Trial Outcomes & Findings for Phase 3 Study of OTO-201 in Acute Otitis Externa (NCT NCT02801370)
NCT ID: NCT02801370
Last Updated: 2020-10-19
Results Overview
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
262 participants
Primary outcome timeframe
At Day 8 (1 week after dosing)
Results posted on
2020-10-19
Participant Flow
Participant milestones
| Measure |
12 mg OTO-201
12 mg ciprofloxacin: single administration
|
Control
Sham Control: Simulated, single adminstration
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
132
|
|
Overall Study
COMPLETED
|
123
|
132
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 3 Study of OTO-201 in Acute Otitis Externa
Baseline characteristics by cohort
| Measure |
Control
n=130 Participants
Sham Control: Simulated, single administration
|
Total
n=260 Participants
Total of all reporting groups
|
12 mg OTO-201
n=130 Participants
12 mg ciprofloxacin: single administration
|
|---|---|---|---|
|
Age, Continuous
|
34.796 years
STANDARD_DEVIATION 19.2708 • n=107 Participants
|
35.760 years
STANDARD_DEVIATION 19.9244 • n=206 Participants
|
36.724 years
STANDARD_DEVIATION 20.5866 • n=99 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=107 Participants
|
150 Participants
n=206 Participants
|
75 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
55 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
41 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=107 Participants
|
173 Participants
n=206 Participants
|
87 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
109 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
111 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=107 Participants
|
260 participants
n=206 Participants
|
130 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At Day 8 (1 week after dosing)Population: Intent-to-treat analysis set: All subjects who were randomized and did not have Group A Streptococci cultured on Day 1
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Outcome measures
| Measure |
12 mg OTO-201
n=130 Participants
12 mg ciprofloxacin: single administration
|
Control
n=130 Participants
Sham Control: Simulated, single adminstration
|
|---|---|---|
|
Number of Subjects Considered a Clinical Cure at Day 8
|
91 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: At Day 15 (2 weeks after dosing)Population: Intent-to-treat analysis set: All subjects who were randomized and and did not have Group A Streptococci cultured on Day 1.
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Outcome measures
| Measure |
12 mg OTO-201
n=130 Participants
12 mg ciprofloxacin: single administration
|
Control
n=130 Participants
Sham Control: Simulated, single adminstration
|
|---|---|---|
|
Number of Subjects Considered a Clinical Cure at Day 15
|
97 Participants
|
69 Participants
|
Adverse Events
12 mg OTO-201
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
12 mg OTO-201
n=127 participants at risk
12 mg ciprofloxacin: single administration
|
Control
n=132 participants at risk
Sham Control: Simulated, single administration
|
|---|---|---|
|
Infections and infestations
Otitis externa
|
2.4%
3/127 • Adverse events were reported during dosing and up to 1 month following dosing.
|
6.8%
9/132 • Adverse events were reported during dosing and up to 1 month following dosing.
|
|
Ear and labyrinth disorders
Ear Pain
|
2.4%
3/127 • Adverse events were reported during dosing and up to 1 month following dosing.
|
2.3%
3/132 • Adverse events were reported during dosing and up to 1 month following dosing.
|
|
Ear and labyrinth disorders
Ear pruritis
|
2.4%
3/127 • Adverse events were reported during dosing and up to 1 month following dosing.
|
1.5%
2/132 • Adverse events were reported during dosing and up to 1 month following dosing.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/127 • Adverse events were reported during dosing and up to 1 month following dosing.
|
2.3%
3/132 • Adverse events were reported during dosing and up to 1 month following dosing.
|
|
Nervous system disorders
Headache
|
2.4%
3/127 • Adverse events were reported during dosing and up to 1 month following dosing.
|
0.76%
1/132 • 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