Otitis MediaPhase 2NCT01312038
Effect of Simethicone on Eustachian Tube Dysfunction
A Phase 2 study testing Simethicone in people with Otitis Media, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Simethicone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 years
- Healthy subjects other than current upper respiratory tract infection ("cold")
- Jackson Score of 6 on screening
- Subject reports symptom onset within 4 days of entry visit
- Unilateral or bilateral middle-ear pressure <-50 mmH2O
Who cannot join
- Otoscopic diagnosis of unilateral or bilateral otitis media
- Presence of tympanostomy tubes or tympanic membrane perforations bilaterally
- Asthma or any chronic medical disease or condition
- Use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control)
- Use of an experimental drug within 3 months of study
- An unusual or allergic reaction to simethicone, food dyes, or preservatives
- Pregnancy or breast feeding
- Ear surgery other than tympanostomy tube insertion
Trial locations and contacts
1 site in 1 country.
United States1 site
Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold 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) 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.
Read the detailed description
For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.
- Conditions
- Otitis Media
- Being tested
- Simethicone, Placebo
- Keywords
- Eustachian tube, otitis, middle-ear pressure, simethicone
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimethiconeDrug
single 125 mg chewable tablet
PlaceboDrug
chewable calcium tablet
| Study group | Role | What they receive |
|---|---|---|
| simethicone | Experimental | 125 mg tablet Receives: Drug: Simethicone |
| placebo | Placebo comparator | chewable calcium tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Measured: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William J. Doyle, University of Pittsburgh
- Investigators
- William J Doyle, PhD, Principal investigator, Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312038
- Sponsor's protocol ID
- PRO011010385
- Status last verified
- Jun 2016
- First submitted
- 9 Mar 2011
- Last updated
- 27 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction
- ClinicalTrials.gov ID
- NCT01312038
- Acronym / sponsor ID
- PRO011010385
- Conditions
- Otitis Media
- Keywords
- Eustachian tube, otitis, middle-ear pressure, simethicone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Mar 2011 (estimated)
- Results
- Posted 27 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simethicone | Experimental | Drug: Simethicone125 mg tablet |
| placebo | Placebo comparator | Drug: Placebochewable calcium tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 50 years
- Healthy subjects other than current upper respiratory tract infection ("cold")
- Jackson Score of 6 on screening
- Subject reports symptom onset within 4 days of entry visit
- Unilateral or bilateral middle-ear pressure <-50 mmH2O
Key exclusion criteria (8 listed)
- Otoscopic diagnosis of unilateral or bilateral otitis media
- Presence of tympanostomy tubes or tympanic membrane perforations bilaterally
- Asthma or any chronic medical disease or condition
- Use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control)
- Use of an experimental drug within 3 months of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simethiconesingle 125 mg chewable tablet | Drug | simethicone |
| Placebochewable calcium tablet | Drug | placebo |
Primary outcome
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
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Doyle, PhD principal investigator
Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simethicone in people with Otitis Media, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.