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

LG Life Sciences

Status and phase: Completed; Phase 4

Conditions: Chronic Renal Failure; Turner Syndrome; Infant, Small for Gestational Age; Short Stature, Idiopathic; Growth Hormone Deficiency

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03015909

LG-HGCL008

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Eutropin pen inj.

Other group

Treatment:

Drug: Somatropin