Growth Hormone DisordersiNCGSNCT00455728
A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders
An observational study of Growth Hormone Disorders, run by Ipsen at 1 site in United Kingdom.
Trial summary
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Growth Hormone Disorders
- How many people
- 3,690 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to Dec 2016
- 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 NutropinAq in the specialised paediatric endocrinology centres
Who may be able to join
- Children of either sex who are treated with NutropinAq® for the treatment of growth failure
- Patients who are willing to comply with follow-up appointments throughout study participation
- Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable
Who cannot join
- Patients not treated with NutropinAq®
- Patients with closed epiphyses
- Patients with active neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.
Read the detailed description
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.
- Conditions
- Growth Hormone Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).
Measured: Every 3 months until study completion
Secondary outcomes (1)
Treatment height measurements until epiphyseal closure is achieved.
Measured: Every 3 months until study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2007 (estimated)
- Study startJun 2006
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisordersStudies of the same condition, open and under way.
- More trials run by IpsenThe 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
- 3,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455728
- Sponsor's protocol ID
- 2-79-58035-005
- Other IDs
- EUPAS7948
- Acronym
- iNCGS
- Status last verified
- Jan 2019
- First submitted
- 3 Apr 2007
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Coutant R, Bosch Munoz J, Dumitrescu CP, Schnabel D, Sert C, Perrot V, Dattani M. Effectiveness and Overall Safety of NutropinAq(R) for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq(R) European Registry (iNCGS). Front Endocrinol (Lausanne). 2021 May 25;12:676083. doi: 10.3389/fendo.2021.676083. eCollection 2021.
PubMed 34113318
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
- ClinicalTrials.gov ID
- NCT00455728
- Acronym / sponsor ID
- iNCGS / 2-79-58035-005
- Conditions
- Growth Hormone Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,690 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2006 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Apr 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.
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.
Detailed description
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children treated with NutropinAq in the specialised paediatric endocrinology centres
Key inclusion criteria (3 listed)
- Children of either sex who are treated with NutropinAq® for the treatment of growth failure
- Patients who are willing to comply with follow-up appointments throughout study participation
- Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable
Key exclusion criteria (3 listed)
- Patients not treated with NutropinAq®
- Patients with closed epiphyses
- Patients with active neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse events
Time frame: Every 3 months until study completion
Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).
1 secondary outcome
Treatment height measurements until epiphyseal closure is achieved.
Time frame: Every 3 months until study completion
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 7 Jan 2019.
- Derived from this study: PubMed 34113318Coutant R, Bosch Munoz J, Dumitrescu CP, Schnabel D, Sert C, Perrot V, Dattani M. Effectiveness and Overall Safety of NutropinAq(R) for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq(R) European Registry (iNCGS). Front Endocrinol (Lausanne). 2021 May 25;12:676083. doi: 10.3389/fendo.2021.676083. eCollection 2021.
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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.
Ipsen Medical Director study director
Ipsen
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 Disorders, run by Ipsen at 1 site in United Kingdom.
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 3 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 7 Jan 2019. 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 United Kingdom. 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 participants with adverse events (time frame: Every 3 months until study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455728, which also lists 1 linked publication.
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 7 Jan 2019.