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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
Sponsor:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Otitis Media
Interventions Drug: Simethicone
Drug: Placebo
Enrollment 25
Recruitment Details Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.
Pre-assignment Details Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.
Arm/Group Title Simethicone Placebo
Hide 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
Arm/Group Title Simethicone Placebo Total
Hide 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 Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
Analysis done by ears with evaluable tests.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
27.1  (9.1) 32.8  (11.7) 29.8  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
9
  69.2%
10
  83.3%
19
  76.0%
Male
4
  30.8%
2
  16.7%
6
  24.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  15.4%
3
  25.0%
5
  20.0%
White
11
  84.6%
9
  75.0%
20
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ears pre-treatment/ears post-treatment
Arm/Group Title Simethicone-treated Placebo
Hide Arm/Group Description:
Outcome measure in each evaluable ear.
Outcome measure in each evaluable ear
Overall Number of Participants Analyzed 13 12
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
22 18
Mean (Standard Deviation)
Unit of Measure: ratio
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value =0.93
Comments [Not Specified]
Method Paired T-test
Comments df=34
Show Statistical Analysis 2 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value =0.39
Comments [Not Specified]
Method Paired T-test
Comments df = 31
Time Frame The subjects were assessed throughout the experimental procedure which lasted for 2 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Simethicone Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Simethicone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Simethicone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/12 (0.00%) 
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.
Results Point of Contact
Name/Title: Ellen Mandel, MD
Organization: Middle Ear Physiology Laboratory
Phone: 412-692-6214
Responsible Party: William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01312038     History of Changes
Other Study ID Numbers: PRO011010385
First Submitted: March 9, 2011
First Posted: March 10, 2011
Results First Submitted: February 19, 2016
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016