Dose Ranging Study of OTO-201 in AOMT

Sponsor
Otonomy, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02719158
Collaborator
(none)
95
1
3
5
19.1

Study Details

Study Description

Brief Summary

Dose Ranging Study of OTO-201 in AOMT

Condition or Disease Intervention/Treatment Phase
  • Drug: 6 mg ciprofloxacin
  • Drug: 12 mg ciprofloxacin
  • Other: Sham
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

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
A 1-Month, Prospective, Multicenter, Randomized, Dose-Ranging, Sham-Controlled, Blinded Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Media With Tympanostomy Tubes in Pediatric Subjects
Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jul 1, 2016

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:
  • OTIPRIO
  • 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:
  • OTIPRIO
  • 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

    1. 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

    2. 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).

    3. 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

    1. Absence of Otorrhea [Up to Two Weeks]

      Absence of otorrhea (middle ear drainage)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Otonomy, Inc.
    ClinicalTrials.gov Identifier:
    NCT02719158
    Other Study ID Numbers:
    • 201-201508
    First Posted:
    Mar 25, 2016
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Otonomy, Inc.
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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%
    2. Primary Outcome
    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
    3. Primary Outcome
    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
    4. Secondary Outcome
    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

    [Not Specified]

    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
    Email medinfo@otonomy.com
    Responsible Party:
    Otonomy, Inc.
    ClinicalTrials.gov Identifier:
    NCT02719158
    Other Study ID Numbers:
    • 201-201508
    First Posted:
    Mar 25, 2016
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Sep 1, 2020