Genetic DisorderPhase 4NCT01734486
Growth Response in Girls With Turner Syndrome
A Phase 4 study testing somatropin in people with Genetic Disorder and Turner Syndrome, run by Novo Nordisk A/S at 15 sites in France.
Trial summary
This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Genetic Disorder, Turner Syndrome
- 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
- 31 participants
- Where
- 15 sitesFrance
- Study dates
- 23 Sep 1996to 21 May 2003
- Phase
- Phase 4
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Turner syndrome
- If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
- If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
- Measured parental height available
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Novo Nordisk Investigational Site
Besançon, 25030
Novo Nordisk Investigational Site
Bordeaux, 33000
Novo Nordisk Investigational Site
Dunkirk, 59385
Novo Nordisk Investigational Site
Grenoble, 38043
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Lorient
Novo Nordisk Investigational Site
Nice, 06202
Novo Nordisk Investigational Site
Paris
Novo Nordisk Investigational Site
Reims
Novo Nordisk Investigational Site
Rennes, 35056
Novo Nordisk Investigational Site
Rouen, 76031
Novo Nordisk Investigational Site
Tarbes
Novo Nordisk Investigational Site
Toulouse, 31059
Novo Nordisk Investigational Site
Tours, 37044
Novo Nordisk Investigational Site
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
This trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.
- Conditions
- Genetic Disorder, Turner Syndrome
- Being tested
- somatropin
- Medical subject headings
- Genetic Diseases, Inborn, Turner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
0.9 UI/kg/week. Subcutaneous injection for 3 years
somatropinDrug
1.8 UI/kg/week. Subcutaneous injection for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: somatropin |
| High dose | Experimental | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height gain, SDS (Standard Deviation Score)
Height gain in cm
Secondary outcomes (2)
Height
Bone maturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study start23 Sep 1996
- Primary completion21 May 2003
- Study completion21 May 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT01734486
- Sponsor's protocol ID
- GHTUR/F/3
- Status last verified
- Feb 2017
- First submitted
- 22 Nov 2012
- 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
- Growth Response in Girls With Turner Syndrome During a Three-year GH Treatment Comparing Two Dose Regimens. Identification of Predictive Factors of Growth Response
- ClinicalTrials.gov ID
- NCT01734486
- Acronym / sponsor ID
- GHTUR/F/3
- Conditions
- Genetic Disorder, Turner Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 1996 (actual)
- Primary completion
- 21 May 2003 (actual)
- Study completion
- 21 May 2003 (actual)
- First posted
- 27 Nov 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 trial is conducted in Europe. The aim of the trial is to evaluate growth response of two somatropin dose regimens in girls with Turner Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: somatropin |
| High dose | Experimental | Drug: somatropin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Turner syndrome
- If age below 3 years, either body height below - 1 SD (standard deviation) with average growth velocity according to chronological age or body height below 0 SD with growth velocity below -1 SD according to chronological age
- If age above 3 years, body height below - 1 SD with average growth velocity according to chronological age
- Measured parental height available
- Written informed consent
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 |
|---|---|---|
| somatropin0.9 UI/kg/week. Subcutaneous injection for 3 years | Drug | Low dose |
| somatropin1.8 UI/kg/week. Subcutaneous injection for 3 years | Drug | High dose |
Primary outcome
Height gain, SDS (Standard Deviation Score)
Height gain in cm
2 secondary outcomes
Height
Bone maturation
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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing somatropin in people with Genetic Disorder and Turner Syndrome, run by Novo Nordisk A/S at 15 sites 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 5 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 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 15 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Height gain, SDS (Standard Deviation Score). 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.