentin Sensitivity
COMPLETED191 Analytics
PHASE2COMPLETED
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Dentin SensitivityUnlock trial analytics

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 to 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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Frequently asked questions about nitrate and fluoride

What is Nitrate used for?

Nitrate is an investigational small molecule being developed by GSK plc for the treatment of dentin sensitivity, also known as dentinal hypersensitivity or dentin hypersensitivity. It is being studied for its ability to reduce dental pain associated with these conditions.

Who makes Nitrate?

Nitrate is being developed by GSK plc, a pharmaceutical company traded on the London Stock Exchange under the ticker GSK. The drug is currently in clinical development for dentin sensitivity and related hypersensitivity conditions.

What phase is Nitrate in?

Nitrate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains in early-stage development for dentin hypersensitivity.

What clinical trials is Nitrate in?

Nitrate has been studied in three completed clinical trials. NCT01587950 was a Phase 1 study with 12 participants, NCT02226562 was a Phase 2 study with 191 participants, and NCT03943095 was a Phase 2 study with 123 participants, all evaluating its effects on dentin hypersensitivity.

Is Nitrate the same as potassium nitrate?

Nitrate is being studied in formulations that include potassium nitrate, as indicated by the clinical trial NCT01587950, which evaluated the effects of potassium nitrate in reducing dentinal hypersensitivity. However, Nitrate as a drug asset may refer to the active ingredient or the product.