A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
研究概览
简要总结
This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
- •Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
- •Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
- •Be willing and able to comply with the protocol for the duration of the trial
- •Have access to the Internet
- •Be able to read, speak and understand English
- •If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide
排除标准
- •Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
- •Severe illness during the previous 6 months
- •Active malignancy (except non-melanomatous skin malignancies)
- •Diabetes mellitus (type I or II)
- •Pregnancy or lactation
- •Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
- •Participation in any other investigational study during the duration of participation in this trial
结局指标
主要结局
Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
时间窗: 90 Days
次要结局
- Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices(90 Days)
- Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.(90 Days)
- Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.(90 Days)