Effect of Simethicone on Eustachian Tube Dysfunction
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ClinicalTrials.gov Identifier: NCT01312038 |
Recruitment Status :
Completed
First Posted : March 10, 2011
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Otitis Media | Drug: Simethicone Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: simethicone
125 mg tablet
|
Drug: Simethicone
single 125 mg chewable tablet |
Placebo Comparator: placebo
chewable calcium tablet
|
Drug: Placebo
chewable calcium tablet |
- Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) [ Time Frame: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment ]The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312038
United States, Pennsylvania | |
Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | William J Doyle, PhD | Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC |
Responsible Party: | William J. Doyle, Professor of Otolaryngology, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT01312038 History of Changes |
Other Study ID Numbers: |
PRO011010385 |
First Posted: | March 10, 2011 Key Record Dates |
Results First Posted: | June 27, 2016 |
Last Update Posted: | June 27, 2016 |
Last Verified: | June 2016 |
Eustachian tube otitis middle-ear pressure simethicone |
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases Simethicone |
Antifoaming Agents Molecular Mechanisms of Pharmacological Action Emollients Dermatologic Agents |