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

January 1, 2019 updated by: LG Life Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeong-gi
      • Suwon, Gyeong-gi, Korea, Republic of, 16499
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Eutropin pen inj.
Drug: Somatropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time Frame: Day 57
Day 57
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time Frame: Day 57
Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 57
Fear assessed by a questionnaire
Time Frame: Screening, Day 57
Ask of fearness how the child feels about the needle
Screening, Day 57
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
Screening, Day 57
Treatment compliance of EutropinPen Inj. (%)
Time Frame: Day 57
Day 57

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2016

Primary Completion (Actual)

December 21, 2017

Study Completion (Actual)

December 21, 2017

Study Registration Dates

First Submitted

November 10, 2016

First Submitted That Met QC Criteria

January 8, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

January 1, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-HGCL008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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