EUCTR2014-001337-86-GB进行中（未招募）1 期
A 6-month, prospective, randomized, multicenter, placebo-controlled safety study of OTO-104 given at 3-month intervals by intratympanic injection in subjects with unilateral Meniere's disease, followed by a 6-month open-label extension
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Otonomy Inc.
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subject is a male or female aged 18 to 80 years, inclusive.
- •2.Subject has a diagnosis of definite unilateral Meniere’s disease by 1995 AAO-HNS criteria.
- •3.Subject agrees to maintain their current standard of care treatments for Meniere’s disease while on-study, including but not limited to low-salt diet, diuretic, and/or betahistine.
- •4.Female subjects of childbearing potential (i.e., not surgically sterile and/or not post-menopausal (=6 months since last menstrual period and 45 years of age or older)) must have a negative urine pregnancy test before randomization. Women of childbearing potential who are not abstinent from sex with male partners may be entered into the study if they are using and willing to continue to use adequate contraceptive precautions for the duration of the study (e.g., oral contraceptives, contraceptive implant or injection, intrauterine device, condom and spermicide, or diaphragm and spermicide).
- •5.Subject is willing to comply with the protocol and attend all study visits.
- •6.Subject is able to provide written informed consent, including agreement to specific privacy language either within the informed consent or in ancillary documents compliant with Data Protection Act in the United Kingdom before the initiation of any study-related procedures.
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Subject has an infection in the ear, sinuses, or upper respiratory system.
- •2.Subject is pregnant or lactating.
- •3.Subject has a history of immunodeficiency disease.
- •4.Subject has active or recent (<1 month prior to screening) middle ear disease, including but not limited to: chronic otitis media, acute otitis media, middle ear effusions, middle ear atelectasis, or cholesteatoma.
- •5.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 a monomeric, atelectatic or atrophic tympanic membrane.
- •6.Subject has a history of tympanostomy tubes that includes evidence of perforation or lack of closure.
- •7.Subject has a history of previous endolymphatic sac surgery.
- •8.Subject has a history of previous use of intratympanic gentamicin in the affected ear.
- •9.Subject has history of drop attacks.
- •10.Subject has used systemic steroids within 1 month prior to screening.
- •11.Subject has had intratympanic steroids within 1 month prior to screening.
- •12.Subject has experienced an adverse reaction to intratympanic injection of steroids.
- •13.Subject has any other clinically significant illness or medical condition that, in the investigator’s and the medical monitor’s opinion, would prohibit the subject from participating in the study.
- •14.Subject has previously been randomized to a trial of OTO-104.
研究者
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