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

NCT00743990 | Completed DMC

• 1 other identifier: 29273
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Tract Diseases

Keywords

Cough symptoms; Cold symptoms; Congestion; Children; URI; Alternative cough symptom treatment

Outcome Measures

Primary Outcomes (1)

• Subjective assessment of cough and congestion symptoms

  24 hours

Study Arms (3)

A

ACTIVE COMPARATOR

Other: Ointment containing camphor, eucalyptus oil, and menthol

B

PLACEBO COMPARATOR

Other: Petroleum jelly

3

NO INTERVENTION

no intervention

Interventions

Ointment containing camphor, eucalyptus oil, and menthol OTHER

One time use

A

Petroleum jelly OTHER

One time use

B

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cough and congestion attributed to upper respiratory tract infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead
• Procter and Gamble: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Related Publications (1)

• 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.

  PMID: 21059712 DERIVED

MeSH Terms

Conditions

Respiratory Tract Diseases; Cough

Interventions

Eucalyptus Oil; Menthol; Petrolatum

Condition Hierarchy (Ancestors)

Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes

Study Officials

• Ian M Paul, MD, MSc

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

US (1)