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

Phase 4

Completed

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

• Registration Number: NCT03015909
• Lead Sponsor: LG Life Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Study First Submitted: 2016-11-10
• Study First Submitted QC: 2017-01-08
• Study First Posted: 2017-01-10
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-01
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eutropin pen inj.	Somatropin	-

Primary Outcome Measures

Name	Time	Method
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.	Day 57
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.	Day 57

Secondary Outcome Measures

Name	Time	Method
Benefits of EutropinPen inj. assessed by a questionnaire	Day 57	1. Ease of use; 2. Unit; 3. High dose packing; 4. Grip; 5. Design; 6. Less pain
Fear assessed by a questionnaire	Screening, Day 57	Ask of fearness how the child feels about the needle
Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire	Screening, Day 57	1. Ask ease of use at each injection step (1\~5 pts); 2. Preparation time for injection
Treatment compliance of EutropinPen Inj. (%)	Day 57

Trial Locations

Locations (1)

Ajou university hospital; 🇰🇷 Suwon, Gyeong-gi, Korea, Republic of