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Octenidine Dihydrocloride in aqueous

Phase 2

Preoperative Skin Preparation | Small molecule | Dermatology |Becton, Dickinson and Company|Trials Updated: Apr 23, 2021

Octenidine Dihydrocloride in aqueous target and mechanism

ModalitySmall molecule

Also known as Octenidine Dihydrocloride in aqueous solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Octenidine Dihydrocloride in aqueous clinical trials

Octenidine Dihydrocloride in aqueous · 1 trial · 1 indication

Phase 2 1
NCT03229759Evaluation of the Antimicrobial Effectiveness of an Antimicrobial ClothPreoperative Skin Preparation
COMPLETED99 Analytics
PHASE2COMPLETED
Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth
Preoperative Skin PreparationUnlock trial analytics

Study Endpoints

Primary Endpoints

Bacterial Count at 10 Minutes Post Application
10 minutes after application of test product
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Investigational ProductEXPERIMENTALPolyester cloth impregnated with investigational product
Vehicle Control (VC)PLACEBO_COMPARATORPolyester cloth impregnated with the vehicle control
Saline Control (SC)PLACEBO_COMPARATORSaline applied wtih polyester cloth

Interventions

NameTypeDescription
Octenidine Dihydrocloride in aqueous solutionDRUGapplication of investigational product
Vehicle ControlOTHERapplication of vehicle control
Saline ControlOTHERapplication of placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and/or females, at least 18 years or older and of any race. * Are in good general health. * Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral...

Countries:United States
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Frequently asked questions about Octenidine Dihydrocloride in aqueous

What is octenidine dihydrochloride in aqueous solution used for?

Octenidine dihydrochloride in aqueous solution is being developed for preoperative skin preparation, a dermatology use in which skin is treated before surgery to reduce microorganisms at the surgical site. Becton, Dickinson and Company is developing it, and the program has reached Phase 2 clinical development.

Who is developing octenidine dihydrochloride in aqueous solution?

Becton, Dickinson and Company, which trades under the ticker BDX, is the developer of octenidine dihydrochloride in aqueous solution. The company has studied the agent in a Phase 2 trial in preoperative skin preparation, and the program remains in clinical development.

What phase is octenidine dihydrochloride in aqueous solution in?

Octenidine dihydrochloride in aqueous solution is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The agent is investigational and is not an approved product for preoperative skin preparation.

What clinical trial has studied octenidine dihydrochloride in aqueous solution?

Octenidine dihydrochloride in aqueous solution has been evaluated in the Phase 2 trial NCT03229759, titled Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth. That completed trial enrolled 99 participants in the United States, included adults 18 years and older of all sexes, and accepted healthy volunteers.

How was the Phase 2 trial of octenidine dihydrochloride in aqueous solution designed?

The Phase 2 trial NCT03229759 was a randomized, double-blind, placebo-controlled study of octenidine dihydrochloride in aqueous solution for preoperative skin preparation. It enrolled 99 participants and has been completed. The study took place in the United States and enrolled healthy volunteers aged 18 years and older.

Is octenidine dihydrochloride in aqueous solution the same as octenidine dihydrochloride in aqueous?

Yes, octenidine dihydrochloride in aqueous and octenidine dihydrochloride in aqueous solution refer to the same investigational product from Becton, Dickinson and Company. Both names describe the aqueous formulation studied in Phase 2 for preoperative skin preparation under trial NCT03229759.