CompletedPhase 4

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

South Korea116 participantsStarted 2016-08-11

Plain-language 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.

Who can participate

Age range4 Years – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Day 57

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

Timeframe: Day 57

Trial details

NCT IDNCT03015909

SponsorLG Life Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-12-21

View on ClinicalTrials.gov More Short Stature, Idiopathic trials