Effect of Simethicone on Eustachian Tube Dysfunction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01312038
First received: March 9, 2011
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Negative Middle Ear Pressure
Drug: Simethicone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • change in Eustachian tube function measures [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: simethicone
125 mg tablet
Drug: Simethicone
single 125 mg chewable tablet
Placebo Comparator: placebo
chewable calcium tablet
Drug: Placebo
chewable calcium tablet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01312038

Locations
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
Investigators
Principal Investigator: William J Doyle, PhD Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
  More Information

No publications provided

Responsible Party: William J. Doyle, Professor of Otolaryngology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01312038     History of Changes
Other Study ID Numbers: PRO011010385
Study First Received: March 9, 2011
Last Updated: August 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Eustachian tube
otitis
middle-ear pressure
simethicone

Additional relevant MeSH terms:
Simethicone
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Emollients
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014