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

This study has been completed.
Procter and Gamble
Information provided by:
Penn State University Identifier:
First received: August 28, 2008
Last updated: May 7, 2010
Last verified: August 2009
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.

Condition Intervention
Respiratory Tract Diseases Other: Ointment containing camphor, eucalyptus oil, and menthol Other: Petroleum jelly

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of a Medicated Topical Therapy, Petrolatum, and No Treatment on Nocturnal Cough and Congestion for Children With Upper Respiratory Infections

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Subjective assessment of cough and congestion symptoms [ Time Frame: 24 hours ]

Enrollment: 143
Study Start Date: October 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Other: Ointment containing camphor, eucalyptus oil, and menthol
One time use
Placebo Comparator: B Other: Petroleum jelly
One time use
No Intervention: 3
no intervention


Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00743990

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Sponsors and Collaborators
Penn State University
Procter and Gamble
Principal Investigator: Ian M Paul, MD, MSc Penn State University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ian M Paul MD, MSc Penn State Children's Hospital, Penn State Hershey Medical Center Identifier: NCT00743990     History of Changes
Other Study ID Numbers: 29273
Study First Received: August 28, 2008
Last Updated: May 7, 2010

Keywords provided by Penn State University:
Cough symptoms
Cold symptoms
Alternative cough symptom treatment

Additional relevant MeSH terms:
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents processed this record on September 21, 2017