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

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015909
• Other study ID #: LG-HGCL008
• Status: Completed
• Phase: Phase 4
• Start date: August 11, 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: January 2019
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Dwarfism
• Dwarfism, Pituitary
• Gonadal Dysgenesis
• Growth Hormone Deficiency
• Infant, Small for Gestational Age
• Kidney Failure, Chronic
• Primary Ovarian Insufficiency
• Renal Insufficiency
• Short Stature, Idiopathic
• Turner Syndrome

Intervention

Drug:
• Somatropin

Locations

Country	Name	City	State
Korea, Republic of	Ajou university hospital	Suwon	Gyeong-gi

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.		Day 57
Primary	Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.		Day 57
Secondary	Benefits of EutropinPen inj. assessed by a questionnaire	Ease of use; Unit; High dose packing; Grip; Design; Less pain	Day 57
Secondary	Fear assessed by a questionnaire	Ask of fearness how the child feels about the needle	Screening, Day 57
Secondary	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	Screening, Day 57
Secondary	Treatment compliance of EutropinPen Inj. (%)		Day 57