Foetal Growth ProblemPhase 4NCT00519844
Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction
A Phase 4 study testing somatropin in people with Foetal Growth Problem and Small for Gestational Age, run by Novo Nordisk A/S at 1 site in France.
Trial summary
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Foetal Growth Problem, Small for Gestational Age
- What is being tested?
- somatropin
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2005to Jan 2006
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children treated for 3 years with Maxomat® because of small for gestational age
- Postnatal growth failure by the age of 3 years or more
- No associated growth hormone deficiency
- Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
- Bone age no more than 13 years for girls and no more than 15 years for boys
Who cannot join
- Known, evolving tumour
- Hypertrophic cardiomyopathy
- Hypertension not controlled on maximum therapy
- Benign intracranial hypertension
- Known glucose intolerance or known diabetes mellitus
- Acute or active chronic hepatitis
- Chronic renal failure
- Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Being tested
- somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference
Measured: after 3 months of treatment
Secondary outcomes (4)
Clinical (adverse events)
Biological (fasting glucose, fasting insulin, liver enzymes)
Tolerance of the treatment
Compliance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJul 2005
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foetal Growth ProblemStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT00519844
- Sponsor's protocol ID
- GHLIQUID-1670
- Other IDs
- 2005-000318-11, 2005
- Status last verified
- Nov 2015
- First submitted
- 22 Aug 2007
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product
- ClinicalTrials.gov ID
- NCT00519844
- Acronym / sponsor ID
- GHLIQUID-1670
- Conditions
- Foetal Growth Problem, Small for Gestational Age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 23 Aug 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 trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children treated for 3 years with Maxomat® because of small for gestational age
- Postnatal growth failure by the age of 3 years or more
- No associated growth hormone deficiency
- Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
- Bone age no more than 13 years for girls and no more than 15 years for boys
Key exclusion criteria (8 listed)
- Known, evolving tumour
- Hypertrophic cardiomyopathy
- Hypertension not controlled on maximum therapy
- Benign intracranial hypertension
- Known glucose intolerance or known diabetes mellitus
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 |
|---|---|---|
| somatropin | Drug | – |
Primary outcome
Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference
Time frame: after 3 months of treatment
4 secondary outcomes
Clinical (adverse events)
Biological (fasting glucose, fasting insulin, liver enzymes)
Tolerance of the treatment
Compliance
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 13 Nov 2015.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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 4 study testing somatropin in people with Foetal Growth Problem 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 5 inclusion and 8 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 13 Nov 2015. 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 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?
Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference (time frame: after 3 months of treatment). 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 13 Nov 2015.