NCT01526408终止3 期
Treatment of Hearing Fluctuation in Unilateral Meniere's Disease: A Randomized, Placebo-controlled Clinical Trial of Famciclovir
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 11
- 主要终点
- Pure-tone Threshold Change
研究概览
简要总结
The specific aim of this study is to determine the efficacy of treatment with famciclovir in unilateral Meniere's Disease patients, specifically whether hearing can be improved. The investigators will determine the percentage of unilateral Meniere's Disease patients experiencing an absence of hearing fluctuation after 3 months of treatment with famciclovir as compared to the placebo arm.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral Meniere's Disease
- •2 vertigo episodes of at least 20 minutes
- •Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
- •Less than 45 dB 4-frequency pure-tone average in the affected ear
- •Tinnitus and/or aural fullness
- •Willing to undergo the clinical trial procedures
- •Signed informed consent
排除标准
- •Acute or chronic middle ear disease in either ear
- •Only hearing ear
- •4-frequency pure-tone average > 45 dB in either ear
- •Known allergy to famciclovir or any of the ingredients in the formulation
- •Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
- •Must not have had previous inner ear surgery
- •History of immunodeficiency diseases such as HIV
- •History of renal insufficiency or other kidney diseases
- •A female of child-bearing potential who is pregnant
- •History of noncompliance to medical regimens
- •Unwilling to or unable to comply with the protocol, including scheduling study evaluations
研究组 & 干预措施
Placebo Arm
Placebo Comparator
Treatment with 3 months of placebo
干预措施: Placebo (Drug)
Active Arm
Active Comparator
Treatment with 3 months of active drug
干预措施: Famciclovir (Drug)
结局指标
主要结局
Pure-tone Threshold Change
时间窗: 3 months
Change in hearing from baseline to after 3 months of treatment
次要结局
- Tinnitus and/or Dizziness Handicap Change(3 months)
研究者
M. Jennifer Derebery
Principal Investigator
House Research Institute
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