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

NCT ID: NCT00762476

Last Updated: 2012-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 411 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-11-30

Brief 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.

Detailed 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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

3804-291

Intervention Type: DRUG

• topical
• apply 2 pumps
• apply at least every 4 hours or after hand washing

3804-250A

Group Type: EXPERIMENTAL

3804-250A

Intervention Type: DRUG

• topical product
• apply 2 pumps
• apply at least every 4 hours or after hand washing

Interventions

3804-250A

• topical product
• apply 2 pumps
• apply at least every 4 hours or after hand washing

Intervention Type: DRUG

3804-291

• topical
• apply 2 pumps
• apply at least every 4 hours or after hand washing

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hill Top Research

INDUSTRY

Sponsor Role: collaborator

TKL Research, Inc.

INDUSTRY

Sponsor Role: collaborator

The Dial Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald B Turner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Michael E Casser, MD

Role: PRINCIPAL_INVESTIGATOR

TKL Research, Inc.

Locations

TKL Research, Inc.

Paramus, New Jersey, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

CS990108

Identifier Type: -

Identifier Source: secondary_id

13805

Identifier Type: -

Identifier Source: secondary_id

TM&R-0062-08-TXC

Identifier Type: -

Identifier Source: org_study_id