Idiopathic Short StaturePhase 3NCT01786902

Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature

A Phase 3 study testing DA-3002 in people with Idiopathic Short Stature, run by Dong-A ST Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Growth hormone therapy will improve the height of idiopathic short statured children. DA-3002(Recombinant Human Growth hormone)treated group for 26 weeks, will be compared to non-treatment group in efficacy and safety. Read more about this study

Who is it for?: Ages 4 to 13 years
Conditions the study is for: Idiopathic Short Stature
What is being tested?: DA-3002
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: No sites listed yet
Study dates: Feb 2012to Apr 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

Chronological Age ≥ 4
Bone Age <11 (for girls) and <13 (for boys)
Height <3rd percentile for age
normal thyroid function

Who cannot join

endocrine and/or metabolic disorders
growth failure caused by other disorders
previous use of drugs that could interfere with Growth Hormone treatment

About this study

Official title: Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature

Conditions: Idiopathic Short Stature
Being tested: DA-3002
Keywords: growth hormone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DA-3002Drug
Also called Recombinant Human Growth Hormone

Study groups in NCT01786902
Study group	Role	What they receive
DA-3002 Treatment group	Experimental	1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week) Receives: Drug: DA-3002
Non-treatment control group	No intervention	Height be measured with no treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized Height Velocity(cm/Year) After 26 Weeks
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.
Measured: 26 weeks

Secondary outcomes (1)

Changes in Height Standard Deviation Score After 26 Weeks
The Height Standard Deviation Score was calculated as height minus reference mean height divided by the standard deviation of the reference mean height, both given by a reference growth table for the corresponding chronological age at the height measurement. Greater Height Standard Deviation Score indicates greater height.
Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Apr 2014

First posted8 Feb 2013 (estimated)
Study startFeb 2012
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Idiopathic Short StatureStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01786902
Sponsor's protocol ID: DA3002_ISS_III
Status last verified: Sep 2017
First submitted: 6 Feb 2013
Last updated: 19 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome

All Idiopathic Short Stature trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Multi-Center, Controlled, Randomized Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-3002(Recombinant Humn Growth Hormone)Treatment in Children With Idiopathic Short Stature
ClinicalTrials.gov ID: NCT01786902
Acronym / sponsor ID: DA3002_ISS_III
Conditions: Idiopathic Short Stature
Keywords: growth hormone
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 8 Feb 2013 (estimated)
Results: Posted 29 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DA-3002 Treatment group	Experimental	Drug: DA-30021.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)
Non-treatment control group	No intervention	–Height be measured with no treatment

Who may qualify

Ages: 4 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

Chronological Age ≥ 4
Bone Age <11 (for girls) and <13 (for boys)
Height <3rd percentile for age
normal thyroid function

Key exclusion criteria (3 listed)

endocrine and/or metabolic disorders
growth failure caused by other disorders
previous use of drugs that could interfere with Growth Hormone treatment

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
DA-3002Also: Recombinant Human Growth Hormone	Drug	DA-3002 Treatment group

Primary outcome

Annualized Height Velocity(cm/Year) After 26 Weeks
Time frame: 26 weeks
Height Velocity calculated with height measured at Baseline and after 26 weeks was converted to annual growth rate.

1 secondary outcome

Changes in Height Standard Deviation Score After 26 Weeks
Time frame: 26 weeks

Results and safety

Results posted to the registry on 29 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DA-3002 Treatment Group	36	32
Non-treatment Control Group	34	31

Primary outcome: Annualized Height Velocity(cm/Year) After 26 Weeks

Time frame: 26 weeks. Mean (Standard Deviation). Unit: cm/year

Measure	DA-3002 Treatment Group n = 36	Non-treatment Control Group n = 32
Value	10.68 (1.95)	5.72 (1.72)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DA-3002 Treatment Group	1 of 36 (2.8%)	19 of 36 (52.8%)	Not reported
Non-treatment Control Group	1 of 31 (3.2%)	14 of 31 (45.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Idiopathic Short Stature

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Human Growth Hormone Injection (Sinotropin AQ) for the Treatment of Children With Idiopathic Short Stature
Idiopathic Short Stature (ISS)
Active, not recruitingPhase 3
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
SGA, Turner Syndrome

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.

Hanwook Yoo, MD principal investigator

Asan Medical Center

Byungkyu Suh, MD study director

Seoul St. Mary's Hospital

Cheolwoo Ko, MD study director

Kyungpook National University Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DA-3002 in people with Idiopathic Short Stature, run by Dong-A ST Co., Ltd..

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 4 inclusion and 3 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Annualized Height Velocity(cm/Year) After 26 Weeks (time frame: 26 weeks). 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 NCT01786902.

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 19 Oct 2017.