Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
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.
|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|
- 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
- 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.
|Study Start Date:||August 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
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.
|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|
|Principal Investigator:||Ronald B Turner, MD||University of Virginia School of Medicine|
|Principal Investigator:||Michael E Casser, MD||TKL Research, Inc.|