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Marketed Strip, Prototype Dilator

Phase 1

Healthy Subjects | Unknown | Other |GSK plc|Last Updated: Nov 24, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Marketed Strip, Prototype Dilator · 1 trial · 1 indication

Phase 1 1
NCT01495494A Multiple Use Tolerability Study of a Breathe Right Nasal Strip PrototypeHealthy Subjects
COMPLETED80 Analytics
PHASE1COMPLETED
A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Dermal response score of the application site of the nasal strip
Baseline through 7 days

Secondary Endpoints

Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Marketed nasal stripACTIVE_COMPARATORMarketed nasal strip
Prototype nasal dilatorEXPERIMENTALPrototype nasal dilator

Interventions

NameTypeDescription
Marketed Nasal StripDEVICEBreathe Right Nasal Strips - Clear small/medium strip
Prototype Nasal DilatorDEVICEPrototype Nasal Dilator AB2R11
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Eligibility Criteria

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

Inclusion Criteria: * Healthy subjects

Countries:United States
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Frequently asked questions about Marketed Strip, Prototype Dilator

What is Marketer Strip, Prototype Dilator used for?

Marketed Strip, Prototype Dilator is a nasal strip prototype being studied for use in healthy subjects. It is currently in Phase 1 clinical development as an investigational product. The prototype is designed for multiple use and is being evaluated for tolerability in a clinical trial setting.

Who makes Marketer Strip, Prototype Dilator?

Marketed Strip, Prototype Dilator is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK. The company is conducting clinical research on this nasal strip prototype in the United States.

What phase is Marketer Strip, Prototype Dilator in?

Marketed Strip, Prototype Dilator is in Phase 1 clinical development. The Phase 1 trial has been completed, and the product remains investigational. It has not been approved by regulatory authorities and is still in the early stages of clinical testing.

What clinical trials is Marketer Strip, Prototype Dilator in?

Marketed Strip, Prototype Dilator has one completed clinical trial, NCT01495494, titled "A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype." This Phase 1 study enrolled 80 healthy subjects in the United States and was active-controlled, though not double-blinded.

Is Marketer Strip, Prototype Dilator FDA approved?

Marketed Strip, Prototype Dilator is not FDA approved. It is an investigational product currently in Phase 1 clinical development. The completed Phase 1 trial assessed tolerability in healthy subjects, but the product has not yet received regulatory approval for any use.