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

NCT03015909 — Phase 4, Completed, 116 participants, LG Life Sciences

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT03015909
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	116 (Actual)
Sponsor	LG Life Sciences (Industry)
Conditions	Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure, Turner Syndrome
Interventions	Somatropin (Drug)
Dates	start 2016-08-11, primary completion 2017-12-21, completion 2017-12-21, first posted 2017-01-10, last updated 2019-01-03
Locations	1 site in South Korea

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Eutropin pen inj.	Other	Drug: Somatropin

Somatropin (Drug)

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 4 Years to 15 Years

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

+Locations (1)

Facility	City	Country	Status
Ajou university hospital	Suwon, Gyeonggi-do	South Korea

+Publications

Results publication: 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. PMID 31908426

My Notes

Public

To Read Reading Read