Treatment of chronic suppurative otitis media with the antimicrobial peptide OP-145 (AMP60.4Ac) in adults

OctoPlus BV0 个研究点目标入组 50 人开始时间: 2015年10月14日最近更新: 2023年11月20日

适应症

试验速览

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32287316/ (added 12/05/2021)

•1. Aged 18 years or older
•2. Legally competent, no psychiatric history
•3. Diagnosis of CSOM with chronic proliferative mucosal changes > 6 months
•4. A clear perforation of the tympanic membrane to allow proper inspection of the middle ear mucosa
•5. Antibiotic therapy resistant (having received adequate treatment for CSOM for at least 2 periods of in total = 6 weeks within the past year with at least two different ear drops and the last treatment period having occurred within the last 6 months before screening)

•1. Cholesteatoma in the ear to be treated (i.e. CSOM with cholesteatoma)
•2. Presence of a radical cavity in the ear to be treated
•3. Use of systemic immune suppressants or antibiotics, use of topical antibiotics, corticosteroids or other eardrops in one of the ears until 4 weeks before study start
•4. Down’s syndrome or other congenital anomalies to the external or middle ear or to the area of the Eustachian tube – middle ear” of the ear to be treated
•5. Presence of immune disorders, e.g. primary immune deficiency, immune proliferative disorders, Multiple Sclerosis, Crohn’s Disease, rheumatoid arthritis or Primary Ciliary Dyskinesia
•6. Severe dizziness or severe headache, impacting on subjects’ daily life activities
•7. Facialis nerve disorders on the side of the ear to be treated
•8. Pregnancy, the wish to become pregnant or to breastfeed during the study, or, in case of a male subject, the wish to make his partner pregnant during the study
•9. Prior participation in the dose-finding study of the program

发起方

OctoPlus BV