We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00743990
First Posted: August 29, 2008
Last Update Posted: November 24, 2017
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.
Collaborator:
Procter and Gamble
Information provided by (Responsible Party):
Penn State University
  Purpose
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00743990


Locations
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
Investigators
Principal Investigator: Ian M Paul, MD, MSc Penn State University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00743990     History of Changes
Other Study ID Numbers: 29273
First Submitted: August 28, 2008
First Posted: August 29, 2008
Last Update Posted: November 24, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Cough
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Menthol
Petrolatum
Camphor
Antipruritics
Dermatologic Agents
Emollients
Anti-Infective Agents, Local
Anti-Infective Agents