Growth DisorderPhase 3NCT00174421
Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height
A Phase 3 study testing Treatment with Genotropin in different dosages in people with Growth Disorder, run by Pfizer.
Trial summary
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Disorder
- What is being tested?
- Treatment with Genotropin in different dosages
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2001to Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participation in the 90-080 study
Who cannot join
- Any severe, acute or chronic disease
- Any other identifiable reason for short stature
About this study
Official title: Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
- Conditions
- Growth Disorder
- Being tested
- Treatment with Genotropin in different dosages
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Genotropin in different dosagesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Final height, compared to the expected familial target height
Secondary outcomes (1)
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2001
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00174421
- Sponsor's protocol ID
- 98-8122-011
- Other IDs
- A6281219
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 3 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium
- ClinicalTrials.gov ID
- NCT00174421
- Acronym / sponsor ID
- 98-8122-011
- Conditions
- Growth Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Aug 2005
- First posted
- 15 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.
This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in the 90-080 study
Key exclusion criteria (2 listed)
- Any severe, acute or chronic disease
- Any other identifiable reason for short stature
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 |
|---|---|---|
| Treatment with Genotropin in different dosages | Drug | – |
Primary outcome
Final height, compared to the expected familial target height
1 secondary outcome
Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry
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 3 May 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 Treatment with Genotropin in different dosages in people with Growth Disorder, 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 1 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 3 May 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?
Final height, compared to the expected familial target height. 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 3 May 2007; AzTrials last refreshed its copy on 8 Nov 2026.