Skip to main content
OpenTrials
Completed

NCT Number: NCT03015909

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Short Stature, Idiopathic Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Chromosome Disorders Chronic Disease Chronic Renal Failure Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Disorders of Sex Development Dwarfism Dwarfism, Pituitary Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency Heart Defects, Congenital Heart Diseases Hypopituitarism Hypothalamic Diseases Infant, Small for Gestational Age Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Renal Insufficiency Renal Insufficiency, Chronic Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou university hospital

Suwon, Gyeonggi-do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

Primary outcomes

  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

  1. Benefits of EutropinPen inj. assessed by a questionnaire

    Time frame: Day 57

    • Ease of use
    • Unit
    • High dose packing
    • Grip
    • Design
    • Less pain

  2. Fear assessed by a questionnaire

    Time frame: Screening, Day 57

    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

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

  4. Treatment compliance of EutropinPen Inj. (%)

    Time frame: Day 57

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2017
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.