CTIS2023-503340-13-00招募中1 期
A multicenter, double-blinded, randomized, placebo-controlled trial to compare the effectiveness of intratympanic injections methylPREDnisolone versus placebo in the treatment of vertigo attacks in MENière’s disease (PREDMEN trial). - PREDME
eiden University Medical Center0 个研究点目标入组 148 人开始时间: 2023年3月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
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 65+（—）
- 性别
- All
入选标准
- •Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015., Age > 18 years at the start of the trial., = 4 vertigo attacks over the last 6 months.
排除标准
- •Bilateral Meniere'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 MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma)., Otitis media with effusion based on tympanogram results., History of intratympanic injections with corticosteroid less than 6 months ago., History of intratympanic injections with gentamicin or ear surgery for treating MD., Women of child bearing age not using contraception, pregnant women, nursing women.
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