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Completed

NCT Number: NCT00743990

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

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.

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Key information

Conditions

Respiratory Tract Diseases Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Signs and Symptoms Signs and Symptoms, Respiratory

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ointment containing camphor, eucalyptus oil, and menthol

Other

One time use

Petroleum jelly

Other

One time use

Primary outcomes

  1. Subjective assessment of cough and congestion symptoms

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Procter and Gamble

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 29, 2008
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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