Acute Otitis ExternaPhase 3NCT02801370
Phase 3 Study of OTO-201 in Acute Otitis Externa
A Phase 3 study testing 12 mg ciprofloxacin in people with Acute Otitis Externa and Swimmer's Ear, run by Otonomy, Inc. at 2 sites in 2 countries.
Trial summary
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s). Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Acute Otitis Externa, Swimmer's Ear
- What is being tested?
- 12 mg ciprofloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 262 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2016to Dec 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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is a male or female age 6 months or older
- Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
- Subject or subject's caregiver is willing to comply with the protocol and attend all study visits
Who cannot join
- Subject has tympanic membrane perforation
- Subject has eczematoid otitis externa
- Subject has diabetes mellitus
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Call Otonomy call center for trial locations
San Diego, California, 92121
About this study
Official title: A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
- Conditions
- Acute Otitis Externa, Swimmer's Ear
- Being tested
- 12 mg ciprofloxacin, Sham Control
- Medical subject headings
- Otitis Externa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 mg ciprofloxacinDrug
Also called OTIPRIO
Single administration of OTO-201
Sham ControlDrug
Simulated, single adminstration
| Study group | Role | What they receive |
|---|---|---|
| OTO-201 | Experimental | Not described Receives: Drug: 12 mg ciprofloxacin |
| Control | Sham comparator | Not described Receives: Drug: Sham Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Considered a Clinical Cure at Day 8
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
Measured: At Day 8 (1 week after dosing)
Secondary outcomes (1)
Number of Subjects Considered a Clinical Cure at Day 15
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
Measured: At 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 posted15 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionNov 2016
- Study completionDec 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 ExternaStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 262 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
- NCT02801370
- Sponsor's protocol ID
- 201-201609
- Status last verified
- Sep 2020
- First submitted
- 13 Jun 2016
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT02801370
- Acronym / sponsor ID
- 201-201609
- Conditions
- Acute Otitis Externa, Swimmer's Ear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Otonomy, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Jun 2016 (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.
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTO-201 | Experimental | Drug: 12 mg ciprofloxacin |
| Control | Sham comparator | Drug: Sham Control |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is a male or female age 6 months or older
- Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
- Subject or subject's caregiver is willing to comply with the protocol and attend all study visits
Key exclusion criteria (3 listed)
- Subject has tympanic membrane perforation
- Subject has eczematoid otitis externa
- Subject has diabetes mellitus
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 |
|---|---|---|
| 12 mg ciprofloxacinAlso: OTIPRIOSingle administration of OTO-201 | Drug | OTO-201 |
| Sham ControlSimulated, single adminstration | Drug | Control |
Primary outcome
Number of Subjects Considered a Clinical Cure at Day 8
Time frame: At Day 8 (1 week after dosing)
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
1 secondary outcome
Number of Subjects Considered a Clinical Cure at Day 15
Time frame: At 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 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 12 mg ciprofloxacin in people with Acute Otitis Externa and Swimmer's Ear, run by Otonomy, Inc. at 2 sites in 2 countries.
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 2 sites in United States, Canada. 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 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 Considered a Clinical Cure at Day 8 (time frame: At Day 8 (1 week after dosing)). 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 Oct 2020.