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5% nitrate

Phase 2

Dentine Hypersensitivity | Small molecule | Other |GSK plc|Last Updated: Jan 26, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

5% nitrate · 1 trial · 1 indication

Phase 2 1
NCT01115452Efficacy of Potassium Nitrate Solution in Reducing Dentinal HypersensitivityDentine Hypersensitivity
COMPLETED32 Analytics
PHASE2COMPLETED
Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity
Dentine HypersensitivityUnlock trial analytics

Study Endpoints

Primary Endpoints

Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 5 Using a Visual Analog Scale (VAS) in 5% Potassium Nitrate Solution and 2.5% Potassium Nitrate Solution
Baseline and immediately after treatment on Day 5

Response to a one second application of air from a standard dental unit syringe applied to the surface of hypersensitive tooth. After each stimuli participant rated the intensity of pain on a 100 millimeter VAS, on which 0 represented "no pain" and 100 represented the" worst pain imaginable". Change from baseline was calculated as mean score at the given time point minus mean score at baseline.

Secondary Endpoints

Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli Immediately Following Treatment on Day 1 Using a VAS
Baseline and immediately after treatment on Day 1
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 10 Mins Post Treatment on Day 1 Using a VAS
Baseline and 10 mins post treatment on Day 1
Between Treatment Comparison of the Adjusted Mean Change From Baseline of Response to Evaporative (Air) Stimuli at 20 Mins Post Treatment on Day 1 Using a VAS.
Baseline and 20 mins post treatment on Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
5% KNO3 solutionEXPERIMENTALParticipants to apply 5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.
2.5% KNO3 solutionEXPERIMENTALParticipants to apply 2.5% potassium nitrate solution to a single sensitive tooth for two minutes, in each of the five day treatment period.
Sterile WaterPLACEBO_COMPARATORParticipants to apply sterile water to a single sensitive tooth for two minutes, in each of the five day treatment period.

Interventions

NameTypeDescription
5% Potassium nitrateDRUG5% potassium nitrate solution
2.5% Potassium nitrateDRUG2.5% potassium nitrate solution
Sterile waterOTHERSterile water
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Self-reported history of dentinal hypersensitivity lasting more than 6 months and a primary complaint of sensitive teeth * Three teeth that can be isolated that meet all of the following criteria at the screening visit: * Teeth showing signs of facial/cervical gingival recessi...

Countries:United States
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Frequently asked questions about 5% nitrate

What is 5% nitrate used for?

5% nitrate is an investigational small molecule being studied for the treatment of dentine hypersensitivity, a condition characterized by sharp pain in teeth when exposed to hot, cold, sweet, or acidic stimuli. It is currently in Phase 2 clinical development.

Who makes 5% nitrate?

5% nitrate is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational treatment for dentine hypersensitivity.

What phase is 5% nitrate in?

5% nitrate is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness for treating dentine hypersensitivity.

What clinical trials is 5% nitrate in?

5% nitrate has one completed Phase 2 clinical trial registered under NCT01115452, titled 'Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity.' This randomized, double-blind, placebo-controlled trial enrolled 32 participants in the United States to evaluate the treatment's effect on dentine hypersensitivity.

Is 5% nitrate the same as potassium nitrate?

5% nitrate is a formulation of potassium nitrate, as indicated by the clinical trial title 'Efficacy of Potassium Nitrate Solution in Reducing Dentinal Hypersensitivity.' The drug is being studied as a solution for the treatment of dentine hypersensitivity.