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NCT01312038 · ClinicalTrials.gov registry record · Phase 2
Effect of Simethicone on Eustachian Tube Dysfunction
A Phase 2 study of Otitis Media, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT01312038: Completed Phase 2 study of Otitis Media, sponsored by University of Pittsburgh.
NCT01312038 is a Phase 2 study of Otitis Media that has completed, run by University of Pittsburgh. The registered enrollment target is 25 participants, below the 4,342-participant average among 14 other Otitis Media trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01312038, a Phase 2 study of Otitis Media, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Simethicone
Study Locations (1)
Pennsylvania
- Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT01312038 record still lists
NCT01312038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 4,342-participant average among 14 other Otitis Media trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Otitis Media appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01312038 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01312038 about?
NCT01312038 is a clinical study titled "Effect of Simethicone on Eustachian Tube Dysfunction". 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...
What is the current status of trial NCT01312038?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-03. Estimated completion is 2014-07.
What conditions does trial NCT01312038 study?
This clinical trial studies the following conditions: Otitis Media.
What interventions are being tested in trial NCT01312038?
The interventions under investigation include: Placebo (DRUG), Simethicone (DRUG).
Who is sponsoring clinical trial NCT01312038?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01312038 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Otitis Media
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01312038's enrollment target sits among peer trials
25 15th of 14 the lowest of 14 other Otitis Media trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Otitis Media trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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