Effect of Effect of a Medicated Topical Therapy , Petrola... | NCT00743990

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

NCT00743990

Sponsor

Penn State University

Status

Completed

Last Update Posted

Nov 24, 2017Actual

Enrollment

143Actual

Phase

Not Applicable

Conditions

Respiratory Tract Diseases

Interventions

Ointment containing camphor, eucalyptus oil, and menthol
Petroleum jelly

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 28, 2008

First Submission Date that Met QC Criteria

Aug 28, 2008

First Posted Date

Aug 29, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2017

Last Update Posted Date

Nov 24, 2017Actual

Name	Class
Procter and Gamble	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Other: Ointment containing camphor, eucalyptus oil, and menthol
B	Placebo Comparator		Other: Petroleum jelly
3	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ointment containing camphor, eucalyptus oil, and menthol	Other	One time use	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective assessment of cough and congestion symptoms		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ian M Paul, MD, MSc	Penn State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S. Hershey Medical Center		Hershey	Pennsylvania	17033-0850	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21059712	Derived	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.

ID	Term
D012120	Respiration Disorders
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000078122	Eucalyptus Oil
D008610	Menthol
D010577	Petrolatum

ID	Term
D010938	Plant Oils
D009821	Oils
D008055	Lipids
D028321	Plant Preparations
D001688

ID	Term
D012140	Respiratory Tract Diseases
D003371	Cough