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Autoimmunity in Inner Ear Disease Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Autoimmunity in Inner Ear Disease conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Autoimmunity in Inner Ear Disease Clinical research trials and Autoimmunity in Inner Ear Disease healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Autoimmunity in Inner Ear Disease. Autoimmunity in Inner Ear Disease Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Autoimmunity in Inner Ear Disease clinical trial. Human subjects often receive the most effective healthcare possible for their Autoimmunity in Inner Ear Disease condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Autoimmunity in Inner Ear Disease  Autoimmunity in Inner Ear Disease
Autoimmunity in Inner Ear Disease
For Condition: Hearing Loss, Sensorineural
Status: No longer recruiting
Sponsor(s): National Institute on Deafness and Other Communication Disorders (NIDCD) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Dr.Harris, Study Chair,
UCSD Medical Center
San Diego, California, 92103-8895
United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States
New York University
New York City, New York,
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242-1078
United States
Johns Hopkins Univ
Baltimore, Maryland, 21287-0008
United States
University of Texas, Southwestern Medical Center at Dallas
Dallas, Texas,
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-5245
United States
Univ of Michigan
Ann Arbor, Michigan, 48109-0005
United States
House Ear Institute
Los Angeles, California, 90057
United States
Additional Information:
Study ID Numbers: NIDCD-1158; UO1 DC 03209
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000361
Other Hearing Loss, Sensorineural Studies:
1. Autoimmunity in Inner Ear Disease
Related Studies:
Other Hearing Loss, Sensorineural Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
Autoimmunity in Inner Ear Disease
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