Effect of Simethicone on Eustachian Tube Dysfunction

Otitis Media Clinical Trial

Official title:

A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312038
• Other study ID #: PRO011010385
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2011
• Last updated: June 23, 2016
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: June 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis Media

Intervention

Drug:
• Simethicone
single 125 mg chewable tablet
• Placebo
chewable calcium tablet

Locations

Country	Name	City	State
United States	Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)	The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow	After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment	No