Otitis Media With EffusionPhase 3NCT01949155
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
A Phase 3 study testing OTO-201 in people with Otitis Media With Effusion, run by Otonomy, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of 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 17 years
- Conditions the study is for
- Otitis Media With Effusion
- 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
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2014
- Phase
- Phase 3
- 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 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is a male or female aged 6 months to 17 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: Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Read the detailed description
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or >2 years.
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.
- Conditions
- Otitis Media With Effusion
- Being tested
- OTO-201, Sham
- Keywords
- otitis media, otorrhea, middle ear effusion, tympanostomy tubes
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTO-201Drug
Single, intratympanic injection
ShamDrug
Simulated single, intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| OTO-201 | Experimental | OTO-201: Single, intratympanic injection:
One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. Receives: Drug: OTO-201 |
| Sham | Sham comparator | Sham: Simulated single, intratympanic injection:
One sham injection into each ear during surgery. Receives: Drug: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Were Treatment Failures.
Cumulative proportion of treatment failures:
The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.
Measured: Day 15 - 2 weeks after dosing
Secondary outcomes (2)
Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry
Safety variables included the frequency of adverse events (AEs) and results from otoscopic examinations, tympanometry, audiometry measurements.
Measured: Up to one month
Microbiological Response
Subjects whose samples tested positive for bacteria in either or both ears at baseline with documented eradication or presumed eradication post-baseline.
Measured: Day 15 - 2 weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otonomy, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl LeBel, PhD, Study director, Otonomy, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949155
- Sponsor's protocol ID
- 201-201303
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2013
- Last updated
- 11 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001.
PubMed 26985629
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, P3 Study of OTO-201 Given as a Single IT Injection For Intra-Operative Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
- ClinicalTrials.gov ID
- NCT01949155
- Acronym / sponsor ID
- 201-201303
- Conditions
- Otitis Media With Effusion
- Keywords
- otitis media, otorrhea, middle ear effusion, tympanostomy tubes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Posted 11 Nov 2016
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 confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Detailed description
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).
Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.
Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or >2 years.
Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTO-201 | Experimental | Drug: OTO-201OTO-201: Single, intratympanic injection: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. |
| Sham | Sham comparator | Drug: ShamSham: Simulated single, intratympanic injection: One sham injection into each ear during surgery. |
Who may qualify
- Ages
- 6 months to 17 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 17 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-201Single, intratympanic injection | Drug | OTO-201 |
| ShamSimulated single, intratympanic injection | Drug | Sham |
Primary outcome
Percentage of Participants Who Were Treatment Failures.
Time frame: Day 15 - 2 weeks after dosing
Cumulative proportion of treatment failures: The efficacy endpoint for both trials was the cumulative proportion of study treatment failures through Day 15, defined as the occurrence of any of the following events: otorrhea as determined by a blinded assessor on or after 3 days post-surgery, otic or systemic antibacterial drug use for any reason any time post-surgery, as well as patients who missed visits or were lost-to-follow-up.
2 secondary outcomes
Evaluation of Adverse Events, Otoscopic Exams, Audiometry and Tympanometry
Time frame: Up to one month
Microbiological Response
Time frame: Day 15 - 2 weeks after dosing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26985629Mair EA, Park AH, Don D, Koempel J, Bear M, LeBel C. Safety and Efficacy of Intratympanic Ciprofloxacin Otic Suspension in Children With Middle Ear Effusion Undergoing Tympanostomy Tube Placement: Two Randomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2016 May 1;142(5):444-51. doi: 10.1001/jamaoto.2016.0001.
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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.
Carl LeBel, PhD study director
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 3 study testing OTO-201 in people with Otitis Media With Effusion, 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 11 Nov 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Nov 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?
Percentage of Participants Who Were Treatment Failures. (time frame: Day 15 - 2 weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01949155, which also lists 1 linked publication.
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 11 Nov 2016.