Trial Outcomes & Findings for Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients (NCT NCT01395966)
NCT ID: NCT01395966
Last Updated: 2015-10-22
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
2015-10-22
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
|
109
|
110
|
112
|
|
Overall Study
COMPLETED
|
99
|
91
|
104
|
|
Overall Study
NOT COMPLETED
|
10
|
19
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study to Assess the 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=109 Participants
Ear drops
DF289: Ear drops
|
DF277
n=110 Participants
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=112 Participants
Ear drops
DF289 plus DF277: Ear drops
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
109 Participants
n=39 Participants
|
110 Participants
n=41 Participants
|
112 Participants
n=35 Participants
|
331 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
3.5 years
STANDARD_DEVIATION 2.7 • n=39 Participants
|
3.5 years
STANDARD_DEVIATION 2.6 • n=41 Participants
|
3.2 years
STANDARD_DEVIATION 2.5 • n=35 Participants
|
3.4 years
STANDARD_DEVIATION 2.6 • n=31 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=39 Participants
|
68 Participants
n=41 Participants
|
64 Participants
n=35 Participants
|
198 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=39 Participants
|
42 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
133 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From baseline until the end of the study ( up to 22 days)Outcome measures
| Measure |
DF289
n=109 Participants
Ear drops
DF289: Ear drops
|
DF277
n=110 Participants
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=112 Participants
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Time to Cessation of Otorrhea
|
7.69 days
Interval 4.78 to 11.44
|
22 days
Interval 7.43 to 22.0
|
3.75 days
Interval 3.04 to 4.39
|
Adverse Events
DF289
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
DF277
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
DF289 Plus DF277
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DF289
n=108 participants at risk
Ear drops
DF289: Ear drops
|
DF277
n=106 participants at risk
Ear drops
DF277: Ear drops
|
DF289 Plus DF277
n=113 participants at risk
Ear drops
DF289 plus DF277: Ear drops
|
|---|---|---|---|
|
Ear and labyrinth disorders
auricular swelling
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Ear and labyrinth disorders
ear pain
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
1.9%
2/106 • Number of events 2 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Ear and labyrinth disorders
otorrhoea
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Ear and labyrinth disorders
ear canal erythema
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Ear and labyrinth disorders
ear discomfort
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Ear and labyrinth disorders
ear haemorrahage
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Infections and infestations
otitis media
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
2.8%
3/106 • Number of events 3 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
1.8%
2/113 • Number of events 2 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Infections and infestations
otitis media acute
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Infections and infestations
ear infection fungal
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Infections and infestations
otitis externa
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Skin and subcutaneous tissue disorders
excessive granulation tissue
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Infections and infestations
rash
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.88%
1/113 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Skin and subcutaneous tissue disorders
dermatitis
|
0.93%
1/108 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/106 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
|
Skin and subcutaneous tissue disorders
eczema
|
0.00%
0/108 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.94%
1/106 • Number of events 1 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
0.00%
0/113 • During all the study (22 days)
Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting. One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.
|
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