NCT03015909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

January 3, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

November 10, 2016

Last Update Submit

January 1, 2019

Conditions

Short Stature, IdiopathicInfant, Small for Gestational AgeGrowth Hormone DeficiencyChronic Renal FailureTurner Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 (4)

  • Benefits of EutropinPen inj. assessed by a questionnaire

    Day 57

  • Fear assessed by a questionnaire

    Screening, Day 57

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

    Screening, Day 57

  • Treatment compliance of EutropinPen Inj. (%)

    Day 57

Study Arms (1)

Eutropin pen inj.

OTHER
Drug: Somatropin

Interventions

SomatropinDRUG
Eutropin pen inj.

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects who has diseases below on screening visit
  • Diabetes
  • Malignant tumor
  • Epiphyseal closure
  • Chronic kidney disease (recieved kidney transplantation)
  • Acute respitory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Related Publications (1)

  • 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: 31908426DERIVED

MeSH Terms

Conditions

DwarfismDwarfism, PituitaryKidney Failure, ChronicTurner Syndrome

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesSex Chromosome Disorders of Sex DevelopmentHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesSex Chromosome DisordersChromosome DisordersGonadal Disorders

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2016

First Posted

January 10, 2017

Study Start

August 11, 2016

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

January 3, 2019

Record last verified: 2019-01

Locations

KR(1)