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

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ClinicalTrials.gov Identifier: NCT03015909
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Short Stature, Idiopathic Infant, Small for Gestational Age Growth Hormone Deficiency Chronic Renal Failure Turner Syndrome Drug: Somatropin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 11, 2016
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

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Arms and Interventions
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Arm Intervention/treatment
Eutropin pen inj. Drug: Somatropin


Outcome Measures
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Primary Outcome Measures :
  1. Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire. [ Time Frame: Day 57 ]
  2. Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire. [ Time Frame: Day 57 ]

Secondary Outcome Measures :
  1. Benefits of EutropinPen inj. assessed by a questionnaire [ Time Frame: Day 57 ]
    1. Ease of use
    2. Unit
    3. High dose packing
    4. Grip
    5. Design
    6. Less pain

  2. Fear assessed by a questionnaire [ Time Frame: Screening, Day 57 ]
    Ask of fearness how the child feels about the needle

  3. Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire [ Time Frame: Screening, Day 57 ]
    1. Ask ease of use at each injection step (1~5 pts)
    2. Preparation time for injection

  4. Treatment compliance of EutropinPen Inj. (%) [ Time Frame: Day 57 ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015909


Locations
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Korea, Republic of
Ajou university hospital
Suwon, Gyeong-gi, Korea, Republic of, 16499
Sponsors and Collaborators
LG Life Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT03015909    
Other Study ID Numbers: LG-HGCL008
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Dwarfism
Kidney Failure, Chronic
Turner Syndrome
Gonadal Dysgenesis
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases