A Multicenter, Open-label, Randomized Two Arm Cross Over Study Assessing Dyad (Subject and Caregiver) and Adult Subject Perception of Convenience and Preference of the Newly Developed Genotropin Mark VII Pen.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®
研究概览
简要总结
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 8 years.
- •Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
排除标准
- •Subjects with Prader-Willi syndrome or chronic renal insufficiency.
- •Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
- •Subjects with chronic systemic disorders, such as diabetes and heart disease.
研究组 & 干预措施
Mark VII/Current pen
Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
干预措施: Genotropin Pen (Device)
Mark VII/Current pen
Subject will use Mark VII pen for 2 months followed by Current pen for 2 months
干预措施: MARK VII pen (Device)
Current pen/Mark VII
Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
干预措施: Genotropin Pen (Device)
Current pen/Mark VII
Subject will use current Genotropin pen for 2 months followed by Mark VII pen for 2 months
干预措施: MARK VII pen (Device)
结局指标
主要结局
Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®
时间窗: Month 4
Participants were asked the following question from Section II of the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool, "Thinking about the Genotropin pen and the new injection pen you used over the past few months, please compare both injection pens and choose which one is easier to use overall?" Choices included: Genotropin Pen® easier to use, new injection pen easier to use, or no difference.
次要结局
- Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen®(Month 4)
- Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen®(Month 4)
- Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen®(Month 4)
- Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen(Month 4)
- Ease of Use of Each Injection Pen(Month 2 and Month 4)