Trial · NCT01312038
Effect of Simethicone on Eustachian Tube Dysfunction
NCT01312038, Phase 2, Completed, University of Pittsburgh; results first posted 2016-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of Simethicone on Eustachian Tube Dysfunction. Trials, record NCT01312038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01312038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Simethicone on Eustachian Tube Dysfunction
- NCT number
- NCT01312038
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Otitis Media
- Interventions
- Simethicone, Placebo
- First posted
- 2011-03-10
- Last updated
- 2016-06-27
- Results first posted
- 2016-06-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment | ears pre-treatment/ears post-treatment | ratio | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Simethicone-treated | Pre treatment FGE at -200 daPa | 0.17 | Standard Deviation 0.28 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Placebo | Pre treatment FGE at -200 daPa | 0.24 | Standard Deviation 0.34 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Simethicone-treated | post-treatment FGE at -200 daPa | 0.19 | Standard Deviation 0.28 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Placebo | post-treatment FGE at -200 daPa | 0.23 | Standard Deviation 0.32 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Simethicone-treated | Pre -treatment FGE at 200 daPa | 0.24 | Standard Deviation 0.31 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Placebo | Pre -treatment FGE at 200 daPa | 0.30 | Standard Deviation 0.34 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Simethicone-treated | Post-treatment FGE at 200 daPa | 0.24 | Standard Deviation 0.29 | ratio |
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Placebo | Post-treatment FGE at 200 daPa | 0.34 | Standard Deviation 0.37 | ratio |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Simethicone | 13 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Simethicone | 13 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | NOT COMPLETED | Simethicone | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Simethicone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Simethicone | 0 | 13 |
| Total, other adverse events | Placebo | 0 | 12 |
| Total, serious adverse events | Simethicone | 0 | 13 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Simethicone vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01312038
GET https://conductscience.org/api/trials/v1/NCT01312038/registered