Otitis MediaPhase 3NCT02600559

Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

A Phase 3 study testing OTO-201 (ciprofloxacin) in people with Otitis Media, 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

Search all trials

Trial summary

This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any… Read more about this study

Who is it for?: Ages 6 months to 17 years
Conditions the study is for: Otitis Media
What is being tested?: OTO-201 (ciprofloxacin)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 501 participants
Where: 1 siteUnited States
Study dates: Oct 2015to Jul 2016
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 history of otitis media requiring bilateral 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 TT placement
Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
Subject has a history of sensorineural hearing loss

Trial locations and contacts

1 site in 1 country.

United States1 site

Email Otonomy Central Contact for Trial Locations
San Diego, California, 92121

Other trials in United States

About this study

Official title: An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes

Conditions: Otitis Media
Being tested: OTO-201 (ciprofloxacin)
Keywords: Otitis media, Ear infection, Tympanostomy tubes
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.

OTO-201 (ciprofloxacin)Drug
Also called OTIPRIO

Study groups in NCT02600559
Study group	Role	What they receive
0.1 mL OTO-201	Experimental	Ciprofloxacin Receives: Drug: OTO-201 (ciprofloxacin)

What is being measured

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

Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Measured: Week 4
Number of Subjects With Post-surgical Otorrhea
Absence or presence of otorrhea (drainage from the middle ear)
Measured: 8 weeks

Secondary outcomes (4)

Adverse Events
Evaluation of adverse events
Measured: Up to Eight Weeks
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 4
Measured: Week 4
Caregiver Burden - Ear Discharge Control
Ear Drop Caregiver Burden Questionnaire at Week 8
Measured: Week 8
Caregiver Burden - Ear Drops Administration
Ear Drop Caregiver Burden Questionnaire at Week 8
Measured: Week 8

Timeline

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

Oct 2015Jul 2016

First posted9 Nov 2015 (estimated)
Study startOct 2015
Primary completionJul 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 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 501 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02600559
Sponsor's protocol ID: 201-201507
Status last verified: Sep 2020
First submitted: 5 Nov 2015
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

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
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

All 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: An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
ClinicalTrials.gov ID: NCT02600559
Acronym / sponsor ID: 201-201507
Conditions: Otitis Media
Keywords: Otitis media, Ear infection, Tympanostomy tubes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 501 participants (actual)
Lead sponsor: Otonomy, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 9 Nov 2015 (estimated)
Results: Posted 22 Sep 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
0.1 mL OTO-201	Experimental	Drug: OTO-201 (ciprofloxacin)Ciprofloxacin

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 history of otitis media requiring bilateral 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 TT placement
Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis
Subject has a history of sensorineural hearing loss

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-201 (ciprofloxacin)Also: OTIPRIO	Drug	0.1 mL OTO-201

Primary outcome

Number of Subjects With Post-surgical Otorrhea
Time frame: Week 4
Absence or presence of otorrhea (drainage from the middle ear)
Number of Subjects With Post-surgical Otorrhea
Time frame: 8 weeks
Absence or presence of otorrhea (drainage from the middle ear)

4 secondary outcomes

Adverse Events
Time frame: Up to Eight Weeks
Caregiver Burden - Ear Discharge Control
Time frame: Week 4
Caregiver Burden - Ear Discharge Control
Time frame: Week 8
Caregiver Burden - Ear Drops Administration
Time frame: Week 8

Results and safety

Results posted to the registry on 22 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	501	478

Primary outcome: Number of Subjects With Post-surgical Otorrhea

Time frame: Week 4. Count of participants. Unit: Participants

Measure	6 mg OTO-201 n = 501
Absence of Otorrhea	383
Presence of Otorrhea	118

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

Primary outcome: Number of Subjects With Post-surgical Otorrhea

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	6 mg OTO-201 n = 501
Absence of Otorrhea	334
Presence of Otorrhea	167

Population analysed: Safety analysis set: All subjects who received study drug

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported during dosing and up to 2 months following tympanostomy tube surgery.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
6 mg OTO-201	1 of 501 (0.2%)	200 of 501 (39.9%)	0 of 501

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 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
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

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.

Dean Hakanson, MD 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 3 study testing OTO-201 (ciprofloxacin) in people with Otitis Media, 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. 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 22 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 Post-surgical Otorrhea (time frame: Week 4). The study lists 2 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 NCT02600559.

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.