ISRCTN84220089已完成不适用
An interventional, randomized, double-blind, placebo-controlled, parallel-assignment, safety/efficacy study for treatment of chronic middle ear infection in adult patients with the antimicrobial peptide OP-145
OctoPlus N.V. (The Netherlands)0 个研究点目标入组 0 人开始时间: 2008年1月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
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
入选标准
- •Inclusion criteria for the Part I dose finding study:
- •1. Adults >= 18 years, males and females
- •2. Legally competent, no psychiatric history
- •3. Chronic otitis media with a clear perforation of the tympanic membrane >3 months
- •4. Chronic proliferative mucosal changes (confirmed by Computerised Tomography (CT) scan)
- •5. Antibiotic therapy resistant (Adequately treated with at least 2 different eardrops for >6 weeks)
- •Inclusion criteria for the Part II randomised controlled study:
- •1. Adults, both males and females, over 18 years of age
- •2. Legally competent, with no history of psychiatric disorders
- •3. Chronic otitis media with a clear perforation of the tympanic membrane, lasting longer than 6 months
- •4. Chronic proliferative mucosal changes (confirmed with CT scan)
- •5. Antibiotic therapy resistant (Adequately treated with at least 2 different eardrops for >6 weeks)
排除标准
- •Exclusion criteria for the Part I dose finding study:
- •1. Presence of cholesteatoma in the treated ear (confirmed with CT-scan)
- •2. History of mastoidectomy in the treated ear (resulting in a 'radicaalholte')
- •3. Pregnant and breastfeeding women
- •4. Patients that have been using topical, oral or parenteral antibiotics or steroids in the last 30 days
- •5. Patients that have been using prednison or any other immunosuppressive agent in the last 30 days
- •6. Patients with serious headaches
- •7. Patients with Down syndrome or other congenital anomalies in the upper respiratory tract
- •8. Immunocompromized patients or patients with auto-immune disorders
- •9. History of seizures
- •10. Patients with deficits at the nervus facialis
- •Exclusion criteria for the Part II randomised controlled study:
- •1. Presence of cholesteatoma in the treated ear (confirmed with CT-scan)
- •2. History of mastoidectomy in the treated ear (resulting in a 'radicaalholte')
- •3. Pregnant and breastfeeding women
- •4. Patients that have been using topical, oral or parenteral antibiotics or steroids in the last 30 days
- •5. Patients that have been using prednison or any other immunosuppressive agent in the last 30 days
- •6. Patients with serious headaches
- •7. Patients with Down syndrome or other congenital anomalies in the upper respiratory tract
- •8. Immunocompromized patients or patients with auto-immune disorders
- •9. History of seizures
- •10. Patients with deficits at the nervus facialis
- •11. Patients who were included in the Part I dose finding study
研究者
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