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NCT00743990 Clinical Trial

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

Respiratory Tract Diseases Clinical Trial

Official title:
Effect of a Medicated Topical Therapy, Petrolatum, and No Treatment on Nocturnal Cough and Congestion for Children With Upper Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00743990
Other study ID # 29273
Secondary ID
Status Completed
Phase N/A
First received August 28, 2008
Last updated November 21, 2017
Start date October 2008
Est. completion date March 2010

Study information
Verified date November 2017
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 11 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Ointment containing camphor, eucalyptus oil, and menthol
One time use
• Petroleum jelly
One time use

Locations
Country Name City State
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Penn State University Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Subjective assessment of cough and congestion symptoms 24 hours
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