Trial Outcomes & Findings for Open-Label Study of OTO-201 for Treatment of AOMT (NCT NCT02408796)
NCT ID: NCT02408796
Last Updated: 2020-10-19
Results Overview
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.
COMPLETED
PHASE2
39 participants
Day 29
2020-10-19
Participant Flow
Participant milestones
| Measure |
OTO-201
6 mg OTO-201
OTO-201
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study of OTO-201 for Treatment of AOMT
Baseline characteristics by cohort
| Measure |
OTO-201
n=39 Participants
6 mg OTO-201
OTO-201
|
|---|---|
|
Age, Continuous
|
2.16 years
STANDARD_DEVIATION 1.170 • n=39 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: Safety analysis set: All enrolled and treated subjects; subjects could have either unilateral or bilateral (one ear or both ears) acute otitis media with tympanostomy tubes in place (AOMT)
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done after administering OTO-201 to be sure there is no infection remaining or no new infection.
Outcome measures
| Measure |
OTO-201
n=58 affected ears
6 mg OTO-201
OTO-201
|
|---|---|
|
Number of Ears With Otorrhea (Drainage From the Middle Ear)
|
8 affected ears
|
PRIMARY outcome
Timeframe: Day 1Population: Safety analysis set: All enrolled and treated subjects.
Issues Administering OTO-201 onto the Tympanic Membrane and the Auditory Canal-facing Side of the Tympanostomy Tube (answered "yes")
Outcome measures
| Measure |
OTO-201
n=58 ears
6 mg OTO-201
OTO-201
|
|---|---|
|
Feasibility of Administration Questionnaire
|
2 ears
|
SECONDARY outcome
Timeframe: Day 15Population: Safety analysis set: All enrolled and treated subjects
Acute otitis media with tympanostomy tubes in place (AOMT) refers to subjects that have ear tubes present, but have a middle ear infection. Otorrhea is fluid drainage from the middle ear. This outcome is assessed during the otoscopic examination of each affected ear (the ear with the infection). All subjects have otorrhea in the affected ear at Baseline and the assessment is done 15 days after administering OTO-201 to see if it worked and there is no more drainage from the middle ear.
Outcome measures
| Measure |
OTO-201
n=58 affected ears
6 mg OTO-201
OTO-201
|
|---|---|
|
Number of Ears With no More Otorrhea (Drainage From the Middle Ear)
|
50 affected ears
|
Adverse Events
OTO-201
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OTO-201
n=39 participants at risk
6 mg OTO-201
OTO-201
|
|---|---|
|
General disorders
Pyrexia
|
23.1%
9/39 • 1 month
|
|
General disorders
Device Extrusion
|
10.3%
4/39 • 1 month
|
|
Infections and infestations
Sinusitis
|
7.7%
3/39 • 1 month
|
|
Infections and infestations
Otitis Media
|
5.1%
2/39 • 1 month
|
|
Infections and infestations
Otitis Media Acute
|
5.1%
2/39 • 1 month
|
|
Infections and infestations
Pharyngitis Streptococcal
|
5.1%
2/39 • 1 month
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • 1 month
|
|
Immune system disorders
Seasonal Allergy
|
5.1%
2/39 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication subject to Sponsor consent.
- Publication restrictions are in place
Restriction type: OTHER