Effect of Simethicone on Eustachian Tube Dysfunction - Full Text View

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
Otitis Media	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:

MedlinePlus related topics: Common Cold Ear Infections

Drug Information available for: Simethicone

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow


Enrollment:	25
Study Start Date:	March 2011
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (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 (Adult)
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


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
Results First Received:	February 19, 2016
Last Updated:	June 23, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:


Eustachian tube otitis middle-ear pressure simethicone

Additional relevant MeSH terms:


Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases Simethicone	Antifoaming Agents Molecular Mechanisms of Pharmacological Action Emollients Dermatologic Agents

ClinicalTrials.gov processed this record on September 28, 2016