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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743990
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : November 24, 2017
Procter and Gamble
Information provided by (Responsible Party):
Penn State University

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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Diseases Other: Ointment containing camphor, eucalyptus oil, and menthol Other: Petroleum jelly Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743990

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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
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Principal Investigator: Ian M Paul, MD, MSc Penn State University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Penn State University Identifier: NCT00743990    
Other Study ID Numbers: 29273
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Keywords provided by Penn State University:
Cough symptoms
Cold symptoms
Alternative cough symptom treatment
Additional relevant MeSH terms:
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Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Dermatologic Agents
Anti-Infective Agents, Local
Anti-Infective Agents