Trial Outcomes & Findings for Sudden Deafness Treatment Trial (NCT NCT00097448)
NCT ID: NCT00097448
Last Updated: 2017-04-04
Results Overview
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
255 participants
Primary outcome timeframe
2 months
Results posted on
2017-04-04
Participant Flow
Consecutive consenting adults with SSNHL from 16 academic medical centers around the United States.
All subject presenting within 14 days of SSNHL onset.
Participant milestones
| Measure |
Oral Steroids
Prednisone 60mg per day x 14 days, 5 day taper.
|
Intratympanic Steroids
1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
130
|
|
Overall Study
COMPLETED
|
121
|
129
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sudden Deafness Treatment Trial
Baseline characteristics by cohort
| Measure |
Oral Steroids
n=125 Participants
Prednisone 60mg per day x 14 days, 5 day taper.
|
Intratympanic Steroids
n=130 Participants
1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
125 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 14 • n=5 Participants
|
51 years
STANDARD_DEVIATION 15 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
127 participants
n=7 Participants
|
249 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Intention-to-treat
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Outcome measures
| Measure |
Oral Steroids
n=121 Participants
Prednisone
|
IT Steroids
n=129 Participants
methylprednisolone
|
|---|---|---|
|
Hearing Improvement
|
30.7 dB
Standard Deviation 21.7
|
28.7 dB
Standard Deviation 21.5
|
Adverse Events
Oral Steroids
Serious events: 5 serious events
Other events: 121 other events
Deaths: 0 deaths
IT Steroids
Serious events: 6 serious events
Other events: 127 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Steroids
n=125 participants at risk
Prednisone
|
IT Steroids
n=130 participants at risk
methylprednisolone
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukemia
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
myocardial infarction
|
0.80%
1/125 • Number of events 1
|
0.77%
1/130 • Number of events 1
|
|
Renal and urinary disorders
Bladder cancer
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Cardiac disorders
Endocarditis
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/125
|
0.77%
1/130 • Number of events 1
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
|
Renal and urinary disorders
Hyponatremia
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
|
Nervous system disorders
Transient ischemic attack
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
|
Nervous system disorders
Syncope
|
0.80%
1/125 • Number of events 1
|
0.00%
0/130
|
Other adverse events
| Measure |
Oral Steroids
n=125 participants at risk
Prednisone
|
IT Steroids
n=130 participants at risk
methylprednisolone
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
3.2%
4/125 • Number of events 4
|
53.8%
70/130 • Number of events 186
|
|
Ear and labyrinth disorders
Vertigo
|
10.4%
13/125 • Number of events 14
|
26.9%
35/130 • Number of events 49
|
|
Endocrine disorders
Hyperglycemia
|
28.8%
36/125 • Number of events 39
|
16.2%
21/130 • Number of events 21
|
|
Ear and labyrinth disorders
Eaer infection
|
1.6%
2/125 • Number of events 2
|
5.4%
7/130 • Number of events 7
|
|
Nervous system disorders
Sleep disturbance
|
35.2%
44/125 • Number of events 44
|
6.9%
9/130 • Number of events 9
|
|
Endocrine disorders
Appetite change
|
22.4%
28/125 • Number of events 28
|
4.6%
6/130 • Number of events 7
|
|
Ear and labyrinth disorders
Tympnaic membrane perforation
|
0.00%
0/125
|
3.8%
5/130 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place