An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
研究概览
简要总结
Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
详细描述
Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation provides a higher concentration and thereby a smaller volume to be administered. ZomaJet Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin and into the subcutaneous tissue without the use of a needle. The mode of administration is referred to as "transjection". By use of ZomaJet Vision X, both transjection and reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet Vision X.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy
排除标准
- 未提供
结局指标
主要结局
To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
次要结局
未报告次要终点