Growth Hormone DisorderPhase 3NCT01502124
Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
A Phase 3 study testing somatropin in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 21 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children
- What is being tested?
- somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 21 sitesUnited States
- Study dates
- 8 May 2001to 5 Mar 2003
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
- Naïve to growth hormone therapy
Who cannot join
- Known or suspected allergy to the trial product or related products
- Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
- Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
- Pregnancy or the intention to become pregnant
- Breast-feeding
- Administration of other growth-altering medication
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Novo Nordisk Investigational Site
Akron, Ohio, 44308-1062
Novo Nordisk Investigational Site
Atlanta, Georgia, 30342
Novo Nordisk Investigational Site
Chicago, Illinois, 60612
Novo Nordisk Investigational Site
Chicago, Illinois, 60614
Novo Nordisk Investigational Site
Gainesville, Florida, 32608
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Lexington, Kentucky, 40536-0284
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Los Angeles, California, 90048-1869
Novo Nordisk Investigational Site
Louisville, Kentucky, 40202
Novo Nordisk Investigational Site
Manhasset, New York, 11030
Novo Nordisk Investigational Site
Miami, Florida, 33155
Novo Nordisk Investigational Site
Orlando, Florida, 32806-1101
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15212
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224
Novo Nordisk Investigational Site
Seattle, Washington, 98105
Novo Nordisk Investigational Site
Tampa, Florida, 33607
Novo Nordisk Investigational Site
Washington D.C., District of Columbia, 20010
Novo Nordisk Investigational Site
Wichita, Kansas, 67226
Novo Nordisk Investigational Site
Wilmington, Delaware, 19899
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655
About this study
Official title: Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.
- Being tested
- somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
somatropinDrug
Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
| Study group | Role | What they receive |
|---|---|---|
| Lyophilized | Active comparator | Not described Receives: Drug: somatropin |
| Liquid | Experimental | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (especially injection site reactions)
Serious adverse events
Secondary outcomes (2)
IGF-1 (Insulin-like growth factor 1) concentration
IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study start8 May 2001
- Primary completion5 Mar 2003
- Study completion5 Mar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502124
- Sponsor's protocol ID
- HGH-2124
- Status last verified
- Feb 2017
- First submitted
- 29 Dec 2011
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency
- ClinicalTrials.gov ID
- NCT01502124
- Acronym / sponsor ID
- HGH-2124
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 8 May 2001 (actual)
- Primary completion
- 5 Mar 2003 (actual)
- Study completion
- 5 Mar 2003 (actual)
- First posted
- 30 Dec 2011 (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.
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with 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 |
|---|---|---|
| Lyophilized | Active comparator | Drug: somatropin |
| Liquid | Experimental | Drug: somatropin |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
- Naïve to growth hormone therapy
Key exclusion criteria (6 listed)
- Known or suspected allergy to the trial product or related products
- Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
- Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
- Pregnancy or the intention to become pregnant
- Breast-feeding
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 |
|---|---|---|
| somatropinInjected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists | Drug | Lyophilized |
| somatropinInjected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists | Drug | Liquid |
Primary outcome
Adverse events (especially injection site reactions)
Serious adverse events
2 secondary outcomes
IGF-1 (Insulin-like growth factor 1) concentration
IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
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 28 Feb 2017.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
21 sites 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 in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 21 sites in United States.
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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. 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?
Adverse events (especially injection site reactions). 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?
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 28 Feb 2017.