Trial Outcomes & Findings for Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media (NCT NCT03766373)
NCT ID: NCT03766373
Last Updated: 2019-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
1 Day
Results posted on
2019-12-05
Participant Flow
Participant milestones
| Measure |
Drug: OP0201
Drug: OP0201 20mg: OP0201
|
Drug: Placebo
Drug: Placebo 0mg: Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
Baseline characteristics by cohort
| Measure |
Drug: OP0201
n=12 Participants
Drug: OP0201 20mg: OP0201
|
Drug: Placebo
n=12 Participants
Drug: Placebo 0mg: Placebo
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 13.24 • n=99 Participants
|
45.7 years
STANDARD_DEVIATION 16.15 • n=107 Participants
|
49.5 years
STANDARD_DEVIATION 14.98 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 DayOutcome measures
| Measure |
Drug: OP0201
n=12 Participants
Drug: OP0201 20mg: OP0201
|
Drug: Placebo
n=12 Participants
Drug: Placebo 0mg: Placebo
|
|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
6 Participants
|
Adverse Events
Drug: OP0201
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Drug: Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Drug: OP0201
n=12 participants at risk
Drug: OP0201 20mg: OP0201
|
Drug: Placebo
n=12 participants at risk
Drug: Placebo 0mg: Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Eye disorders
Lacrimation increased
|
8.3%
1/12 • Number of events 1 • 7 days
|
0.00%
0/12 • 7 days
|
|
Gastrointestinal disorders
Feeling cold
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 7 days
|
8.3%
1/12 • Number of events 1 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
8.3%
1/12 • Number of events 1 • 7 days
|
16.7%
2/12 • Number of events 2 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60