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This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1 mL OTO-201 | Experimental | Ciprofloxacin |
|
| 0.2 mL OTO-201 | Experimental | Ciprofloxacin |
|
| 0.4 mL OTO-201 | Experimental | Ciprofloxacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTO-201 (ciprofloxacin) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Otoscopic Examination: Tympanic Membrane | Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day) | Up to 1 month |
| Otoscopic Examination: Middle Ear | Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit) | Up to 1 month |
| Feasibility of Administration | Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy". | Day1 |
| Overall Adverse Events | Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing | up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | 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 | Day 15 (two weeks from dosing) |
| Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) |
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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 |
|---|---|---|---|---|---|---|
| Email Otonomy Central Contact for Trial Locations | San Diego | California | 92121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single administration |
| FG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration |
| FG002 | 24 mg OTO-201 | 24 mg ciprofloxacin: single administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6 mg OTO-201 | 6 mg ciprofloxacin: single administration |
| BG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: 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 | Otoscopic Examination: Tympanic Membrane | Number of subjects with a tympanic membrane that was rated as "Not able to Visualize" or "Abnormal" at Baseline that was rated as "Normal" at Day 29 (final study day) | Safety analysis set: All subjects who received study drug. | Posted | Count of Participants | Participants | Up to 1 month |
|
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 | 6 mg OTO-201 | 6 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 (18.0) | 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 |
| D010031 | Otitis |
| ID | Term |
|---|---|
| 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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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 |
| Day 15 (2 weeks from dosing) |
| BG002 | 24 mg OTO-201 | 24 mg ciprofloxacin: single administration |
| BG003 | 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 |
|
24 mg ciprofloxacin: single administration |
|
|
| Primary | Otoscopic Examination: Middle Ear | Number of subjects with a middle ear that was rated as "Not Able to Visualize" or "Abnormal" at Baseline that had a middle ear rated as "Normal" at Day 29 (final study visit) | Safety analysis set: All subjects that received drug | Posted | Count of Participants | Participants | Up to 1 month |
|
|
|
| Primary | Feasibility of Administration | Ease of administering OTO-201 to the external ear canal. Number of subjects that investigators rated ease of administration as either "easy" or "very easy". | Safety analysis set: All subjects who receieved study drug | Posted | Count of Participants | Participants | Day1 |
|
|
|
| Primary | Overall Adverse Events | Number of Subjects with and without adverse events during the study from dosing up to 1 month after dosing | Safety analysis set: All subjects that received study drug | Posted | Count of Participants | Participants | up to 1 month |
|
|
|
| Secondary | Number of Subjects Considered a Clinical Cure at Day 15 (Intent-to-treat Analysis Set) | 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 were used for assessments of clinical activity | Posted | Count of Participants | Participants | Day 15 (two weeks from dosing) |
|
|
|
| Secondary | Number of Subjects Considered a Clinical Cure at Day 15 (Per-protocol Analysis Set) | 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 | Per-protocol Analysis Set defined as all subjects in the ITT analysis set who received study drug, completed Visit 4 (Day 15), and did not have a major protocol deviation. | Posted | Count of Participants | Participants | Day 15 (2 weeks from dosing) |
|
|
|
| 25 |
| 0 |
| 25 |
| 2 |
| 25 |
| EG001 | 12 mg OTO-201 | 12 mg ciprofloxacin: single administration | 0 | 25 | 0 | 25 | 5 | 25 |
| EG002 | 24 mg OTO-201 | 24 mg ciprofloxacin: single administration | 0 | 25 | 0 | 25 | 10 | 25 |
| Ear pain | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypacusis | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
|
Publication subject to Sponsor consent.
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |