Trial Outcomes & Findings for Dose Ranging Study of OTO-201 in AOMT (NCT NCT02719158)
NCT ID: NCT02719158
Last Updated: 2020-10-19
Results Overview
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
COMPLETED
PHASE2
95 participants
Up to 1 month
2020-10-19
Participant Flow
Participant milestones
| Measure |
6 mg OTO-201
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
12 mg ciprofloxacin: single administration of OTO-201
|
Control
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
38
|
19
|
|
Overall Study
COMPLETED
|
38
|
38
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Ranging Study of OTO-201 in AOMT
Baseline characteristics by cohort
| Measure |
6 mg OTO-201
n=37 Participants
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=38 Participants
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=18 Participants
Sham Control: simulated, single administration
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.004 years
STANDARD_DEVIATION 3.0546 • n=5 Participants
|
3.955 years
STANDARD_DEVIATION 2.9111 • n=7 Participants
|
3.551 years
STANDARD_DEVIATION 2.4583 • n=5 Participants
|
3.498 years
STANDARD_DEVIATION 2.8915 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
18 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: Safety analysis set: all subjects who received study drug.
Number of subjects with adverse events during the study from dosing up to 1 month after dosing
Outcome measures
| Measure |
6 mg OTO-201
n=38 Participants
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=38 Participants
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=19 Participants
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
|
19 Participants
|
14 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: 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.
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).
Outcome measures
| Measure |
6 mg OTO-201
n=38 Participants
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=38 Participants
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=7 normal affected ears at Baseline
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Otoscopic Examination: Auricle and Meatus
|
2 abnormal affected ears at Day 29
|
0 abnormal affected ears at Day 29
|
0 abnormal affected ears at Day 29
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: 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.
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).
Outcome measures
| Measure |
6 mg OTO-201
n=23 normal affected ears at Baseline
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=15 normal affected ears at Baseline
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=10 normal affected ears at Baseline
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Otoscopic Examination: Tympanic Membrane
|
1 abnormal ears at Day 29
|
0 abnormal ears at Day 29
|
0 abnormal ears at Day 29
|
SECONDARY outcome
Timeframe: Up to Two WeeksPopulation: 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.
Absence of otorrhea (middle ear drainage)
Outcome measures
| Measure |
6 mg OTO-201
n=37 Participants
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=38 Participants
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=18 Participants
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Absence of Otorrhea
|
20 Participants
|
23 Participants
|
2 Participants
|
Adverse Events
6 mg OTO-201
12 mg OTO-201
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
6 mg OTO-201
n=38 participants at risk
6 mg ciprofloxacin: single administration of OTO-201
|
12 mg OTO-201
n=38 participants at risk
12 mg ciprofloxacin: single administration of OTO-201
|
Control
n=19 participants at risk
Sham Control: simulated, single administration
|
|---|---|---|---|
|
Infections and infestations
Otitis media acute
|
10.5%
4/38 • Adverse events were reported during dosing and up to 1 month following dosing.
|
2.6%
1/38 • Adverse events were reported during dosing and up to 1 month following dosing.
|
5.3%
1/19 • Adverse events were reported during dosing and up to 1 month following dosing.
|
|
General disorders
Pyrexia
|
2.6%
1/38 • Adverse events were reported during dosing and up to 1 month following dosing.
|
13.2%
5/38 • Adverse events were reported during dosing and up to 1 month following dosing.
|
0.00%
0/19 • Adverse events were reported during dosing and up to 1 month following dosing.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication subject to Sponsor consent.
- Publication restrictions are in place
Restriction type: OTHER