Phase 2
N=411
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
Common Cold
Bottom Line
View on ClinicalTrials.gov: NCT00762476 ↗Enrolled (actual)
411
Serious AEs
0.5%
Results posted
Apr 2012
Primary outcome: Primary: The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. — 47.1; 43.9 cold illnesses per 100 subjects — p=>0.5000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3804-250A (Drug); 3804-291 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Dial Corporation
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. |
47.1; 43.9 | >0.5000 |
| SECONDARY Rhinovirus Infections. |
58.7; 59.0 | >0.5000 |
| SECONDARY Rhinovirus-associated Colds |
24.3; 20.0 | 0.3451 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00762476). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.