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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OTO-201 | Experimental |
| |
| Control | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 mg ciprofloxacin | Drug | Single administration of OTO-201 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Day 8 (1 week after dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Day 15 (2 weeks after dosing) |
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Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Carl LeBel, PhD | Otonomy, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Call Otonomy call center for trial locations | San Diego | California | 92121 | United States | ||
| Call Otonomy call center for trial locations |
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| ID | Title | Description |
|---|---|---|
| FG000 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration |
| FG001 | Control | Sham Control: Simulated, single adminstration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
262 subjects randomized (132 sham, 130 OTO-201). 2 sham subjects positive for Group A strep and not in ITT population (Baseline characteristics and efficacy) leaving 130 sham, 130 OTO-201. ITT subjects analyzed as randomized. Safety population (AE/SAE) analyzed by what was received (132 sham, 127 OTO-201) regardless of culture, but had be dosed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration |
| BG001 | Control | Sham Control: Simulated, single administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent-to-treat analysis set: All subjects who were randomized and did not have Group A Streptococci cultured on Day 1 | Posted | Count of Participants | Participants | At Day 8 (1 week after dosing) |
|
Adverse events were reported during dosing and up to 1 month following dosing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otitis externa | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Otonomy | 1-800-826-6411 | medinfo@otonomy.com |
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| ID | Term |
|---|---|
| D010032 | Otitis Externa |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Sham Control | Drug | Simulated, single adminstration |
|
| Saskatoon |
| Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | Intent-to-treat analysis set: All subjects who were randomized and and did not have Group A Streptococci cultured on Day 1. | Posted | Count of Participants | Participants | At Day 15 (2 weeks after dosing) |
|
|
|
| 127 |
| 0 |
| 127 |
| 12 |
| 127 |
| EG001 | Control | Sham Control: Simulated, single administration | 0 | 132 | 0 | 132 | 18 | 132 |
| Ear Pain | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ear pruritis | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
|
Publication subject to Sponsor consent.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |