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| Descriptive Information Fields | |||||||||
| Brief Title † | Autoimmunity in Inner Ear Disease | ||||||||
| Official Title † | |||||||||
| Brief Summary | The purpose of this study is to determine whether prednisone, methotrexate, and cyclophosphamide are effective in the treatment of rapidly progressive sensorineural hearing loss in both ears. This condition is called autoimmune inner ear disease (AIED), because it is thought that the hearing loss is triggered by an autoimmune process. Treatment attempts to suppress or control this process with powerful anti-inflammatory drugs. This is a Phase III, outpatient study. All study participants will be assigned to one of four different groups testing the experimental use of drugs. The study is scheduled to run for 18 months, with a minimum of 11 visits per participant. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Hearing Loss, Sensorineural | ||||||||
| Intervention † | Drug: Corticosteroids Drug: Methotrexate |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | |||||||||
| Start Date † | March 1998 | ||||||||
| Completion Date | November 2002 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000361 | ||||||||
| Organization ID | NIDCD-1158 | ||||||||
| Secondary IDs †† | UO1 DC 03209 | ||||||||
| Study Sponsor † | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Verification Date | April 2006 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | April 21, 2006 | ||||||||