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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

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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Simethicone Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction
Study Start Date : March 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Simethicone

Arm Intervention/treatment
Experimental: simethicone
125 mg tablet
Drug: Simethicone
single 125 mg chewable tablet

Placebo Comparator: placebo
chewable calcium tablet
Drug: Placebo
chewable calcium tablet

Primary Outcome Measures :
  1. 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

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.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01312038

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United States, Pennsylvania
Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: William J Doyle, PhD Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
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Responsible Party: William J. Doyle, Professor of Otolaryngology, University of Pittsburgh Identifier: NCT01312038    
Other Study ID Numbers: PRO011010385
First Posted: March 10, 2011    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016
Last Verified: June 2016
Keywords provided by William J. Doyle, University of Pittsburgh:
Eustachian tube
middle-ear pressure
Additional relevant MeSH terms:
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Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents