Dose Ranging Study of OTO-201 in AOMT
Study Details
Study Description
Brief Summary
Dose Ranging Study of OTO-201 in AOMT
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 6 mg OTO-201 6 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.1 mL supra-tympanostomy tube (STT) administration to the affected ear(s) |
Drug: 6 mg ciprofloxacin
Single administration of OTO-201
Other Names:
|
Experimental: 12 mg OTO-201 12 mg OTO-201 (sustained-release suspension of ciprofloxacin), single 0.2 mL supra-tympanostomy tube (STT) administration to the affected ear(s) |
Drug: 12 mg ciprofloxacin
Single administration of OTO-201
Other Names:
|
Sham Comparator: Sham (empty syringe) Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s) |
Other: Sham
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Adverse Events [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 [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 [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).
Secondary Outcome Measures
- Absence of Otorrhea [Up to Two Weeks]
Absence of otorrhea (middle ear drainage)
Eligibility Criteria
Criteria
Inclusion Criteria includes, but is not limited to:
-
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
Exclusion Criteria includes, but is not limited to:
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Contact Otonomy call center for trial locations | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Otonomy, Inc.
Investigators
- Study Chair: Carl LeBel, PhD, Otonomy, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201-201508
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control |
---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration |
Period Title: Overall Study | |||
STARTED | 38 | 38 | 19 |
COMPLETED | 38 | 38 | 18 |
NOT COMPLETED | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control | Total |
---|---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration | Total of all reporting groups |
Overall Participants | 37 | 38 | 18 | 93 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
3.004
(3.0546)
|
3.955
(2.9111)
|
3.551
(2.4583)
|
3.498
(2.8915)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
15
40.5%
|
18
47.4%
|
7
38.9%
|
40
43%
|
Male |
22
59.5%
|
20
52.6%
|
11
61.1%
|
53
57%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
3
8.1%
|
3
7.9%
|
2
11.1%
|
8
8.6%
|
Not Hispanic or Latino |
33
89.2%
|
35
92.1%
|
16
88.9%
|
84
90.3%
|
Unknown or Not Reported |
1
2.7%
|
0
0%
|
0
0%
|
1
1.1%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
8
21.6%
|
9
23.7%
|
5
27.8%
|
22
23.7%
|
White |
29
78.4%
|
27
71.1%
|
11
61.1%
|
67
72%
|
More than one race |
0
0%
|
2
5.3%
|
1
5.6%
|
3
3.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
1
5.6%
|
1
1.1%
|
Region of Enrollment (participants) [Number] | ||||
United States |
37
100%
|
38
100%
|
18
100%
|
93
100%
|
Outcome Measures
Title | Number of Subjects With Adverse Events |
---|---|
Description | Number of subjects with adverse events during the study from dosing up to 1 month after dosing |
Time Frame | Up to 1 month |
Outcome Measure Data
Analysis Population Description |
---|
Safety analysis set: all subjects who received study drug. |
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control |
---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration |
Measure Participants | 38 | 38 | 19 |
Count of Participants [Participants] |
19
51.4%
|
14
36.8%
|
4
22.2%
|
Title | Otoscopic Examination: Auricle and Meatus |
---|---|
Description | 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). |
Time Frame | Up to 1 month |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control |
---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration |
Measure Participants | 38 | 38 | 19 |
Measure normal affected ears at Baseline | 21 | 17 | 7 |
Number [abnormal affected ears at Day 29] |
2
|
0
|
0
|
Title | Otoscopic Examination: Tympanic Membrane |
---|---|
Description | 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). |
Time Frame | Up to 1 month |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control |
---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration |
Measure Participants | 38 | 38 | 19 |
Measure normal affected ears at Baseline | 23 | 15 | 10 |
Number [abnormal ears at Day 29] |
1
|
0
|
0
|
Title | Absence of Otorrhea |
---|---|
Description | Absence of otorrhea (middle ear drainage) |
Time Frame | Up to Two Weeks |
Outcome Measure Data
Analysis Population Description |
---|
Modified intent-to-treat analysis set: all subjects who were randomized, received treatment, did not have group A streptococci cultured on Visit 1 (Day 1), and had at least 1 on-therapy visit. |
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control |
---|---|---|---|
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration |
Measure Participants | 37 | 38 | 18 |
Count of Participants [Participants] |
20
54.1%
|
23
60.5%
|
2
11.1%
|
Adverse Events
Time Frame | Adverse events were reported during dosing and up to 1 month following dosing. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | 6 mg OTO-201 | 12 mg OTO-201 | Control | |||
Arm/Group Description | 6 mg ciprofloxacin: single administration of OTO-201 | 12 mg ciprofloxacin: single administration of OTO-201 | Sham Control: simulated, single administration | |||
All Cause Mortality |
||||||
6 mg OTO-201 | 12 mg OTO-201 | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/38 (0%) | 0/38 (0%) | 0/19 (0%) | |||
Serious Adverse Events |
||||||
6 mg OTO-201 | 12 mg OTO-201 | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/38 (0%) | 0/38 (0%) | 0/19 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
6 mg OTO-201 | 12 mg OTO-201 | Control | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/38 (13.2%) | 6/38 (15.8%) | 1/19 (5.3%) | |||
General disorders | ||||||
Pyrexia | 1/38 (2.6%) | 5/38 (13.2%) | 0/19 (0%) | |||
Infections and infestations | ||||||
Otitis media acute | 4/38 (10.5%) | 1/38 (2.6%) | 1/19 (5.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Publication subject to Sponsor consent.
Results Point of Contact
Name/Title | Medical Information Call Center |
---|---|
Organization | Otonomy, Inc. |
Phone | 1-800-826-6411 |
medinfo@otonomy.com |
- 201-201508