Genetic DisorderPhase 3NCT01529944
Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
A Phase 3 study testing somatropin in people with Genetic Disorder and Noonan Syndrome, run by Novo Nordisk A/S at 1 site in Sweden.
Trial summary
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Genetic Disorder, Noonan Syndrome
- What is being tested?
- somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2008to Oct 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in the GHNOO-1658 trial
- Subject has completed genetic testing of PTPN11 mutation
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.
- Conditions
- Genetic Disorder, Noonan Syndrome
- Being tested
- somatropin
- Medical subject headings
- Genetic Diseases, Inborn, Noonan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
somatropinDrug
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
| Study group | Role | What they receive |
|---|---|---|
| Low dose 33 mcg/kg/day | Experimental | Not described Receives: Drug: somatropin |
| High dose 66 mcg/kg/day | Experimental | Not described Receives: Drug: somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in height SDS (Standard Deviation Score) (referenced to normal population)
Measured: From baseline until final height is reached
Secondary outcomes (6)
Final height SDS (referenced to normal population)
Measured: From baseline until final height is reached
Final height SDS (referenced to Noonan population)
Measured: From baseline until final height is reached
Change in height SDS (referenced to Noonan population)
Measured: From baseline until final height is reached
Number of subjects with final height SDS above - 2SDS (reference to normal population)
Measured: When final height is reached
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
Measured: When final height is reached
Adverse events
Measured: From baseline until final 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 posted9 Feb 2012 (estimated)
- Study startSep 2008
- Primary completionOct 2008
- Study completionOct 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT01529944
- Sponsor's protocol ID
- GHNOO-3680
- Other IDs
- 2008-004535-38, 2008
- Status last verified
- Aug 2023
- First submitted
- 2 Jan 2012
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
- ClinicalTrials.gov ID
- NCT01529944
- Acronym / sponsor ID
- GHNOO-3680
- Conditions
- Genetic Disorder, Noonan Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Feb 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 this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose 33 mcg/kg/day | Experimental | Drug: somatropin |
| High dose 66 mcg/kg/day | Experimental | Drug: somatropin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participation in the GHNOO-1658 trial
- Subject has completed genetic testing of PTPN11 mutation
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 |
|---|---|---|
| somatropinResults from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658. | Drug | Low dose 33 mcg/kg/day |
| somatropinResults from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658. | Drug | High dose 66 mcg/kg/day |
Primary outcome
Change in height SDS (Standard Deviation Score) (referenced to normal population)
Time frame: From baseline until final height is reached
6 secondary outcomes
Final height SDS (referenced to normal population)
Time frame: From baseline until final height is reached
Final height SDS (referenced to Noonan population)
Time frame: From baseline until final height is reached
Change in height SDS (referenced to Noonan population)
Time frame: From baseline until final height is reached
Number of subjects with final height SDS above - 2SDS (reference to normal population)
Time frame: When final height is reached
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
Time frame: When final height is reached
Adverse events
Time frame: From baseline until final 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 9 Aug 2023.
- 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?
A Phase 3 study testing somatropin in people with Genetic Disorder and Noonan Syndrome, run by Novo Nordisk A/S at 1 site in Sweden.
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 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 9 Aug 2023. 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 Sweden. 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 SDS (Standard Deviation Score) (referenced to normal population) (time frame: From baseline until final 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 9 Aug 2023.