Noonan SyndromePhase 3NCT00452725
Effect of MAXOMAT ® on the Growth of Small Children to NOONAN's Syndrome
A Phase 3 study testing MAXOMAT ®, biosynthetic growth hormone in people with Noonan Syndrome, run by Sanofi at 1 site in France.
Trial summary
1. Clinical Objective : To improve the growth of these children 2. Genetic objective : A study of the genetics of the syndrome Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Noonan Syndrome
- What is being tested?
- MAXOMAT ®, biosynthetic growth hormone
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Oct 1997to Jul 2010
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy
Who cannot join
- Age < 3 years
- Height ≥ -2 SD
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome
- Clinical Objective : To improve the growth of these children
- Genetic objective : A study of the genetics of the syndrome
- Conditions
- Noonan Syndrome
- Being tested
- MAXOMAT ®, biosynthetic growth hormone
- Medical subject headings
- Noonan Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAXOMAT ®, biosynthetic growth hormoneDrug
2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of height : gain in height and rate of growth
Measured: at each visit (every 3 months) or every 6 months
Secondary outcomes (1)
Clinical and laboratory test safety
Measured: every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startOct 1997
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noonan SyndromeStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie SEBILLE, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452725
- Sponsor's protocol ID
- MAX08
- Status last verified
- Oct 2010
- First submitted
- 23 Mar 2007
- Last updated
- 5 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Growth Hormone MAXOMAT ® on the Growth of Small Children and Adolescents (<-2 SD) Due to NOONAN's Syndrome
- ClinicalTrials.gov ID
- NCT00452725
- Acronym / sponsor ID
- MAX08
- Conditions
- Noonan Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 1997
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 27 Mar 2007 (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.
- Clinical Objective : To improve the growth of these children
- Genetic objective : A study of the genetics of the syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children and adolescents with Noonan's syndrome with a height < -2 SD and no progressive cardiopathy
Key exclusion criteria (3 listed)
- Age < 3 years
- Height ≥ -2 SD
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| MAXOMAT ®, biosynthetic growth hormone2 posologies according to age (children and adolescents) treatment is planned for a 2 year duration | Drug | – |
Primary outcome
Evaluation of height : gain in height and rate of growth
Time frame: at each visit (every 3 months) or every 6 months
1 secondary outcome
Clinical and laboratory test safety
Time frame: every 6 months
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 5 Oct 2010.
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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.
Marie SEBILLE study director
Sanofi
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 MAXOMAT ®, biosynthetic growth hormone in people with Noonan Syndrome, run by Sanofi 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 3 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 5 Oct 2010. 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.
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?
Evaluation of height : gain in height and rate of growth (time frame: at each visit (every 3 months) or every 6 months). 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 5 Oct 2010.