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3804-250A

Phase 2

Common Cold | Small molecule | Infectious Disease |IQVIA Holdings, Inc.|Last Updated: Apr 16, 2012

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment411

FDA Designations

No designations recorded

Clinical trial landscape

3804-250A · 1 trial · 1 indication

Phase 2 1
NCT00762476Efficacy Trial of 3804-250A in the Prevention of Cold IllnessesCommon Cold
COMPLETED411 Analytics
PHASE2COMPLETED
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Common Cold
NCT00762476411
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Study Endpoints

Primary Endpoints

The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
10 weeks

Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group

Secondary Endpoints

Rhinovirus Infections.
10 weeks
Rhinovirus-associated Colds
10 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
3804-250AEXPERIMENTAL -

Interventions

NameTypeDescription
3804-250ADRUG* topical product * apply 2 pumps * apply at least every 4 hours or after hand washing
3804-291DRUG* topical * apply 2 pumps * apply at least every 4 hours or after hand washing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * healthy normal * good general health Exclusion Criteria: * pregnancy * insulin dependent diabetes * daily smoker * skin disease on the hands/wrists * immunological disorders * occupation involving frequent handwashing * common cold symptoms

Countries:United States
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