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Autoimmunity in Inner Ear Disease

This study has been terminated.
Study NCT00000361.   Last updated on April 21, 2006.   Information provided by National Institute on Deafness and Other Communication Disorders (NIDCD)

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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.

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
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment 
Start Date  March 1998
Completion Date November 2002
Eligibility Criteria 

Inclusion Criteria:

  • Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.
  • Are in good general health.
  • Are sterile or use contraception (if a woman of child-bearing age).
  • Are able to speak and understand English or Spanish.

Exclusion Criteria:

  • Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.
  • Have used corticosteroids for more than 30 days within the past 90 days. Patients who have been off corticosteroids for at least 30 days may be eligible.
  • Have any significant heart, lung, digestive, blood, or neurologic disorders.
  • Have tuberculosis (TB), brittle or unstable insulin-dependent diabetes mellitus, active malignancy or prior chemotherapy, pancreatitis, active peptic ulcer disease, kidney failure, history of shingles, or known (other) autoimmune disease.
  • Have had a positive test for HIV, hepatitis C or B.
  • Have any type of middle ear disorder.
  • Are breast-feeding or pregnant.
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 
Study Chair:     Dr. Jeffrey Harris        
Principal Investigator:     Dr. Patrick Brookhouser        
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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