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Trial NCT00000361

Resource URI: http://static.linkedct.org/resource/trials/NCT00000361
PropertyValue
linkedct:brief_title Autoimmunity in Inner Ear Disease
linkedct:condition <http://static.linkedct.org/resource/condition/5691>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date November 2002
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000361
rdfs:label Trial NCT00000361
linkedct:lastchanged_date April 21, 2006
linkedct:lead_sponsor_agency National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:location <http://static.linkedct.org/resource/location/141940>
linkedct:location <http://static.linkedct.org/resource/location/145135>
linkedct:location <http://static.linkedct.org/resource/location/147466>
linkedct:location <http://static.linkedct.org/resource/location/163702>
linkedct:location <http://static.linkedct.org/resource/location/183068>
linkedct:location <http://static.linkedct.org/resource/location/186420>
linkedct:location <http://static.linkedct.org/resource/location/188369>
linkedct:location <http://static.linkedct.org/resource/location/210455>
linkedct:location <http://static.linkedct.org/resource/location/213499>
linkedct:nct_id NCT00000361
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NIDCD-1158
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14957>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14997>
linkedct:overall_status Terminated
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000361>
linkedct:phase Phase 3
linkedct:secondary_id UO1 DC 03209
linkedct:source National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:start_date March 1998
linkedct:study_design Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2006