NCT01973114Unknown2 期
A Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Determine the Efficacy, the Duration of Action, and Safety of Latanoprost in Patients With Menière's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- Synphora AB
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Change in speech discrimination score in noise from Baseline
研究概览
简要总结
The purpose of the study is to evaluate the dose regimen, efficacy and safety of latanoprost for the treatment of Menière's disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 18 years of age
- •Definitive unilateral Menière's disease (AAO-HNS 1995)
- •Disease stage II - III: PTA4 (Pure Tone Average) (0.5, 1.0, 2.0 and 3.0kHz) between 25dB and 70dB
- •Speech discrimination score in silence: No better than 85%
- •At least three vertigo attacks (lasting ≥ 20 minutes) during the last three months prior to inclusion
- •Tinnitus during the last three months prior to inclusion
- •Signed written informed consent
排除标准
- •Medical or psychiatric conditions which could jeopardize or would compromise the subject's ability to participate in the trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial, dementia, alcohol or substance abuse.
- •Bilateral Menière's disease
- •Chronic otitis media on the ear affected by Menière's disease
- •Subjects not fluent in Swedish language
- •Bronchial asthma
- •Previous intratympanic injection of gentamicin or surgical therapy
- •Previous intratympanic steroid therapy less than six months prior to inclusion
- •Known hypersensitivity to local anesthetics
- •Pregnant women
- •Nursing mothers
研究组 & 干预措施
Group 1
Experimental
One intratympanic injection of latanoprost (Day1)
干预措施: Latanoprost (Drug)
Group 2
Placebo Comparator
One intratympanic injection of placebo
干预措施: Placebo (Other)
Group 3
Experimental
Three intratympanic injections of latanoprost (Day 1, 2 and 3)
干预措施: Latanoprost (Drug)
Group 4
Placebo Comparator
Three intratympanic injections of placebo (Day 1, 2 and 3)
干预措施: Placebo (Other)
结局指标
主要结局
Change in speech discrimination score in noise from Baseline
时间窗: 2 weeks
次要结局
- Change in proportion of days with vertigo attacks from run-in period(3 months)
- Change in pure tone audiometry from Baseline(3 months)
- Change in speech discrimination score in noise from Baseline(3 months)
- Change in THI-25 (Tinnitus Handicap Inventory) score from Baseline(3 months)
- Evaluation of adverse events and vital signs as measure of safety and tolerability(3 months)
- Change in hearing (Likert scale), tinnitus (Likert scale) and vertigo (Likert scale) from run-in period(3 months)
- Comparison of number of drop attacks in each treatment arm(3 months)
研究者
研究点 (12)
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