NCT02719158

Brief Summary

Dose Ranging Study of OTO-201 in AOMT

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

September 24, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

March 21, 2016

Results QC Date

September 1, 2020

Last Update Submit

September 24, 2020

Conditions

Acute Otitis MediaAOMT

Keywords

Acute otitis media with tympanostomy tubesOTIPRIO

Outcome Measures

Primary Outcomes (3)

  • Number of Subjects With Adverse Events

    Number of subjects with adverse events during the study from dosing up to 1 month after dosing

    Up to 1 month

  • Otoscopic Examination: Auricle and Meatus

    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).

    Up to 1 month

  • Otoscopic Examination: Tympanic Membrane

    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).

    Up to 1 month

Secondary Outcomes (1)

  • Absence of Otorrhea

    Up to Two Weeks

Study Arms (3)

6 mg OTO-201

EXPERIMENTAL

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

12 mg OTO-201

EXPERIMENTAL

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

Sham (empty syringe)

SHAM COMPARATOR

Sham (empty syringe), single 0.1 mL STT administration to the affected ear(s)

Other: Sham

Interventions

6 mg ciprofloxacinDRUG

Single administration of OTO-201

Also known as: OTIPRIO
6 mg OTO-201
12 mg ciprofloxacinDRUG

Single administration of OTO-201

Also known as: OTIPRIO
12 mg OTO-201
ShamOTHER
Sham (empty syringe)

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Otonomy call center for trial locations

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Ciprofloxacinsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Medical Information Call Center
Organization
Otonomy, Inc.
medinfo@otonomy.com
1-800-826-6411

Study Officials

  • Carl LeBel, PhD

    Otonomy, Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 25, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

October 19, 2020

Results First Posted

September 24, 2020

Record last verified: 2020-09

Locations

US(1)