Effect of Simethicone on Eustachian Tube Dysfunction
A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
June 27, 2016
CompletedJune 27, 2016
June 1, 2016
3.3 years
March 9, 2011
February 19, 2016
June 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
simethicone
EXPERIMENTAL125 mg tablet
placebo
PLACEBO COMPARATORchewable calcium tablet
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ellen Mandel, MD
- Organization
- Middle Ear Physiology Laboratory
Study Officials
- PRINCIPAL INVESTIGATOR
William J Doyle, PhD
Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Otolaryngology
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 10, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 27, 2016
Results First Posted
June 27, 2016
Record last verified: 2016-06