NCT03079557已完成2 期
A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial
St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- BMI
研究概览
简要总结
This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of the stomach. These injections will be repeated every six months.
The study sample will be adolescents with obesity who have not responded to standard conservative treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written (signed) informed consent
- •Age and gender adjusted body mass index (ISO-BMI) ≥ 35 or ISO-BMI > 30 with comorbidities including hypertension, non-alcoholic fatty liver disease, hyperlipidemia or impaired glucose tolerance
- •Having partaken in a comprehensive multi-disciplinary lifestyle treatment for obesity of duration 12 months or more, without achieving a clinically significant weight loss (non-responder)
排除标准
- •Known hypersensitivity to excipients in the investigational medicine product (IMP)
- •Neuromuscular disorders
- •History of dysphagia
- •History of aspiration tendency or aspiration pneumonia
- •Known lung disease under continuous treatment
- •Congenital or acquired heart disease
- •Previous experience of side effects to Botulinum toxin type A
- •Present gastric diseases or dysfunction
- •Previous bariatric surgery
- •History of cancer
- •Serious binge eating disorder
- •Untreated hypothyroidism
- •Use of aminoglycoside antibiotics or spectinomycin in the week prior to injection, or any other medicinal product that interfere with neuromuscular transmission (neuromuscular blocking agents)
- •Medication known to affect appetite
- •Syndromic obesity
- •Mentally immature to a degree that there is doubt about the subject's ability to assent
- •Issues relating to language or culture that may complicate trial participation
- •Pregnancy or breastfeeding
研究组 & 干预措施
Intragastric botulinum toxin type A
Experimental
Botulinum toxin A (Allergan) injected intragastrically in the antrum
干预措施: Intragastric botulinum toxin type A (Drug)
结局指标
主要结局
BMI
时间窗: 12 months
Proportion of participants reaching a reduction in BMI z-score equal to or more than 1
次要结局
- Injection interval(12 months)
- Patient adherence to treatment(12 months)
- Incidence of treatment-emergent adverse events(2 years)
研究者
研究点 (1)
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