User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Usefulness and Reliability of E-Device Functions
研究概览
简要总结
The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC)
- •Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent
排除标准
- •Known hypersensitivity to somatropin or any of the excipients
- •Epiphyseal fusion
- •Active neoplasia (either newly diagnosed or recurrent)
- •History of intracranial hypertension with papilledema
- •Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL
- •Severe congenital malformations
- •Severe psychomotor retardation
- •Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
- •Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
- •Chronic infectious disease
- •Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
- •Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
- •Proliferative or preproliferative diabetic retinopathy
- •Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
- •Precocious puberty
- •Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
- •Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
- •Participation to any clinical study within the 30 days preceding study entry
研究组 & 干预措施
Saizen® E-Device
干预措施: Saizen® E-Device (Device)
结局指标
主要结局
Usefulness and Reliability of E-Device Functions
时间窗: 2 Weeks
Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.
Subjects' Overall Impression After Using E-Device
时间窗: 2 Weeks
Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
次要结局
- Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)(Day 1 up to Day 90)
- Subjects' Feedback Immediately After Initial Training During Inclusion Visit(Inclusion visit (Day 1))
- Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit(Inclusion visit (Day 1))