Effect of Simethicone on Eustachian Tube Dysfunction

NCT ID: NCT01312038

Last Updated: 2016-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

simethicone

125 mg tablet

Group Type: EXPERIMENTAL

Simethicone

Intervention Type: DRUG

single 125 mg chewable tablet

placebo

chewable calcium tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

chewable calcium tablet

Interventions

Simethicone

single 125 mg chewable tablet

Intervention Type: DRUG

Placebo

chewable calcium tablet

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

William J. Doyle

Professor of Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William J Doyle, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC

Locations

Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO011010385

Identifier Type: -

Identifier Source: org_study_id