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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03015909 |
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Date of registration:
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10/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
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Scientific title:
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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 |
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Date of first enrolment:
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August 11, 2016 |
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Target sample size:
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116 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03015909 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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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
Age minimum:
4 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Chronic Renal Failure
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Turner Syndrome
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Infant, Small for Gestational Age
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Short Stature, Idiopathic
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Intervention(s)
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Drug: Somatropin
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Primary Outcome(s)
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Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
[Time Frame: Day 57]
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Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
[Time Frame: Day 57]
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Secondary Outcome(s)
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Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
[Time Frame: Screening, Day 57]
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Benefits of EutropinPen inj. assessed by a questionnaire
[Time Frame: Day 57]
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Fear assessed by a questionnaire
[Time Frame: Screening, Day 57]
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Treatment compliance of EutropinPen Inj. (%)
[Time Frame: Day 57]
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Secondary ID(s)
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LG-HGCL008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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