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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00762476
Other study ID # TM&R-0062-08-TXC
Secondary ID CS99010813805
Status Completed
Phase Phase 2
First received September 26, 2008
Last updated March 21, 2012
Start date August 2008
Est. completion date November 2008

Study information

Verified date March 2012
Source The Dial Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of 3804-250A in the prevention of the common cold. The study will also evaluate whether 3804-250A prevents rhinovirus infection, a virus that causes many common colds.


Description:

Rhinovirus infections are the most frequent cause up to 80% of cold illnesses during the fall rhinovirus season. While viral upper respiratory infections are generally mild and self-limited, they are associated with an enormous economic burden both in lost productivity and in expenditures for treatment. Rhinovirus infection is frequently associated with medical complications that have substantial morbidity such as acute otitis media and exacerbation of asthma.

Marketed treatment options for rhinovirus consist primarily of symptomatic cold remedies have only modest effects on specific cold symptoms. 3804-250A is under investigation for the prevention of rhinovirus infection by interruption of person-to-person transmission appears to be technologically and economically feasible.

The study is a randomized, double-blind, Placebo controlled, multi-site, parallel design clinical trial conducted in the natural setting. The study will be conducted during a 10-week period during the fall rhinovirus epidemic season. Healthy, normal subjects will be recruited and randomly assigned to the AV Lotion or Placebo control group. Subjects will use the assigned test product on a defined schedule and will record the presence of cold illness symptoms daily. Subjects will return to the study site every week during the study for review and clarification of study diary entries, for review and assessment of compliance, for specimen collection for rhinovirus PCR.


Recruitment information / eligibility

Status Completed
Enrollment 411
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
3804-250A
topical product apply 2 pumps apply at least every 4 hours or after hand washing
3804-291
topical apply 2 pumps apply at least every 4 hours or after hand washing

Locations

Country Name City State
United States University of Virginia School of Medicine Charlottesville Virginia
United States TKL Research, Inc. Paramus New Jersey

Sponsors (3)

Lead Sponsor Collaborator
The Dial Corporation Hill Top Research, TKL Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group 10 weeks No
Secondary Rhinovirus Infections. The incidence of rhinovirus infections 10 weeks No
Secondary Rhinovirus-associated Colds The incidence of rhinovirus-associated cold illnesses. 10 weeks No
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