Growth Hormone DeficiencyPhase 3NCT02693522
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
A Phase 3 study testing somatropin and Eutropin in people with Growth Hormone Deficiency, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- somatropin and Eutropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2003to Dec 2004
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 and up
- Patients with maximum serum growth hormone concentration of less than 5 ng/ml
- Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
- Persons who have agreed in writing to participate in this study
Who cannot join
- Persons who are currently under treatment after being diagnosed with a malignant tumor
- Hepatosis
- Renal function disorder
- Intra-cranial hypertension
- Proliferative diabetic retinopathy
- Persons who carry acromegaly activity
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- Fertile women who are not pregnant or who do not take appropriate contraceptive measures and whose urine tested positive for hCG (human Chorionic Gonadotropin)
- Mental patients and/or drug addicts and alcoholics
- Patients who had participated in the other drug study within the last 30 days prior to participating in this study
- Patients considered unfit for this study by the attending physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
The purpose of this study is to evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
- Conditions
- Growth Hormone Deficiency
- Being tested
- somatropin, Eutropin
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Subcutaneous injection
EutropinDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| somatropin | Experimental | Subcutaneous injection Receives: Drug: somatropin |
| Eutropin | Active comparator | Subcutaneous injection Receives: Drug: Eutropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of fat mass (FM) reduction
statistically difference for change from baseline (kg)
Measured: baseline and 24 weeks
Secondary outcomes (3)
Degree of variation in Lean Body Mass
statistically difference for change from baseline (kg)
Measured: baseline and 24 weeks
Degree of variation in Waist to Hip Ratio
statistically difference for change from baseline
Measured: baseline and 24 weeks
Degree of variation in IGF-1
statistically difference for change from baseline (ng/ml)
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startOct 2003
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693522
- Sponsor's protocol ID
- DW_CTP
- Status last verified
- Feb 2016
- First submitted
- 19 Jan 2016
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III of the Comparative Study on the Efficacy and Safety of Recombinant Somatropin Administered to Patients With Adult Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT02693522
- Acronym / sponsor ID
- DW_CTP
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 26 Feb 2016 (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 evaluate the efficacy and safety of recombinant human growth hormone on adult growth hormone deficiency
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somatropin | Experimental | Drug: somatropinSubcutaneous injection |
| Eutropin | Active comparator | Drug: EutropinSubcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 and up
- Patients with maximum serum growth hormone concentration of less than 5 ng/ml
- Patients who can successfully complete this study based on appropriate medical judgment or who expect to benefit from this study
- Persons who have agreed in writing to participate in this study
Key exclusion criteria (10 listed)
- Persons who are currently under treatment after being diagnosed with a malignant tumor
- Hepatosis
- Renal function disorder
- Intra-cranial hypertension
- Proliferative diabetic retinopathy
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 |
|---|---|---|
| somatropinSubcutaneous injection | Drug | somatropin |
| EutropinSubcutaneous injection | Drug | Eutropin |
Primary outcome
Degree of fat mass (FM) reduction
Time frame: baseline and 24 weeks
statistically difference for change from baseline (kg)
3 secondary outcomes
Degree of variation in Lean Body Mass
Time frame: baseline and 24 weeks
Degree of variation in Waist to Hip Ratio
Time frame: baseline and 24 weeks
Degree of variation in IGF-1
Time frame: baseline and 24 weeks
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 29 Feb 2016.
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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 3 study testing somatropin and Eutropin in people with Growth Hormone Deficiency, run by Daewoong Pharmaceutical Co. LTD. 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 4 inclusion and 10 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 29 Feb 2016. 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 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?
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?
Degree of fat mass (FM) reduction (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.