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Trial record 2 of 3 for:    Taste Disorders AND middle-ear disease

Effect of Simethicone on Eustachian Tube Dysfunction

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: NCT01312038
Recruitment Status : Completed
First Posted : March 10, 2011
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 9, 2011
First Posted Date  ICMJE March 10, 2011
Results First Submitted Date  ICMJE February 19, 2016
Results First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE March 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) [ Time Frame: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment ]
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
change in Eustachian tube function measures [ Time Frame: 30 minutes ]
Change History Complete list of historical versions of study NCT01312038 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Effect of Simethicone on Eustachian Tube Dysfunction
Official Title  ICMJE A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction
Brief Summary This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian tube does not open, does not open often enough or is always open. Simethicone, available over-the-counter under several brand names including Gas-X, may help break up the bubbles that may block the opening of the Eustachian tube in the back of the nose during a cold, allowing air to pass between the nose and middle ear. This study requires a single visit to the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient) will be given and Eustachian tube function testing repeated.
Detailed Description For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Otitis Media
Intervention  ICMJE
  • Drug: Simethicone
    single 125 mg chewable tablet
  • Drug: Placebo
    chewable calcium tablet
Study Arms  ICMJE
  • Experimental: simethicone
    125 mg tablet
    Intervention: Drug: Simethicone
  • Placebo Comparator: placebo
    chewable calcium tablet
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2011)
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 50 years
  • Healthy subjects other than current upper respiratory tract infection ("cold")
  • Jackson Score of 6 on screening
  • Subject reports symptom onset within 4 days of entry visit
  • Unilateral or bilateral middle-ear pressure <-50 mmH2O

Exclusion Criteria:

  • Otoscopic diagnosis of unilateral or bilateral otitis media
  • Presence of tympanostomy tubes or tympanic membrane perforations bilaterally
  • Asthma or any chronic medical disease or condition
  • Use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control)
  • Use of an experimental drug within 3 months of study
  • An unusual or allergic reaction to simethicone, food dyes, or preservatives
  • Pregnancy or breast feeding
  • Ear surgery other than tympanostomy tube insertion
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01312038
Other Study ID Numbers  ICMJE PRO011010385
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William J. Doyle, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William J Doyle, PhD Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
PRS Account University of Pittsburgh
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP