Growth Hormone DisorderPhase 3NCT00102817
Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children
A Phase 3 study testing somatropin in people with Growth Hormone Disorder and Pituitary Dwarfism, run by Novo Nordisk A/S at 27 sites in United States.
Trial summary
This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Growth Hormone Disorder, Pituitary Dwarfism
- What is being tested?
- somatropin
- How many people
- 149 participants
- Where
- 27 sitesUnited States
- Study dates
- May 2003to Dec 2006
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 3-15
- Presence of growth failure indicated by height standard deviation score less than equal to -2
- Body mass index greater than or equal to 25th percentile for height age
- IGF concentration less than or equal to 33rd percentile
Who cannot join
None listed.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Novo Nordisk Investigational Site
Akron, Ohio, 44308-1062
Novo Nordisk Investigational Site
Boston, Massachusetts, 02115
Novo Nordisk Investigational Site
Brooklyn, New York, 11219
Novo Nordisk Investigational Site
Buffalo, New York, 14222
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45229
Novo Nordisk Investigational Site
Columbia, South Carolina, 29203
Novo Nordisk Investigational Site
Hershey, Pennsylvania, 17033
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46202-5225
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49008
Novo Nordisk Investigational Site
Kansas City, Missouri, 64108
Novo Nordisk Investigational Site
Los Angeles, California, 90027
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53226-0509
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, 73104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15213
Novo Nordisk Investigational Site
Rockville Centre, New York, 11570
Novo Nordisk Investigational Site
San Antonio, Texas, 78284
Novo Nordisk Investigational Site
San Diego, California, 92093
Novo Nordisk Investigational Site
Seattle, Washington, 98105
Novo Nordisk Investigational Site
St. Petersburg, Florida, 33701
Novo Nordisk Investigational Site
Stanford, California, 94305-5208
Novo Nordisk Investigational Site
Tallahassee, Florida, 32308
Novo Nordisk Investigational Site
Tampa, Florida, 33607
Novo Nordisk Investigational Site
The Bronx, New York, 10467
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655
About this study
Official title: Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.
- Conditions
- Growth Hormone Disorder, Pituitary Dwarfism
- Being tested
- somatropin
- Keywords
- Growth Hormone Disorder
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height standard deviation score
Measured: 12 months
Secondary outcomes (1)
12 months change in height standard deviation score adjusted for parent height z-score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 149 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
- NCT00102817
- Sponsor's protocol ID
- HGH-2147
- Status last verified
- Jan 2017
- First submitted
- 1 Feb 2005
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto
Cohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe
Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.
PubMed 22924571
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.
- ClinicalTrials.gov ID
- NCT00102817
- Acronym / sponsor ID
- HGH-2147
- Conditions
- Growth Hormone Disorder, Pituitary Dwarfism
- Keywords
- Growth Hormone Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 2 Feb 2005 (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). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages 3-15
- Presence of growth failure indicated by height standard deviation score less than equal to -2
- Body mass index greater than or equal to 25th percentile for height age
- IGF concentration less than or equal to 33rd percentile
Key exclusion criteria (0 listed)
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 | – |
Primary outcome
Change in height standard deviation score
Time frame: 12 months
1 secondary outcome
12 months change in height standard deviation score adjusted for parent height z-score
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 18 Jan 2017.
- Results publicationCohen P, Rogol A, Kappelgaard A-M, Weng W, Germak J, Rosenfeld RG on behalf of the American Norditropin Study Group. Efficacy of IGF-I Based Growth Hormone (GH) Dose Titration in Non-GH Deficient (Non-GHD) Children with Short Stature Associated with IGF-I Deficiency (IGFD). Pediatric Academic Societies (PAS)/Lawson Wilkins Pediatric Endocrine Society (LWPES) 2007; Country: Canada City: Toronto
- Results publicationCohen P, Rosenfeld R, Rogol A, Kappelgaard A-M, Mak C, Germak J. Validation of the Efficacy and Safety of IGF-based Dose-titration in Children with Growth Failure Associated with Non-GH-deficient, IGF-I Deficiency: Results of Clinical Trial HGH 2147 on Behalf of the American Norditropin® Clinical Studies Group. 3rd International Congress of the Growth Hormone Research Society and the IGF Society 2006; Country: Japan City: Kobe
- Derived from this study: PubMed 22924571Cohen P, Rogol AD, Weng W, Kappelgaard AM, Rosenfeld RG, Germak J; American Norditropin Study Group. Efficacy of IGF-based growth hormone (GH) dosing in nonGH-deficient (nonGHD) short stature children with low IGF-I is not related to basal IGF-I levels. Clin Endocrinol (Oxf). 2013 Mar;78(3):405-14. doi: 10.1111/cen.12014.
- 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
27 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 Pituitary Dwarfism, run by Novo Nordisk A/S at 27 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 4 inclusion and 0 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 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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?
Change in height standard deviation score (time frame: 12 months). 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 NCT00102817, which also lists 3 linked publications.
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 18 Jan 2017.