NCT00000361终止3 期
Autoimmunity in Inner Ear Disease
National Institute on Deafness and Other Communication Disorders (NIDCD)16 个研究点 分布在 1 个国家开始时间: 1998年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 试验地点
- 16
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
研究点 (16)
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