Phase 2 Completed N=411 Randomized Triple-blind Prevention

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

Common Cold

Source: ClinicalTrials.gov NCT00762476 ↗

Enrolled (actual)

411

Serious AEs

0.5%

Results posted

Apr 2012

Primary outcomePrimary: 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

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.