Chronic Renal Failure, Growth Hormone Deficiency, Infant, Small for Gestational Age, Short Stature, Idiopathic, Turner Syndrome
Conditions
Brief summary
The purpose of this study is to assess the ease of use, preference, and safety after 8 weeks subcutaneous administration of EutropinPen Inj. in patients pretreated with recombinant human growth hormone by reusable device.
Interventions
DRUGSomatropin
Sponsors
LG Life Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who has been using reusable device growth hormone injection in recent 3 months at least for 6 weeks * Subjects who meets the indication of EutropinPen inj.
Exclusion criteria
* Subjects who has diseases below on screening visit * Diabetes * Malignant tumor * Epiphyseal closure * Chronic kidney disease (recieved kidney transplantation) * Acute respitory failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire. | Day 57 |
| Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire. | Day 57 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Benefits of EutropinPen inj. assessed by a questionnaire | Day 57 | 1. Ease of use 2. Unit 3. High dose packing 4. Grip 5. Design 6. Less pain |
| Fear assessed by a questionnaire | Screening, Day 57 | Ask of fearness how the child feels about the needle |
| Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire | Screening, Day 57 | 1. Ask ease of use at each injection step (1\ 5 pts) 2. Preparation time for injection |
| Treatment compliance of EutropinPen Inj. (%) | Day 57 | — |
Countries
South Korea
Outcome results
None listed