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

This study has been completed.
Sponsor:
Collaborator:
Procter and Gamble
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00743990
First received: August 28, 2008
Last updated: May 7, 2010
Last verified: August 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Penn State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ian M Paul MD, MSc Penn State Children's Hospital, Penn State Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00743990     History of Changes
Other Study ID Numbers: 29273
Study First Received: August 28, 2008
Last Updated: May 7, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014