NL-OMON40458撤回3 期
*Efficacy and safety of intratympanic dexamethasone compared to intratympanic gentamicin in patients with proven unilateral Ménière*s disease*; a randomised, double-blind, controlled non-inferiority trial
 - DEXAvsGENTA trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •*Definite unilateral Ménière's disease according to AAO-HNS criteria: two or more definitive spontaneous episodes of vertigo for at least 20 minutes, AND audiometric confirmation of a sensorineural hearing loss, AND tinnitus (other causes excluded)
- •*Not responding to oral medical treatment for at least six months.
- •*Age above 18 years at the start of the trial.
- •*Willing to adhere to the follow up assessments.
排除标准
- •*Ménière's disease in advanced stages (not having vertigo attacks).
- •*bilateral Ménière's disease.
- •*Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
- •*Active additional neuro-otologic disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma).
- •*Concurrent ear pathology that may interfere with IT injections (e.g. active middle ear disease).
- •*Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
- •*History of known adverse and/or allergic reaction to steroids or gentamicin.
- •*Women of child bearing age not using contraception, pregnant women or nursing women.
研究者
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