临床试验/NCT02706730

NCT02706730终止3 期

A 6-Month, Multicenter, Phase 3, Open-Label Extension Safety Study of OTO-104 Given At 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Otonomy, Inc.1 个研究点分布在 1 个国家目标入组 189 人开始时间: 2016年2月最近更新: 2022年12月14日

适应症

干预措施

试验速览

阶段: 3 期
状态: 终止
发起方: Otonomy, Inc.
入组人数: 189
试验地点: 1
主要终点: Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201102 (Phase 2b study of OTO-104) or 104-201506 (Phase 3 study of OTO-104) in order to be eligible for this open-label extension study.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

OTO-104

Experimental

12 mg dexamethasone

干预措施: OTO-104 (Drug)

结局指标

主要结局

Otoscopic Examination - Tympanic Membrane Perforation at Week 24 (Month 6)

时间窗: 6 Months

Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection persisted at the end of study visit (Week 24 \[Month 6\]).

次要结局

未报告次要终点

研究者

发起方

Otonomy, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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