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Sudden Deafness Treatment Trial (SSNHL)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00097448
First received: November 23, 2004
Last updated: February 27, 2013
Last verified: February 2013
Results First Received: November 8, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sudden Deafness
Interventions: Drug: prednisone
Drug: methylprednisolone sodium succinate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Consecutive consenting adults with SSNHL from 16 academic medical centers around the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All subject presenting within 14 days of SSNHL onset.

Reporting Groups
  Description
Oral Steroids Prednisone 60mg per day x 14 days, 5 day taper.
Intratympanic Steroids 1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.

Participant Flow:   Overall Study
    Oral Steroids   Intratympanic Steroids
STARTED   125   130 
COMPLETED   121   129 
NOT COMPLETED   4   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Oral Steroids Prednisone 60mg per day x 14 days, 5 day taper.
Intratympanic Steroids 1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
Total Total of all reporting groups

Baseline Measures
   Oral Steroids   Intratympanic Steroids   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   130   255 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   125   130   255 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 50  (14)   51  (15)   50.5  (14.5) 
Gender 
[Units: Participants]
     
Female   51   53   104 
Male   74   77   151 
Region of Enrollment 
[Units: Participants]
     
United States   122   127   249 
Canada   3   3   6 


  Outcome Measures

1.  Primary:   Hearing Improvement   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Rauch
Organization: Massachusetts Eye and Ear Infirmary
phone: 617-573-1166
e-mail: steven_rauch@meei.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00097448     History of Changes
Other Study ID Numbers: DC006296
U01DC006296 ( US NIH Grant/Contract Award Number )
03-11-055 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
Study First Received: November 23, 2004
Results First Received: November 8, 2012
Last Updated: February 27, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration