Trial Outcomes & Findings for Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients (NCT NCT01404611)
NCT ID: NCT01404611
Last Updated: 2017-10-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
331 participants
Primary outcome timeframe
From baseline until the end of the study (up to 22 days)
Results posted on
2017-10-04
Participant Flow
Participant milestones
| Measure |
DF289
Ear drops
DF289: Ear drops
|
DF277
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Overall Study
STARTED
|
112
|
108
|
111
|
|
Overall Study
COMPLETED
|
104
|
89
|
106
|
|
Overall Study
NOT COMPLETED
|
8
|
19
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Baseline characteristics by cohort
| Measure |
DF289
n=112 Participants
Ear drops
DF289: Ear drops
|
DF277
n=108 Participants
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=111 Participants
Ear drops
DF289 plus DF277: Ear drops
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
112 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
331 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
3.3 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.2 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
3.2 years
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline until the end of the study (up to 22 days)Outcome measures
| Measure |
DF289
n=112 Participants
Ear drops
DF289: Ear drops
|
DF277
n=108 Participants
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=111 Participants
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Time to Cessation of Otorrhea
|
6.83 days
Interval 5.49 to 7.74
|
22 days
Interval 13.93 to 22.0
|
4.94 days
Interval 3.74 to 5.52
|
Adverse Events
DF289
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
DF277
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
DF289 Plus DF277
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DF289
n=112 participants at risk
Ear drops
DF289: Ear drops
|
DF277
n=107 participants at risk
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=111 participants at risk
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Infections and infestations
Mastoiditis
|
0.89%
1/112 • Number of events 1 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
0.00%
0/107 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
0.00%
0/111 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/112 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
0.00%
0/107 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
0.90%
1/111 • Number of events 1 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
Other adverse events
| Measure |
DF289
n=112 participants at risk
Ear drops
DF289: Ear drops
|
DF277
n=107 participants at risk
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=111 participants at risk
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.89%
1/112 • Number of events 1 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
3.7%
4/107 • Number of events 4 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
6.3%
7/111 • Number of events 7 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
4/112 • Number of events 4 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
5.6%
6/107 • Number of events 6 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
5.4%
6/111 • Number of events 6 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
|
Infections and infestations
Nasopharyngitis
|
0.89%
1/112 • Number of events 1 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
5.6%
6/107 • Number of events 7 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
0.90%
1/111 • Number of events 1 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
|
Ear and labyrinth disorders
Otorrhoea
|
6.2%
7/112 • Number of events 8 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
6.5%
7/107 • Number of events 7 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
5.4%
6/111 • Number of events 6 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
|
General disorders
Pyrexia
|
7.1%
8/112 • Number of events 8 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
13.1%
14/107 • Number of events 14 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
9.0%
10/111 • Number of events 10 • During all the study (22 days)
There were 331 patients randomized in the study, but only 330 patients were dosed. Only dosed patients are considered for the Adverse Event Reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
- Publication restrictions are in place
Restriction type: OTHER