Growth Hormone DeficiencyPhase 3TAUBERNCT00156143
Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents
A Phase 3 study testing Blood sample and Radiography in people with Growth Hormone Deficiency, run by Pfizer.
Trial summary
To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation. Read more about this study
- Who is it for?
- Ages 15 to 20 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
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Apr 2005
- 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 15 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males or females : Chronological age > or = 15 years and < or = 20 years for females
- Chronological age > or = 17 years and < or = 20 years for males
- GHD of childhood onset treated for at least 2 years
- Last GH injection at least 12 months before baseline visit
Who cannot join
- Turner's syndrome
- Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN
About this study
Official title: GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.
To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.
- 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 from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2002
- Study completionApr 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT00156143
- Sponsor's protocol ID
- 307-MET-9002-016
- Other IDs
- A6281018
- Acronym
- TAUBER
- Status last verified
- Jul 2007
- First submitted
- 7 Sep 2005
- Last updated
- 30 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.
- ClinicalTrials.gov ID
- NCT00156143
- Acronym / sponsor ID
- TAUBER / 307-MET-9002-016
- Conditions
- Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Study completion
- Apr 2005
- First posted
- 12 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 evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Males or females : Chronological age > or = 15 years and < or = 20 years for females
- Chronological age > or = 17 years and < or = 20 years for males
- GHD of childhood onset treated for at least 2 years
- Last GH injection at least 12 months before baseline visit
Key exclusion criteria (2 listed)
- Turner's syndrome
- Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT > 2 X ULN
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 from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
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 30 Jul 2007.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood sample and Radiography in people with Growth Hormone Deficiency, run by Pfizer.
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 4 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 30 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
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 from baseline of the % of fat mass assessed by DEXA after 1 year 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 30 Jul 2007.