Effect of Simethicone on Eustachian Tube Dysfunction

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01312038
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Media	Drug: Simethicone; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• 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: Mar 1, 2011
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: William J Doyle, PhD, Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William J. Doyle, Professor of Otolaryngology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01312038
• Other Study ID Numbers: PRO011010385
• First Posted: Mar 10, 2011
• Last Update Posted: Jun 27, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by William J. Doyle, Professor of Otolaryngology, University of Pittsburgh: Eustachian tube; otitis; middle-ear pressure; simethicone
• Additional relevant MeSH terms: Otitis; Otitis Media; Simethicone

Study Results

Participant Flow

Recruitment Details	Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.
Pre-assignment Detail	Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.

Arm/Group Title	Simethicone	Placebo
Arm/Group Description	125 mg tablet Simethicone: single 125 mg chewable tablet	chewable calcium tablet Placebo: chewable calcium tablet
Period Title: Overall Study
STARTED	13	12
COMPLETED	13	12
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Simethicone	Placebo	Total
Arm/Group Description	125 mg tablet Simethicone: single 125 mg chewable tablet	chewable calcium tablet Placebo: chewable calcium tablet	Total of all reporting groups
Overall Participants	13	12	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27.1 (9.1)	32.8 (11.7)	29.8 (10.6)
Sex: Female, Male (Count of Participants)
Female	9 69.2%	10 83.3%	19 76%
Male	4 30.8%	2 16.7%	6 24%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 15.4%	3 25%	5 20%
White	11 84.6%	9 75%	20 80%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	12 100%	25 100%

Outcome Measures

1. Primary Outcome

Title	Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
Description	The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Time Frame	After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment

Outcome Measure Data

Analysis Population Description

ears pre-treatment/ears post-treatment

Arm/Group Title	Simethicone-treated	Placebo
Arm/Group Description	Outcome measure in each evaluable ear.	Outcome measure in each evaluable ear
Measure Participants	13	12
Measure ears	22	18
Pre treatment FGE at -200 daPa	0.17 (0.28)	0.24 (0.34)
post-treatment FGE at -200 daPa	0.19 (0.28)	0.23 (0.32)
Pre -treatment FGE at 200 daPa	0.24 (0.31)	0.30 (0.34)
Post-treatment FGE at 200 daPa	0.24 (0.29)	0.34 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Simethicone-treated, Placebo
	Comments	Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.93
	Comments
	Method	Paired T-test
	Comments	df=34

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Simethicone-treated, Placebo
	Comments	Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.39
	Comments
	Method	Paired T-test
	Comments	df = 31

Adverse Events

Time Frame	The subjects were assessed throughout the experimental procedure which lasted for 2 hours.
Arm/Group Title	Simethicone		Placebo
Arm/Group Description	125 mg tablet Simethicone: single 125 mg chewable tablet		chewable calcium tablet Placebo: chewable calcium tablet
All Cause Mortality
	Simethicone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Simethicone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Simethicone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.