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Prototype

Phase 1

Dental Plaque | Small molecule | ENT |Pfizer, Inc.|Last Updated: Jun 5, 2019

Success Probability

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Market & Valuation

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Trial Design

PLACEBO_CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Prototype · 1 trial · 1 indication

Phase 1 1
NCT00762151A Study to Investigate the Anti-Plaque Effect of AN0128 ToothpasteDental Plaque
COMPLETED18 Analytics
PHASE1COMPLETED
A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste
Dental PlaqueUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in the gingival margin plaque index in a 24-hour post-treatment (no brushing)
Baseline (time zero), 24 hour time point
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Study Design & Arms

MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Negative ControlPLACEBO_COMPARATORRegular Toothpaste
Positive ControlACTIVE_COMPARATORStandard anti-plaque and anti-bacterial toothpaste.
PrototypeACTIVE_COMPARATORAN0128 Toothpaste

Interventions

NameTypeDescription
Negative Control (Regular Toothpaste)OTHERRegular Toothpaste
Positive Control (anti-plaque/anti-bacterial toothpaste)OTHERStandard anti-plaque and anti-bacterial toothpaste
Prototype (AN0128 Toothpaste)DRUGAN0128 Toothpaste
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must be between ages 18 to 65 years inclusive * Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present * Must give written informed consent * Be in good general health * Must discontinue oral hygiene for 24-hours after initial appointment * No known histor...

Countries:United States
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Frequently asked questions about Prototype

What is Prototype used for?

Prototype is an investigational small molecule being developed for the treatment of dental plaque. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Prototype?

Prototype is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating dental plaque.

What phase is Prototype in?

Prototype is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The drug is being studied for its potential to treat dental plaque.

What clinical trials is Prototype in?

Prototype has one completed Phase 1 clinical trial, NCT00762151, titled "A Study to Investigate the Anti-Plaque Effect of AN0128 Toothpaste." The trial enrolled 18 participants in the United States and was placebo-controlled.

Is Prototype FDA approved?

Prototype is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for dental plaque. The drug has not yet completed the clinical trials required for regulatory approval.