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Effect of Effect of a Medicated Topical Therapy , Petrolatum, and No Treatment on Nocturnal Cough

NCT ID: NCT00743990

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Tract Diseases

Keywords

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Cough symptoms Cold symptoms Congestion Children URI Alternative cough symptom treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Ointment containing camphor, eucalyptus oil, and menthol

Intervention Type OTHER

One time use

B

Group Type PLACEBO_COMPARATOR

Petroleum jelly

Intervention Type OTHER

One time use

3

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ointment containing camphor, eucalyptus oil, and menthol

One time use

Intervention Type OTHER

Petroleum jelly

One time use

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cough and congestion attributed to upper respiratory tract infection

Exclusion Criteria

* 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
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian M Paul, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21059712 (View on PubMed)

Other Identifiers

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29273

Identifier Type: -

Identifier Source: org_study_id