Effect of Simethicone on Eustachian Tube Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01312038
First received: March 9, 2011
Last updated: June 23, 2016
Last verified: June 2016
Results First Received: February 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Otitis Media
Interventions: Drug: Simethicone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.

Reporting Groups
  Description
Simethicone

125 mg tablet

Simethicone: single 125 mg chewable tablet

Placebo

chewable calcium tablet

Placebo: chewable calcium tablet


Participant Flow:   Overall Study
    Simethicone     Placebo  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis done by ears with evaluable tests.

Reporting Groups
  Description
Simethicone

125 mg tablet

Simethicone: single 125 mg chewable tablet

Placebo

chewable calcium tablet

Placebo: chewable calcium tablet

Total Total of all reporting groups

Baseline Measures
    Simethicone     Placebo     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age  
[units: years]
Mean (Standard Deviation)
  27.1  (9.1)     32.8  (11.7)     29.8  (10.6)  
Gender  
[units: participants]
     
Female     9     10     19  
Male     4     2     6  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     2     3     5  
White     11     9     20  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     13     12     25  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: mandele@pitt.edu



Responsible Party: William J. Doyle, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01312038     History of Changes
Other Study ID Numbers: PRO011010385
Study First Received: March 9, 2011
Results First Received: February 19, 2016
Last Updated: June 23, 2016
Health Authority: United States: Institutional Review Board