Growth Hormone DeficiencyPhase 4CARELNCT00145457
IGF1 Generation Test
A Phase 4 study testing Blood sample and Radiography in people with Growth Hormone Deficiency, run by Pfizer at 8 sites in France.
Trial summary
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Blood sample and Radiography
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 8 sitesFrance
- Study dates
- Apr 2001to Jan 2005
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female aged of more than 4 years.
- GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities
Who cannot join
- Previous treatment with GH
- Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Pfizer Investigational Site
Besançon, 25030
Pfizer Investigational Site
Bordeaux, 33000
Pfizer Investigational Site
Dunkirk, 59385
Pfizer Investigational Site
Limoges, 87042
Pfizer Investigational Site
Nice, 06202
Pfizer Investigational Site
Paris, 75674
Pfizer Investigational Site
Tarbes, 65013
Pfizer Investigational Site
Toulouse, 31059
About this study
Official title: A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.
- Conditions
- Growth Hormone Deficiency
- Being tested
- Blood sample, Radiography
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
RadiographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2001
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 82 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145457
- Sponsor's protocol ID
- 307-MET-9002-040
- Other IDs
- A6281023
- Acronym
- CAREL
- Status last verified
- May 2007
- First submitted
- 1 Sep 2005
- Last updated
- 6 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study on the Capacity of the IGF-1 Stimulation Test to Predict the Growth Promoting Effect of Standard and High Doses of Genotonorm® in Prepubertal Children With Growth Hormone Deficiency.
- ClinicalTrials.gov ID
- NCT00145457
- Acronym / sponsor ID
- CAREL / 307-MET-9002-040
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Jan 2005
- First posted
- 5 Sep 2005 (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.
To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female aged of more than 4 years.
- GHD defined as a peak GH level < 20 mUI/ml at two different pharmacological GH provocative tests including one done with two pharmacological agents and both performed within the year before the inclusion, according to the current recommendations of the French Health Authorities
Key exclusion criteria (2 listed)
- Previous treatment with GH
- Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy
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 |
|---|---|---|
| Blood sample | Procedure or surgery | – |
| Radiography | Procedure or surgery | – |
Primary outcome
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.
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 6 Jun 2007.
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Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
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Active, not recruitingObservational study
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Growth Hormone Deficiency Without Epiphyseal Closure
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.
Pfizer CT.gov Call Center study director
Pfizer
8 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 Blood sample and Radiography in people with Growth Hormone Deficiency, run by Pfizer at 8 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 2 inclusion and 2 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 6 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.. 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 6 Jun 2007.