Growth DisorderNCT01578135
French National Registry of Children Born Small for Gestational Age Treated With Somatropin
An observational study of Growth Disorder and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in France.
Trial summary
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Disorder, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 291 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2007to 9 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010. Phase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I).
Who may be able to join
- Born small for gestational age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)
This study is conducted in Europe. The aim of the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)
- Conditions
- Growth Disorder, Small for Gestational Age
- Being tested
- somatropin
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Patients are to fill in a questionnaire at inclusion in registry
somatropinDrug
Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Not described Receives: Drug: somatropin | |
| Phase II | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth in height
Measured: 6 months after inclusion into registry and then annually until adult height is reached
Secondary outcomes (3)
Blood pressure: Systolic and diastolic
Measured: 6 months after inclusion into registry and then annually until adult height is reached
Bone age
Measured: 6 months after inclusion into registry and then annually until adult height is reached
Insulin-Like Growth Factor 1 (IGF-1)
Measured: 6 months after inclusion into registry and then annually until adult height is reached
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start18 Mar 2007
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth 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
- Prospective
- Enrolment
- 291 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
- NCT01578135
- Sponsor's protocol ID
- GHSGA-1757
- Status last verified
- Oct 2022
- First submitted
- 13 Apr 2012
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French National Longitudinal Prospective Follow-up of Children Born Small for Gestational Age and Treated With Norditropin SimpleXx (French Health Authorities Commitment)
- ClinicalTrials.gov ID
- NCT01578135
- Acronym / sponsor ID
- GHSGA-1757
- Conditions
- Growth Disorder, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2007 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 16 Apr 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 the study is to describe the patient population and therapeutic practices (study phase I), assess efficacy on growth and adult height and assess tolerance of somatropin (Norditropin® SimpleXx®) (study phase II)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Drug: somatropin |
| Phase II | – | Drug: somatropin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Phase I: All patients born SGA treated with Norditropin® SimpleXx® (somatropin) whether they were previously treated with another growth hormone for this indication or not from the 29th of April 2005 until 29th of April 2010. Phase II: Sub-population randomly selected (every 5th patient being included in registry in study phase I).
Key inclusion criteria (1 listed)
- Born small for gestational age
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 |
|---|---|---|
| somatropinPatients are to fill in a questionnaire at inclusion in registry | Drug | Phase I |
| somatropinPatients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached | Drug | Phase II |
Primary outcome
Growth in height
Time frame: 6 months after inclusion into registry and then annually until adult height is reached
3 secondary outcomes
Blood pressure: Systolic and diastolic
Time frame: 6 months after inclusion into registry and then annually until adult height is reached
Bone age
Time frame: 6 months after inclusion into registry and then annually until adult height is reached
Insulin-Like Growth Factor 1 (IGF-1)
Time frame: 6 months after inclusion into registry and then annually until adult height is reached
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 20 Oct 2022.
- 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
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 Disorder and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in France.
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 20 Oct 2022. 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 France. 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?
Growth in height (time frame: 6 months after inclusion into registry and then annually until adult height is reached). 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 20 Oct 2022.