Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses

Common Cold Clinical Trial

Official title:

A MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II EFFICACY TRIAL OF AV LOTION (FORMULA NO. 3804-250A) FOR THE PREVENTION OF COLD ILLNESS IN HUMAN SUBJECTS

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

• Common Cold

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