Growth Hormone DisorderGrowthWIN IINCT01543867
Safety and Efficacy of Long-term Somatropin Treatment in Children
An observational study of Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem
- What is being tested?
- somatropin
- How many people
- 5,442 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Dec 2011
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children treated with somatropin
Who may be able to join
- In need of somatropin or current user
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)
This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age, Genetic Disorder, Turner Syndrome
- Being tested
- somatropin
- Medical subject headings
- Genetic Diseases, Inborn, Turner Syndrome, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Prescribed at the discretion of the treating physician according to product labelling
| Study group | Role | What they receive |
|---|---|---|
| Users of somatropin | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Up to 10 years
Secondary outcomes (4)
Number of patients continuing somatropin treatment
Measured: Up to 10 years
Change in height
Measured: Up to 10 years
Onset of puberty in children small for gestational age
Measured: Up to 10 years
Co-morbidities in children small for gestational age
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2001
- Primary completionDec 2011
- Study completionDec 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,442 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
- NCT01543867
- Sponsor's protocol ID
- GH-1930
- Acronym
- GrowthWIN II
- Status last verified
- Mar 2015
- First submitted
- 28 Feb 2012
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)
- ClinicalTrials.gov ID
- NCT01543867
- Acronym / sponsor ID
- GrowthWIN II / GH-1930
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age, Genetic Disorder, Turner Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,442 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 5 Mar 2012 (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 study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Users of somatropin | – | Drug: somatropin |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children treated with somatropin
Key inclusion criteria (1 listed)
- In need of somatropin or current user
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 |
|---|---|---|
| somatropinPrescribed at the discretion of the treating physician according to product labelling | Drug | Users of somatropin |
Primary outcome
Number of adverse events
Time frame: Up to 10 years
4 secondary outcomes
Number of patients continuing somatropin treatment
Time frame: Up to 10 years
Change in height
Time frame: Up to 10 years
Onset of puberty in children small for gestational age
Time frame: Up to 10 years
Co-morbidities in children small for gestational age
Time frame: Up to 10 years
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 30 Mar 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Growth Hormone Disorder
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
Solid Tumor, Advanced Solid Tumor
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
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
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in Germany.
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 1 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 30 Mar 2015. 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 Germany. 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.
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?
Number of adverse events (time frame: Up to 10 years). 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 30 Mar 2015.