Nctid:
NCT00000361
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000034381", "term"=>"Hearing Loss"}, {"id"=>"D000006319", "term"=>"Hearing Loss, Sensorineural"}], "ancestors"=>[{"id"=>"D000006311", "term"=>"Hearing Disorders"}, {"id"=>"D000004427", "term"=>"Ear Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}, {"id"=>"D000012678", "term"=>"Sensation Disorders"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M24420", "name"=>"Hearing Loss", "asFound"=>"Hearing Loss", "relevance"=>"HIGH"}, {"id"=>"M6840", "name"=>"Deafness", "relevance"=>"LOW"}, {"id"=>"M9407", "name"=>"Hearing Loss, Sensorineural", "asFound"=>"Hearing Loss, Sensorineural", "relevance"=>"HIGH"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M7601", "name"=>"Ear Diseases", "relevance"=>"LOW"}, {"id"=>"M10779", "name"=>"Labyrinth Diseases", "relevance"=>"LOW"}, {"id"=>"M10782", "name"=>"Labyrinthitis", "relevance"=>"LOW"}, {"id"=>"M9400", "name"=>"Hearing Disorders", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"M15490", "name"=>"Sensation Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008727", "term"=>"Methotrexate"}], "ancestors"=>[{"id"=>"D000000020", "term"=>"Abortifacient Agents, Nonsteroidal"}, {"id"=>"D000000019", "term"=>"Abortifacient Agents"}, {"id"=>"D000012102", "term"=>"Reproductive Control Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000000964", "term"=>"Antimetabolites, Antineoplastic"}, {"id"=>"D000000963", "term"=>"Antimetabolites"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000003879", "term"=>"Dermatologic Agents"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000005493", "term"=>"Folic Acid Antagonists"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000018501", "term"=>"Antirheumatic Agents"}, {"id"=>"D000019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M14121", "name"=>"Prednisone", "relevance"=>"LOW"}, {"id"=>"M11703", "name"=>"Methotrexate", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M6727", "name"=>"Cyclophosphamide", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M7074", "name"=>"Dermatologic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M8619", "name"=>"Folic Acid Antagonists", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}, {"id"=>"M20604", "name"=>"Antirheumatic Agents", "relevance"=>"LOW"}, {"id"=>"T447", "name"=>"Folinic Acid", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antirheumatic Agents", "abbrev"=>"ARhu"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}, {"name"=>"Reproductive Control Agents", "abbrev"=>"Repr"}, {"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}}, "statusModule"=>{"overallStatus"=>"TERMINATED", "startDateStruct"=>{"date"=>"1998-03"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2006-04", "completionDateStruct"=>{"date"=>"2002-11"}, "lastUpdateSubmitDate"=>"2006-04-21", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2006-04-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Autoimmune Diseases", "Cyclophosphamide", "Hearing", "Labyrinth Diseases", "Methotrexate", "Prednisone"], "conditions"=>["Hearing Loss, Sensorineural"]}, "descriptionModule"=>{"briefSummary"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Have sensorineural (nerve/inner ear) hearing loss of at least 30 dB in each ear, which has rapidly progressed.\n* Are in good general health.\n* Are sterile or use contraception (if a woman of child-bearing age).\n* Are able to speak and understand English or Spanish.\n\nExclusion Criteria:\n\n* Have had any previous reaction to prednisone, or history of psychiatric reaction to corticosteroids.\n* 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.\n* Have any significant heart, lung, digestive, blood, or neurologic disorders.\n* 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.\n* Have had a positive test for HIV, hepatitis C or B.\n* Have any type of middle ear disorder.\n* Are breast-feeding or pregnant."}, "identificationModule"=>{"nctId"=>"NCT00000361", "briefTitle"=>"Autoimmunity in Inner Ear Disease", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)"}, "orgStudyIdInfo"=>{"id"=>"NIDCD-1158"}, "secondaryIdInfos"=>[{"id"=>"U01DC003209", "link"=>"https://reporter.nih.gov/quickSearch/U01DC003209", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Corticosteroids", "type"=>"DRUG"}, {"name"=>"Methotrexate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90057", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"House Ear Institute", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"92103-8895", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"UCSD Medical Center", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"52242-1078", "city"=>"Iowa City", "state"=>"Iowa", "country"=>"United States", "facility"=>"Univ of Iowa Hosp and Clinic", "geoPoint"=>{"lat"=>41.66113, "lon"=>-91.53017}}, {"zip"=>"21287-0008", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Univ", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts Eye and Ear Infirmary", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48109-0005", "city"=>"Ann Arbor", "state"=>"Michigan", "country"=>"United States", "facility"=>"Univ of Michigan", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"New York University", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"44195-5245", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Cleveland Clinic Foundation", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"University of Texas, Southwestern Medical Center at Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}], "overallOfficials"=>[{"name"=>"Dr. Jeffrey Harris", "role"=>"STUDY_CHAIR"}, {"name"=>"Dr. Patrick Brookhouser", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)", "class"=>"NIH"}}}}
