Respiratory Tract DiseasesNCT00743990
Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough
A study testing Ointment containing camphor, eucalyptus oil, and menthol and Petroleum jelly in people with Respiratory Tract Diseases, run by Penn State University at 1 site in United States.
Trial summary
This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children. Read more about this study
- Who is it for?
- Ages 2 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Ointment containing camphor, eucalyptus oil, and menthol and Petroleum jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cough and congestion attributed to upper respiratory tract infection
Who cannot join
- Children with signs or symptoms of more serious or treatable disease
- Presence of itchy, watery eyes or frequent sneezing
- Tachypnea (respiratory rate >95%ile) or labored breathing
- Symptoms for 8 or more days
- History of asthma in the past 2 years, chronic lung disease, or seizure disorder
- History of an allergic reaction to camphor, menthol, eucalyptus, petrolatum, cedarleaf oil, nutmeg oil, thymol, turpentine oil, Over-the-counter medication containing VVR components
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
About this study
Official title: Effect of a Medicated Topical Therapy, Petrolatum, and No Treatment on Nocturnal Cough and Congestion for Children With Upper Respiratory Infections
This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.
- Conditions
- Respiratory Tract Diseases
- Being tested
- Ointment containing camphor, eucalyptus oil, and menthol, Petroleum jelly
- Keywords
- Cough symptoms, Cold symptoms, Congestion, Children, URI, Alternative cough symptom treatment
- Medical subject headings
- Respiratory Tract Diseases, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ointment containing camphor, eucalyptus oil, and mentholOther
One time use
Petroleum jellyOther
One time use
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Other: Ointment containing camphor, eucalyptus oil, and menthol |
| B | Placebo comparator | Not described Receives: Other: Petroleum jelly |
| 3 | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective assessment of cough and congestion symptoms
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Ian M Paul, MD, MSc, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743990
- Sponsor's protocol ID
- 29273
- Status last verified
- Nov 2017
- First submitted
- 28 Aug 2008
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paul IM, Beiler JS, King TS, Clapp ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms. Pediatrics. 2010 Dec;126(6):1092-9. doi: 10.1542/peds.2010-1601. Epub 2010 Nov 8.
PubMed 21059712
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Medicated Topical Therapy, Petrolatum, and No Treatment on Nocturnal Cough and Congestion for Children With Upper Respiratory Infections
- ClinicalTrials.gov ID
- NCT00743990
- Acronym / sponsor ID
- 29273
- Conditions
- Respiratory Tract Diseases
- Keywords
- Cough symptoms, Cold symptoms, Congestion, Children, URI, Alternative cough symptom treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Oct 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to subjectively evaluate whether a single application of Vicks® VapoRub® (VVR) ointment or a control ointment (petrolatum) will be superior to no treatment for control of nocturnal cough and congestion due to upper respiratory tract infection (URI) as rated by both parents and children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Ointment containing camphor, eucalyptus oil, and menthol |
| B | Placebo comparator | Other: Petroleum jelly |
| 3 | No intervention | –no intervention |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Cough and congestion attributed to upper respiratory tract infection
Key exclusion criteria (6 listed)
- Children with signs or symptoms of more serious or treatable disease
- Presence of itchy, watery eyes or frequent sneezing
- Tachypnea (respiratory rate >95%ile) or labored breathing
- Symptoms for 8 or more days
- History of asthma in the past 2 years, chronic lung disease, or seizure disorder
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 |
|---|---|---|
| Ointment containing camphor, eucalyptus oil, and mentholOne time use | Other | A |
| Petroleum jellyOne time use | Other | B |
Primary outcome
Subjective assessment of cough and congestion symptoms
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Derived from this study: PubMed 21059712Paul IM, Beiler JS, King TS, Clapp ER, Vallati J, Berlin CM Jr. Vapor rub, petrolatum, and no treatment for children with nocturnal cough and cold symptoms. Pediatrics. 2010 Dec;126(6):1092-9. doi: 10.1542/peds.2010-1601. Epub 2010 Nov 8.
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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.
Ian M Paul, MD, MSc principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ointment containing camphor, eucalyptus oil, and menthol and Petroleum jelly in people with Respiratory Tract Diseases, run by Penn State University at 1 site 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 1 inclusion and 6 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 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subjective assessment of cough and congestion symptoms (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743990, which also lists 1 linked publication.
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 24 Nov 2017.