Bilateral Middle Ear Effusion Requiring Tympanostomy Tube PlacementPhase 1NCT01755286
OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Phase 1 study testing OTO-201 in people with Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement, run by Otonomy, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement
- What is being tested?
- OTO-201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is a male or female aged 6 months to 12 years, inclusive
- Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
- Subject's caregiver is willing to comply with the protocol and attend all study visits
Who cannot join
- Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Call/Email Otonomy Central Contact for Trial Locations
San Diego, California, 92121
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
- Being tested
- OTO-201, Placebo, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-201Drug
Also called ciprofloxacin
Single intra-operative injection
PlaceboDrug
Single intratympanic injection
ShamDrug
Simulated single intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| 4 mg OTO-201 | Experimental | Not described Receives: Drug: OTO-201 |
| 12 mg OTO-201 | Experimental | Not described Receives: Drug: OTO-201 |
| Vehicle for OTO-201 | Placebo comparator | Not described Receives: Drug: Placebo |
| Sham | Sham comparator | Not described Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
Measured: Up to 1 month
Secondary outcomes (2)
Clinical Activity
Evaluation of physician reported and caregiver reported otorrhea
Measured: Up to 1 month
Microbiological Eradication
Microbiological eradication of pretherapy bacteria
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Middle Ear Effusion Requiring Tympanostomy Tube PlacementStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study chair, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755286
- Sponsor's protocol ID
- 201-201101
- Status last verified
- Jun 2013
- First submitted
- 18 Dec 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo- and Sham-Controlled, Multicenter, Phase 1b Study of OTO-201 Given as a Single Intratympanic Injection for Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
- ClinicalTrials.gov ID
- NCT01755286
- Acronym / sponsor ID
- 201-201101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 4 mg OTO-201 | Experimental | Drug: OTO-201 |
| 12 mg OTO-201 | Experimental | Drug: OTO-201 |
| Vehicle for OTO-201 | Placebo comparator | Drug: Placebo |
| Sham | Sham comparator | Drug: Sham |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subject is a male or female aged 6 months to 12 years, inclusive
- Subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement
- Subject's caregiver is willing to comply with the protocol and attend all study visits
Key exclusion criteria (3 listed)
- Subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement
- Subject has a history of sensorineural hearing loss
- Subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the 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 |
|---|---|---|
| OTO-201Also: ciprofloxacinSingle intra-operative injection | Drug | 12 mg OTO-201, 4 mg OTO-201 |
| PlaceboSingle intratympanic injection | Drug | Vehicle for OTO-201 |
| ShamSimulated single intratympanic injection | Drug | Sham |
Primary outcome
Safety
Time frame: Up to 1 month
Evaluation of adverse events, otoscopic exams, audiometry, and tympanometry
2 secondary outcomes
Clinical Activity
Time frame: Up to 1 month
Microbiological Eradication
Time frame: Up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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.
Carl LeBel, PhD study chair
Otonomy, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTO-201 in people with Bilateral Middle Ear Effusion Requiring Tympanostomy Tube Placement, run by Otonomy, Inc. 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 3 inclusion and 3 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 19 Jun 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (time frame: Up to 1 month). 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 19 Jun 2013.