Acute Otitis MediaPhase 2NCT02719158

Dose Ranging Study of OTO-201 in AOMT

A Phase 2 study testing 6 mg ciprofloxacin and 12 mg ciprofloxacin in people with Acute Otitis Media and AOMT, run by Otonomy, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dose Ranging Study of OTO-201 in AOMT Read more about this study

Who is it for?: Ages 6 months to 17 years
Conditions the study is for: Acute Otitis Media, AOMT
What is being tested?: 6 mg ciprofloxacin and 12 mg ciprofloxacin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 95 participants
Where: 1 siteUnited States
Study dates: Feb 2016to Jul 2016
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 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 acute otitis media with tympanostomy tubes (AOMT)
Subject's caregiver is willing to comply with the protocol an attend all study visits

Who cannot join

Subject has a history of sensorineural hearing loss
Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
Subject has a history of known immunodeficiency disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Otonomy call center for trial locations
San Diego, California, 92121

Other trials in United States

About this study

Official title: A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects

Dose Ranging Study of OTO-201 in AOMT

Read the detailed description

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Conditions: Acute Otitis Media, AOMT
Being tested: 6 mg ciprofloxacin, 12 mg ciprofloxacin, Sham
Keywords: Acute otitis media with tympanostomy tubes, OTIPRIO
Medical subject headings: Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

6 mg ciprofloxacinDrug
Also called OTIPRIO
Single administration of OTO-201
12 mg ciprofloxacinDrug
Also called OTIPRIO
Single administration of OTO-201
ShamOther

Study groups in NCT02719158
Study group	Role	What they receive
6 mg OTO-201	Experimental	6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) Receives: Drug: 6 mg ciprofloxacin
12 mg OTO-201	Experimental	12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) Receives: Drug: 12 mg ciprofloxacin
Sham (empty syringe)	Sham comparator	Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s) Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Measured: Up to 1 month
Otoscopic Examination: Auricle and Meatus
Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).
Measured: Up to 1 month
Otoscopic Examination: Tympanic Membrane
Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).
Measured: Up to 1 month

Secondary outcomes (1)

Absence of Otorrhea
Absence of otorrhea (middle ear drainage)
Measured: Up to Two Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Jul 2016

First posted25 Mar 2016 (estimated)
Study startFeb 2016
Primary completionJun 2016
Study completionJul 2016

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 Acute Otitis MediaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Care provider
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02719158
Sponsor's protocol ID: 201-201508
Status last verified: Sep 2020
First submitted: 21 Mar 2016
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
ClinicalTrials.gov ID: NCT02719158
Acronym / sponsor ID: 201-201508
Conditions: Acute Otitis Media, AOMT
Keywords: Acute otitis media with tympanostomy tubes, OTIPRIO
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Otonomy, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Jun 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 25 Mar 2016 (estimated)
Results: Posted 24 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Dose Ranging Study of OTO-201 in AOMT

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (care provider)
Number of arms: 3

Arm	Type	Receives
6 mg OTO-201	Experimental	Drug: 6 mg ciprofloxacin6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
12 mg OTO-201	Experimental	Drug: 12 mg ciprofloxacin12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s)
Sham (empty syringe)	Sham comparator	Other: ShamSham (empty syringe), single 0.1 mL STT administration to the affected ear(s)

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 acute otitis media with tympanostomy tubes (AOMT)
Subject's caregiver is willing to comply with the protocol an attend all study visits

Key exclusion criteria (3 listed)

Subject has a history of sensorineural hearing loss
Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
Subject has a history of known immunodeficiency disease

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
6 mg ciprofloxacinAlso: OTIPRIOSingle administration of OTO-201	Drug	6 mg OTO-201
12 mg ciprofloxacinAlso: OTIPRIOSingle administration of OTO-201	Drug	12 mg OTO-201
Sham	Other	Sham (empty syringe)

Primary outcome

Number of Subjects With Adverse Events
Time frame: Up to 1 month
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Otoscopic Examination: Auricle and Meatus
Time frame: Up to 1 month
Number of affected ears (i.e., those ears that were infected) whose external ear and ear canal (auricle and meatus), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The auricle and meatus of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the auricle and meatus with treatment (i.e., a safety measure).
Otoscopic Examination: Tympanic Membrane
Time frame: Up to 1 month
Number of affected ears (i.e., those ears that were infected) whose ear drum (tympanic membrane), when examined through an otoscope, appeared normal at Baseline and appeared abnormal at Day 29. The tympanic membrane of each infected ear was examined using an otoscope and was assessed as either normal or abnormal at every visit. This outcome looks to see if there was a worsening of the condition of the tympanic membrane with treatment (i.e., a safety measure).

1 secondary outcome

Absence of Otorrhea
Time frame: Up to Two Weeks

Results and safety

Results posted to the registry on 24 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
6 mg OTO-201	38	38
12 mg OTO-201	38	38
Control	19	18

Primary outcome: Number of Subjects With Adverse Events

Time frame: Up to 1 month. Count of participants. Unit: Participants

Measure	6 mg OTO-201 n = 38	12 mg OTO-201 n = 38	Control n = 19
Value	19	14	4

Population analysed: Safety analysis set: all subjects who received study drug.

Primary outcome: Otoscopic Examination: Auricle and Meatus

Time frame: Up to 1 month. Number. Unit: abnormal affected ears at Day 29

Measure	6 mg OTO-201 n = 38	12 mg OTO-201 n = 38	Control n = 19
Value	2	0	0

Population analysed: Safety Population (19 sham, 38 6mg, 38 12 mg) who could have had one or 2 affected ears at Baseline (that is, it was not necessary for both ears to be infected to take part in the study). This is why the number of ears in each group do not equal twice the number of participants.

Primary outcome: Otoscopic Examination: Tympanic Membrane

Time frame: Up to 1 month. Number. Unit: abnormal ears at Day 29

Measure	6 mg OTO-201 n = 38	12 mg OTO-201 n = 38	Control n = 19
Value	1	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were reported during dosing and up to 1 month following dosing.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 mg OTO-201	0 of 38 (0%)	5 of 38 (13.2%)	0 of 38
12 mg OTO-201	0 of 38 (0%)	6 of 38 (15.8%)	0 of 38
Control	0 of 19 (0%)	1 of 19 (5.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
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Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
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Recruiting
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Recruiting
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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 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 2 study testing 6 mg ciprofloxacin and 12 mg ciprofloxacin in people with Acute Otitis Media and AOMT, 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 Oct 2020. 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 24 Sep 2020). 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?

Number of Subjects With Adverse Events (time frame: Up to 1 month). The study lists 3 primary outcomes in all. 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 NCT02719158.

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 Oct 2020.