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Nitrate

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Nitrate · 1 trial · 2 indications

Phase 1 1
NCT01587950The Effects of Potassium Nitrate in Reducing Dentinal HypersensitivityDentinal Hypersensitivity
COMPLETED12 Analytics
PHASE1COMPLETED
The Effects of Potassium Nitrate in Reducing Dentinal Hypersensitivity
Dentinal HypersensitivityUnlock trial analytics

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 to 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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Frequently asked questions about Nitrate

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.