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临床试验/NCT02035397
NCT02035397进行中(未招募)2 期

Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
20
试验地点
1
主要终点
Body weight

研究概览

简要总结

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 35

排除标准

  • Known hypersensitivity to medication
  • Neuro muscular disease
  • Dysphagia
  • Tendency for aspiration
  • Use of aminoglycoside antibiotics and/or spectinomycin lately
  • Previous side effects of botox injections
  • Previous bariatric surgery
  • Previous cancer in GI-tract
  • Other obesity treatment last 12 months
  • Severe eating disorder
  • Hypothyroidism
  • Pregnancy/brest feeding
  • Reduced competence to consent

研究组 & 干预措施

Botulinum toxin A

Experimental

Botulinum toxin type A injection in muscles of stomach wall

干预措施: Botulinum Toxin Type A (Drug)

Saline solution

Placebo Comparator

Placebo (saline solution) injection first 6 months, then active treatment

干预措施: Botulinum Toxin Type A (Drug)

Saline solution

Placebo Comparator

Placebo (saline solution) injection first 6 months, then active treatment

干预措施: Saline solution (Drug)

结局指标

主要结局

Body weight

时间窗: Change from baseline to 6 months; 1 year; 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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