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

This study has been completed.
Sponsor:
Collaborators:
Hill Top Research
TKL Research, Inc.
Information provided by (Responsible Party):
The Dial Corporation
ClinicalTrials.gov Identifier:
NCT00762476
First received: September 26, 2008
Last updated: March 21, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Common Cold
 Drug: 3804-250A
Drug: 3804-291
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by The Dial Corporation:

Primary Outcome Measures:
  • The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group


Secondary Outcome Measures:
  • Rhinovirus Infections. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The incidence of rhinovirus infections

  • Rhinovirus-associated Colds [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    The incidence of rhinovirus-associated cold illnesses.


Enrollment: 411
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: 3804-291
  • topical
  • apply 2 pumps
  • apply at least every 4 hours or after hand washing
Experimental: 3804-250A Drug: 3804-250A
  • topical product
  • apply 2 pumps
  • apply at least every 4 hours or after hand washing

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00762476

Locations
United States, New Jersey
TKL Research, Inc.
Paramus, New Jersey, United States, 07652
United States, Virginia
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
The Dial Corporation
Hill Top Research
TKL Research, Inc.
Investigators
Principal Investigator: Ronald B Turner, MD University of Virginia School of Medicine
Principal Investigator: Michael E Casser, MD TKL Research, Inc.
  More Information

No publications provided

Responsible Party: The Dial Corporation
ClinicalTrials.gov Identifier: NCT00762476     History of Changes
Other Study ID Numbers: TM&R-0062-08-TXC, CS990108, 13805
Study First Received: September 26, 2008
Results First Received: February 8, 2012
Last Updated: March 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The Dial Corporation:
cold, common
rhinovirus

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013