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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03015909 (opens ClinicalTrials.gov in a new tab)Other idLG-HGCL008
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
116 participants (actual)
Sponsor
LG Life Sciences · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

South Korea

Start
11 Aug 2016
Primary completion
21 Dec 2017
Completion
21 Dec 2017
First posted
10 Jan 2017 (estimated)
Last update posted
3 Jan 2019
Conditions
Short Stature, Idiopathic · Infant, Small for Gestational Age · Growth Hormone Deficiency · Chronic Renal Failure · Turner Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 4

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

    NCT03015909

    11 Aug 2016 to 21 Dec 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SomatropinDrug

Arms1

  • Other

    Eutropin pen inj.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.

    Time frame · Day 57

  2. Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.

    Time frame · Day 57

Secondary outcomes(4)

  1. Benefits of EutropinPen inj. assessed by a questionnaire

    Time frame · Day 57

    Registry description

    1. Ease of use 2. Unit 3. High dose packing 4. Grip 5. Design 6. Less pain

  2. Fear assessed by a questionnaire

    Time frame · Screening, Day 57

    Registry description

    Ask of fearness how the child feels about the needle

  3. Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire

    Time frame · Screening, Day 57

    Registry description

    1. Ask ease of use at each injection step (1\~5 pts) 2. Preparation time for injection

  4. Treatment compliance of EutropinPen Inj. (%)

    Time frame · Day 57

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2019

Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial.

Lee et al. 2019Patient preference and adherence

PMID 31908426PMC6929929DOI 10.2147/ppa.s229536PUB-31908426

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years up to 15 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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