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Autoimmunity in Inner Ear Disease

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000361
First Posted: November 3, 1999
Last Update Posted: April 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
November 2, 1999
November 3, 1999
April 24, 2006
March 1998
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Complete list of historical versions of study NCT00000361 on ClinicalTrials.gov Archive Site
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Autoimmunity in Inner Ear Disease
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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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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Hearing Loss, Sensorineural
  • Drug: Corticosteroids
  • Drug: Methotrexate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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November 2002
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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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000361
NIDCD-1158
U01DC003209 ( U.S. NIH Grant/Contract )
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National Institute on Deafness and Other Communication Disorders (NIDCD)
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Study Chair: Dr. Jeffrey Harris
Principal Investigator: Dr. Patrick Brookhouser
National Institute on Deafness and Other Communication Disorders (NIDCD)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP