A Phase 2 interventional study of 3804-250A and 3804-291 in Common Cold, sponsored by The Dial Corporation. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-16.
Sponsored by The Dial Corporation · Phase 2, Interventional, and Prevention
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.
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.
180 studies on the registry are indexed under Common Cold; 22 are open to participants now.
This study's enrollment of 411 is above the median of 167 across 151 interventional studies indexed under Common Cold.
Browse Common Cold studies →The Dial Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 3804-291
Drug: 3804-250A
* topical product * apply 2 pumps * apply at least every 4 hours or after hand washing
* topical * apply 2 pumps * apply at least every 4 hours or after hand washing
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
Time frame: 10 weeks
Rhinovirus Infections.
The incidence of rhinovirus infections
Time frame: 10 weeks
Rhinovirus-associated Colds
The incidence of rhinovirus-associated cold illnesses.
Time frame: 10 weeks
| Milestone | Placebo | 3804-250A |
|---|---|---|
| Started | 206 | 205 |
| Completed | 183 | 169 |
| Not completed | 23 | 36 |
| Withdrew: Adverse event | 7 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Protocol violation | 5 | 6 |
| Withdrew: Physician decision | 2 | 14 |
| Withdrew: Withdrawal by subject | 6 | 12 |
| Withdrew: Antibiotic use | 0 | 1 |
| Withdrew: Non-compliance with study visits | 0 | 2 |
| Withdrew: Seasonal allergies | 1 | 0 |
Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
| cold illnesses per 100 subjects | Placebo | 3804-250A |
|---|---|---|
| The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. | 47.1 | 43.9 |
The incidence of rhinovirus infections
| rhinovirus infections per 100 subjects | Placebo | 3804-250A |
|---|---|---|
| Rhinovirus Infections. | 58.7 | 59.0 |
The incidence of rhinovirus-associated cold illnesses.
| RV-associated cold illnesses per 100 sub | Placebo | 3804-250A |
|---|---|---|
| Rhinovirus-associated Colds | 24.3 | 20.0 |
Collected over 10 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/206 (1%) | 23/206 (11.2%) |
| 3804-250A | — | 0/205 (0%) | 16/205 (7.8%) |
| Event | Placebo | 3804-250A |
|---|---|---|
| Ulna fractureInjury, poisoning and procedural complications | 1/206 | 0/205 |
| Skin lacerationInjury, poisoning and procedural complications | 1/206 | 0/205 |
| Cervical vertebral fractureInjury, poisoning and procedural complications | 1/206 | 0/205 |
| Nerve injuryInjury, poisoning and procedural complications | 1/206 | 0/205 |
| excoriationInjury, poisoning and procedural complications | 1/206 | 0/205 |
| NephrolithiasisRenal and urinary disorders | 1/206 | 0/205 |
| Event | Placebo | 3804-250A |
|---|---|---|
| Skin lacerationInjury, poisoning and procedural complications | 23/206 | 16/205 |
| ExcoriationInjury, poisoning and procedural complications | 14/206 | 13/205 |
| thermal burnInjury, poisoning and procedural complications | 12/206 | 8/205 |
| HeadacheNervous system disorders | 8/206 | 6/205 |
| Application site pruritusGeneral disorders | 1/206 | 7/205 |
| ScratchInjury, poisoning and procedural complications | 7/206 | 7/205 |
| Open woundInjury, poisoning and procedural complications | 6/206 | 3/205 |
| DysmenorrhoeaReproductive system and breast disorders | 5/206 | 1/205 |
| Application site vesiclesGeneral disorders | 2/206 | 4/205 |
| Oral herpesInfections and infestations | 4/206 | 1/205 |
| Age, Categorical(Participants) | Placebo | 3804-250A | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 203 | 200 | 403 |
| >=65 years | 3 | 5 | 8 |
| Age Continuous(years) | Placebo | 3804-250A | Total |
|---|---|---|---|
| Mean | 37.3 ± 14.56 | 36.2 ± 14.23 | 36.7 ± 14.39 |
| Sex: Female, Male(Participants) | Placebo | 3804-250A | Total |
|---|---|---|---|
| Female | 150 | 155 | 305 |
| Male | 56 | 50 | 106 |
| Region of Enrollment(participants) | Placebo | 3804-250A | Total |
|---|---|---|---|
| United States | 206 | 205 | 411 |
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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