| Trial ID: | L1667 |
| Source ID: | NCT03015909
|
| Associated Drug: |
Somatropin
|
| Title: |
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Short Stature, Idiopathic|Infant, Small for Gestational Age|Growth Hormone Deficiency|Chronic Renal Failure|Turner Syndrome
|
| Interventions: |
DRUG: Somatropin
|
| Outcome Measures: |
Primary: 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: Benefits of EutropinPen inj. assessed by a questionnaire, 1. Ease of use 2. Unit 3. High dose packing 4. Grip 5. Design 6. Less pain, Day 57|Fear assessed by a questionnaire, Ask of fearness how the child feels about the needle, Screening, Day 57|Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire, 1. Ask ease of use at each injection step (1\~5 pts) 2. Preparation time for injection, Screening, Day 57|Treatment compliance of EutropinPen Inj. (%), Day 57
|
| Sponsor/Collaborators: |
Sponsor: LG Life Sciences
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE4
|
| Enrollment: |
116
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-08-11
|
| Completion Date: |
2017-12-21
|
| Results First Posted: |
|
| Last Update Posted: |
2019-01-03
|
| Locations: |
Ajou university hospital, Suwon, Gyeong-gi, 16499, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT03015909
|
