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

NCT ID: NCT03015909

Last Updated: 2019-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-11

Study Completion Date

2017-12-21

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Eutropin pen inj.

Group Type OTHER

Somatropin

Intervention Type DRUG

Interventions

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Somatropin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ajou university hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Lee JE, Kim SY, Yoo JH, Hwang IT, Lim JS, Yi KH, Rhie YJ, Lee GM, Nam HK, Chae HW, Kim EY, Cheon CK, Lee J, Shim YS, Lee Y, Kim EY, Hwang JS. 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. Patient Prefer Adherence. 2019 Dec 20;13:2195-2205. doi: 10.2147/PPA.S229536. eCollection 2019.

Reference Type DERIVED
PMID: 31908426 (View on PubMed)

Other Identifiers

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LG-HGCL008

Identifier Type: -

Identifier Source: org_study_id

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