A prospective, randomized, double blind, placebo-controlled, multicenter, Phase 3 efficacy and safety study of OTO-104 given as a single intratympanic injection in subjects with unilateral Meniere’s disease.

Otonomy Inc.0 个研究点目标入组 160 人开始时间: 2015年12月15日最近更新: 2019年6月30日

试验速览

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•- Subject is a male or female aged 18 to 85 years, inclusive.
•- Subject has a diagnosis of definite unilateral Meniere’s disease by 1995 AAO-HNS criteria.
•- Subject self-reports active, definitive vertigo episodes for the 2 months prior to the study lead-in period.
•- Subject has documented asymmetric sensorineural hearing loss at screening or within the past 12 months according to AAO-HNS 1995 criteria defined as one of the following:
•a. The arithmetic mean of hearing thresholds (pure tone average, PTA) at 250, 500 and 1000 Hz of 15 dB or more higher than the PTA of 1000, 2000, and 3000 Hz,
•b. The arithmetic mean of PTA at 500, 1000, 2000 and 3000 Hz is 20 dB or more poorer in the ear in question than on the opposite side,
•c. It is the judgment of the investigator that the subject’s hearing loss meets reasonable audiometric criteria for hearing loss characteristic of Meniere’s disease, and if so, it should be justified and documented.
•- Subject is able to use the telephone to complete their daily diary.
•At the completion of the first 28 days of the lead-in period:
•- Subject completed at least 22 of 28 diary entries during the 4-week lead-in period.
•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 40

•- Subject has an infection in the ear, sinuses, or upper respiratory system at the time of randomization.
•- Subject is pregnant or lactating.
•- Subject has a history of immunodeficiency disease.
•- Subject has an abnormality of the tympanic membrane in the affected ear that would increase the risk associated with intratympanic injection including but not limited to monomeric tympanic membrane.
•- Subject has used systemic steroids within 1 month prior to entering the lead-in period.
•- Subject has previously been randomized to a trial of OTO-104.

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