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

Synphora AB0 个研究点开始时间: 2013年6月24日最近更新: 2016年6月27日

试验速览

暂无简介。

•? At least 18 years of age
•? Definite unilateral Menière’s disease (AAO-HNS 1995)
•? Disease stage II-IV: PTA4 (pure tone average at 4 frequencies, 0.5, 1.0, 2.0, and 3.0 kHz) > 25 dB (AAO-HNS 1995).
•? Speech discrimination score in silence (using 50 Swedish PB words) no better than 85%. The signal level at the first measurement (Visit 1) is to be adjusted to each patient’s most comfortable level. This signal level is to be applied at the second measurement (Visit 2a/Day 1).
•? At least three vertigo attacks (lasting = 20 minutes) during the three last months prior to inclusion
•? Tinnitus during the last three months prior to inclusion
•- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•? Any medical or psychiatric condition, which could jeopardize or would compromise the subject’s ability to participate in this trial or decrease the likelihood of obtaining satisfactory data to achieve the objective of the trial e.g. dementia, alcohol or substance abuse
•? Bilateral Menière’s disease
•? Chronic otitis media on the ear affected by Menière’s disease
•? Subjects not fluent in the Swedish language
•? Bronchial asthma
•? Previous intratympanic gentamicin or surgical therapy
•? Previous intratympanic steroid therapy less than six months prior to inclusion
•- Known hypersensitivity to local anesthetics
•? Pregnant women
•? Nursing women

发起方