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临床试验/NCT01058317
NCT01058317撤回2 期

Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Massachusetts Eye and Ear Infirmary0 个研究点开始时间: 2010年1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
撤回
主要终点
Decreased number of surgeries

研究概览

简要总结

Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
  • Child under age 10
  • Informed consent and where appropriate informed assent
  • Children who have undergone at least 4 documented surgical interventions in the past year.

排除标准

  • Parental or child refusal to participate
  • Heart failure
  • Atrio-ventricular heart block
  • Cardiac anomalies
  • Low resting heart rate
  • Low resting blood pressure
  • Wolff-Parkinson White Syndrome
  • Unexplained syncope
  • Asthma or Reactive airway disease
  • Renal or liver failure
  • Expected long fasting periods, >12 hours
  • Diabetes Mellitus
  • Hypersensitivity to propranolol

研究组 & 干预措施

Children treated with propranolol

Experimental

干预措施: Propranolol (Drug)

结局指标

主要结局

Decreased number of surgeries

时间窗: 3 months

次要结局

  • Improved voice quality(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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