Effect of Simethicone on Eustachian Tube Dysfunction
Completed · Phase 2 · Has a placebo group
Conditions studied: Otitis Media
In brief
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.
Key facts
- Study ID
- NCT01312038
- Run by
- University of Pittsburgh
- People needed
- 25
- Starts
- 2011-03-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2016-06-27
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.