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Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.

Primary Purpose

Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Somatropin
Sponsored by
LG Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Stature, Idiopathic

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ajou university hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Eutropin pen inj.

Arm Description

Outcomes

Primary Outcome Measures

Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.

Secondary Outcome Measures

Benefits of EutropinPen inj. assessed by a questionnaire
Ease of use Unit High dose packing Grip Design Less pain
Fear assessed by a questionnaire
Ask of fearness how the child feels about the needle
Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
Ask ease of use at each injection step (1~5 pts) Preparation time for injection
Treatment compliance of EutropinPen Inj. (%)

Full Information

First Posted
November 10, 2016
Last Updated
January 1, 2019
Sponsor
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03015909
Brief Title
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
Official Title
A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 11, 2016 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure, Turner Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eutropin pen inj.
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Somatropin
Primary Outcome Measure Information:
Title
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time Frame
Day 57
Title
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time Frame
Day 57
Secondary Outcome Measure Information:
Title
Benefits of EutropinPen inj. assessed by a questionnaire
Description
Ease of use Unit High dose packing Grip Design Less pain
Time Frame
Day 57
Title
Fear assessed by a questionnaire
Description
Ask of fearness how the child feels about the needle
Time Frame
Screening, Day 57
Title
Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
Description
Ask ease of use at each injection step (1~5 pts) Preparation time for injection
Time Frame
Screening, Day 57
Title
Treatment compliance of EutropinPen Inj. (%)
Time Frame
Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ajou university hospital
City
Suwon
State/Province
Gyeong-gi
ZIP/Postal Code
16499
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31908426
Citation
Lee JE, Kim SY, Yoo JH, Hwang IT, Lim JS, Yi KH, Rhie YJ, Lee GM, Nam HK, Chae HW, Kim EY, Cheon CK, Lee J, Shim YS, Lee Y, Kim EY, Hwang JS. Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial. Patient Prefer Adherence. 2019 Dec 20;13:2195-2205. doi: 10.2147/PPA.S229536. eCollection 2019.
Results Reference
derived

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Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.

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