Common ColdPhase 2NCT00762476
Efficacy Trial of 3804-250A in the Prevention of Cold Illnesses
A Phase 2 study testing 3804-250A and 3804-291 in people with Common Cold, run by The Dial Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- 3804-250A and 3804-291
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 411 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy normal
- good general health
Who cannot join
- pregnancy
- insulin dependent diabetes
- daily smoker
- skin disease on the hands/wrists
- immunological disorders
- occupation involving frequent handwashing
- common cold symptoms
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia School of Medicine
Charlottesville, Virginia, 22908
TKL Research, Inc.
Paramus, New Jersey, 07652
About this study
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 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.
Read the detailed description
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.
- Conditions
- Common Cold
- Being tested
- 3804-250A, 3804-291
- Keywords
- cold, common, rhinovirus
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3804-250ADrug
- topical product
- apply 2 pumps
- apply at least every 4 hours or after hand washing
3804-291Drug
- topical
- apply 2 pumps
- apply at least every 4 hours or after hand washing
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: 3804-291 |
| 3804-250A | Experimental | Not described Receives: Drug: 3804-250A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (2)
Rhinovirus Infections.
The incidence of rhinovirus infections
Measured: 10 weeks
Rhinovirus-associated Colds
The incidence of rhinovirus-associated cold illnesses.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Dial Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hill Top Research, TKL Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Ronald B Turner, MD, Principal investigator, University of Virginia School of MedicineMichael E Casser, MD, Principal investigator, TKL Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762476
- Sponsor's protocol ID
- TM&R-0062-08-TXC
- Other IDs
- CS990108, 13805
- Status last verified
- Mar 2012
- First submitted
- 26 Sep 2008
- Last updated
- 16 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00762476
- Acronym / sponsor ID
- TM&R-0062-08-TXC
- Conditions
- Common Cold
- Keywords
- cold, common, rhinovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- The Dial CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Hill Top Research, TKL Research, Inc.
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 16 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 3804-291 |
| 3804-250A | Experimental | Drug: 3804-250A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy normal
- good general health
Key exclusion criteria (7 listed)
- pregnancy
- insulin dependent diabetes
- daily smoker
- skin disease on the hands/wrists
- immunological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3804-250A* topical product * apply 2 pumps * apply at least every 4 hours or after hand washing | Drug | 3804-250A |
| 3804-291* topical * apply 2 pumps * apply at least every 4 hours or after hand washing | Drug | Placebo |
Primary outcome
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses.
Time frame: 10 weeks
Comparison of the total number of incidence of cold illnesses over the course of the study per 100 subjects in each treatment group
2 secondary outcomes
Rhinovirus Infections.
Time frame: 10 weeks
Rhinovirus-associated Colds
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald B Turner, MD principal investigator
University of Virginia School of Medicine
Michael E Casser, MD principal investigator
TKL Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 3804-250A and 3804-291 in people with Common Cold, run by The Dial Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Efficacy Endpoint of This Study is the Incidence of Cold Illnesses. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.