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临床试验/NL-OMON56096
NL-OMON56096招募中2 期

Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss. - AC102-201

Audiocure Pharma GmbH0 个研究点目标入组 20 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
招募中
入组人数
20
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC)
  • •approved informed consent form (ICF)
  • •2. Female or male patients aged between 18 and 85 years (inclusive) at the day
  • •of Screening
  • •3. Unilateral ISSNHL
  • •4. Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
  • •5. Patients with an absolute air conduction hearing threshold of at least 65 dB
  • •(average of the three most affected consecutive frequencies between 0.25 and 8
  • •6. Patients with a relative hearing loss of at least 30 dB compared to the
  • •current audiogram of the non-affected ear (average of the three most affected
  • •consecutive frequencies between 0.25 and 8 kHz)
  • •7. Willing and able to attend the trial visits
  • •8. Able to read and understand trial documents and follow Investigator and
  • •trial personnel instructions during visits. Willing and able to comply with
  • •procedures of audiological assessments (in particular pure tone audiometry and
  • •speech audiometry)
  • •9. Female patients must meet one of the following criteria:
  • •o If of childbearing potential - have a negative urine pregnancy test and agree
  • •to use a highly effective medically accepted contraceptive method for at least
  • •30 days after the last study medication intake
  • •o If of non-childbearing potential - should be surgically sterile (i.e. has
  • •undergone complete hysterectomy, bilateral oophorectomy, or bilateral tubal
  • •ligation) or in a postmenopausal state (at least one year without menses at
  • •Male patients with sexual partners who could become pregnant must meet the
  • •following criteria:
  • •o Patient is unable to procreate, defined as surgically sterile (i.e. has
  • •undergone a vasectomy at last 6 months before Screening)
  • •o Patient agrees to use one of the accepted contraceptive regimens for at least
  • •30 days after the last study medication intake

排除标准

  • •1. Insufficient handling of the language used in the speech audiometry tests
  • •2. a) Bilateral hearing loss
  • •b) Sudden hearing loss in the only hearing ear (i.e. pre-existing hearing loss
  • •in the contralateral ear of 40 dB or more measured by PTA in the range of 0.5-4
  • •3. Acute hearing loss from noise trauma, barotrauma or head trauma in either
  • •ear at any time
  • •4. Congenital hearing loss
  • •5. Conductive hearing loss or combined hearing loss (determined by a 4PTA > 10
  • •dB). Only if the limit for bone conduction is reached, tympanogram type can be
  • •used (other than A).
  • •6. Suspected perilymph fistula or round window membrane rupture in either ear
  • •7. Otitis media or otitis externa that is ongoing or ended within 30 days prior
  • •to randomization or is occurring several times per year
  • •8. Patients with abnormality of the tympanic membrane or the outer ear canal
  • •that would preclude intratympanic administration
  • •9. Evidence or history of vestibular schwannoma (acoustic neuroma) or other
  • •retrocochlear damage in the affected ear
  • •10. History of ISSNHL in the past 1 year in the affected ear.
  • •11. History of radiation-induced hearing loss, fluctuating hearing,
  • •endolymphatic hydrops or Menière's disease in either ear
  • •12. History of chronic inflammatory or chronic suppurative ear disease or
  • •cholesteatoma in the affected ear
  • •13. History of otosclerosis in the affected ear
  • •14. Family history of hearing impairment other than age-related
  • •15. Medical History of one of the following diseases:
  • •o Human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
  • •o Systemic mycosis and parasitosis (amoebic or worm infections)
  • •o Acute and chronic bacterial infections
  • •o Tuberculosis
  • •o Severe osteoporosis
  • •o Narrow and wide-angle glaucoma, corneal ulceration and corneal
  • •o Severe ulcerative colitis with impending perforation, with abscesses or
  • •purulent inflammations
  • •o Exercise-induced angina, known class III or IV heart failure, as defined by
  • •the New York Heart Association (NYHA) functional classification system
  • •o Gastric or duodenal ulcer, existing or treated within <1 year prior to
  • •randomization
  • •o Myasthenia gravis
  • •o Patients with diagnosed anxiety disorders, psychosis, depression,
  • •schizophrenia, suicidal ideation or other significant psychiatric conditions.
  • •Inclusion only after critical evaluation by the Investigator
  • •16. Uncontrolled systolic (>180 mmHg) or diastolic (>100 mmHg) blood pressure
  • •at Screening
  • •17. Difficult to control diabetes
  • •18. Treatment with medication listed in 4.4 of the protocol
  • •19. Patients who have answered yes to questions 4 or 5 of the C-SSRS
  • •20. Hypersensitivity to prednisolone
  • •21. Concurrent participation in another clinical study or participation in
  • •another clinical study within 30 days or 5 half-lives of the respective
  • •experimental drug (whichever is longer) prior to Screening Visit
  • 另有 7 项未显示

研究者

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Phase II, Multi-Center, Randomized, Blinded Study... | 临床试验