Trial Outcomes & Findings for Effect of Simethicone on Eustachian Tube Dysfunction (NCT NCT01312038)
NCT ID: NCT01312038
Last Updated: 2016-06-27
Results Overview
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment
Results posted on
2016-06-27
Participant Flow
Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.
Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.
Participant milestones
| Measure |
Simethicone
125 mg tablet
Simethicone: single 125 mg chewable tablet
|
Placebo
chewable calcium tablet
Placebo: chewable calcium tablet
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Simethicone on Eustachian Tube Dysfunction
Baseline characteristics by cohort
| Measure |
Simethicone
n=13 Participants
125 mg tablet
Simethicone: single 125 mg chewable tablet
|
Placebo
n=12 Participants
chewable calcium tablet
Placebo: chewable calcium tablet
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
32.8 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
29.8 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
25 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatmentPopulation: ears pre-treatment/ears post-treatment
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Outcome measures
| Measure |
Simethicone-treated
n=22 ears
Outcome measure in each evaluable ear.
|
Placebo
n=18 ears
Outcome measure in each evaluable ear
|
|---|---|---|
|
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
Pre treatment FGE at -200 daPa
|
0.17 ratio
Standard Deviation 0.28
|
0.24 ratio
Standard Deviation 0.34
|
|
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
post-treatment FGE at -200 daPa
|
0.19 ratio
Standard Deviation 0.28
|
0.23 ratio
Standard Deviation 0.32
|
|
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
Pre -treatment FGE at 200 daPa
|
0.24 ratio
Standard Deviation 0.31
|
0.30 ratio
Standard Deviation 0.34
|
|
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
Post-treatment FGE at 200 daPa
|
0.24 ratio
Standard Deviation 0.29
|
0.34 ratio
Standard Deviation 0.37
|
Adverse Events
Simethicone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place