NCT01058317撤回2 期
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
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
- 否
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
相似试验
已完成
不适用
Propranolol therapy for pediatric hemangioma and lymphangiomapediatric hemangioma and lymphangiomaJPRN-UMIN000005990Tohoku University Hospital
已完成
不适用
Propranolol for infantile hemangiomasInfantile hemangiomasJPRN-UMIN000011944Plastic and Reconstructive Surgery, Keio university, School of medicine30
Unknown
2 期
''Efficacy of Propranolol in the Treatment of Infantile Hemangioma"Infantile HemangiomaNCT04684667Assiut University100
已完成
2 期
Propranolol in treatment of hemangiomaHemangioma.Hemangioma, any siteIRCT2014041817325N1Ardabil University of Medical Sciences20
招募中
不适用
Propranolol and Von Hippel-Lindau DiseaseHemangioblastoma of CNSVon Hippel-Lindau DiseaseNCT05424016Assistance Publique - Hôpitaux de Paris85
