Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months (NCT NCT03818815)
NCT ID: NCT03818815
Last Updated: 2020-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
Days 1-28
Results posted on
2020-08-18
Participant Flow
Participant milestones
| Measure |
Drug: OP0201 + Antibiotics
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
OP0201 20mg per day+Amoxicillin-clavulanate: OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo +Antibiotics
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
Placebo 0mg per day+Amoxicillin-clavulanate: Placebo 0mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
47
|
|
Overall Study
COMPLETED
|
48
|
42
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
Baseline characteristics by cohort
| Measure |
Drug: OP0201 + Antibiotics
n=56 Participants
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=47 Participants
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.4 months
STANDARD_DEVIATION 4.70 • n=93 Participants
|
13.2 months
STANDARD_DEVIATION 5.01 • n=4 Participants
|
13.3 months
STANDARD_DEVIATION 4.82 • n=27 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
55 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
96 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Days 1-28Population: Subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
Outcome measures
| Measure |
Drug: OP0201 + Antibiotics
n=55 Participants
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=48 Participants
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Number of Participants With Adverse Events
|
48 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: Day 4Population: Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.
Percentage of study participants with no bulging tympanic membrane
Outcome measures
| Measure |
Drug: OP0201 + Antibiotics
n=54 Participants
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=46 Participants
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Evaluation of Efficacy (Otoscopy)
|
51 Percentage of participants
|
47.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Day 12Population: Subjects who were randomized excluding the first 3 subjects dosed (subject numbers 1001, 1002 and 1003), as there was a known device malfunction for these subjects. Subjects will be summarized and analyzed based on randomization assignment, regardless of treatment received.
Percentage of study participants with no middle ear effusion
Outcome measures
| Measure |
Drug: OP0201 + Antibiotics
n=54 Participants
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=46 Participants
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Evaluation of Efficacy (Otoscopy)
|
55.9 Percentage of participants
|
37.9 Percentage of participants
|
Adverse Events
Drug: OP0201 + Antibiotics
Serious events: 0 serious events
Other events: 48 other events
Deaths: 0 deaths
Placebo Comparator: Placebo + Antibiotics
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug: OP0201 + Antibiotics
n=55 participants at risk
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=48 participants at risk
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Vascular disorders
KAWASAKIS DISEASE
|
0.00%
0/55 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
2.1%
1/48 • Number of events 1 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
Other adverse events
| Measure |
Drug: OP0201 + Antibiotics
n=55 participants at risk
OP0201 20mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
Placebo Comparator: Placebo + Antibiotics
n=48 participants at risk
Placebo 0 mg per day+oral Amoxicillin-clavulanate in two divided doses for 10 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
43.6%
24/55 • Number of events 24 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
45.8%
22/48 • Number of events 23 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
6/55 • Number of events 6 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
8.3%
4/48 • Number of events 4 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
General disorders
Pyrexia
|
5.5%
3/55 • Number of events 3 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
2.1%
1/48 • Number of events 1 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.1%
5/55 • Number of events 5 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
4.2%
2/48 • Number of events 2 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
3/55 • Number of events 3 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
4.2%
2/48 • Number of events 2 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
2/55 • Number of events 2 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
6.2%
3/48 • Number of events 3 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.5%
3/55 • Number of events 3 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
0.00%
0/48 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge Discolouration
|
5.5%
3/55 • Number of events 3 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
0.00%
0/48 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.5%
8/55 • Number of events 8 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
10.4%
5/48 • Number of events 5 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
10.9%
6/55 • Number of events 6 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
10.4%
5/48 • Number of events 5 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
60.0%
33/55 • Number of events 39 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
41.7%
20/48 • Number of events 21 • 28 days
The Safety Population analyzed includes all subjects who received at least one intranasal spray of study treatment. Subjects will be summarized and analyzed based on treatment received. The number of participant analyzed differs from the number of participants assigned to each arm by 1 due to a protocol deviation of one subject assigned Active was inadvertently dosed with Placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place