Study to Compare Injection Anxiety Immediately Before the Administration of Each Dose of Tev-Tropin® Between a Needle-syringe Injection Method and a Needle-free Injection Method in Pediatric Subjects With Human Growth Hormone Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Subject-reported Injection Anxiety Immediately Before Administration
研究概览
简要总结
The purpose of this study is to obtain psychological response and user preference information on the use of the T jet® device versus the traditional subcutaneous injection administration of Tev Tropin®.
This study will compare subject-reported injection anxiety immediately before the administration of each dose of Tev-Tropin® between a needle-syringe injection method and a needle-free injection method (T-jet®)
详细描述
The primary efficacy endpoint was the difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5-point FIS immediately before administration. A higher score denoted greater anxiety.
The injection anxiety score was to be reported by the subject from a row of five faces with values ranging from 5 (the face with the most negative affect) to 1 (the face with the most positive affect).
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
- 7 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must require a routine Tev-Tropin® dose that does not exceed 2.5 mg in one injection (0.5 mL) using the dosing schedule individualized for each patient by their prescribing physician
- •Male, age 7-17 years, with the capability to provide assent, as determined by the investigator and/or parent or legal guardian
- •Clinically definite growth hormone deficiency as previously diagnosed by the investigator or other physician
- •Subjects must be using Tev-Tropin® prior to enrollment for 28 days
- •Informed consent signed by parent(s) or legal custodian of patient prior to study entry and patient assent as determined by the investigator and/or subject's parent or legal custodian
排除标准
- •More than one subcutaneous injection per Tev-Tropin® dose
- •Female gender
- •Use of any other needle-free injection device at any time
- •Current use of another human growth hormone product other than Tev-Tropin®
- •Concurrent treatment with other routine injectable medications
- •History of benign intracranial hypertension
- •Significant communication difficulties, or medical or psychiatric condition, that affects the subject's and/or caregiver's ability to perform the necessary functions to complete the study, or any condition which the investigator in their medical judgment thinks may interfere with participation in the study
- •Use of an investigational drug within 30 days prior to randomization
- •Contraindications related to routine use of Tev-Tropin® as per investigators' medical judgment (e.g., subjects with closed epiphyses, active proliferative or severe non-proliferative diabetic retinopathy, active malignancy, acute critical illness, or Prader-Willi syndrome who are severely obese or have severe respiratory impairment)
- •Current participation in another pharmaceutical or device study
- •Previous participation in this study
结局指标
主要结局
Subject-reported Injection Anxiety Immediately Before Administration
时间窗: 28 days; Period 1: 14 days, Period 2: 14 days
The difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5 point scale immediately before administration, which scale consisted of a row of five faces with values from 1(most positive)to 5(most negative or greater anxiety.) The score is an average of the Period 1 (Days 1-14) and Period 2 (Days 15-28) assessments; like groups were combined and then averaged. There were 3 visits: Visit 1 (Begin Period 1) Screening and Randomized assignment, Visit 2 (first day of Period 2) Cross over to other assignment, Visit 3 End of Study.
次要结局
- Subject-reported Injection Pain Immediately Following Administration.(28 days; Period 1: 14 days, Period 2: 14 days)
- Subject or Caregiver Reported Perception of Ease of Preparation as Recorded Weekly on a 5-point Scale.(2 weeks)
- Subject or Caregiver Reported Perception of Ease of Administration as Recorded Weekly on a 5-point Scale.(28 Days; end of Period 1(14 days) and end of Period 2 (14 days))
- Subject-reported Overall Satisfaction Following the End of Each Period of the Study.(28 Days; end of Period 1(14 days) and end of Period 2 (14 days))