EUCTR2016-000326-19-NO进行中（未招募）1 期
Treatment of obesity in adolescents by endoscopic injection of Botulinum toxin A - A randomised, double blind, placebo-controlled phase II-trial followed by an open-label cohort-controlled extension
St Olavs Hospital Trondheim University Hospital0 个研究点目标入组 140 人开始时间: 2016年4月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •adolesent (12-18 years), BMI or ISO-BMI > 35, not having achieved a clinically important, sustainable weight loss in a comprehensive multi-disciplinary lifestyle programme for obesity
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known hypersensitivity to excipients in IMP, neuromuscular disorders, history of disphagia, history of aspiration tendency or aspiration pneumonia, known lung disease under continuous treatment, congenital of acquired heart disease, previous experience of side effects for injections of BTA, present gastric diseases of dysfunction, previous experience of side effects for BTxA, previous bariatric surgery, history of cancer, serious binge eating disorder, untreated hyperthyroidism, use of aminoglycoside antibiotics or spectinomycin last week, use of any other medicinal products that interfere with neuromuscular transmission (neuromuscular blocking agents), medication known to affect appetite, syndromal obesity, mentally immature to the degree that there is doubt about the subject's ability to consent, issues related to language and culture that may complicate trial participation, pregnant or lactating women.
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