EUCTR2013-002077-21-CZ进行中（未招募）1 期
Efficacy and Safety of AM-111 in the Treatment of Acute InnerEar Hearing Loss - HEALOS
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
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. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
- •2. Mean hearing threshold of equal to or worse than (=) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies (pure tone average”, PTA);*
- •3. Mean hearing loss of equal to or worse than (=) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;*
- •4. Age = 18 and = 65 years on the day of screening;
- •5. Negative urine pregnancy test for women of childbearing potential. Women are not considered to be of childbearing potential if they meet one of the following criteria:
- •- They have had a hysterectomy or tubal ligation at least one cycle prior to signing the Informed Consent Form (ICF) or
- •- They are post-menopausal, with at least one year since their last menstrual period;
- •6. Willing and able to attend the trial visits;
- •7. Able to read and understand trial documents and follow Investigator instructions;
- •8. Able to understand and follow trial personnel instructions during audiologic measurements;
- •9. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
- •10. Willing and able to protect the ear canal and middle ear from water exposure for as long as the tympanic membrane is not fully closed;
- •11. Signed Institutional Review Board (IRB) / Independent Ethics Committee (IEC) approved ICF.
- •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 245
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Bilateral ISSNHL;
- •2. Acute hearing loss from noise trauma, barotrauma or head trauma;
- •3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière’s disease in the affected ear;
- •4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
- •5. History of acoustic neuroma or other retrocochlear damage in the affected ear;
- •6. History of otosclerosis in the affected ear;
- •7. Suspected perilymph fistula or membrane rupture in the affected ear;
- •8. Congenital hearing loss;
- •9. History of ISSNHL in the past 2 years;
- •10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;
- •11. Radiation therapy in the head and neck area within the past 5 years;
- •12. Abnormality of the tympanic membrane in the affected ear that would preclude i.t. administration;
- •13. Any pre-treatment within two weeks prior to enrolment, ongoing treatment or planned treatment of ISSNHL-related hearing loss or tinnitus including pharmacological medication or non-pharmacological treatment (other than prednisolone or prednisone reserve therapy following FUV2);
- •14. Any therapy known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the 3 months prior to trial inclusion;
- •15. History within the past 2 years or presence of drug abuse or alcoholism;
- •16. Subjects with diagnosed anxiety disorders, depression, schizophrenia or other significant psychiatric diseases requiring current drug treatment or subjects who required treatment in the previous 3 months prior to enrolment for any of these diseases;
- •17. Any clinically relevant respiratory, cardiovascular, neurological disorder (except vertigo or tinnitus) or other abnormality that in the opinion of the Investigator or Sponsor may pose a safety risk to a subject in this study, which may confound efficacy or safety assessment, or may interfere with study participation;
- •18. Known or suspected ongoing active infection of HIV, hepatitis C or B, or herpes zoster;
- •19. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
- •20. Women of childbearing potential who are unwilling or unable to use an effective method of avoiding pregnancy from the screening visit until the end of the study (FUV4). Effective methods of avoiding pregnancy are contraceptive methods with a Pearl index of less than 1 used consistently and correctly (including implantable, injectable, oral and transdermal contraceptives, intrauterine devices, diaphragm with spermicide, male or female condoms with spermicide, or cervical cap, or a sterile sexual partner, or being abstinent);
- •21. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomisation (TV).
研究者
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