Short Stature, IdiopathicPhase 4NCT03015909
Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj.
A Phase 4 study testing Somatropin in people with Short Stature, Idiopathic and Infant, Small for Gestational Age, run by LG Life Sciences at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency
- What is being tested?
- Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Aug 2016to 21 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Subjects who has diseases below on screening visit
- Diabetes
- Malignant tumor
- Epiphyseal closure
- Chronic kidney disease (recieved kidney transplantation)
- Acute respitory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure, Turner Syndrome
- Being tested
- Somatropin
- Medical subject headings
- Dwarfism, Dwarfism, Pituitary, Kidney Failure, Chronic, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
| Study group | Role | What they receive |
|---|---|---|
| Eutropin pen inj. | Other | Not described Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Measured: Day 57
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Measured: Day 57
Secondary outcomes (4)
Benefits of EutropinPen inj. assessed by a questionnaire
- Ease of use
- Unit
- High dose packing
- Grip
- Design
- Less pain
Measured: Day 57
Fear assessed by a questionnaire
Ask of fearness how the child feels about the needle
Measured: Screening, Day 57
Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
- Ask ease of use at each injection step (1~5 pts)
- Preparation time for injection
Measured: Screening, Day 57
Treatment compliance of EutropinPen Inj. (%)
Measured: Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start11 Aug 2016
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Short Stature, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015909
- Sponsor's protocol ID
- LG-HGCL008
- Status last verified
- Jan 2019
- First submitted
- 10 Nov 2016
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31908426
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03015909
- Acronym / sponsor ID
- LG-HGCL008
- Conditions
- Short Stature, Idiopathic, Infant, Small for Gestational Age, Growth Hormone Deficiency, Chronic Renal Failure, Turner Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eutropin pen inj. | Other | Drug: Somatropin |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Subjects who has diseases below on screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin | Drug | Eutropin pen inj. |
Primary outcome
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time frame: Day 57
Preference for EutropinPen Inj. against previous reusable device assessed by a questionnaire.
Time frame: Day 57
4 secondary outcomes
Benefits of EutropinPen inj. assessed by a questionnaire
Time frame: Day 57
Fear assessed by a questionnaire
Time frame: Screening, Day 57
Ease of use for EutropinPen Inj. at each injection step assessed by a questionnaire
Time frame: Screening, Day 57
Treatment compliance of EutropinPen Inj. (%)
Time frame: Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 31908426Lee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Somatropin in people with Short Stature, Idiopathic and Infant, Small for Gestational Age, run by LG Life Sciences at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of use for EutropinPen Inj. against previous reusable device assessed by a questionnaire. (time frame: Day 57). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03015909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.