Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
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
3 other identifiers
interventional
411
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 26, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 16, 2012
CompletedApril 16, 2012
March 1, 2012
3 months
September 26, 2008
February 8, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Rhinovirus Infections.
10 weeks
Rhinovirus-associated Colds
10 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATOR3804-250A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- healthy normal
- good general health
You may not qualify if:
- pregnancy
- insulin dependent diabetes
- daily smoker
- skin disease on the hands/wrists
- immunological disorders
- occupation involving frequent handwashing
- common cold symptoms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Dial Corporationlead
- Hill Top Researchcollaborator
- TKL Research, Inc.collaborator
Study Sites (2)
TKL Research, Inc.
Paramus, New Jersey, 07652, United States
University of Virginia School of Medicine
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ronald Turner
- Organization
- University of Virginia
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald B Turner, MD
University of Virginia School of Medicine
- PRINCIPAL INVESTIGATOR
Michael E Casser, MD
TKL Research, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2008
First Posted
September 30, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
April 16, 2012
Results First Posted
April 16, 2012
Record last verified: 2012-03