Effect of Simethicone on Eustachian Tube Dysfunction

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Simethicone

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