临床试验/NCT02801370

NCT02801370已完成3 期

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Otonomy, Inc.1 个研究点分布在 1 个国家目标入组 262 人开始时间: 2016年6月最近更新: 2020年10月19日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Otonomy, Inc.
入组人数: 262
试验地点: 1
主要终点: Number of Subjects Considered a Clinical Cure at Day 8

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 a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围: 6 Months 至 —（Child, 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-201

Experimental

干预措施: 12 mg ciprofloxacin (Drug)

Control

Sham Comparator

干预措施: Sham Control (Drug)

结局指标

主要结局

Number of Subjects Considered a Clinical Cure at Day 8

时间窗: At Day 8 (1 week after dosing)

Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3

次要结局

Number of Subjects Considered a Clinical Cure at Day 15(At Day 15 (2 weeks after dosing))

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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