JPRN-UMIN000000936已完成1 期
Phase I-II study for therapeutic efficacy of local recombinant human local insulin like growth factor 1 treatment via biodegradable gelatin hydrogels for acute sensorineural hearing loss - Clinical trial of local IGF1 treatment for acute sensorineural hearing loss
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
研究概览
简要总结
In total, 25 patients received the test treatment at a median of 23 days (range, 15–32) after the onset of SSHL, between 2007 and 2009. At 12 weeks after the test treatment, 48% (95% CI, 28–69%; P = 0.086) of patients showed hearing improvement, and the proportion increased to 56% (95% CI, 35¬–76%; P = 0.015) at 24 weeks. No serious adverse events were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •The exclusion criteria are as follows; (1) presenting active chronic otittis media, acute otittis media, otittis media with effusion or dysfunction of the auditory tube, (2) history of previous other treatments including systemic application of batroxobin, progtagrandin I, and hyper oxygen therapy, except for systemic steroid application, (3) presenting malignant tumors, (4) presenting severe liver dysfunction (AST>100, ALT >100), (5) presenting uncontrolled diabetes (HbA1c>10), (6) presenting pituitary or adrenal dysfunction, (7)severe systemic illness with an expected life expectancy, (8) pregnant or lactating women, (9) history of drug allergy, (10) treated with batroxobin or prostagrandin E1or I after the onset of hearing loss, (11) past history of alcohol or drug dependence within 1 year, (12) individuals who are diagnosed as inappropriate for the trial (ie: difficulty in a 24-week follow up).
研究者
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